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IEC 60204-1Safety of machinery - Electrical equipment of machines - Part 1: General requirementsIEC 60204-1:2016 applies to electrical, electronic and programmable electronic equipment and systems to machines not portable by hand while working, including a group of machines working together in a co-ordinated manner. The equipment covered by this part of IEC 60204 commences at the point of connection of the supply to the electrical equipment of the machine. This sixth edition cancels and replaces the fifth edition published in 2005. It constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: added requirements to address applications involving power drive systems (PDS); revised electromagnetic compatibility (EMC) requirements; clarified overcurrent protection requirements; requirements for determination of the short circuit current rating of the electrical equipment; revised protective bonding requirements and terminology; reorganization and revision to Clause 9, including requirements pertaining to safe torque off of PDS, emergency stop, and control circuit protection; revised symbols for actuators of control devices; revised technical documentation requirements; general updating to current special national conditions, normative standards, and bibliographical references.IEC/TC 44 Electrical equipment of industrial machines2016-10-00SafetyNone
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ISO/TR 20218-1Robotics - Safety design for industrial robot systems - Part 1: End effectorsThis document provides guidance on safety measures for the design and integration of end-effectors used for robot systems. The integration includes the following: the manufacturing, design and integration of end-effectors; the necessary information for use. This document provides additional safety guidance on the integration of robot systems, as described in ISO 10218‑2:2011.ISO/TC 299 Robots and robotic devices2018-08-00SafetyNone
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ISO/TS 15066Robots and robotic devices - Collaborative robotsISO/TS 15066:2016 specifies safety requirements for collaborative industrial robot systems and the work environment, and supplements the requirements and guidance on collaborative industrial robot operation given in ISO 10218‑1 and ISO 10218‑2. ISO/TS 15066:2016 applies to industrial robot systems as described in ISO 10218‑1 and ISO 10218‑2. It does not apply to non-industrial robots, although the safety principles presented can be useful to other areas of robotics.ISO/TC 299 Robots and robotic devices2016-02-00SafetyNone
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ISO/TR 20218-2Robotics - Safety design for industrial robot systems - Part 2: Manual load/unload stationsISO/TR 20218-2:2017 is applicable to robot systems for manual load/unload applications in which a hazard zone is safeguarded by preventing access to it. For this type of application, it is important to consider the need for both access restrictions to hazard zones and for ergonomically suitable work places. ISO/TR 20218-2:2017 supplements ISO 10218-2:2011 and provides additional information and guidance on reducing the risk of intrusion into the hazard zones in the design and safeguarding of manual load/unload installations.ISO/TC 299 Robots and robotic devices2017-12-00SafetyNone
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ISO/TR 14121-2Safety of machinery - Risk assessment - Part 2: Practical guidance and examples of methodsISO/TR 14121-2:2012 gives practical guidance on conducting risk assessment for machinery in accordance with ISO 12100 and describes various methods and tools for each step in the process. It gives examples of different measures that can be used to reduce risk and is intended to be used for risk assessment on a wide variety of machinery in terms of complexity and potential for harm. Its intended users are those involved in the design, installation or modification of machinery (for example, designers, technicians or safety specialists).ISO/TC 199 Safety of machinery2012-06-00SafetyNone
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ISO/TR 22100-1Safety of machinery - Relationship with ISO 12100 - Part 1: How ISO 12100 relates to type-B and type-C standardsISO/TR 22100-1:2015 provides assistance to the designer/manufacturer of machinery and related components as to how the system of existing type-A, type-B and type-C machinery safety standards should be applied in order to design a machine to achieve a level of tolerable risk by adequate risk reduction. It explains the general principles of ISO 12100 and how this type-A standard should be used for practical cases in conjunction with type-B and type-C machinery safety standards. ISO/TR 22100-1:2015 provides assistance to standards writing committees on how ISO 12100 and type-B and type-C standards relate and explains their function in the risk assessment and risk reduction process according to ISO 12100. It includes an overview of existing categories of type-B standards to assist standards readers and writers to navigate the many standards.ISO/TC 199 Safety of machinery2015-05-00SafetyNone
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ISO/TR 22100-2Safety of machinery - Relationship with ISO 12100 - Part 2: How ISO 12100 relates to ISO 13849-1ISO/TR 22100-2:2013 describes the general relationship between ISO 12100 and ISO 13849‑1 used to reduce the risk of harm. It focuses on the use of safety-related parts of control systems in relation to risk assessment and the risk reduction process.ISO/TC 199 Safety of machinery2013-12-00SafetyNone
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ISO/TR 23849Guidance on the application of ISO 13849-1 and IEC 62061 in the design of safety-related control systems for machineryISO/TR 23849:2010 is intended to explain the application of IEC 62061 and ISO 13849-1 in the design of safety-related control systems for machinery.ISO/TC 199 Safety of machinery2010-05-00SafetyNone
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ISO/TR 22100-3Safety of machinery - Relationship with ISO 12100 - Part 3: Implementation of ergonomic principles in safety standardsISO/TR 22100-3:2016 describes the main ergonomic risk factors influencing the safety of machinery and gives a framework for incorporating them into the design of machines by the integration of important ergonomic principles relating to: avoiding stressful postures and movements during use of the machine; designing machines, and more especially hand-held and mobile machines, which can be operated easily; avoiding as far as possible noise, vibration, thermal effects.ISO/TC 199 Safety of machinery2016-10-00SafetyNone
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IEC/TR 62366-2Medical devices - Part 2: Guidance on the application of usability engineering to medical devicesIEC/TR 62366-2:2016 contains background information and provides guidance that addresses specific areas that experience suggests can be helpful for those implementing a usability engineering (human factors engineering) process both as defined in IEC 62366-1:2015 and as supporting goals other than safety. This technical report is not intended to be used for regulatory purposes. It contains no requirements and only provides guidance and tutorial information.ISO/TC 210 Quality management and corresponding general aspects for medical devices2016-04-00SafetyNone
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IEC/DIS 80601-2-77Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of medical robots for surgeryThis International standard applies to the basic safety and essential performance of robotically assisted surgical equipment (RASE) and robotically assisted surgical system (RASS), hereafter referred to as ME Equipment and ME System together with thier interface conditions.ISO/TC 299 Robots and robotic devicesOpenSafetyNone
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IEC/DIS 80601-2-78Medical electrical equipment - Part 2-78: Particular requirements for the basic safety and essential performance of medical robots for rehabilitation, compensation or alleviation of disease, injury or disabilityThis International standard applies to general requirements for basic safety and essential performance of medical robots that physically interact with a patient to support or perform rehabilitation, assessment, compensation or alleviation related to the patients movement functions following an impairment. This particular standard does not apply for: (external limb) prosthetic devices (use: ISO 22523), electric wheelchairs (use: ISO 7176 series), diagnostic imaging equipment (e.g. MRI, use: IEC 60601-2-33), personal care robots (use: ISO 13482).ISO/TC 299 Robots and robotic devicesOpenSafetyNone
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ISO/CD 21260Safety of machinery - Mechanical safety data for physical contacts between moving machinery and peopleThis International Standard is currently under development.ISO/TC 199 Safety of machineryOpenSafetyNone
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IEC 80001-1 ED2Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 1: Application of risk managementThis International Standard is currently under development.IEC/SC 62
Electrical equipment in medical practice
OpenSafetyNone
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EN ISO 10218-1Robots and robotic devices - Safety requirements for industrial robots - Part 1: Robots (ISO 10218-1:2011)ISO 10218-1:2011 specifies requirements and guidelines for the inherent safe design, protective measures and information for use of industrial robots. It describes basic hazards associated with robots and provides requirements to eliminate, or adequately reduce, the risks associated with these hazards. ISO 10218-1:2011 does not address the robot as a complete machine. noise emission is generally not considered a significant hazard of the robot alone, and consequently noise is excluded from the scope of ISO 10218-1:2011. ISO 10218-1:2011 does not apply to non‑industrial robots, although the safety principles established in ISO 10218 can be utilized for these other robots.CEN/TC 310 Advanced manufacturing technologies2011-07-00SafetyMachinery-Directive
(Type C)
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EN ISO 10218-2Robots and robotic devices - Safety requirements for industrial robots - Part 2: Robot systems and integration (ISO 10218-2:2011)ISO 10218-2:2011 specifies safety requirements for the integration of industrial robots and industrial robot systems as defined in ISO 10218-1, and industrial robot cell(s). The integration includes the following: the design, manufacturing, installation, operation, maintenance and decommissioning of the industrial robot system or cell; necessary information for the design, manufacturing, installation, operation, maintenance and decommissioning of the industrial robot system or cell; component devices of the industrial robot system or cell. ISO 10218-2:2011 describes the basic hazards and hazardous situations identified with these systems, and provides requirements to eliminate or adequately reduce the risks associated with these hazards. ISO 10218-2:2011 also specifies requirements for the industrial robot system as part of an integrated manufacturing system. ISO 10218-2:2011 does not deal specifically with hazards associated with processes (e.g. laser radiation, ejected chips, welding smoke). Other standards can be applicable to these process hazards.CEN/TC 310 Advanced manufacturing technologies2011-07-00SafetyMachinery-Directive
(Type C)
18
EN ISO 13482Robots and robotic devices - Safety requirements for personal care robots (ISO 13482:2014)ISO 13482:2014 specifies requirements and guidelines for the inherently safe design, protective measures, and information for use of personal care robots, in particular the following three types of personal care robots: mobile servant robot, physical assistant robot, person carrier robot. These robots typically perform tasks to improve the quality of life of intended users, irrespective of age or capability. ISO 13482:2014 describes hazards associated with the use of these robots, and provides requirements to eliminate, or reduce, the risks associated with these hazards to an acceptable level. ISO 13482:2014 covers human-robot physical contact applications. ISO 13482:2014 presents significant hazards and describes how to deal with them for each personal care robot type. ISO 13482:2014 covers robotic devices used in personal care applications, which are treated as personal care robots. ISO 13482:2014 is limited to earthbound robots. ISO 13482:2014 does not apply to: robots travelling faster than 20 km/h, robot toys, water-borne robots and flying robots, industrial robots (see ISO 10218), robots as medical devices, military or public force application robots. The scope of ISO 13482:2014 is limited primarily to human care related hazards but, where appropriate, it includes domestic animals or property (defined as safety-related objects), when the personal care robot is properly installed and maintained and used for its intended purpose or under conditions which can reasonably be foreseen.CEN/TC 310 Advanced manufacturing technologies2014-02-00SafetyMachinery-Directive
(Type C)
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EN 614-2+A1Safety of machinery - Ergonomic design principles - Part 2: Interactions between the design of machinery and work tasksThis European Standard establishes the ergonomics principles and procedures to be followed during the design process of machinery and operator work tasks. This European Standard deals specifically with task design in the context of machinery design, but the principles and methods may also be applied to job design. This European Standard is directed to designers and manufacturers of machinery and other work equipment. It will also be helpful to those who are concerned with the use of machinery and work equipment, e.g. to managers, organizers, operators and supervisors. In this European Standard the designer refers to the person or group of persons responsible for the design.CEN/TC 122 Ergonomics2008-09-00SafetyMachinery-Directive
(Type B)
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EN 842+A1Safety of machinery - Visual danger signals - General requirements, design and testingThis European Standard describes criteria for the perception of visual danger signals in the area that people are intended to perceive and to react to such a signal. It specifies the safety and ergonomic requirements and the corresponding physical measurements and subjective visual check. It also provides guidance for the design of the signals to be clearly perceived and differentiated as described in 5.3 of EN 292-2:1991. This European Standard does not apply to danger indicators: Presented in either written or pictorial form; Transmitted by data display units. This European Standard does not apply to special regulations such as those for public disaster and public transport.CEN/TC 122 Ergonomics2008-09-00SafetyMachinery-Directive
(Type B)
21
EN 894-1+A1Safety of machinery - Ergonomics requirements for the design of displays and control actuators - Part 1: General principles for human interactions with displays and control actuatorsThis European Standard applies to the design of displays and control actuators on machinery. It specifies general principles for human interaction with displays and control actuators, to minimise operator errors and to ensure an efficient interaction between the operator and the equipment. It is particularly important to observe these principles when an operator error may lead to injury or damage to health.CEN/TC 122 Ergonomics2008-10-00SafetyMachinery-Directive
(Type B)
22
EN 894-2+A1Safety of machinery - Ergonomics requirements for the design of displays and control actuators - Part 2: DisplaysThis European Standard gives guidance on the selection, design and location of displays to avoid potential ergonomic hazards associated with their use. It specifies ergonomics requirements and covers visual, audible and tactile displays. It applies to displays used in machinery (e. g. devices and installations, control panels, operating and monitoring consoles) for occupational and private use. Specific ergonomics requirements for visual display terminals (VDTs) used for office tasks are given in the standard EN ISO 9241.CEN/TC 122 Ergonomics2008-10-00SafetyMachinery-Directive
(Type B)
23
EN 894-3+A1Safety of machinery - Ergonomics requirements for the design of displays and control actuators - Part 3: Control actuatorsThis European Standard gives guidance on the selection, design and location of control actuators so that they are adapted to the requirements of the operators, are suitable for the control task in question and take account of the circumstances of their use. It applies to manual control actuators used in equipment for occupational and private use. It is particularly important to observe the recommendations in this European Standard where operating a control actuator may lead to injury or damage to health, either directly or as a result of a human error.CEN/TC 122 Ergonomics2008-10-00SafetyMachinery-Directive
(Type B)
24
EN 894-4Safety of machinery - Ergonomics requirements for the design of displays and control actuators - Part 4: Location and arrangement of displays and control actuatorsThis European Standard contains ergonomic requirements for the location and arrangement of displays and control actuators in order to avoid hazards associated with their use. This European Standard applies to displays and control actuators for machinery and other interactive equipment (e. g. devices and installations, instrument panels, control and monitoring consoles). This European Standard is not applicable to the location and arrangement of displays and control actuators which are manufactured before the date of its publication as EN.CEN/TC 122 Ergonomics2010-06-00SafetyMachinery-Directive
(Type B)
25
EN 1005-1+A1Safety of machinery - Human physical performance - Part 1: Terms and definitionsThis European Standard provides terms and definitions on concepts and parameters used for EN 1005-21, prEN 1005-3, EN 1005-4 and EN 1005-5. Basic concepts and general ergonomic principles for the design of machinery are dealt with in EN 292-1, EN 292-2 and EN 614-1. This document is not applicable to specify the machinery which is manufactured before the date of publication of this document by CEN.CEN/TC 122 Ergonomics2008-10-00SafetyMachinery-Directive
(Type B)
26
EN 1005-2+A1Safety of machinery - Human physical performance - Part 2: Manual handling of machinery and component parts of machineryThis European Standard specifies ergonomic recommendations for the design of machinery involving manual handling of machinery and component parts of machinery, including tools linked to the machine, in professional and domestic applications. This European Standard applies to the manual handling of machinery, component parts of machinery and objects processed by the machine (input/output) of 3 kg or more, for carrying less than 2 m. Objects of less than 3 kg are dealt with in prEN 1005-51). The standard provides data for ergonomic design and risk assessment concerning lifting, lowering and carrying in relation to the assembly/erection, transport and commissioning (assembly, installation, adjustment), operation, fault finding, maintenance, setting, teaching or process changeover and decommissioning, disposal and dismantling of machinery. This standard provides current data on the general population and certain sub-populations (clarified in annex A). This part of the standard does not cover the holding of objects (without walking), pushing or pulling of objects, hand-held machines, or handling while seated. This document is not applicable to specify the machinery which are manufactured before the date of publication of this document by CEN.CEN/TC 122 Ergonomics2008-10-00SafetyMachinery-Directive
(Type B)
27
EN 1005-3+A1Safety of machinery - Human physical performance - Part 3: Recommended force limits for machinery operationThis European Standard presents guidance to the manufacturer of machinery or its component parts and the writer of C-standards in controlling health risks due to machine-related muscular force exertion. This standard specifies recommended force limits for actions during machinery operation including construction, transport and commissioning (assembly, installation, adjustment), use (operation, cleaning, fault finding, maintenance, setting, teaching or process changeover) decommissioning, disposal and dismantling. The standard applies primarily to machines which are manufactured after the date of issue of the standard. This standard applies on one hand to machinery for professional use operated by the adult working population, who are healthy workers with ordinary physical capacity, and on the other hand to machinery for domestic use operated by the whole population including youth and old people. The recommendations are derived from research on European population. This document is not applicable to specify the machinery which are manufactured before the date of publication of this document by CEN.CEN/TC 122 Ergonomics2008-10-00SafetyMachinery-Directive
(Type B)
28
EN 1005-4+A1Safety of machinery - Human physical performance - Part 4: Evaluation of working postures and movements in relation to machineryThis European Standard presents guidance when designing machinery or its component parts in assessing and affecting health risks due only to machine-related postures and movements, i.e. during assembly, installation, operation, adjustment, maintenance, cleaning, repair, transport, and dismantlement. This European Standard specifies requirements for postures and movements without any or with only minimal external force exertion. The requirements are intended to reduce the health risks for nearly all healthy adults. This European Standard is not applicable to the machinery, which is manufactured before the date of publication of this European Standard by CEN.CEN/TC 122 Ergonomics2008-10-00SafetyMachinery-Directive
(Type B)
29
EN 1005-5Safety of machinery - Human physical performance - Part 5: Risk assessment for repetitive handling at high frequencyThis European Standard presents guidance to the designer of machinery or its component parts and the writer of type C standards in assessing and controlling health and safety risks due to machine-related repetitive handling at high frequency. This European Standard specifies reference data for action frequency of the upper limbs during machinery operation, and it presents a risk assessment method intended for risk reduction option analysis. This European Standard applies to machinery for professional operation by the healthy adult working population. This European Standard is not applicable for repetitive movements and related risks of the neck, back and lower limbs.CEN/TC 122 Ergonomics2007-02-00SafetyNone
30
EN ISO 12100Safety of machinery - General principles for design - Risk assessment and risk reduction (ISO 12100:2010)ISO 12100:2010 specifies basic terminology, principles and a methodology for achieving safety in the design of machinery. It specifies principles of risk assessment and risk reduction to help designers in achieving this objective. These principles are based on knowledge and experience of the design, use, incidents, accidents and risks associated with machinery. Procedures are described for identifying hazards and estimating and evaluating risks during relevant phases of the machine life cycle, and for the elimination of hazards or sufficient risk reduction. Guidance is given on the documentation and verification of the risk assessment and risk reduction process. ISO 12100:2010 is also intended to be used as a basis for the preparation of type-B or type-C safety standards. It does not deal with risk and/or damage to domestic animals, property or the environment.CEN/TC 114 Safety of machinery2010-11-00SafetyMachinery-Directive
(Type A)
31
EN ISO 13849-1Safety of machinery - Safety-related parts of control systems - Part 1: General principles for design (ISO 13849-1:2015)ISO 13849-1:2015 provides safety requirements and guidance on the principles for the design and integration of safety-related parts of control systems (SRP/CS), including the design of software. For these parts of SRP/CS, it specifies characteristics that include the performance level required for carrying out safety functions. It applies to SRP/CS for high demand and continuous mode, regardless of the type of technology and energy used (electrical, hydraulic, pneumatic, mechanical, etc.), for all kinds of machinery. It does not specify the safety functions or performance levels that are to be used in a particular case. This part of ISO 13849 provides specific requirements for SRP/CS using programmable electronic system(s). It does not give specific requirements for the design of products which are parts of SRP/CS. Nevertheless, the principles given, such as categories or performance levels, can be used.CEN/TC 114 Safety of machinery2015-12-00SafetyMachinery-Directive
(Type B)
32
EN ISO 13849-2Safety of machinery - Safety-related parts of control systems - Part 2: Validation (ISO 13849-2:2012)ISO 13849-2:2012 specifies the procedures and conditions to be followed for the validation by analysis and testing of the specified safety functions, the category achieved, and the performance level achieved by the safety-related parts of a control system (SRP/CS) designed in accordance with ISO 13849-1.CEN/TC 114 Safety of machinery2012-10-00SafetyMachinery-Directive
(Type B)
33
EN ISO 13850Safety of machinery - Emergency stop function - Principles for design (ISO 13850:2015)ISO 13850:2015 Standard specifies functional requirements and design principles for the emergency stop function on machinery, independent of the type of energy used. It does not deal with functions such as reversal or limitation of motion, deflection of emissions (e.g. radiation, fluids), shielding, braking or disconnecting, which can be part of the emergency stop function.The requirements for this International Standard apply to all machines, with exception to: machines where an emergency stop would not reduce the risk; hand-held or hand-operated machines.CEN/TC 114 Safety of machinery2015-11-00SafetyMachinery-Directive
(Type B)
34
EN ISO 13855Safety of machinery - Positioning of safeguards with respect to the approach speeds of parts of the human body (ISO 13855:2010)ISO 13855:2010 establishes the positioning of safeguards with respect to the approach speeds of parts of the human body. It specifies parameters based on values for approach speeds of parts of the human body and provides a methodology to determine the minimum distances to a hazard zone from the detection zone or from actuating devices of safeguards.The values for approach speeds (walking speed and upper limb movement) in ISO 13855:2010 are time tested and proven in practical experience. ISO 13855:2010 gives guidance for typical approaches. Other types of approach, for example running, jumping or falling, are not considered in ISO 13855:2010. Safeguards considered in ISO 13855:2010 include: electro-sensitive protective equipment, including light curtains and light grids (AOPDs), and laser scanners (AOPDDRs) and two-dimensional vision systems; pressure-sensitive protective equipment, especially pressure-sensitive mats; two-hand control devices; interlocking guards without guard locking.CEN/TC 114 Safety of machinery2010-05-00SafetyMachinery-Directive
(Type B)
35
EN ISO 13856-2Safety of machinery - Pressure-sensitive protective devices - Part 2: General principles for design and testing of pressure-sensitive edges and pressure-sensitive bars (ISO 13856-2:2013)ISO 13856-2:2012 establishes general principles and specifies requirements for the design and testing of pressure-sensitive edges and pressure-sensitive bars used as safeguards and not as actuating devices for normal operation. ISO 13856-2:2012 is applicable to pressure-sensitive edges and pressure-sensitive bars, with or without an external reset facility, used to detect persons or body parts that can be exposed to hazards such as those caused by the moving parts of machines. It is not applicable to determining the suitability of a pressure-sensitive edge or pressure-sensitive bar for a particular safeguarding application, selection of an appropriate performance level for safety-related parts of control systems (SRP/CSs) other than to give minimum values,dimensioning or configuring of the effective sensing area of pressure-sensitive edges or pressure-sensitive bars in relation to any particular application or to stopping devices according to IEC 60204-1 used only for normal operation, including emergency stopping of machinery.CEN/TC 114 Safety of machinery2013-04-00SafetyMachinery-Directive
(Type B)
36
EN ISO 13856-3Safety of machinery - Pressure-sensitive protective devices - Part 3: General principles for design and testing of pressure-sensitive bumpers, plates, wires and similar devices (ISO 13856-3:2013)ISO 13856-3:2013 establishes general principles and specifies requirements for the design and testing of those pressure-sensitive protective devices, with or without an external reset facility, that are not specified in either ISO 13856‑1 or ISO 13856‑2, and the majority of which are produced for specific applications and are not available as "off-the-shelf" items. ISO 13856-3:2013 also gives specific requirements for the following pressure-sensitive protective devices: pressure-sensitive bumpers; pressure-sensitive plates; pressure-sensitive wires (trip wires). It deals with the design of a pressure-sensitive device with regard to safety and reliability rather than its suitability for particular applications. It is not applicable to specifying the dimensions of pressure-sensitive protective devices in relation to any particular application, or stopping devices according to IEC 60204‑1 used for the normal operation, including emergency stopping of machinery. While requirements are given for the immunity of the device to electromagnetic disturbances, these are not intended to cover all aspects of electromagnetic compatibility (EMC).CEN/TC 114 Safety of machinery2013-07-00SafetyMachinery-Directive
(Type B)
37
EN ISO 13857Safety of machinery - Safety distances to prevent hazard zones being reached by upper and lower limbs (ISO 13857:2008)ISO 13857:2007 establishes values for safety distances in both industrial and non-industrial environments to prevent machinery hazard zones being reached. The safety distances are appropriate for protective structures. It also gives information about distances to impede free access by the lower limbs. It covers people of 14 years and older (the 5th percentile stature of 14 year olds is approximately 1 400 mm). In addition, for upper limbs only, it provides information for children older than 3 years (5th percentile stature of 3 year olds is approximately 900 mm) where reaching through openings needs to be addressed.CEN/TC 114 Safety of machinery2008-03-00SafetyMachinery-Directive
(Type B)
38
EN ISO 14159Safety of machinery - Hygiene requirements for the design of machinery (ISO 14159:2002)This International Standard specifies hygiene requirements of machines and provides information for the intended use to be provided by the manufacturer. It applies to all types of machines and associated equipment used in applications where hygiene risks to the consumer of the product can occur. This International Standard does not cover requirements relative to the uncontrolled egress of microbiological agents from the machine.CEN/TC 114 Safety of machinery2008-04-00SafetyMachinery-Directive
(Type B)
39
EN 349+A1Safety of machinery - Minimum gaps to avoid crushing of parts of the human bodyThe object of this European Standard is to enable the user (e. g. standard makers, designers of machinery) to avoid hazards from crushing zones. It specifies minimum gaps relative to parts of the human body and is applicable when adequate safety can be achieved by this method. This European Standard is applicable to risks from crushing hazards only and is not applicable to other possible hazards, e. g. impact, shearing, drawing-in. CEN/TC 114 Safety of machinery2008-06-00SafetyMachinery-Directive
(Type B)
40
EN 60204-11Safety of machinery - Electrical equipment of machines - Part 11: Requirements for HV equipment for voltages above 1000 V a.c. or 1500 V d.c. and not exceeding 36 kV (IEC 60204-11:2000, EN 60204-11/AC:2010)Applies to the electrical and electronic equipment and systems of machines, including a group of machines working together in a coordinated manner, but excluding higher level system aspects (i.e. communications between systems).CLC/TC 44X Safety of machinery - Electrotechnical aspects2000-11-00SafetyMachinery-Directive
(Type C)
41
EN 60335-1Household and similar electrical appliances - Safety - Part 1: General requirements (IEC 60335-1:2010, modified)IEC 60335-1:2010 deals with the safety of electrical appliances for household and similar purposes, their rated voltage being not more than 250 V for single-phase appliances and 480 V for other appliances. Battery-operated appliances and other d.c. supplied appliances are within the scope of this standard. Appliances not intended for normal household use but which nevertheless may be a source of danger to the public, such as appliances intended to be used by laymen in shops, in light industry and on farms, are within the scope of this standard. Examples of such appliances are catering equipment, cleaning appliances for commercial use, and appliances for hairdressers. The principal changes in this edition as compared with the fourth edition are as follows:
- updated the text of the standard to align with the most recent editions of the dated normative references;
- modified the functional safety requirements using programmable electronic circuits including software validation requirements;
- updated Clause 29 to cover insulation requirements subjected to high frequency voltages as in switch mode power supply circuits;
- updated Subclause 30.2 to further align the pre-selection option with the end-product test option;
- deleted some notes and converted many other notes to normative text;
- clarified requirements for class III constructions.
The attention of National Committees is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period following publication of a new, amended or revised IEC publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recommendation of the committee that the content of this publication be adopted for implementation nationally not earlier than 12 months or later than 36 months from the date of publication. The contents of the corrigenda of July 2010 and April 2011 have been included in this copy.
CLC/TC 61 Safety of household and similar electrical appliances2012-01-00SafetyMachinery-Directive
(Type C)
42
EN 61310-1Safety of machinery - Indication, marking and actuation - Part 1: Requirements for visual, acoustic and tactile signals (IEC 61310-1:2007)Specifies requirements for visual, acoustic and tactile methods of indicating safety-related information, at the human-machine interface and to exposed persons. It specifies a system of colours, safety signs, markings and other warnings, intended for use in the indication of hazardous situations and health hazards and for meeting certain emergencies. It also specifies ways of coding visual, acoustic and tactile signals for indicators and actuators to facilitate the safe use and monitoring of the machinery. It includes the following significant technical changes with respect to the previous edition: Adapted to the basic standards IEC 60073, IEC 60417, ISO 3864-1, ISO 7000 and ISO 7010.CLC/TC 44X Safety of machinery - Electrotechnical aspects2008-02-00SafetyMachinery-Directive
(Type B)
43
EN 61310-2Safety of machinery - Indication, marking and actuation - Part 2: Requirements for marking (IEC 61310-2:2007)It gives general rules on marking for identification of machinery, for safe use related to mechanical and electrical hazards, and for the avoidance of hazards arising from incorrect connections. Includes the following significant technical changes with respect to the previous edition: Annex A: additional safety signs included and updated.CLC/TC 44X Safety of machinery - Electrotechnical aspects2008-01-00SafetyMachinery-Directive
(Type B)
44
EN 61310-3Safety of machinery - Indication, marking and actuation - Part 3: Requirements for the location and operation of actuators (IEC 61310-3:2007)Specifies safety-related requirements for actuators, operated by the hand or by other parts of the human body, at the human-machine interface. It gives general requirements for the standard direction of movement for actuators; the arrangement of an actuator in relation to other actuators; the correlation between an action and its final effects. It includes the following significant technical changes with respect to the previous edition: Table 1, Table 2 and Table A.1 have been revised editorially.CLC/TC 44X Safety of machinery - Electrotechnical aspects2008-02-00SafetyMachinery-Directive
(Type B)
45
EN 61496-1Safety of machinery - Electro-sensitive protective equipment - Part 1: General requirements and tests (IEC 61496-1:2012)IEC 61496-1:2012 specifies general requirements for the design, construction and testing of non-contact electro-sensitive protective equipment (ESPE) designed specifically to detect persons as part of a safety related system. Special attention is directed to functional and design requirements that ensure an appropriate safety-related performance is achieved. An ESPE may include optional safety-related functions, the requirements for which are given in Annex A. This third edition cancels and replaces the second edition published in 2004 and its amendment 1 (2007). The main changes with respect to the previous edition are as follows: The design, test and verification requirements have been updated to make them consistent with the latest standards for functional safety and EMC. The contents of the corrigendum of April 2015 have been included in this copy.CLC/TC 44X Safety of machinery - Electrotechnical aspects2013-11-00SafetyMachinery-Directive
(Type B)
46
EN 62061Safety of machinery - Functional safety of safety-related electrical, electronic and programmable electronic control systems (IEC 62061:2005/A2:2015)Specifies requirements and makes recommendations for the design, integration and validation of safety-related electrical, electronic and programmable electronic control systems (SRECS) for machines. It is applicable to control systems used, either singly or in combination, to carry out safety-related control functions on machines that are not portable by hand while working, including a group of machines working together in a co-ordinated manner.CLC/TC 44X Safety of machinery - Electrotechnical aspects2015-08-00SafetyMachinery-Directive
(Type B)
47
EN ISO 14971Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.CEN/CLC/TC 3 Quality management and corresponding general aspects for medical devices2012-07-00SafetyMedical-Device-Directive
48
ISO/TR 24971Guidance on the application of ISO 14971Provides guidance in addressing specific areas of ISO 14971 (Medical devices - Application of risk management to medical devices) when implementing risk management. This guidance is intended to assist manufacturers and other users of the standard to understand the role of international product safety and process standards in risk management, develop the policy for determining the criteria for risk acceptability, incorporate production and post-production feedback loop into risk management, differentiate between "information for safety" and "disclosure of residual risk", and evaluate overall residual risk.IEC/SC 62A Common aspects of electrical equipment used in medical practice2012-10-00SafetyNone
49
EN ISO 13485Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization. The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes. If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls. If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.CEN/CLC/TC 3 Quality management and corresponding general aspects for medical devices2016-03-00SafetyMedical-Device-Directive
50
EN ISO 16201Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006)ISO 16201:2006 specifies functional and technical requirements and test methods for environmental control systems intended for use to alleviate or compensate for a disability. Such systems are also known as electronic aids to daily living. The aim of ISO 16201:2006 is to provide safety requirements and recommendations for manufacturers of such environmental control systems. Target devices are not covered by ISO 16201:2006. Technical requirements for items of equipment connected within the system are to be covered by their own specific standards, e.g. adjustable beds.CEN/TC 293 Assistive products for persons with disability2006-10-00SafetyMedical-Device-Directive
51
EN 60601-1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)IEC 60601-1:2005 contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. The contents of the corrigenda of December 2006 and December 2007, the interpretation sheets of April 2008, January 2009 and May 2013 have been included in this copy.CLC/TC 62 Electrical equipment in medical practice2006-10-00SafetyMedical-Device-Directive
52
EN 60601-1-6Medical electrical equipment - General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010)IEC 60601-1-6:2010 specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical electrical equipment. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this collateral standard has been complied with and the acceptance criteria documented in the usability validation plan have been met (see 5.9 of IEC 62366:2007), then the residual risks, as defined in ISO 14971, associated with usability of me equipment are presumed to be acceptable, unless there is objective evidence to the contrary (see 4.1.2 of IEC 62366:2007). The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards. This document cancels and replaces the second edition of IEC 60601-1-6 which has been technically revised. It was revised to align with the usability engineering process in IEC 62366. To allow for equipment manufacturers and testing organizations to make products and to equip themselves for conducting revised tests in accordance with this third edition, it is recommended by SC 62A that the content of this document not be adopted for mandatory implementation earlier than 3 years from the date of publication for equipment newly designed and not earlier than 5 years from the date of publication for equipment already in production.CLC/TC 62 Electrical equipment in medical practice2010-04-00SafetyMedical-Device-Directive
53
EN 60601-1-11Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2010)IEC 60601-1-11:2010 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems which are intended by their manufacturer for use in the home healthcare environment, regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The object of IEC 60601-1-11:2010 is to specify general requirements that are in addition to those of the general standard IEC 60601-1:2005 and to serve as the basis for particular standards.CLC/TC 62 Electrical equipment in medical practice2010-06-00SafetyMedical-Device-Directive
54
EN 62366Medical devices - Application of usability engineering to medical devices (IEC 62366:2007)Specifies a process for a manufacturer to analyse, specify, design, verify and validate usability, as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this International Standard has been complied with and the acceptance criteria documented in the usability validation plan have been met, then the residual risks, as defined in ISO 14971, associated with usability of a medical device are presumed to be acceptable, unless there is objective evidence to the contrary. This International Standard does not apply to clinical decision-making relating to the use of a medical device.CLC/TC 62 Electrical equipment in medical practice2008-01-00SafetyMedical-Device-Directive
55
EN ISO 14155Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes. The principles set forth in ISO 14155:2011 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations. ISO 14155:2011 specifies general requirements intended to protect the rights, safety and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and principal investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. ISO 14155:2011 does not apply to in vitro diagnostic medical devices.CEN/TC 258 Clinical investigation of medical devices2011-10-00SafetyMedical-Device-Directive
56
ISO/TR 22100-4Safety of machinery - Relationship with ISO 12100 - Part 4: Guidance to machinery manufacturers for consideration of related IT-security (cyber security) aspectsThis document gives machine manufacturers guidance on potential security aspects in relation to safety of machinery when putting a machine into service or placing on the market for the first time. It provides essential information to identify and address IT-security threats which can influence safety of machinery. This document gives guidance but does not provide detailed specifications on how to address IT-security aspects which can influence safety of machinery. This document does not address the bypass or defeat of risk reduction measures through physical manipulation.ISO/TC 199 Safety of machinery2018-12-00SafetyNone
57
EN 55011Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement (CISPR 11:2015, modified)EN 55011 applies to industrial, scientific and medical electrical equipment operating in the frequency range 0 Hz to 400 GHz and to domestic and similar appliances designed to generate and/or use locally radio-frequency energy. This standard covers emission requirements related to radio-frequency (RF) disturbances in the frequency range of 9 kHz to 400 GHz. Measurements need only be performed in frequency ranges where limits are specified in Clause 6. For ISM RF applications in the meaning of the definition found in the ITU Radio Regulations (see Definition 3.13), this standard covers emission requirements related to radio-frequency disturbances in the frequency range of 9 kHz to 18 GHz. Requirements for ISM RF lighting equipment and UV irradiators operating at frequencies within the ISM frequency bands defined by the ITU Radio Regulations are contained in this standard. Equipment covered by other CISPR product and product family emission standards are excluded from the scope of this standard.CLC/TC 210 Electromagnetic compatibility (EMC)2016-04-00TestNone
58
IEC/TR 60601-4-2Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systemsIEC/TR 60601-4-2 applies to the performance of medical electrical equipment or a medical electrical system in the presence of electromagnetic disturbances.IEC/SC 62A Common aspects of electrical equipment used in medical practice2016-05-00TestNone
59
ISO 9283Manipulating industrial robots - Performance criteria and related test methodsThis International Standard describes methods of specifying and testing the following performance characteristics of manipulating industrial robots: pose accuracy and pose repeatability; multi-directional pose accuracy variation; distance accuracy and distance repeatability; position stabilization time; position overshoot; drift of pose characteristics; exchangeability; path accuracy and path repeatability; path accuracy on reorientation; cornering deviations; path velocity characteristics; minimum posing time; static compliance; weaving deviations.ISO/TC 299 Robots and robotic devices1998-04-00TestNone
60
ISO/TR 13309Manipulating industrial robots - Informative guide on test equipment and metrology methods of operation for robot performance evaluation in accordance with ISO 9283Supplies information on the state-of-the-art of test equipment operating principles. Additional information is provided that describes the applications of current test equipment technology to ISO 9283.ISO/TC 299 Robots and robotic devices1995-05-00TestNone
61
ISO/TS 16955Prosthetics - Quantification of physical parameters of ankle foot devices and foot unitsISO/TS 16955:2016 describes quantitative methods to evaluate or assess key performance indicators of prosthetic ankle foot devices. For each method, the set-up and test configurations are described. Also included is a variety of parameters which are derived or calculated from the recorded data.ISO/TC 168 Prosthetics and orthotics2016-06-00TestNone
62
ISO 18646-1Robotics - Performance criteria and related test methods for service robots - Part 1: Locomotion for wheeled robotsISO 18646-1:2016 describes methods for specifying and evaluating the locomotion performance of wheeled robots in indoor environments.ISO/TC 299 Robots and robotic devices2016-09-00TestNone
63
IEC 62366-1Medical devices - Part 1: Application of usability engineering to medical devicesIEC 62366-1:2015 specifies a process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety. This usability engineering (human factors engineering) process permits the manufacturers to assess and mitigate risks associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use.ISO/TC 210 Quality management and corresponding general aspects for medical devices2015-02-00TestNone
64
ISO/DIS 18646-2Robotics - Performance criteria and related test methods for service robots - Part 2: NavigationThis International Standard will describe methods of specifying and evaluating the navigation performance of mobile service robots. This project was initiated to provide the evaluation procedure for navigation of mobile robot. The TC plans to develop “manipulation performance”, “exoskeletal robot performance”, “HRI”, “energy efficiency”, etc, in the future. ISO 18646-2 is intended to facilitate understanding on navigation performance of mobile service robots between users and manufacturers. lt defines the important performance characteristics, describes how they shall be specified, and recommends how they should be tested.ISO/TC 299 Robots and robotic devicesOpenTestNone
65
ISO/CD TR 23482-1Robotics - Application of ISO 13482 - Part 1: Safety-related test methodsThis International Standard is currently under development.ISO/TC 299 Robots and robotic devicesOpenTestNone
66
ISO/CD 18646-3Robotics - Performance criteria and related test methods for service robots - Part 3: ManipulationThis International Standard is currently under development.ISO/TC 299 Robots and robotic devicesOpenTestNone
67
ISO/AWI 18646-4Robotics - Performance criteria and related test methods for service robots - Part 4: Wearable robotsThis International Standard is currently under development.ISO/TC 299 Robots and robotic devicesOpenTestNone
68
EN ISO 22523External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)ISO 22523:2006 specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO 9999: 06 03 - 06 15 Orthoses
06 18 - 06 27 Limb prostheses. It covers strength, materials, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components.This International Standard does not cover special seating as it is not classified as an orthosis in ISO 9999 and it is not normally body worn.
CEN/TC 293 Assistive products for persons with disability2006-10-00TestMedical-Device-Directive
69
EN ISO 10328Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)ISO 10328:2016 is suitable for the assessment of the conformity of lower limb prosthetic devices/structures with the strength requirements specified in 4.4 of ISO 22523:2006. Prosthetic ankle-foot devices and foot units on the market, which have demonstrated their compliance with the strength requirements specified in 4.4 of ISO 22523:2006 through submission to the relevant tests of ISO 10328:2006, need not be retested to ISO 22675:2016. ISO 10328:2016 is not suitable to serve as a guide for the selection of a specific lower limb prosthetic device/structure in the prescription of an individual lower limb prosthesis! Any disregard of this warning can result in a safety risk for amputees. ISO 10328:2016 specifies procedures for static and cyclic strength tests on lower-limb prostheses which typically produce compound loadings by the application of a single test force. The compound loads in the test sample relate to the peak values of the components of loading which normally occur at different instants during the stance phase of walking.CEN/TC 293 Assistive products for persons with disability2016-06-00TestMedical-Device-Directive
70
EN ISO 22675Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)ISO 22675:2016 is suitable for the assessment of the conformity of prosthetic ankle-foot devices and foot units with the strength requirements specified in 4.4 of ISO 22523:2006. Prosthetic ankle-foot devices and foot units on the market, which have demonstrated their compliance with the strength requirements specified in 4.4 of ISO 22523:2006 through submission to the relevant tests of ISO 10328:2006, need not be retested to this International Standard. ISO 22675:2016 is not suitable to serve as a guide for the selection of a specific ankle-foot device or foot unit in the prescription of an individual lower limb prosthesis! Any disregard of this warning can result in a safety risk for amputees. ISO 22675:2016 primarily specifies a cyclic test procedure for ankle-foot devices and foot units of external lower limb prostheses, distinguished by the potential to realistically simulate those loading conditions of the complete stance phase of walking from heel strike to toe-off that are relevant to the verification of performance requirements such as strength, durability and service life. CEN/TC 293 Assistive products for persons with disability2016-06-00TestMedical-Device-Directive
71
EN 60601-1-2Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014)IEC 60601-1-2:2014 applies to the basic safety and essential performance of Medical Equipment (ME) equipment and ME systems in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by ME equipment and ME systems.CLC/TC 62 Electrical equipment in medical practice2015-09-00TestMedical-Device-Directive
72
EN 60601-1-8Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC 60601-1-8:2006)Specifies basic safety and essential performance requirements and tests for alarm systems in medical electrical equipment and medical electrical systems and to provide guidance for their application. This is accomplished by defining alarm categories (priorities) by degree of urgency, consistent alarm signals and consistent control states and their marking for all alarm systems.CLC/TC 62 Electrical equipment in medical practice2007-07-00TestMedical-Device-Directive
73
EN ISO 10993-1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)ISO 10993-1:2009 describes: the general principles governing the biological evaluation of medical devices within a risk management process; the general categorization of devices based on the nature and duration of their contact with the body; the evaluation of existing relevant data from all sources; the identification of gaps in the available data set on the basis of a risk analysis; the identification of additional data sets necessary to analyse the biological safety of the medical device; the assessment of the biological safety of the medical device.CEN/TC 206 Biocompatibility of medical and dental materials and devices2009-10-00TestMedical-Device-Directive
74
EN 61131-2Programmable controllers - Part 2: Equipment requirements and tests (IEC 61131-2:2007)IEC 61131-2:2007 specifies requirements and related tests for programmable controllers (PLCs) and their associated peripherals (for example, programming and debugging tools (PADTs), human-machine interfaces (HMIs), etc.) which have as their intended use the control and command of machines and industrial processes. It establishes the definitions and identifies the principal characteristics relevant to the selection and application of PLCs and their associated peripherals. It specifies the minimum requirements for functional, electrical, mechanical, environmental and construction characteristics, service conditions, safety, EMC, user programming and tests applicable to PLCs and the associated peripherals.IEC TC 65/SC 65B - Measurement and control devices2007-09-00TestElectromagnetic-Compatibility-Directive
75
ISO 17664Processing of health care products - Information to be provided by the medical deviceISO 17664:2017 specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use. This includes information for processing prior to use or reuse of the medical device. The provisions of ISO 17664:2017 are applicable to medical devices that are intended for invasive or other direct or indirect patient contact.ISO/TC 198 Sterilization of health care products2017-10-00GeneralNone
76
ISO 8373Robots and robotic devices - VocabularyISO 8373:2012 defines terms used in relation with robots and robotic devices operating in both industrial and non-industrial environments.ISO/TC 299 Robots and robotic devices2012-03-00GeneralNone
77
ISO 9946Manipulating industrial robots - Presentation of characteristicsThis International Standard specifies how characteristics of robots shall be presented by the manufacturer.ISO/TC 299 Robots and robotic devices1999-04-00GeneralNone
78
ISO 14539Manipulating industrial robots - Object handling with grasp-type grippers - Vocabulary and presentation of characteristicsThis International Standard focuses on the functionalities of end effectors and concentrates on grasp-type grippers as defined in 4.1.2.1. This International Standard provides terms to describe object handling and terms of functions, structures, and elements of grasp-type grippers. Annex A, which is informative, provides formats for presenting characteristics of grasp-type grippers. This part can be used in the following ways: a) End effector manufacturers can present the characteristics of their products to robot users, b) Robot users can specify the requirements of end effectors they need, c) Robot users can describe the characteristics of the objects to be handled and of handling the objects in their specific robot applications. This International Standard is also applicable to simple handling systems which are not covered by the definition of manipulating industrial robots, such as pick-and-place or master-slave units.ISO/TC 299 Robots and robotic devices2000-11-00GeneralNone
79
ISO 9999Assistive products for persons with disability - Classification and terminologyISO 9999:2016 establishes a classification and terminology of assistive products, especially produced or generally available, for persons with disability. Assistive products used by a person with disability, but which require the assistance of another person for their operation, are included in the classification. The following items are specifically excluded from this International Standard: items used for the installation of assistive products; solutions obtained by combinations of assistive products that are individually classified in this International Standard; medicines; assistive products and instruments used exclusively by healthcare professionals; non-technical solutions, such as personal assistance, guide dogs or lip-reading; implanted devices; financial support.ISO/TC 173 Assistive products for persons with disability2016-10-00GeneralNone
80
ISO 8549-1Prosthetics and orthotics - Vocabulary - Part 1: General terms for external limb protheses and external orthosesIncludes more than 40 definitions of terms used to describe artificial limbs, the anatomy of those parts of the human body and the personal and procedures involved in the practice of prosthetics and orthotics. It does not apply to breast or other external prostheses, dental prostheses or internal ones.ISO/TC 168 Prosthetics and orthotics1989-07-00GeneralNone
81
ISO 8549-2Prosthetics and orthotics - Vocabulary - Part 2: Terms relating to external limb prostheses and wearers of these prosthesesIncludes 19 definitions of terms used to describe the level of amputation of limbs and limb deficiencies present at birth and their correction. It complements part 1 of this ISO 5849 series.ISO/TC 168 Prosthetics and orthotics1989-07-00GeneralNone
82
ISO 8549-3Prosthetics and orthotics - Vocabulary - Part 3: Terms relating to external orthosesDefinitions of 22 terms relating to external orthoses that encompass joints. It does not include terms for orthoses which only encompass limb segments as these orthoses are limited mainly to use in the treatment of fractures and in sports medicine. It complements parts 1 and 2 of the ISO 5849 series.ISO/TC 168 Prosthetics and orthotics1989-07-00GeneralNone
83
ISO 29783-1Prosthetics and orthotics - Vocabulary - Part 1: normal gaitISO 29783-1:2008 establishes a vocabulary for the description of normal gait.ISO/TC 168 Prosthetics and orthotics2008-12-00GeneralNone
84
ISO 29782Prostheses and orthoses - Factors to be considered when specifying a prosthesis for a person who has had a lower limb amputationISO 29782:2008 describes the factors to be considered when specifying a prosthesis for a person who has had a lower limb amputation.ISO/TC 168 Prosthetics and orthotics2008-12-00GeneralNone
85
ISO 29783-2Prosthetics and orthotics - Vocabulary - Part 2: Prosthetic gaitISO 27983-2:2015 specifies a vocabulary for the description of prosthetic gait.ISO/TC 168 Prosthetics and orthotics2015-02-00GeneralNone
86
ISO 13404Prosthetics and orthotics - Categorization and description of external orthoses and orthotic componentsISO 13404:2007 establishes a means of classifying and describing external orthoses and the components from which they are assembled.ISO/TC 168 Prosthetics and orthotics2007-07-00GeneralNone
87
ISO 21064Prosthetics and orthotics - Foot orthotics - Uses, functions classification and descriptionISO 21064:2017 establishes a method of classifying and describing the devices that are used in the field of foot orthotics. It does not describe the materials or manufacturing methods used for their fabrication.ISO/TC 168 Prosthetics and orthotics2017-07-00GeneralNone
88
IEC/TR 60601-4-1Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomyIEC TR 60601-4-1:2017 is intended to help a manufacturer through the key decisions and steps to be taken to perform a detailed risk management and usability engineering processes for medical electrical equipment or a medical electrical system, hereafter referred to as MEE or MES, employing a degree of autonomy (DOA).ISO/TC 299 Robots and robotic devices2017-05-00GeneralNone
89
ISO 19649Mobile robots - VocabularyISO 19649:2017 defines terms relating to mobile robots that travel on a solid surface and that operate in both industrial robot and service robot applications. It defines terms used for describing mobility, locomotion and other topics relating to the navigation of mobile robots.ISO/TC 299 Robots and robotic devices2017-03-00GeneralNone
90
ISO/DIS 20607Safety of machinery - Instruction handbook - General drafting principlesThis International Standard specifies requirements for the machine manufacturer for preparation of the safety-relevant parts of an instruction handbook for machinery. This International Standard provides further specifications to the general requirements on information for use given in ISO 12100:2010, 6.4, and deals with the safety-related content, the corresponding structure and presentation of the instruction handbook, taking into account all phases of the life cycle of the machine.ISO/TC 199 Safety of machineryOpenGeneralNone
91
ISO/PRF TR 23482-2Robotics - Application of ISO 13482 - Part 2: Application guideThis International Standard is currently under development.ISO/TC 299 Robots and robotic devicesOpenGeneralNone
92
ISO/CD 22166-1Robotics - Part 1: Modularity for service robots - Part 1: General requirementsThis International Standard is currently under development.ISO/TC 299 Robots and robotic devicesOpenGeneralNone
93
ISO/CD 8551Prosthetics and orthotics - Functional deficiencies - Description of the person to be treated with an orthosis, clinical objectives of treatment, and functional requirements of the orthosisThis International Standard is currently under development.ISO/TC 168 Prosthetics and orthoticsOpenGeneralNone
94
IEC 63120 ED1Environmental conscious design of medical electrical equipment - Particular requirements for refurbishment of medical electrical equipment and systems, for re-use of parts, for a management of critical or hazardous substances contained in medical electrical equipment and systems and for a closed loop Business-to-Business take back systemThis International Standard is currently under development.IEC/SC 62
Electrical equipment in medical practice
OpenGeneralNone
95
EN 614-1+A1Safety of machinery - Ergonomic design principles - Part 1: Terminology and general principlesThis European Standard establishes the ergonomic principles to be followed during the process of design of machinery. This European Standard applies to the interactions between operators and machinery when installing, operating, adjusting, maintaining, cleaning, dismantling, repairing or transporting equipment, and outlines the principles to be followed in taking the health, safety and well-being of the operator into account. This European Standard provides a framework within which the range of more specific ergonomics standards and other related standards relevant to machinery design should be applied. The ergonomic principles given in this European Standard apply to all ranges of human abilities and characteristics to ensure safety, health and well-being and overall system performance. Information will need to be interpreted to suit the intended use.CEN/TC 122 Ergonomics2009-02-00GeneralMachinery-Directive
(Type B)
96
EN ISO 15223-1Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)ISO 15223-1:2016 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this document. ISO 15223-1:2016 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements. These symbols may be used on the medical device itself, on its packaging or in the associated documentation. The requirements of this document are not intended to apply to symbols specified in other standards.CEN/CLC/TC 3 Quality management and corresponding general aspects for medical devices2016-11-00GeneralMedical-Device-Directive
97
EN 1041Information supplied by the manufacturer of medical devicesThis standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied. This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography). noTE When national transpositions of the Directives specify the means by which information shall be supplied, this standard does not provide derogation from these requirements for that country.CEN/CLC/TC 3 Quality management and corresponding general aspects for medical devices2008-08-00GeneralMedical-Device-Directive
98
ISO 11593Manipulating industrial robots - Automatic end effector exchange systems - Vocabulary and presentation of characteristicsDefines terms relevant to automatic end effector exchange systems used for manipulating industrial robots. The terms are presented by their symbol, unit, definition and description. The definition includes references to existing standards.ISO/TC 299 Robots and robotic devices1996-08-00GeneralNone
99
ISO/IEC TR 24785Information technology - Taxonomy of cultural and linguistic adaptability user requirementsISO/IEC TR 24785:2009 defines a Taxonomy describing the various elements of cultural and linguistic adaptability user requirements for use in a computer environment.ISO/IEC JTC 1/SC 35 User interfaces2009-02-00ICTNone
100
ISO/IEC 30113-1Information technology - User interface - Gesture-based interfaces across devices and methods - Part 1: FrameworkISO/IEC 30113-1:2015 defines a framework and guidelines for gesture-based interfaces across devices and methods in supporting interoperability. Some of these devices include mice, touch screens, touch pads, 3D mice, joysticks, game controllers, wired gloves, depth-aware cameras, stereo cameras, Web cameras. ISO/IEC 30113-1:2015 does not define or require specific technology for recognizing gesture of users. It focuses on the description of a gesture and its functions for utilizing ICT systems. Operation of a physical keyboard is not addressed in this part of ISO/IEC 30113.ISO/IEC JTC 1/SC 35 User interfaces2015-04-00ICTNone
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