1 of 12

OPEN OXIMETRY COLLABORATIVE COMMUNITY

ISO/IEC Oximeters Joint Working Group

ISO 80601-2-61

Medical Electrical Equipment — Part 2-61: Particular requirements for basic safety and

essential performance of pulse oximeter equipment

ISO TC 121/SC3, JWG10

IEC TC 62, SC62D, JWG5

Sandy Weininger, co-chair, ISO project lead

Bob Kopotic, co-chair

2 of 12

Disclaimer: The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the Department of Health and Human Services. This presentation reflects the views of the authors and should not be construed to represent FDA views or policies.

OSEL Accelerating patient access to innovative, safe, and effective medical devices through best-in-the-world regulatory science

3 of 12

Oversight history

1982 – first marketing of a pulse oximeter
1986 – American Society of Anesthesiologists: Standards for Basic Anesthesia Monitoring – “Blood oxygenation: During all anesthetics, a quantitative method of assessing oxygenation such as pulse oximetry shall be employed”
1992 – ASTM F1415-92 (and 2000) Standard Specification for Pulse Oximeters
1992 – FDA guidance - Noninvasive pulse oximeters and ear oximeters
1998 – ASA: amended standards to include pulse oximetry
2000 - ASTM F1415-2000
2005 – Clinical and Laboratory Standards Institute (CLSI) – HS3-A-Pulse Oximetry; Approved Guideline
2005 – ISO 9919-2005 (IEC 60601-2-54)
2007 – FDA draft guidance - 7/19/2007
2011 – CLSI POCT11-A2 - Pulse Oximetry; Approved Guideline - Second Edition
2013 – FDA guidance
2010, 2020 – ASA: amended to state, “a quantitative method of assessing oxygenation such as pulse oximetry shall be employed”
2011, 2017, 202x – ISO/IEC 80601-2-61,
2022-24 - FDA discussion paper, panel meetings, pending guidance

4 of 12

Benefits of a “compliant” device

Applicable to construction of devices by manufacturers
Product has been demonstrated to be “safe” (definitions from IEC 60601-1)

Basic safety - freedom from unacceptable RISK directly caused by physical HAZARDS when ME EQUIPMENT is used under NORMAL CONDITION and SINGLE FAULT CONDITION
Essential Performance - performance of a clinical or diagnostic function, other than that related to basic safety (IEV 880-18-02), where loss or degradation beyond the limits specified by the manufacturer (IEV 880-14-14) results in an unacceptable risk (IEV 880-18-14)
Note 1 to entry: Essential performance is most easily understood by considering whether loss of the function or degradation of the performance would result in an unacceptable risk.

Notion of essential performance is an engineering term used for establishing acceptance criteria for a manufacturer’s testing, not for the practice of medicine

5 of 12

Medical Device (Pulse Oximeter) Safety Standards

ISO 13485 – Quality Systems

ISO 14971 – Risk Management

ISO 80601-2-61 Safety of Pulse Oximeters

IEC 60601-1 and Collaterals

ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes

ISO 14971:2007 Medical devices — Application of risk management to medical devices

IEC 60601-1:2005+AMD1:2012+AMD2:2020 — Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Process for Design and Development

Process for Identification of unsafe situations

Safety requirements – e.g. electrical, thermal, mechanical, biocompatibility

Specific Safety and performance requirements for pulse oximeters

Standards – establish a minimum internationally accepted safety floor by providing consensus objective test methods and acceptance criteria

What does it mean to be safe? It means that the relevant hazardous situations have been identified and risk control measure built into the device.

This happens most effectively when one has a structured design and development process in place, and then makes good decisions within that process.

ISO 13485 establishes the process for design and development of medical devices.

It works in concert with ISO 14971, which provides the process for identifying and assigning risk to hazardous situations.

These standards establish the “how to” for design, but not the “how good” should the design be.

The “how good” comes from IEC 60601-1, the General Standard for Safety of electromedical devices, which provides answers in terms of safety requirements, test methods, and acceptance criteria.

ISO 80601-2-61, our pulse oximeter standard, inherits these processes and requirements and customizes them for pulse oximeters.

In general, International standard are intended to promote a minimum level of safety and performance that is accepted by regulators around the world. The standard is development with the intent of harmonizing with these local requirements, as has been done with FDA’s guidance document.

Let’s look at what the standard covers

(next slide)

6 of 12

Examples of safety requirements from the ISO standard

“general” safety of electronic medical device
“particular” aspects related to oximeters

Response time
Performance

Accuracy, motion, low perfusion, pigmentation

Conducting a clinical study for performance verification
Labeling

7 of 12

Device performance and user settings may influence the fidelity of the displayed saturation value – especially when the interpretation when the saturation is changing

SaO2 (1) is the true arterial blood value (i.e., reference for SpO2)

Oximeter fidelity

7

8 of 12

Performance metrics

9 of 12

Human Use and Environment issues

Cleaning and disinfecting
Electrostatic discharge (“shock”)
Mechanical shock and vibration
Motion
Poor perfusion

10 of 12

How to determine accuracy – idealized study

11 of 12

Inclusion criteria for performance studies

Using subjective and objective measurement methods for identifying participants

Sample size
Reporting methods

CM-700d Spectrophotometer | Portable | Konica Minolta Sensing

Monk Skin Tone Scale

https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwijjPju87OGAxWHFFkFHVA0AcUQFnoECD4QAQ&url=https%3A%2F%2Fosf.io%2Fpreprints%2Fsocarxiv%2Fpdf4c%2Fdownload&usg=AOvVaw3tvmcd58GHVgZ1ts8_Z0Z-&opi=89978449

12 of 12

Thank you

Questions?