ISO 80601-2-61 2026 电子医疗设备——第2-61部分：关于脉搏血氧仪的基本安全要求及关键性能指标的特殊规定

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International

Standard

ISO 80601-2-61

Medical electrical equipment—

Part 2-61:

Particular requirements for basic

safety and essential performance of

pulse oximeter equipment

Appareils électromédicaux—

Partie 2-61: Exigences particulieres pour la sécurité de base et

les performances essentielles pour les oxymetres de pouls

Reference number

Third edition

2026-04

ISO 2026

ISO 80601-2-61:2026(en)

@ISO 2026

may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or

posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the

address below

or ISO's member body in the country of the requester

ISO copyright office

CP 401·Ch. de Blandonnet 8

CH-1214 Vernier, Geneva

Phone:+41227490111

Email:copyright@iso.org

Website: www.iso.org

Published in Switzerland

iii

ISO 80601-2-61:2026(en)

Contents Page

Foreword ............................................................................................................................................................V

Introduction ................................................................................................................................................ V ii

201.1 Scope, object, and related standards ................................................................................................. 1

201.2 Normative references................................................................................................................................ 3

201.3 Terms and definitions..........................................................................................3

201.4 General requirements.......................................................................................................................... 17

201.5 General requirements for testing of ME equipment .....................................................................19

201.6 Classification of ME equipment and ME systems ........................................................................ 19

201.7 ME equipment identification, marking, and documents.................................................................19

201.8 Protection against electrical hazards from ME equipment.........................................................24

201.9 Protection against mechanical hazards of ME equipment and ME systems............................. 24

201.10 Protection against unwanted and excessive radiation hazards............................................... 24

201.11 Protection against excessive temperatures and other hazards................................................ 24

201.12 Accuracy of controls and instruments and protection against hazardous outputs...............26

201.13 Hazardous situations and fault conditions for ME equipmen .................................................. 41

201.14 Programmable electrical medical systems (PEMS)................................................................... 42

201.15 Construction of ME e q u i p m e n t ............................................................................................... 43

201.16 ME system: ........................................................................................................................................44

201.17 Electromagnetic compatibility of ME equipment and ME system........................................... 44

201.101 Pulse oximeter probes and probe cable extender................................................................... 44

201.102 Saturation pulse information signal ........................................................................................... 45

201.103 Functional connection ................................................................................................................... 45

202 Electromagnetic disturbances-Requirements and tests....................................................... 46

206 Usabilit ............................................................................................................................................... 47

208 General requirements, tests, and guidance for alarm systems in medical electrical

equipment and medical electrical systems........................................................................... 48

211 Requirements for medical electrical equipment and medical electrical systems used in

the home healthcare environment....................................................................................... 48

212 Requirements for medical electrical equipment and medical electrical systems used in

the emergency medical services environment.......................................................................49

Annex C (informative) Guide to marking and labelling requirements for ME equipment and

ME systems

........................................................................................................................... 50

Annex D (informative) Symbols on marking........................................................................................... 54

Annex AA (informative) Particular guidance and rationale.................................................................55

Annex BB (informative) Skin temperature at the pulse oximeter prob............................................... 76

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标签： #医疗设备 #ISO #基本安全

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InternationalStandardISO80601-2-61Medicalelectricalequipment—Part2-61:ParticularrequirementsforbasicsafetyandessentialperformanceofpulseoximeterequipmentAppareilsélectromédicaux—Partie2-61:ExigencesparticulierespourlasécuritédebaseetlesperformancesessentiellespourlesoxymetresdepoulsReferencenumberTh...

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ISO 80601-2-61 2026 电子医疗设备——第2-61部分：关于脉搏血氧仪的基本安全要求及关键性能指标的特殊规定

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