BS EN IEC 80601-2-71-2025 医用电气设备 功能性近红外光谱（NIRS）设备基本安全和基本性能的特殊要求

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BSI Standards Publication
Medical electrical equipment
Part 2-71: Particular requirements for the basic safety and essential
performance of functional near-infrared spectroscopy (NIRS) equipment
BS EN IEC 80601-2-71:2025
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
EN IEC 80601-2-71
February 2025
ICS
11.040.55 Supersedes EN IEC 80601-2-
71:2018
English Version
Medical electrical equipment - Part 2-71: Particular requirements
for the basic safety and essential performance of functional near-
infrared spectroscopy (NIRS) equipment
(IEC 80601-2-71:2025)
Appareils électromédicaux - Partie 2-71: Exigences
particulières pour la sécurité de base et les performances
essentielles des appareils de spectroscopie dans le proche
infrarouge (NIRS) fonctionnelle
(IEC 80601-2-71:2025)
Medizinische elektrische Geräte - Teil 2-71: Besondere
Festlegungen für die Sicherheit einschließlich der
wesentlichen Leistungsmerkmale von funktionalen
Oximetriegeräten
(IEC 80601-2-71:2025)
This European Standard was approved by CENELEC on
2025-02-18. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard witho
ut any alteration.
Up
-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any
CENELEC member.
This European Standard exists in three official versions (English, French, Ger
man). A version in any other language made by translation
under the responsibility of a
CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national el
ectrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, t
he
Netherlands, Norway, Poland, Portu
gal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 20252025
CENELEC
Ref. No. EN IEC 80601-2-71:2025 E
National foreword
This British Standard is the UK implementation of
EN IEC 80601‑2‑71:2025. It is identical to IEC 80601‑2‑71:2025. It
supersedes BS EN IEC 80601‑2‑71:2018, which will be withdrawn on 29
February 2028.
The UK participation in its preparation was entrusted to Technical
Committee CH/62/4, Electromedical equipment.
A list of organizations represented on this committee can be obtained on
request to its committee manager.
Contractual and legal considerations
This publication has been prepared in good faith, however no
representation, warranty, assurance or undertaking (express or
implied) is or will be made, and no responsibility or liability is or will be
accepted by BSI in relation to the adequacy, accuracy, completeness or
reasonableness of this publication. All and any such responsibility and
liability is expressly disclaimed to the full extent permitted by the law.
This publication is provided as is, and is to be used at the
recipient’s own risk.
The recipient is advised to consider seeking professional guidance with
respect to its use of this publication.
This publication is not intended to constitute a contract. Users are
responsible for its correct application.
© The British Standards Institution 2025
Published by BSI Standards Limited 2025
ISBN 978 0 539 16765 8
ICS 11.040.55
Compliance with a British Standard cannot confer immunity from
legal obligations.
This British Standard was published under the authority of the
Standards Policy and Strategy Committee on 31 March 2025.
Amendments/corrigenda issued since publication
Date Text affected
BRITISH STANDARD
BS EN IEC 80601‑2‑71:2025
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
EN IEC 80601-2-71
February 2025
ICS
11.040.55 Supersedes EN IEC 80601-2-
71:2018
English Version
Medical electrical equipment - Part 2-71: Particular requirements
for the basic safety and essential performance of functional near-
infrared spectroscopy (NIRS) equipment
(IEC 80601-2-71:2025)
Appareils électromédicaux - Partie 2-71: Exigences
particulières pour la sécurité de base et les performances
essentielles des appareils de spectroscopie dans le proche
infrarouge (NIRS) fonctionnelle
(IEC 80601-2-71:2025)
Medizinische elektrische Geräte - Teil 2-71: Besondere
Festlegungen für die Sicherheit einschließlich der
wesentlichen Leistungsmerkmale von funktionalen
Oximetriegeräten
(IEC 80601-2-71:2025)
This European Standard was approved by CENELEC on
2025-02-18. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard witho
ut any alteration.
Up
-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any
CENELEC member.
This European Standard exists in three official versions (English, French, Ger
man). A version in any other language made by translation
under the responsibility of a
CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national el
ectrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, t
he
Netherlands, Norway, Poland, Portu
gal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 20252025
CENELEC
All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 80601-2-71:2025 E
BS EN IEC 80601‑2‑71:2025

标签： #电气 #红外光谱 #特殊要求

摘要：

本文详细解读了国际标准BS EN IEC 80601-2-71-2025，该标准是针对医用电气设备中功能性近红外光谱（NIRS）设备基本安全与基本性能提出的特殊要求。作为IEC 80601系列标准的重要组成部分，此规范专门为采用近红外光谱技术进行脑氧合监测、组织血氧检测等临床应用的医疗设备设定了电气安全、电磁兼容性、功能性及机械防护等关键指标。该标准的发布确保了NIRS设备在全球范围内的安全性和性能一致性，对医疗器械制造商、检测机构及临床工程师具有重要参考价值，有助于规范产品设计、降低医疗风险，

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BS EN IEC 80601-2-71-2025 医用电气设备 功能性近红外光谱（NIRS）设备基本安全和基本性能的特殊要求.pdf

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作者：史蒂文 分类：国际标准 价格：20星币 属性：62 页 大小：1.54MB 格式：PDF 时间：2025-09-18

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