EN 60601-1-10:2008/A2:2021

Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

2020-11-16_JO_BT167/DG11868/DV to remove the link to (MDD 93/42/EEC) and M/432

Medizinische elektrische Geräte - Teil 1-10: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen an die Entwicklung von physiologischen geschlossenen Regelkreisen

Appareils électromédicaux - Partie 1-10: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour le développement des régulateurs physiologiques en boucle fermée

Medicinska električna oprema - 1-10. del: Splošne zahteve za osnovno varnost in bistvene lastnosti - Spremljevalni standard: Zahteve za razvoj fizioloških krmilnikov s sklenjeno zanko - Dopolnilo A2 (IEC 60601-1-10:2007/A2:2020)

General Information

• Status: Published
• Publication Date: 15-Jul-2021
• ICS: 11.040 - Medical equipment
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62A - IEC_SC_62A
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 16-Jul-2021
• Completion Date: 16-Jul-2021
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60601-1-10:2008/A2:2021 - Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers (IEC 60601-1-10:2007/A2:2020)

Relations

• Amends: EN 60601-1-10:2008 - Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
• Effective Date: 29-Aug-2017

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-1-10:2008/A2:2021
01-september-2021
Medicinska električna oprema - 1-10. del: Splošne zahteve za osnovno varnost in
bistvene lastnosti - Spremljevalni standard: Zahteve za razvoj fizioloških
krmilnikov s sklenjeno zanko - Dopolnilo A2 (IEC 60601-1-10:2007/A2:2020)
Medical electrical equipment - Part 1-10: General requirements for basic safety and
essential performance - Collateral Standard: Requirements for the development of
physiologic closed-loop controllers (IEC 60601-1-10:2007/A2:2020)
Medizinische elektrische Geräte - Teil 1-10: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen
an die Entwicklung von physiologischen geschlossenen Regelkreisen (IEC 60601-1-
10:2007/A2:2020)
Appareils électromédicaux - Partie 1-10: Exigences générales pour la sécurité de base
et les performances essentielles - Norme collatérale: Exigences pour le développement
des régulateurs physiologiques en boucle fermée (IEC 60601-1-10:2007/A2:2020)
Ta slovenski standard je istoveten z: EN 60601-1-10:2008/A2:2021
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 60601-1-10:2008/A2:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-1-10:2008/A2:2021

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SIST EN 60601-1-10:2008/A2:2021


EUROPEAN STANDARD EN 60601-1-10:2008/A2

NORME EUROPÉENNE

EUROPÄISCHE NORM
July 2021
ICS 11.040.01

English Version
Medical electrical equipment - Part 1-10: General requirements
for basic safety and essential performance - Collateral Standard:
Requirements for the development of physiologic closed-loop
controllers
(IEC 60601-1-10:2007/A2:2020)
Appareils électromédicaux - Partie 1-10: Exigences Medizinische elektrische Geräte - Teil 1-10: Allgemeine
générales pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich des
essentielles - Norme collatérale: Exigences pour le wesentlichen Leistungsmerkmale - Ergänzungsnorm:
développement des régulateurs physiologiques en boucle Anforderungen an die Entwicklung von physiologischen
fermée geschlossenen Regelkreisen
(IEC 60601-1-10:2007/A2:2020) (IEC 60601-1-10:2007/A2:2020)
This amendment A2 modifies the European Standard EN 60601-1-10:2008; it was approved by CENELEC on 2020-08-26. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment the
status of a national standard without 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 amendment exists in three official versions (English, French, German). 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 electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey 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
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 60601-1-10:2008/A2:2021 E

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SIST EN 60601-1-10:2008/A2:2021
EN 60601-1-10:2008/A2:2021 (E)
European foreword
The text of document 62A/1394/FDIS, future IEC 60601-1-10/A2, prepared by SC 62A "Common
aspects of electrical equipment used in medical practice" of IEC/TC 62 "Electrical equipment in
medical practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
EN 60601-1-10:2008/A2:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022-01-16
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024-07-16
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and question
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