SIST EN 60601-1-10:2008/A1:2015

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

2013-10-02 - BT146_DG9211 extended DOW to 2018-12-31
2013-08-13 - Negative assessment from Consultant

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 A1

General Information

• Status: Published
• Publication Date: 13-Aug-2015
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 15-Jun-2015
• Due Date: 20-Aug-2015
• Completion Date: 14-Aug-2015
• 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: EN 60601-1-10:2008/A1:2015 - 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

Relations

• Amends: SIST 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: 01-Sep-2015
• Amends: SIST 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: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-1-10:2008/A1:2015
01-september-2015
0HGLFLQVNDHOHNWULþQDRSUHPDGHO6SORãQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG=DKWHYH]DUD]YRMIL]LRORãNLK
NUPLOQLNRYVVNOHQMHQR]DQNR'RSROQLOR$
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
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
Ta slovenski standard je istoveten z: EN 60601-1-10:2008/A1:2015
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 60601-1-10:2008/A1:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 60601-1-10:2008/A1:2015

---------------------- Page: 2 ----------------------

SIST EN 60601-1-10:2008/A1:2015


EUROPEAN STANDARD EN 60601-1-10:2008/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2015
ICS 11.040

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/A1:2013)
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 der
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/A1:2013) (IEC 60601-1-10:2007/A1:2013)
This amendment A1 modifies the European Standard EN 60601-1-10:2008; it was approved by CENELEC on 2015-04-14. 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 60601-1-10:2008/A1:2015 E

---------------------- Page: 3 ----------------------

SIST EN 60601-1-10:2008/A1:2015
EN 60601-1-10:2008/A1:2015
Foreword
The text of document 62A/888/FDIS, future IEC 60601-1-10:2007/A1, prepared by SC 62A "Common
aspects of electrical equipment used in medical practice" of IEC/TC 62 "Electrical equipment in
medical practice" and ISO/SC 1 "Breathing attachments and anaesthetic machines" and
ISO/SC 3 "Lung ventilators and related devices" of ISO/TC 121 "Anaesthetic and respiratory
equipment" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
EN 60601-1-10:2008/A1:2015.

The following dates are fixed:
(dop) 2016-01-14
• latest date by which the document has to be
implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-12-31
• latest date by which the national
standards conflicting with the
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 [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.

This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive.

For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in
EN 60601-1-10:2008.
Endorsement notice
The text of the International Standard IEC 60601-1-10:2007/A1:2013 was approved by CENELEC as
a European Standard without any modification.
2

---------------------- Page: 4 ----------------------

SIST EN 60601-1-10:2008/A1:2015
EN 60601-1-10:2008/A1:2015
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications

The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.

NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.

NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu

Modifications in Annex ZA of EN 60601-1-10:2008:

Publication Year Title EN/HD Year
Replace the existing references to IEC 60601-1, IEC 60601-1-6 and IEC 60601-1-8 by
the following new references:
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic + corr. March 2010
safety and essential performance
+A1 2012  +A1 2013
+A1/AC 2014
  +A12 2014
IEC 60601-1-6 2010 Medical electrical equipment - EN 60601-1-6 2010
Part 1-6: General requirements for basic
safety and essential performance -
Collateral standard: Usability
+A1 2013  +A1 2015
IEC 60601-1-8 2006 Medical electrical equipment - EN 60601-1-8 2007
Part 1-8: General requirements for basic + corr. March 2010
safety and essential performance -
Collateral Standard: General requirements,
tests and guidance for alarm systems in
medical electrical equipment and medical
electrical systems
+A1 2012  +A1 2013
+A1/AC 2014
Delete the following reference:
IEC 62304 2006 Medical device software - Software life- EN 62304 2006
cycle processes
Add the following reference:
IEC 62366 2007 Medical devices - Application of usability EN 62366 2008
engineering to medical devices

3

---------------------- Page: 5 ----------------------

SIST EN 60601-1-10:2008/A1:2015

---------------------- Page: 6 ----------------------

SIST EN 60601-1-10:2008/A1:2015



IEC 60601-1-10

®


Edition 1.0 2013-11




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE




AMENDMENT 1

AMENDEMENT 1





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



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










INTERNATIONAL

ELECTROTECHNICAL

COMMISSION


COMMISSION

ELECTROTECHNIQUE

PRICE CODE
INTERNATIONALE

E
CODE PRIX


ICS 11.040 ISBN 978-2-83221-133-5



Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

---------------------- Page: 7 ----------------------

SIST EN 60601-1-10:2008/A1:2015
– 2 – 60601-1-10 Amend. 1 © IEC:2013
FOREWORD
This amendment has been prepared by subcommittee 62A: Common aspects
...