EN 60601-1-10:2008/A1:2015
(Amendment)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
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
- 21-May-2015
- Withdrawal Date
- 30-Dec-2018
- 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
- 22-May-2015
- Completion Date
- 22-May-2015
Relations
- Effective Date
- 28-Jan-2023
Overview
EN 60601-1-10:2008/A1:2015 is a European standard that defines general requirements for the basic safety and essential performance of medical electrical equipment, specifically focusing on the development of physiologic closed-loop controllers (PCLCs). This collateral standard complements IEC 60601-1 by addressing the complexities involved in devices that control physiological parameters automatically through closed-loop feedback mechanisms. The standard was prepared by CLC and endorsed as part of harmonized EU directives, ensuring compliance with essential safety and performance requirements in medical electrical equipment incorporating closed-loop control systems.
Key Topics
- Scope and Object: Establishes safety and performance requirements for medical electrical equipment utilizing physiologic closed-loop control, intended to guide manufacturers in designing safe and reliable controllers managing patient physiological responses.
- Normative References: Updates and aligns key references such as IEC 60601-1 (including Amendment 1:2012), IEC 60601-1-6 (usability), IEC 60601-1-8 (alarm systems), and IEC 62366 (usability engineering) to ensure comprehensive coverage of safety, usability, and software lifecycle processes.
- Terminology and Definitions: Clarifies terms related to risk, usability, verification, validation, manufacturer responsibilities, and single fault conditions in line with updated international standards.
- Programmable Electrical Medical Systems (PEMS): Specifies that requirements in Clause 14 of IEC 60601-1 apply to systems incorporating programmable electrical medical systems with physiologic closed-loop controllers, emphasizing integrated software safety and performance.
- Risk Management: Highlights the integration of risk analysis and management practices to mitigate residual risks associated with closed-loop control in medical devices.
- Usability and Training: Stresses usability engineering and training considerations following IEC 62366 to minimize use errors and facilitate safe operation.
- Amendment Details: This A1 amendment updates normative references and removes redundancy with IEC 62304 by incorporating necessary software process requirements directly into IEC 60601-1, streamlining compliance obligations for manufacturers.
Applications
EN 60601-1-10:2008/A1:2015 applies to a broad range of medical electrical devices incorporating closed-loop control of physiological parameters, including but not limited to:
- Respiratory devices: Lung ventilators and anaesthetic machines with automatic feedback systems adjusting ventilation settings based on patient data.
- Infusion pumps: Devices that regulate drug delivery dynamically by monitoring physiological indicators.
- Cardiac devices: Implantable or external systems that modulate cardiac function automatically through closed-loop algorithms.
- Patient monitoring systems: Advanced controllers that adjust therapy in real-time to maintain essential parameters within safe ranges.
By adhering to these requirements, manufacturers ensure that such medical equipment achieves basic safety and maintains essential performance crucial to protecting patient health and supporting clinical effectiveness.
Related Standards
- IEC 60601-1 (General standard): Core standard for basic safety and essential performance of medical electrical equipment, including Amendment 1:2012.
- IEC 60601-1-6: Collateral standard focusing on usability, aligning device design with user needs and minimizing use-related hazards.
- IEC 60601-1-8: Addresses safety requirements and testing methods for alarm systems integral to medical electrical devices.
- IEC 62366: Provides guidance on applying usability engineering processes specific to medical devices to enhance safe usage.
- IEC 62304: Previously referenced for software lifecycle processes but now superseded in this collateral standard by inclusion in IEC 60601-1 Clause 14 to avoid duplication.
- ISO/TC 121 Subcommittees: This standard complements respiratory and anaesthetic device requirements developed by related ISO technical committees.
By consolidating safety, performance, and usability requirements for physiologic closed-loop controllers in medical electrical equipment, EN 60601-1-10:2008/A1:2015 supports manufacturers in designing safer, more reliable devices. Compliance ensures alignment with EU regulatory expectations and international best practices, ultimately enhancing patient safety and clinical outcomes in medical device applications involving closed-loop control technologies.
Frequently Asked Questions
EN 60601-1-10:2008/A1:2015 is a amendment published by CLC. Its full title is "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". This standard covers: 2013-10-02 - BT146_DG9211 extended DOW to 2018-12-31 2013-08-13 - Negative assessment from Consultant
2013-10-02 - BT146_DG9211 extended DOW to 2018-12-31 2013-08-13 - Negative assessment from Consultant
EN 60601-1-10:2008/A1:2015 is classified under the following ICS (International Classification for Standards) categories: 11.040 - Medical equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 60601-1-10:2008/A1:2015 has the following relationships with other standards: It is inter standard links to EN 60601-1-10:2008. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 60601-1-10:2008/A1:2015 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/432. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase EN 60601-1-10:2008/A1:2015 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CLC standards.
Standards Content (Sample)
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
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
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.
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
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
– 2 – 60601-1-10 Amend. 1 © IEC:2013
FOREWORD
This amendment has been prepared by subcommittee 62A: Common aspects
...
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