IEC 60601-1-9:2007/AMD2:2020

Amendment 2 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

Amendement 2 - Appareils électromédicaux - Partie 1-9: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour une conception éco-responsable

General Information

• Status: Published
• Publication Date: 21-Jul-2020
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• ICS: 13.020.01 - Environment and environmental protection in general
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Drafting Committee: WG 20 - TC 62/SC 62A/WG 20
• Current Stage: PPUB - Publication issued
• Start Date: 07-Aug-2020
• Completion Date: 22-Jul-2020

Relations

• Amends: IEC 60601-1-9:2007 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-1-9 ®
Edition 1.0 2020-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 2
AM ENDEMENT 2
Medical electrical equipment –
Part 1-9: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for environmentally conscious design

Appareils électromédicaux –
Partie 1-9: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences pour une conception éco-
responsable
IEC 60601-1-9:2007-07/AMD2:2020-07(en-fr)

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IEC 60601-1-9 ®
Edition 1.0 2020-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 2
AM ENDEMENT 2
Medical electrical equipment –

Part 1-9: General requirements for basic safety and essential performance –

Collateral Standard: Requirements for environmentally conscious design

Appareils électromédicaux –
Partie 1-9: Exigences générales pour la sécurité de base et les performances

essentielles – Norme collatérale: Exigences pour une conception éco-

responsable
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01; 13.020.01 ISBN 978-2-8322-8629-6

– 2 – IEC 60601-1-9:2007/AMD2:2020
© IEC 2020
FOREWORD
This amendment has been prepared by subcommittee 62A: Common aspects of electrical
equipment used in medical practice, of IEC technical committee 62: Electrical equipment in
medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62A/1393/FDIS 62A/1408/RVD
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC web site under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC or
ISO publication in which to make products in accordance with the new requirements and to equip themselves for
conducting new or revised tests. It is the recommendation of the committee that the content of this publication be
adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.

___________
© IEC 2020
INTRODUCTION TO AMENDMENT 2
The first edition of IEC 60601-1-9 was published in 2007 and amended in 2013. Since the
publication of IEC 60601-1-9:2007+A1:2013, the IEC Subcommittee (SC) 62A Secretariat has
been collecting issues from a variety of sources including comments from National
Committees. At the November 2015 meeting of IEC/SC 62A in Kobe, Japan, the
subcommittee initiated a process to identify high-priority issues that need to be considered in
an amendment and should not wait until the second edition of IEC 60601-1-9, which is
presently targeted for publication sometime after 2024.
As directed in item 1 of Kobe Resolution 1, the IEC/SC 62A Chairman Advisory Group (CAG)
considered the 7 issues collected by the SC/62A Secretariat for IEC 60601-1-9:2007 and
determined that none met the selection criteria stated in Kobe Resolution 1.
However, an amendment is needed to update the reference to IEC 60601-1:2005+A1:2012
+A2:
...