IEC 60601-2-37:2001/AMD2:2005

Amendment 2 - Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment

General Information

• Status: Published
• Publication Date: 27-Nov-2005
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 17.140.50 - Electroacoustics
• Technical Committee: SC 62B - Medical imaging equipment, software, and systems
• Drafting Committee: MT 34 - TC 62/SC 62B/MT 34
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 09-Aug-2007

Relations

• Amends: IEC 60601-2-37:2001 - Medical electrical equipment - Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
• Effective Date: 05-Sep-2023
• Revised: IEC 60601-2-37:2007 - Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD 60601-2-37
AMENDMENT 2
2005-11
Amendment 2
Medical electrical equipment –
Part 2-37:
Particular requirements for the safety
of ultrasonic medical diagnostic
and monitoring equipment
 IEC 2005 Droits de reproduction réservés  Copyright - all rights reserved
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– 2 – 60601-2-37 Amend. 2  IEC:2005(E)

FOREWORD
This amendment has been prepared by subcommittee 62B: Diagnostic imaging equipment, 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
62B/591/FDIS 62B/598/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 publication will remain unchanged until
the maintenance result 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• withdrawn;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.
_____________
Page 8
1.3.101 Related international standards
Add, to the existing list, the following new standard.
ISO 14971:2000, Medical devices – Application of risk management to medical devices
Amendment 1 (2003)
Page 19
6.8.2 INSTRUCTIONS FOR USE
aa) Add, on page 20, to the existing list of items, the following new item:

14) declaration of output limits as s
...