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ANSI/AAMI/IEC TIR62348:2012

Current
Current

The latest, up-to-date edition.

ASSESSMENT OF THE IMPACT OF THE MOST SIGNIFICANT CHANGES IN AMENDMENT 1 TO IEC 60601-1:2005 AND MAPPING OF THE CLAUSES OF IEC 60601-1:2005 TO THE PREVIOUS EDITION
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

12-31-2012

Glossary of equivalent standards
Committee representation
Background of AAMI adoption of IEC/TR 62348:2012
FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 Assessment of the changes in Amendment 1:2012
5 Changes impacting many users of the standard
6 Changes impacting particular users of the standard
7 Mapping
Bibliography

Gives a tool to assist users of IEC 60601-1 to trace requirements between the third edition and their source in the documents that form the basis of the third edition; principally the second edition as amended.

Committee
SC 62A
DocumentType
Standard
ISBN
1-57020-475-6
Pages
12
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current
Supersedes

IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV Information technology equipment - Safety - Part 1: General requirements
IEC 61558-2-15:2011 Safety of transformers, reactors, power supply units and combinations thereof - Part 2-15: Particular requirements and tests for isolating transformers for the supply of medical locations
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60127-1:2006+AMD1:2011+AMD2:2015 CSV Miniature fuses - Part 1: Definitions for miniature fuses andgeneral requirements for miniature fuse-links
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
IEC 61558-1:2017 Safety of transformers, reactors, power supply units and combinations thereof - Part 1: General requirements and tests
IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
ISO 14971:2007 Medical devices Application of risk management to medical devices
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems

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