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AAMI TIR62296
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AAMI TIR62296 2009 Edition, January 1, 2009 Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
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Description / Abstract:
This technical report contains a series of recommendations
developed by an expert working group of IEC subcommittee 62A in
response to questions of interpretation of the second edition of
IEC 60601-1.
This technical report is primarily intended to be used by:
– manufacturers of MEDICAL ELECTRICAL EQUIPMENT;
– test houses and others responsible for assessment of compliance with IEC 60601-1:1988, and
– those developing subsequent editions of IEC 60601-1.
The recommendations in the first edition of IEC/TR 62296 were considered in preparing the third edition of IEC 60601-1. As the third edition of IEC 60601-1 has been published, some of the recommendations in the second edition of IEC/TR 62296 have been changed to align with requirements in IEC 60601-1:2005. Seven additional recommendations have been developed by IEC/SC 62A/WG 14 and are included in this edition of IEC/TR 62296. They are recommendations 57 through 63.
This technical report is primarily intended to be used by:
– manufacturers of MEDICAL ELECTRICAL EQUIPMENT;
– test houses and others responsible for assessment of compliance with IEC 60601-1:1988, and
– those developing subsequent editions of IEC 60601-1.
The recommendations in the first edition of IEC/TR 62296 were considered in preparing the third edition of IEC 60601-1. As the third edition of IEC 60601-1 has been published, some of the recommendations in the second edition of IEC/TR 62296 have been changed to align with requirements in IEC 60601-1:2005. Seven additional recommendations have been developed by IEC/SC 62A/WG 14 and are included in this edition of IEC/TR 62296. They are recommendations 57 through 63.