Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
|Publication Date:||1 January 2009|
|ICS Code (Medical equipment):||11.040|
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.