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IEC TR 62296:2009
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Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
IEC 60601-1第二版中未提及的安全方面的考虑因素和新要求的建议
IEC/TR 62296:2009(E)包含IEC小组委员会62A的专家工作组针对IEC 60601-1第二版的解释问题制定的一系列建议。IEC/TR 62296:2009(E)主要用于:
-医疗电气设备制造商;
-测试机构和其他负责评估是否符合IEC 60601-1:19 88的机构,以及
-开发IEC 60601-1后续版本的人员。
在编写IEC 60601-1第三版时考虑了IEC/TR 62296第一版中的建议。随着IEC 60601-1第三版的发布,IEC/TR 62296第二版中的一些建议已经更改,以符合IEC 60601-1:20 05中的要求。IEC/SC 62A/WG 14制定了七项附加建议,并包含在本期IEC/TR 62296中。它们是建议57至63。这第二版取消并取代了2003年出版的第一版。它构成技术修订。本版包括七项新建议:建议57至63。随着IEC 60601-1第三版的发布,该版本中的一些建议已进行更改,以符合IEC 60601-1:20 05中的要求。
IEC/TR 62296:2009(E) 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. IEC/TR 62296:2009(E) 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 second edition cancels and replaces the first edition published in 2003. It constitutes a technical revision. This edition includes seven new recommendations: Recommendations 57 through 63. As the third edition of IEC 60601-1 has been published, some of the recommendations in this edition have been changed to align with requirements in IEC 60601-1:2005.