第二版中未提及的安全方面的考虑因素和新要求的建议

[中文适用范围]： 本技术报告包含由 IEC 技术委员会 62A（医疗实践用电气设备的通用方面）的专家工作组制定的一系列建议，旨在回应关于 IEC 60601-1 第二版解释的问题。本技术报告主要供以下各方使用：医用电气设备制造商；负责评估符合 IEC 60601-1:1988 的测试机构及其他相关方；以及制定 IEC 60601-1 后续版本的人员。IEC/TR 62296 第一版中的建议已在准备 IEC 60601-1 第三版时予以考虑。随着 IEC 60601-1 第三版的发布，本版 IEC/TR 62296 中的一些建议已修改以与 IEC 60601-1:2005 的要求保持一致。IEC/SC 62A/WG 14 还制定了七项额外建议（建议 57 至 63），并包含在本版 IEC/TR 62296 中。 [外文原描述]： 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.