医用电气设备第4-3部分:指南和解释IEC 60601-1第三版中未提及的安全方面的考虑和新要求的建议

[中文适用范围]： 本部分IEC 60601是一份技术报告，包含由IEC分技术委员会62A的专家工作组针对IEC 60601-1:2005及其相关IEC 60601系列配套标准的解释问题制定的一系列建议。 本文档主要供以下人员使用： - 医疗电气设备制造商； - 测试实验室和其他负责评估是否符合IEC 60601-1:2005、IEC 60601-1:2005/AMD1:2012、IEC 60601-1-8:2006、IEC 60601-1-8:2006/AMD1:2012、IEC 60601-1.11:2010、IEC 60601-1-11:2015和IEC 60601-1-12:2014的人员； - 制定IEC 60601-1后续版本的人员。 在准备IEC 60601-1第三版时考虑了IEC TR 62296第一版的建议。同样，预计在准备IEC 60601-1及其相关IEC 60601系列配套标准的未来修订版时，将考虑IEC 60601-4-3中的这些建议。 本文档的目的是使那些对IEC 60601-1第三版及相关配套标准应用感兴趣的人能够获得这些建议/解释。 注：可能存在其他可接受的解决方案，但未在本文档中反映。提醒读者，尽管IEC/SC 62A的多数国家委员会成员已批准发布本文档，但内容仍代表参与起草文件的专家成员的意见。这些建议/解释是由该专家组提名文件审议的结果，但未通过任何国家委员会投票程序正式通过。分发仅供参考。 [外文原描述]： IEC TR 60601-4-3:2018 RLV contains both the official IEC International Standard and its Redline version. The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition. IEC TR 60601-4-3:2018 contains a series of recommendations developed by an expert working group of IEC subcommittee 62A in response to questions of interpretation of IEC 60601-1:2005 and related collateral standards in the IEC 60601 series. IEC TR 60601-4-3:2018 is primarily intended to be used by: – manufacturers of medical electrical equipment; – test laboratories and others responsible for assessment of compliance with IEC 60601 1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012, IEC 60601-1-11:2010, IEC 60601 1 11:2015 and IEC 60601-1-12:2014; – 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. Similarly, it is expected that these recommendations within IEC 60601-4-3 will be considered when preparing future revisions of IEC 60601-1 and related collateral standards in the IEC 60601 series. The object of IEC TR 60601-4-3:2018 is to make the recommendations/interpretations available to those interested in the application of the third edition of IEC 60601-1 and applicable collateral standards. IEC TR 60601-4-3:2018 cancels and replaces the first edition of IEC 60601-4-3 published in 2015. This edition constitutes a technical revision. IEC TR 60601-4-3:2018 includes the following significant technical changes with respect to the previous edition: addition of 47 new recommendations.