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]： IEC 60601 系列的这份文件（技术报告）包含了一系列由 IEC 第 62A 分委员会专家工作组制定的建议，旨在回应关于 IEC 60601-1:2005 及相关衍生标准解释的疑问。本文件主要供以下人员使用：医疗设备制造商；测试实验室及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；以及负责编写 IEC 60601-1 后续版本的人员。第一版 IEC TR 62296 中的建议已考虑用于第三版 IEC 60601-1 的编写。同样，预期这些在 IEC 60601-4-3 中的建议将在编写 IEC 60601-1 及其相关衍生标准的未来修订版时予以考虑。本文件的目的是使对应用第三版 IEC 60601-1 及适用的衍生标准感兴趣的各方能够获得这些建议/解释。注：可能有其他可接受的解决方案未在本文档中反映。读者应注意的是，虽然 IEC/SC 62A 的多数国家委员会成员已批准发布本文件，但其内容仍为参与起草的专家成员的意见。这些建议/解释是该组提名专家考虑的结果，并未经过任何国家委员会的正式投票程序。分发仅供参考。 [外文原描述]： 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.