IEC 61318:2021本文件定义了评估缺陷和验证制造商工艺后的产品符合相应产品标准要求的方法。 本文件详细介绍了带电工作产品缺陷评估的原则，以帮助产品标准制定者规定最佳方法，以实现每个成品工具、装置和设备的适当质量。 本文件未涵盖以下要素，但包含在每个产品标准中: -型式试验； -常规、抽样和验收测试的规定和说明； -缺陷的识别和分类； -风险分析。 本文件不涵盖商业装运或认证的合格评定。 这第四版取消并取代了2007年出版的第三版。本版构成技术修订版。 与上一版相比，此版本包括以下重大技术变更: a)将文件的目的从规定性测试标准变更为协助项目组符合相应产品标准的标准。 b）引入符合性试验、工艺记录、质量控制文件，适应标准产品。 c)改变规定的取样程序，使取样试验适应产品标准。 d)删除“合格评定”一词。 e)引入术语“验证方法”取代“合格评定申请”。

IEC 61318:2021 This document defines methods to assess defects and to verify that products after the manufacturer process meet the requirements of the corresponding product standard.
The principles of assessment of defects for live working products are detailed in this document to assist product standard developers in prescribing the best means to achieve suitable quality of every finished tool, device and piece of equipment.
The following elements are not covered by the present document, but are included in each product standard:
– type tests;
– provisions and description for routine, sampling and acceptance tests;
– identification and classification of defects;
– risk analysis.
This document does not cover conformity assessment of commercial shipments or certifications.
This fourth edition cancels and replaces the third edition published in 2007. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) change of the purpose of the document from a prescriptive testing standard to a standard assisting the project team in the conformance to respective product standard.
b) introduction of conformance test, record of process, quality control documentation, adapted to the standard product.
c) change of prescribed sampling procedure to adapted sampling tests to the product standard.
d) suppression of the term “conformity assessment”.
e) Introduction of the term “verification method” replacing “conformity assessment application”.