本产品提供4小时免费咨询。SEPT将在购买后60天内回答有关标准或检查表的任何问题。新订购“自解压文件格式”选项，以在可编辑的Microsoft Word文档中获取此产品！本检查表是为了符合2005年的3.0版，而不是2012年的3.1版《14电气医疗系统》（PEMS）。本标准包含一般适用于医用电气设备的基本安全和基本性能要求。对于某些类型的医用电气设备，这些要求可以通过附带或特定标准的特殊要求进行补充或修改。如果存在特定标准，则不应单独使用本标准。第14条是本标准的软件部分。 然而，有时很难确定构成符合第14条所述要求的物证的内容。为了弥合这一差距，作者和SEPT专家根据他们对文件的了解和在质量领域的经验，确定了标准中要求的物证项目。这些专家确定的每一项物证都列在清单中:；政策、程序、计划、记录、文件或审查。本检查表围绕物证分类方案构建，包括政策、程序、计划、记录、文件和审查。需要或建议的物证项目超过100项。在本清单中，“手册、报告、脚本和规范”包含在文件类别中。

This product comes with 4 hours of free consultation. SEPT will answer any question concerning the standard or Checklist for 60 days after purchase.New! Order the "Self-Extracting File Format" option to get this product in an editable Microsoft Word document!This checklist was written to conform to edition 3.0 from 2005, not the consolidated 2012 version 3.1Clause 14 Electrical Medical Systems (PEMS).This standard contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone. Clause 14 is the software section of this standard. However, what constitutes physical evidence to meet the requirements outlined in Clause 14 is sometimes difficult to identify. To bridge this gap the author and SEPT experts have identified items of physical evidence called out in the standard based on their knowledge of the document and their experience in the quality field. Each item of physical evidence that was identified by these experts is listed in the checklist as; policy, procedure, plan, records, document or reviews.This checklist is constructed around a classification scheme of physical evidence comprised of policies, procedures, plans, records, documents, and reviews. There are over 100 required or suggested items of physical evidence. In this checklist "manuals, reports, scripts and specifications" are included in the document category.