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！2000年4月版IEC 60601-1-4“医用电气设备——第一部分:安全通用要求——第4节，附属标准:可编程医用电气系统”的新增和更新检查表。为了反映这一变化，SEPT分析了这个新版本，并添加了100多个支持合规性的物证项目（根据要求或建议）。该清单使用了一个物证分类方案，包括程序、计划、记录、文件、审计和审查。本修订版通过提供易于使用的产品证据清单澄清了合规性所需的内容，该清单将帮助任何软件组织满足本标准的要求。 对于医疗器械公司来说，使用检查表将节省时间和金钱，并可能有助于满足某些政府要求。清单是一款价格合理的优质产品！

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!New and updated checklist for the April, 2000 version of IEC 60601-1-4, "Medical Electrical Equipment - Part I: General Requirements for Safety - Section 4, Collateral Standard: Programmable Electrical Medical Systems".To reflect the change SEPT has analyzed this new version and added over 100 physical evidence items that enable compliance, (either as required or recommended items). The Checklist uses a classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews. This revision clarifies what is required for compliance by providing an easy-to-use product evidence list that will assist any software organization in meeting the requirements of this standard. For medical device firms, use of the Checklist will save time and money, and may aid in meeting certain governmental requirements.The Checklist is a quality product at a reasonable price!