IEC 82304-1:2016 健康软件 - 第1部分:产品安全的一般要求

标准编号：IEC 82304-1:2016

中文名称：健康软件 - 第1部分:产品安全的一般要求

英文名称：Health software - Part 1: General requirements for product safety

发布日期：2016-10-27

标准范围

IEC 82304-1:2016适用于在通用计算平台上运行的健康软件产品的安全性和保密性，其主要重点是对制造商的要求。它涵盖整个生命周期，包括健康软件产品的设计、开发、验证、安装、维护和处置。

IEC 82304-1:2016 applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for manufacturers.It covers the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products.

标准预览图