IEC  60601-1第三版 对可编程医疗电气系统PEMS的要求
14可编程医疗电气系统（以下简称PEMS）
14.1概述
本条款适用于PEMS，下列情况除外：
— PESM提供的功能或性能 不属于基本安全或基本性能;；或
— 符合ISO14971标准,，即PEMS的故障不会导致不可接受的风险。
否则，则这章节应适用。
注1：本章要求在整个PEMS开发生命周期要遵照一定的过程，并且要建立该过程的记录。
14.2 文件化
第14章要求的 文件 是ISO14971中规定的记录和文件的补充，应作为风险管理文档的一部分。
14.3 风险管理计划 应引用 PEMS确认计划 （风险管理中 应包含 软件风险的评估）
…… 更详细的要求见 本文档后面附录：IEC 60601-1第三版 对可编程医疗电气系统PEMS的要求
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提供以下 软件文件列表 或 按“软件确认报告 模板”提供相关的文件：（表格用英文填写）
Deliverables（表格用英文填写）
Title 相关文件名称
Document No.:
文档编号
revision #:版本
Date
发布日期
PEMS开发生命周期计划
PEMS requirements specification    PEMS 需求说明
　
　
　
validation verificationSubsystems requirements specification 子系统需求说明
　
　
　
PEMS architecture specification  PEMS架构说明
　
　
　
Subsystems architecture specification  子系统架构说明
　
　
　
Design specification 设计说明
　
　
　
Test specification 测试说明
　
　
　
Descriptive data regarding the design environment   
设计开发环境的相关数据
　
　
　
Verification plan 验证计划
　
　
　
Verification methods and results for each hazard
每个危害的验证方法和结果 （---软件风险的验证）
　
　
　
Validation plan 确认计划
　
　
　
Validation methods and results for each hazard
每个危害的确认方法和结果
　
　
　
Modification/change procedures  设计更改控制程序
　
　
　
Assessment report  评估报告
　
　
　
软件确认报告 模板
（本文档仅供参考，IEC 60601-1第三版 对可编程医疗电气系统PEMS的要求---见此文档后面的附录）
1. 软件描述
简单概述下 软件实现的功能有哪些
1.Purpose and Scope
This document gives a comprehensive overview of the XXXX features that are controlled by software, and describe the intended operational environment.
1.1Product specification and performance
The intended use of this device is ……
1.2Function
如：The software of the XXXX includes the following functions:
●The LCD display Control
●Time clock and NV Memory (nonvolatile memory) management
●Pressure measuring
●Keyboards control (flow meter knot )
●Alarm system (such as buzzer audio alarm control )……
2. Software Development Environment Description
Software development life cycle plan 软件设计生命周期计划
软件生命周期
计划
起始-完成时间
负责人 或小组成员
实际完成时间
设计输出文件
（文件编号+文件名称+版本）
备注
系统分析及软件定义
软件需求分析
软件确认计划
软件详细设计、编程
软件验证（单元测试、系统集成和系统测试）
软件确认（安装与确认）
软件发布、维护、终止
……
3. 软件设计需求及架构
3.1  Third-party and off-the-shelf (OTS) software 第三方或现用软件（适用时）
These requirements should include the following:
– title and manufacturer, version level, release date, patch number and upgrade designation;
– the system hardware and software necessary to support proper operation (e.g. processor type and speed, memory type and size, and system, communication and display software requirements);
– interfaces to the software component;
– safety critical and RISK CONTROL measure functions dependent on the software component.
3.2  Integration 系统集成（对于复杂的系统 适用时）
The developer should establish an integration plan to integrate the components of each PESS and of the PEMS. The plan should include the approach, responsibilities and sequence, and include all software components.
3.3 Requirements specification 需求说明 （依 产品实际情况，包含以下 适用项目的相关内容）
The requirements should include, as appropriate to the PEMS software:
–functional and capability requirements, including ESSENTIAL PERFORMANCE, physical characteristics, and environmental conditions under which the software is to perform;
– interfaces external to the software;
– safety requirements including RISK CONTROL measures for hardware failures and potential software defects and specifications related to methods of operation and maintenance, environmental influences, and RISK CONTROL;
– software driven alarm signals, warnings and OPERATOR messages;
– security requirements, where lack of security would compromise safety;
– human-factors engineering requirements related to the use of the PEMS, including those related to support for manual operations, human-equipment interactions, constraints on personnel, and areas needing concentrated human attention that are sensitive to human errors and training;
– data definition and database requirements;
– installation and acceptance requirements for the PEMS software;
– documentation to be developed;
– operation and execution requirements;
– maintenance requirements.
3.4 Configuration management  配置管理
A configuration management plan should be established that describes:
– the items to be controlled;
– the configuration management activities;
– PROCEDURES and schedule for performing these activities;
– responsibilities for performing these activities;
–PROCEDURES to control the receipt, installation, and acceptance of each software component.
如：
配置管理
描述 其控制管理方式 或 引用的控制文件编号和名称
客户反馈管理
软件版本控制
软件升级控制
软件发布控制
设计更改控制
Modification/change control 更改控制
For modification/change control, the following should be performed:
– identification and recording of change requests;
– analysis and evaluation of the changes;
– approval or disapproval of the request;
– implementation, VERIFICATION and release of the modified software.
软件维护
软件文档控制管理

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