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软件安全级别(Software Safety Classification)

当前时间： 2026-06-30 10:40:45 分类：办公文件 评论(0)
软件安全级别(Software Safety Classification)
前面提到软件生存周期医疗器械软件生存周期（life cycle），在软件生存周期过程标准IEC 62304:2015/YYT 0664-2020版按软件对患者、操作者和其他人员的伤害风险，赋予每个软件系统一个软件安全级别(A、B或C)，即A级、B级和C级，可根据给出的流程图确定软件安全等级（见下图）。软件安全级别影响到生存周期质控及注册申报资料的要求，是十分重要的。

      国内《医疗器械软件注册审查指导原则（2022年修订版）》，软件安全性级别基于软件风险程度分为轻微、中等、严重三个级别，对应IEC62304/YYT0664定义的A级、B级和C级，一般来说嵌入式的软件安全级别应与产品注册分类一致。

同，《医疗器械网络安全注册审查指导原则（2022年修订版）》网络安全性级别与软件安全级别一致。若网络安全的安全性级别低于软件的安全性级别，需详述理由并按网络安全的安全性级别提交相应注册申报资料。同样，人工智能医疗器械的风险水平可用软件安全性级别表述。

     国内法规整体采用YY/T0664的软件安全级别，网络安全和算法作为软件的一部分进行监管，不同级别的软件，要求提供的注册申报资料（含网络安全，算法）有不同的要求。

     FDA软件现行指南《Content of Premarket Submissions for Device Software Functions  June 14, 2023》中将注册申报软件需要提交的资料分为基本文档级别（Basic Documentation Level）和增强文档级别（Enhanced Documentation Level），按照指南中给出的表1 文档清单要求提供相关的软件资料（这个后续整理）。

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  1. CONNECT:[ UseTime:0.000497s ] mysql:host=127.0.0.1;port=3306;dbname=wenku;charset=utf8mb4
  2. SHOW FULL COLUMNS FROM `fenlei` [ RunTime:0.000553s ]
  3. SELECT * FROM `fenlei` WHERE `fid` = 0 [ RunTime:0.000252s ]
  4. SELECT * FROM `fenlei` WHERE `fid` = 63 [ RunTime:0.000291s ]
  5. SHOW FULL COLUMNS FROM `set` [ RunTime:0.000488s ]
  6. SELECT * FROM `set` [ RunTime:0.000198s ]
  7. SHOW FULL COLUMNS FROM `article` [ RunTime:0.000505s ]
  8. SELECT * FROM `article` WHERE `id` = 818078 LIMIT 1 [ RunTime:0.000337s ]
  9. UPDATE `article` SET `lasttime` = 1782855465 WHERE `id` = 818078 [ RunTime:0.000696s ]
  10. SELECT * FROM `fenlei` WHERE `id` = 64 LIMIT 1 [ RunTime:0.000297s ]
  11. SELECT * FROM `article` WHERE `id` < 818078 ORDER BY `id` DESC LIMIT 1 [ RunTime:0.003874s ]
  12. SELECT * FROM `article` WHERE `id` > 818078 ORDER BY `id` ASC LIMIT 1 [ RunTime:0.002051s ]
  13. SELECT * FROM `article` WHERE `id` < 818078 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.001267s ]
  14. SELECT * FROM `article` WHERE `id` < 818078 ORDER BY `id` DESC LIMIT 10,10 [ RunTime:0.000977s ]
  15. SELECT * FROM `article` WHERE `id` < 818078 ORDER BY `id` DESC LIMIT 20,10 [ RunTime:0.003113s ]
0.091230s