ISO 11737-2-2019 Sterilization of health care products-Microbiological methods Part 2 Tests of sterility performed in the definition, validation and maintenance

VIP免费

3.0 逍遥000 2026-09-29 8 410.71KB 24 页 200质量币

侵权投诉

Sterilization of health care products —

Microbiological methods —

Part 2:

Tests of sterility performed in



maintenance of a sterilization process

Stérilisation des produits de santé — Méthodes microbiologiques —



de la validation et de la maintenance d'un procédé de stérilisation

INTERNATIONAL

STANDARD

ISO

11737-2

Third edition

2019-12

Reference number

ISO 11737-2:2019(E)











CP 401 • Ch. de Blandonnet 8



Phone: +41 22 749 01 11





Website: www.iso.org

Published in Switzerland

ISO 11737-2:2019(E)

Foreword ........................................................................................................................................................................................................................................

Introduction ................................................................................................................................................................................................................................

1 Scope ................................................................................................................................................................................................................................. 1

  ...................................................................................................................................................................................... 1

  ..................................................................................................................................................................................... 1

4 General ............................................................................................................................................................................................................................ 3

5 Selection of product .......................................................................................................................................................................................... 4

  ........................................................................................................................................................................................................... 4

5.2 Sample item portion (SIP) ............................................................................................................................................................. 4

5.3 Packaging of product and sample item portions ....................................................................................................... 5

6 Methods for performing tests of sterility.................................................................................................................................... 5

7 Assessment of the method for performing tests of sterility ....................................................................................6

8 Maintenance of the method for performing tests of sterility................................................................................. 6

Annex A (informative)

maintenance of a sterilization process ......................................................................................................................................... 7

Annex B (informative) Typical assignment of responsibilities .............................................................................................. 14

Bibliography .............................................................................................................................................................................................................................15

Contents Page

文档加载中……请稍候！
如果长时间未打开，您也可以点击刷新试试。

下载文档到电脑，查找使用更方便

立即下载 VIP免费下载

标签： #ISO #无菌性测试 #灭菌

摘要：

医疗用品的灭菌--微生物学方法第二部分:进行的无菌性测试在灭菌工艺的界定、验证及维持过程中进行的无菌性测试

展开>> 收起<<

ISO 11737-2-2019 Sterilization of health care products-Microbiological methods Part 2 Tests of sterility performed in the definition, validation and maintenance.PDF

共24页,预览24页

还剩页未读，继续阅读

声明：如果您的权利被侵害，请联系我们的进行举报。

ISO 11737-2-2019 Sterilization of health care products-Microbiological methods Part 2 Tests of sterility performed in the definition, validation and maintenance

相关推荐

相关内容

热门标签

举报选择: