ISO TS 21387-2020医疗器械灭菌 采用参数放行的环氧乙烷灭菌工艺验证及常规处理要求指南
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TECHNICAL
SPECIFICATION
ISO/TS
21387
First edition
2020-09
Sterilization of medical devices —
Guidance on the requirements for the
validation and routine processing of
ethylene oxide sterilization processes
using parametric release
Stérilisation des dispositifs médicaux—Lignes directrices concernant
les exigences de validation et de traitement de routine des procédés de
stérilisationà I'oxyde d'éthylène par libération paramétrique
Reference number
ISO/TS 21387:2020(E)
@ISO 2020
ISO/TS 21387:2020(E)
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Published in Switzerland
ii ◎ISO 2020-All rights reserved
ISO /TS 21387:2020(E)
Contents Page
Foreword ....................................................................................................................................................................iv
Introductio ................................................................................................................................................................. V
1 Scope.................................................................................................................................................................. 1
2 Normative references ................................................................................................................................ 1
3 Terms and definitions ..................................................................................................................................1
4 Quality management systems ....................................................................................................................
2
5 Sterilization agent characterization ...........................................................................................................
2
6 Process and equipment characterization ..............................................................................................
2
6.1 General ................................................................................................................................................ 2
6.2 Process characterization ................................................................................................................ 2
6.3 Equipment characterization ............................................................................................................2
7Product definiti n
...........................................................................................................................................4
7.1 General ................................................................................................................................................ 4
7.2 Product safety , quality and performance ......................................................................................4
7.3 Microbiological quality .................................................................................................................... 4
8 Process definition ............................................................................................................................................
5
9 Validation ...........................................................................................................................................................
5
9.1 General .................................................................................................................................................
5
9.2 Installation qualification ....................................................................................................................6
9.2.1 Equipment .......................................................................................................................... 6
9.2.2 Installation qualification .................................................................................................... 7
9.3 Operational qualification ................................................................................................................... 7
9.4 Performance qualification ............................................................................................................... 8
9.4.1 General ................................................................................................................................ 8
9.4.2 Performance qualification — Microbiological ..............................................................9
9.4.3 Performance qualification — Physica ............................................................................ 9
9.5 Review and approval of validation...................................................................................................9
10 Routine monitoring and contro ............................................................................................................ 10
11 Product release from sterilization ........................................................................................................ 11
12 Maintaining process effectivenes ............................................................................................................12
12.1 General ............................................................................................................................................ 12
12.2 Maintenance of equipmen ...............................................................................................................12
12.3 Requalification ...................................................................................................................................12
12.4 Assessment of change .................................................................................................................... 12
12.5 Assessment of equivalence ............................................................................................................ 13
13 ISO 11135:2014,AnnexA .......................................................................................................................... 13
14 ISO 11135:2014,AnnexB ........................................................................................................................13
AnnexA (informative ) Establishing specifications for parametric release based on routine
processing data ........................................................................................................................................ 14
Bibliography ............................................................................................................................................................ 17
◎ISO 2020-All rights reserved iii
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作者：冒牌货
分类：法规规范
价格：60质量币
属性：24 页
大小：284.32KB
格式：PDF
时间：2025-12-31
