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)

C ISO 2020

be reproduced or utilized otherwise in any form or by any means,electronic or mechanical,including photocopying,or posting

on the internet or an intranet,without prior written permission.Permission can be requested from either ISO at the address

below or ISO's member body in the country of the requester.

ISO copyright office

CP 401·Ch.de Blandonnet 8

CH-1214 Vernier,Geneva

Phone:+41227490111

Email:copyright@iso.org

Website:www.iso.org

Published in Switzerland

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 ....................................................................................................................

5 Sterilization agent characterization ...........................................................................................................

6 Process and equipment characterization ..............................................................................................

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 ............................................................................................................................................

9 Validation ...........................................................................................................................................................

9.1 General .................................................................................................................................................

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

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标签： #医疗器械 #验证 #指南

摘要：

TECHNICALSPECIFICATIONISO/TS21387Firstedition2020-09Sterilizationofmedicaldevices—GuidanceontherequirementsforthevalidationandroutineprocessingofethyleneoxidesterilizationprocessesusingparametricreleaseStérilisationdesdispositifsmédicaux—Lignesdirectricesconcernantlesexigencesdevalidationetdetraitem...

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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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