ISO 17665-2024 医疗器械湿热灭菌工艺的开发、验证和常规控制要求医疗保健产品灭菌湿热灭菌要求

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Sterilization of health care

products—Moist heat—

Requirements for the development,

validation and routine control of

a sterilization process for medical

devices

Stérilisation des produits de santé—Chaleur humide—

Exigences pour le développement,la validation etle controle de

routine d'un procédé de stérilisation des dispositifs médicaux

ISO 17665:2024(en)

International

Standard

ISO 17665

First edition

2024-03

◎ISO 2024

ISO 17665:2024(en)

◎ISO 2024

Allrights reserved.Unless otherwise specified,or required in the context of its implementation,no part of this publication may

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 ofthe 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

iii

ISO 17665:2024(en)

Contents Page

Forewor ...................................................................................................................................................................................... V

Introduction ........................................................................................................................................................................... vi

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

1.1 Inclusions ........................................................................................................................................................... 1

1.2 Exclusions ...........................................................................................................................................................

2 Normative references ............................................................................................................................................. 2

3 Terms and definitions ...............................................................................................................................................

4 Genera ....................................................................................................................................................................... 12

5 Sterilizing agent characterization ..................................................................................................................... 13

5.1 Sterilizing agen ............................................................................................................................................... 13

5.2 Microbicidal effectivenes .............................................................................................................................14

5.3 Effects on materials ...................................................................................................................................... 14

5.4 Environmental consideration ..................................................................................................................... 14

6 Process and equipment characterization ..................................................................................................... 14

6.1 Genera .............................................................................................................................................................14

6.2 Process characterization ..............................................................................................................................14

6.3 Saturated steam sterilization processes ................................................................................................. 15

6.4 Contained product sterilization processes ........................................................................................... 16

6.5 Equipmen ...........................................................................................................................................................17

7 Product definition ................................................................................................................................................... 18

8 Process definition ..................................................................................................................................................... 20

9 Validation .....................................................................................................................................................................22

9.1 Genera ........................................................................................................................................................... 22

9.2 Installation qualification (IQ) .................................................................................................................. 23

9.3 Operational qualification (0Q ................................................................................................................... 23

9.4 Performance qualification (PQ) .............................................................................................................. 24

9.5 Review and approval of validation ........................................................................................................... 26

10 Routine monitoring and contro .........................................................................................................................26

10.1 Routine monitoring ....................................................................................................................................... 26

10.2 Operational status ......................................................................................................................................... 26

10.3 Process verification .......................................................................................................................................27

10.4 Evaluation of additional data for saturated steam sterilization processes ...................................

10.5 Evaluation of additional data for contained product sterilization processes ..............................27

10.6 Record retention ........................................................................................................................................... 28

11 Product release from sterilization ................................................................................................................... 28

12 Maintaining process effectivenes ..................................................................................................................... 28

12.1 Purpose .......................................................................................................................................................... 28

12.2 Demonstration of continued effectivenes ............................................................................................... 28

12.3 Recalibration ................................................................................................................................................... 29

12.4 Equipment maintenance ........................................................................................................................... 29

12.5 Requalification ............................................................................................................................................. 29

12.6 Assessment of change ..................................................................................................................................30

Annex A (informative ) Guidance on the principles of moist heat sterilization and rationales for

requirements ........................................................................................................................................................... 31

Annex B (informative ) Establishment and evaluation of a sterilization process primarily based

on microbiological inactivation ........................................................................................................................... 59

Annex C( informative ) Establishment and evaluation of a sterilization process primarily based

on the measurement of physical parameters .............................................................................................. 73

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标签： #医疗器械 #验证 #ISO

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ReferencenumberSterilizationofhealthcareproducts—Moistheat—Requirementsforthedevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevicesStérilisationdesproduitsdesanté—Chaleurhumide—Exigencespourledéveloppement,lavalidationetlecontrolederoutined'unprocédédestérilisationdesdisposi...

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ISO 17665-2024 医疗器械湿热灭菌工艺的开发、验证和常规控制要求医疗保健产品灭菌湿热灭菌要求

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