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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Reference number
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
ii
ISO 17665:2024(en)
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◎ISO 2024
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Published in Switzerland
◎ISO 2024-All rights reserved
iii
ISO 17665:2024(en)
Contents Page
Forewor ...................................................................................................................................................................................... V
Introduction ........................................................................................................................................................................... vi
1 Scope ...................................................................................................................................................................................
1
1.1 Inclusions ........................................................................................................................................................... 1
1.2 Exclusions ...........................................................................................................................................................
1
2 Normative references ............................................................................................................................................. 2
3 Terms and definitions ...............................................................................................................................................
2
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 ...................................
27
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
◎ISO 2024-All rights reserved
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ReferencenumberSterilizationofhealthcareproducts—Moistheat—Requirementsforthedevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevicesStérilisationdesproduitsdesanté—Chaleurhumide—Exigencespourledéveloppement,lavalidationetlecontrolederoutined'unprocédédestérilisationdesdisposi...
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作者：薛定谔的龙猫
分类：法规规范
价格：60质量币
属性：164 页
大小：1.67MB
格式：PDF
时间：2025-11-13
