SFS-EN ISO 17665:2024:en

Soveltamisala

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This document provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices. It also contains guidance which is intended to explain the requirements set forth in the normative sections. The guidance given is intended to promote good practice related to moist heat sterilization processes according to this document. The application within industrial and health care settings is considered.

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Sisällysluettelo

Foreword
Introduction
1 Scope

1.1 Inclusions
1.2 Exclusions

2 Normative references
3 Terms and definitions
4 General
5 Sterilizing agent characterization

5.1 Sterilizing agent
5.2 Microbicidal effectiveness
5.3 Effects on materials
5.4 Environmental consideration

6 Process and equipment characterization

6.1 General
6.2 Process characterization
6.3 Saturated steam sterilization processes
6.4 Contained product sterilization processes
6.5 Equipment

7 Product definition
8 Process definition
9 Validation

9.1 General
9.2 Installation qualification (IQ)
9.3 Operational qualification (OQ)
9.4 Performance qualification (PQ)
9.5 Review and approval of validation

10 Routine monitoring and control

10.1 Routine monitoring
10.2 Operational status
10.3 Process verification
10.4 Evaluation of additional data for saturated steam sterilization processes
10.5 Evaluation of additional data for contained product sterilization processes.
10.6 Record retention

11 Product release from sterilization
12 Maintaining process effectiveness

12.1 Purpose
12.2 Demonstration of continued effectiveness
12.3 Recalibration
12.4 Equipment maintenance
12.5 Requalification
12.6 Assessment of change

Annex A Guidance on the principles of moist heat sterilization and rationales for requirements (informative)
Annex B Establishment and evaluation of a sterilization process primarily based on microbiological inactivation (informative)
Annex C Establishment and evaluation of a sterilization process primarily based on the measurement of physical parameters (informative)
Annex D Examples of moist heat sterilization cycles (informative)
Annex E Temperature and pressure of saturated steam for use in moist heat sterilization (informative)
Annex F Guidance on the application of the normative requirements in health care facilities (informative)
Annex G Guidance on the designation of a medical device to a product family and processing category for sterilization by moist heat (informative)
Annex H Guidance on the application of the normative requirements in industrial settings (informative)

Bibliography

Näytä kaikki

Foreword
Introduction
1 Scope

1.1 Inclusions
1.2 Exclusions

2 Normative references
3 Terms and definitions
4 General
5 Sterilizing agent characterization

5.1 Sterilizing agent
5.2 Microbicidal effectiveness
5.3 Effects on materials
5.4 Environmental consideration

6 Process and equipment characterization

6.1 General
6.2 Process characterization
6.3 Saturated steam sterilization processes
6.4 Contained product sterilization processes
6.5 Equipment

7 Product definition
8 Process definition
9 Validation

9.1 General
9.2 Installation qualification (IQ)
9.3 Operational qualification (OQ)
9.4 Performance qualification (PQ)
9.5 Review and approval of validation

10 Routine monitoring and control

10.1 Routine monitoring
10.2 Operational status
10.3 Process verification
10.4 Evaluation of additional data for saturated steam sterilization processes
10.5 Evaluation of additional data for contained product sterilization processes.
10.6 Record retention

11 Product release from sterilization
12 Maintaining process effectiveness

12.1 Purpose
12.2 Demonstration of continued effectiveness
12.3 Recalibration
12.4 Equipment maintenance
12.5 Requalification
12.6 Assessment of change

Annex A Guidance on the principles of moist heat sterilization and rationales for requirements (informative)
Annex B Establishment and evaluation of a sterilization process primarily based on microbiological inactivation (informative)
Annex C Establishment and evaluation of a sterilization process primarily based on the measurement of physical parameters (informative)
Annex D Examples of moist heat sterilization cycles (informative)
Annex E Temperature and pressure of saturated steam for use in moist heat sterilization (informative)
Annex F Guidance on the application of the normative requirements in health care facilities (informative)
Annex G Guidance on the designation of a medical device to a product family and processing category for sterilization by moist heat (informative)
Annex H Guidance on the application of the normative requirements in industrial settings (informative)

Bibliography

Tuoteryhmä(t)

11.080.01 Sterilointi ja desinfiointi, yleistä »

Sidokset

Velvoittavat viittaukset

ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
ISO 11138-3:2017 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
ISO 11140-1:2014 Sterilization of health care products — Chemical indicators — Part 1: General requirements

ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
ISO 11138-3:2017 Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
ISO 11140-1:2014 Sterilization of health care products — Chemical indicators — Part 1: General requirements
ISO 11140-3:2007 Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
ISO 11140-3:2007/Cor 1:2007 Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test — Technical Corrigendum 1
ISO 11140-4:2007 Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
ISO 11140-5:2007 Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
ISO 11140-6:2022 Sterilization of health care products — Chemical indicators — Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers
ISO 11607-1:2019 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2019 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11737-1:2018 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
ISO 11737-2:2019 Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

Tekninen komitea

CEN/TC 204 Sterilization of medical devices »

Direktiivi

2017/745
2017/746

http://ec.europa.eu »

Vahvistuspäivä

10.05.2024

Julkaisupäivä

14.05.2024

Painos

1

Sivumäärä

165

Julkaisun kieli

englanti