ISO 17665:2024 Standard

Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices

Available format(s)

Hardcopy , PDF

Language(s)

English, French

Published date

01-03-2024

Publisher

International Organization for Standardization

€219.00

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Summarise this standard

AI-generated summary

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.

Committee	ISO/TC 198
DocumentType	Standard
Pages	154
PublisherName	International Organization for Standardization
Status	Current
Supersedes	ISO/TS 17665-3:2013 ISO/TS 17665-2:2009 ISO/FDIS 17665 ISO 17665-1:2006

Standards	Relationship
I.S. EN ISO 17665:2024	Equivalent
DIN EN ISO 17665:2024-09	Equivalent
BS EN ISO 17665:2024	Equivalent
DS/ISO 17665:2024	Identical
SS-EN ISO 17665:2024	Identical
DS/EN ISO 17665:2024	Identical
UNE-EN ISO 17665:2025	Identical

Frequently Asked Questions

ISO 17665 is an international standard published by International Organization for Standardization (ISO), and is applied internationally rather than in a single country.

ISO 17665 is published by International Organization for Standardization (ISO). It is an international standard.

ISO 17665 belongs to the topic area of medical device processing and information. It is an international standard published by International Organization for Standardization (ISO).

ISO 17665 provides requirements, guidance or test methods for medical-device packaging, sterilisation or product information controls. It is an international standard published by International Organization for Standardization (ISO).

ISO 17665 is International Organization for Standardization (ISO)'s standard for medical device processing and information, while ISO 11607-2 covers terminally sterilised medical device packaging (International). ISO 17665 provides requirements, guidance or test methods for medical-device packaging, sterilisation or product information controls. ISO 11607-2 specifies requirements for sterile barrier systems and packaging process validation for terminally sterilised medical devices.

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ISO 17665:2024

Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices

Abstract

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International Equivalents

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What is the difference between ISO 17665 and ISO 11607-2?