ISO/TS 17665-3:2013

Sterilization of health care products — Moist heat — Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization

ISO/TS 17665-3:2013 provides guidance about the attributes of a medical device to be considered by the user when assigning a medical device to a product family for the purpose of identifying and aligning it to a processing category for a specific moist heat sterilization process.

Stérilisation des produits de santé — Chaleur humide — Partie 3: Directives concernant la désignation d'un dispositif médical pour une famille de produits et catégorie de traitement pour la stérilisation à la vapeur

General Information

• Status: Withdrawn
• Publication Date: 11-Apr-2013
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: ISO/TC 198 - Sterilization of health care products
• Drafting Committee: ISO/TC 198 - Sterilization of health care products

Relations

• Revised: 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
• Effective Date: 23-Apr-2020

Standards Content (Sample)

TECHNICAL ISO/TS
SPECIFICATION 17665-3
First edition
2013-04-15
Sterilization of health care
products — Moist heat —
Part 3:
Guidance on the designation of a
medical device to a product family
and processing category for steam
sterilization
Stérilisation des produits de santé — Chaleur humide —
Partie 3: Directives concernant la désignation d’un dispositif médical
pour une famille de produits et catégorie de traitement pour la
stérilisation à la vapeur
Reference number
ISO/TS 17665-3:2013(E)
©
ISO 2013

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ISO/TS 17665-3:2013(E)

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ii © ISO 2013 – All rights reserved

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ISO/TS 17665-3:2013(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
4.1 General attributes . 2
4.2 Detailed attributes . 2
5 Product family (pf) . 5
5.1 Example 1 — pf 1 . 6
5.2 Example 2 — pf 24. 6
5.3 Example 3 — pf 27. 7
6 Processing category . 8
7 Sterilization process parameters . 8
8 Additional considerations . 8
8.1 Services . 8
8.2 Process selection . 9
Annex A (informative) Process parameters .
...