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PD ISO/TS 17665-3:2013

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-12-2013

Superseded date

08-05-2024

Superseded by

BS EN ISO 17665:2024

€365.60
Excluding VAT
Summarise this standard

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Product family (pf)
6 Processing category
7 Sterilization process parameters
8 Additional considerations
Annex A (informative) - Process parameters
Annex B (informative) - Characterization of a
        procedure set - Examples
Annex C (informative) - Designating a processing
        category
Annex D (informative) - Processing categories
        - Examples
Bibliography

Specifies 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 indentifying the aligning it to a processing category for a specific moist head sterilization process.

Committee
CH/198
DocumentType
Standard
Pages
62
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

This part of ISO 17665 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.

NOTE While this part of ISO 17665 is applicable to health care facilities, it may be used by a manufacturer of a sterile medical device and/or whenever information on reprocessing is required (see ISO17664).

Standards Relationship
ISO/TS 17665-3:2013 Identical

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A newer version of this standard is available.

View Current Edition
€365.60
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