PD ISO/TS 17665-3:2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Hardcopy , PDF
English
31-12-2013
08-05-2024
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Superseded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 |
A newer version of this standard is available.
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