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PD CEN ISO/TS 13004:2014

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Sterilization of health care products — Radiation — Substantiation of selected sterilization dose: Method VDmaxSD
Available format(s)

Hardcopy , PDF

Superseded date

01-04-2023

Language(s)

English

Published date

07-31-2014

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Definition and maintenance of product families for
  sterilization dose substantiation and sterilization
  dose auditing
5 Selection and testing of product for substantiating and
  auditing a selected sterilization dose
6 Method VD[MAX][SD] - Substantiation of a selected
  sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5,
  or 35 kGy
7 Maintaining process effectiveness
8 Tables of values for SIP equal to 1,0 VD[max][SD], SIP
  dose reduction factor and augmentation dose corresponding
  to applicable values of average bioburden for selected
  sterilization doses of 17,5, 20, 22,5, 27,5, 30, 32,5
  and 35 kGy
9 Worked examples
Bibliography

Defines a method for substantiating a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 10[-6] or less for radiation sterilization of health care products.

ISO/TS 13004:2013 describes a method for substantiating a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 10?6 or less for radiation sterilization of health care products. ISO/TS 13004:2013 also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.

Committee
CH/198
DevelopmentNote
Renumbers and supersedes BS PD ISO/TS 13004. 2014 Version incorporates corrigendum to BS PD ISO/TS 13004. (07/2014)
DocumentType
Standard
Pages
68
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
CEN ISO/TS 13004:2014 Identical
ISO/TS 13004:2013 Identical

ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11737-2:2009 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose

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Hardcopy - English
PDF - English
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