CEN ISO/TS 13004:2014

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Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO/TS 13004:2013)

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Withdrawn date: 28-06-2023

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Published date: 28-05-2014

Publisher: Comite Europeen de Normalisation

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Table of Contents - (Show below) - (Hide below)

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

Abstract - (Show below) - (Hide below)

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.

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Committee	CEN/TC 204
Document Type	Technical Specification
ISBN
Pages
Published
Publisher	Comite Europeen de Normalisation
Status	Withdrawn

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Equivalent Standard(s)	Relationship
ONORM ONR CEN ISO/TS 13004 : 2014	Identical
PD CEN ISO/TS 13004:2014	Identical
DIN CEN ISO/TS 13004;DIN SPEC 13223:2014-10	Identical
UNI CEN ISO/TS 13004 : 2014	Identical
ISO/TS 13004:2013	Identical
DIN CEN ISO/TS 13004;DIN SPEC 13223:2014-10	Identical
S.R. CEN ISO/TS 13004:2014	Identical

Standards Referencing This Book - (Show below) - (Hide below)

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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