NF EN ISO 11137-2

NF EN ISO 11137-2

December 2015
Standard Current

Sterilization of health care products - Radiation - Part 2 : establishing the sterilization dose

ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.

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Main informations

Collections

National standards and national normative documents

Publication date

December 2015

Number of pages

85 p.

Reference

NF EN ISO 11137-2

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-103-2

Print number

1

International kinship

ISO 11137-2:2013

European kinship

EN ISO 11137-2:2015
Sumary
Sterilization of health care products - Radiation - Part 2 : establishing the sterilization dose

ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.

ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.

Replaced standards (1)
NF EN ISO 11137-2
August 2013
Standard Cancelled
Sterilization of health care products - Radiation - Part 2 : establishing the sterilization dose

<p>ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10<sup>−6</sup>. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.</p> <p>ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.</p>

Table of contents
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  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Définition et maintenance des familles de produits pour la détermination de la dose, la justification de la dose et l'audit de la dose stérilisante
  • 5 Choix et essai de produit pour l'établissement de la dose stérilisante
  • 6 Méthodes d'établissement de la dose
  • 7 Méthode 1: détermination de la dose à l'aide des informations de charge biologique
  • 8 Méthode 2: Détermination de la dose à l'aide des informations de fraction positive du dosage incrémental pour déterminer un facteur d'extrapolation
  • 9 Méthode VDmax - Justification de la dose stérilisante de 25 kGy ou de 15 kGy
  • 10 Audit de la dose stérilisante
  • 11 Exemples d'application
  • Bibliographie
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