NF EN ISO 11137-3

NF EN ISO 11137-3

July 2017
Standard Current

Sterilization of health care products - Radiation - Part 3 : guidance on dosimetric aspects of development, validation and routine control

ISO 11137-3:2017 gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process.

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Main informations

Collections

National standards and national normative documents

Publication date

July 2017

Number of pages

51 p.

Reference

NF EN ISO 11137-3

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-103-3

Print number

1

International kinship

ISO 11137-3:2017

European kinship

EN ISO 11137-3:2017
Sumary
Sterilization of health care products - Radiation - Part 3 : guidance on dosimetric aspects of development, validation and routine control

ISO 11137-3:2017 gives guidance on meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004 relating to dosimetry and its use in development, validation and routine control of a radiation sterilization process.

Replaced standards (1)
NF EN ISO 11137-3
October 2006
Standard Cancelled
Sterilization of health care products - Radiation - Part 3 : guidance on dosimetric aspects

ISO 11137-3:2006 gives guidance on the requirements in ISO 11137 parts 1 and 2 relating to dosimetry. Dosimetry procedures related to the development, validation and routine control of a radiation sterilization process are described.

Table of contents
  • Avant-propos européen
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes, définitions et symboles
  • 4 Mesure de la dose
  • 5 Établissement de la dose maximale acceptable
  • 6 Établissement de la dose stérilisante
  • 7 Qualification de l'installation
  • 8 Qualification opérationnelle
  • 9 Qualification des performances
  • 10 Surveillance et contrôle de routine
  • Annexe A (informative) Modélisation mathématique
  • Annexe B (informative) Tableaux des références pour les essais de dosimétrie pendant la QI/QO/QP
  • Annexe C (informative) Tolérances associées aux doses utilisées dans le réglage/ la justification de la dose stérilisante de l'ISO 11137-2 et l'ISO/ TS
    13004
  • Annexe D (informative) Application de l'incertitude de la mesure de dose dans le réglage des doses cibles du procédé
  • Bibliographie
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