NF EN ISO 11137-3

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.

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Main informations

Collections

National standards and national normative documents

Publication date

October 2006

Number of pages

29 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 - 20/10/2006

International kinship

ISO 11137-3:2006

European kinship

EN ISO 11137-3:2006
Sumary
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.

Replaced standards (3)
NF EN 552
October 1994
Standard Cancelled
Sterilization of medical devices. Validation and routine control of sterilization by irradiation.

Ce document spécifie les exigences concernant la validation, la maîtrise du procédé et la surveillance de lastérilisation des dispositifs médicaux par irradiation.

NF EN 552/A1
July 1999
Standard Cancelled
Sterilization of medical devices - Validation and routine control of sterilization by irradiation

Le présent document modifie les annexes A et B.

NF EN 552/A2
February 2001
Standard Cancelled
Sterilization of medical devices - Validation and routine control of sterilization by irradiation

Le présent document modifie le paragraphe 4.2.1 b), pour résoudre les différences dans l'interprétation des prescriptions techniques concernant l'établissement de la dose stérilisante.

Standard replaced by (1)
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.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Mesure de la dose
    1
  • 5 Sélection et étalonnage des systèmes de dosimétrie
    2
  • 5.1 Généralités
    2
  • 5.2 Sélection des systèmes de dosimétrie
    2
  • 5.3 Étalonnage du système de dosimétrie
    2
  • 6 Établissement de la dose maximale acceptable
    2
  • 7 Établissement de la dose stérilisante
    3
  • 8 Qualification de l'installation
    4
  • 9 Qualification opérationnelle
    5
  • 9.1 Généralités
    5
  • 9.2 Irradiateurs à rayons gamma
    5
  • 9.3 Irradiateurs à faisceau d'électrons
    7
  • 9.4 Irradiateurs à rayons X
    8
  • 10 Qualification des performances
    10
  • 10.1 Généralités
    10
  • 10.2 Rayons gamma et rayons X
    10
  • 10.3 Faisceau d'électrons
    11
  • 11 Surveillance et contrôle de routine
    12
  • 11.1 Généralités
    12
  • 11.2 Fréquence des mesurages de la dose
    13
  • Annexe A (informative) Modélisation mathématique
    14
  • Bibliographie
    17
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