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ISO 11737-2 FRENCH

Stérilisation des produits de santé — Méthodes microbiologiques — Partie 2: Contrôles de stérilité pratiqués au moment de la définition, de la validation et de la maintenance d'un procédé de stérilisation

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Organization: ISO
Publication Date: 1 December 2019
Status: active
Page Count: 26
ICS Code (Medical microbiology): 07.100.10
ICS Code (Sterilization and disinfection in general): 11.080.01

Document History

ISO 11737-2 FRENCH
December 1, 2019
Stérilisation des produits de santé — Méthodes microbiologiques — Partie 2: Contrôles de stérilité pratiqués au moment de la définition, de la validation et de la maintenance d'un procédé de stérilisation
A description is not available for this item.
ISO 11737-2 FRENCH
November 15, 2009
Stérilisation des dispositifs médicaux - Méthodes microbiologiques - Partie 2: Contrôles de stérilité pratiqués au moment de la définition, de la validation et de la maintenance d'un procédé de stérilisation
A description is not available for this item.

References

This document references:
ISO 14644-7 - Cleanrooms and associated controlled environments Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
Published by ISO on October 1, 2004
This part of ISO 14644 specifies the minimum requirements for the design, construction, installation, test and approval of separative devices, in those respects where they differ from cleanrooms as...
This document references:
ISO 10012 - Measurement Management Systems - Requirements for Measurement Processes and Measuring Equipment
Published by ISO on April 15, 2003
This International Standard specifies generic requirements and provides guidance for the management of measurement processes and metrological confirmation of measuring equipment used to support and...
This document references:
14644-4 - Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up
Published by ISO on November 1, 2022
This document specifies the process for creating a cleanroom from requirements through to its design, construction and start-up. It applies to new, refurbished and modified cleanroom installations....
This document references:
ISO 11137-1 - Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2
Published by ISO on November 1, 2018
A description is not available for this item.
This document references:
ISO 11137-2 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
Published by ISO on June 1, 2013
This part of ISO 11137 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...
This document references:
ISO 14937 - Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
Published by ISO on October 15, 2009
Inclusions This International Standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a...
This document references:
ISO 17665-1 - Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Published by ISO on August 15, 2006
Inclusions This part of ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. NOTE Although the scope of this...
This document references:
ISO 9000 - Quality management systems — Fundamentals and vocabulary
Published by ISO on September 15, 2015
This International Standard describes the fundamental concepts and principles of quality management which are universally applicable to the following: — organizations seeking sustained success...
This document references:
ISO 9001 - Quality management systems — Requirements
Published by ISO on September 15, 2015
This International Standard specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet...
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