NF EN ISO 11137-2

NF EN ISO 11137-2

July 2006
Standard Cancelled

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

ISO 11137-2:2006 specifies methods of 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. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.ISO 11137-2:2006 defines product families for dose establishment and dose auditing.

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Main informations

Collections

National standards and national normative documents

Publication date

July 2006

Number of pages

76 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 - 30/06/2006

International kinship

ISO 11137-2:2006

European kinship

EN ISO 11137-2:2006
Sumary
Sterilization of health care products - Radiation - Part 2 : establishing the sterilization dose

ISO 11137-2:2006 specifies methods of 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. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose.

ISO 11137-2:2006 defines product families for dose establishment and dose auditing.

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 11137-2
July 2008
Standard Cancelled
Sterilization of health care products - Radiation - Part 2 : establishing the sterilization dose

ISO 11137-2:2006 specifies methods of 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. It also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2006 defines product families for dose establishment and dose auditing.

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