Sterilization of medical devices. Validation and routine control of sterilization by irradiation.

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Main informations

Collections

National standards and national normative documents

Publication date

January 1994

Release date

juin 2006

Number of pages

34 p.

Reference

NF EN 552

ICS Codes

11.080.01 Sterilization and disinfection in general

Print number

1 - 01/11/1994

European kinship

EN 552:1994

Standard replaced by (3)

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.

NF EN ISO 11137-3

October 2006

Standard Cancelled

Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects

NF EN ISO 11137-1

June 2006

Standard Cancelled

Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

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