Standard Swedish standard · SS-EN ISO 11137-2:2015/A1:2023

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)

Status: Valid

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Standard Swedish standard · SS-EN ISO 11137-2:2015/A1:2023

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
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Scope
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 sterilization dose to achieve a sterility assurance level, SAL, of 10-6. This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.

This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit.

Subjects

Sterilization and disinfection in general (11.080.01)


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Standard Swedish standard · SS-EN ISO 11137-2:2015/A1:2023

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
Subscribe on standards - Read more Dölj
Price: 833 SEK
standard ikon pdf

PDF

Price: 833 SEK
standard ikon

Paper

Price: 1 332,80 SEK
standard ikon pdf + standard ikon

PDF + paper

Show more Show less

Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-80042362

Edition: 1

Approved: 4/24/2023

No of pages: 16

Amendment: SS-EN ISO 11137-2:2015