Standard Swedish standard · SS-EN ISO 11137-2:2007

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)

Status: Withdrawn

· Replaced by: SS-EN ISO 11137-2:2012 Corrected by: SS-EN ISO 11137-2:2007/AC:2009
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Standard Swedish standard · SS-EN ISO 11137-2:2007

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)
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Scope
This part of ISO 11137 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. This part of ISO 11137 also specifies methods of dose auditing in order to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for dose establishment and dose auditing.

Subjects

Sterilization and disinfection in general (11.080.01)


Buy this standard

Standard Swedish standard · SS-EN ISO 11137-2:2007

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2006, corrected version 2006-08-01)
Subscribe on standards - Read more Dölj
Price: 1 615 SEK
standard ikon pdf

PDF

Price: 1 615 SEK
standard ikon

Paper

Show more Show less

Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-62904

Edition: 2

Approved: 8/24/2007

No of pages: 67

Replaces: SS-EN 552 , SS-EN 552/A1 , SS-EN 552/A2 , SS-EN ISO 11137-2:2006

Replaced by: SS-EN ISO 11137-2:2012