Standard ISO standard · ISO 11137-2:2013

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

Status: Valid

· Amended by: ISO 11137-2:2013/Amd 1:2022
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Standard ISO standard · ISO 11137-2:2013

Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
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Scope
ISO 11137-2:2013 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. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.

Subjects

Sterilization and disinfection in general (11.080.01)


Buy this standard

Standard ISO standard · ISO 11137-2:2013

Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
Subscribe on standards - Read more Dölj
Price: 3 026 SEK
standard ikon pdf

PDF

Price: 3 026 SEK
standard ikon

Paper

Show more Show less

Product information

Language: English

Written by: ISO

International title:

Article no: STD-916239

Edition: 3

Approved: 5/21/2013

No of pages: 76

Replaces: ISO 11137-2:2012