BAS EN ISO 11137-2:2013
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
General Information
Status: Withdrawn
No. of pages: 76
Language: English
Edition: 2.
Adoption method: Endorsment
Publication date: 12.06.2013
Technical committee:
Directive:
90/385/EEC, Active implantable medical devices
93/42/EEC, Medical devices;
98/79/EC, In vitro diagnostic medical devices;
93/42/EEC, Medical devices;
98/79/EC, In vitro diagnostic medical devices;
...
Abstract
ISO 11137-2:2011 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. ISO 11137-2:2011 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2011 defines product families for sterilization dose establishment and sterilization dose audit.
Lifecycle
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Original document and degree of correspondence
- EN ISO 11137-2:2012, identical
- ISO 11137-2:2012, identical