BAS EN ISO 11137-2:2008
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
General Information
Status: Withdrawn
No. of pages: 72
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 21.07.2008
Technical committee:
Directive:
90/385/EEC, Active implantable medical devices
93/42/EEC, Medical devices;
93/42/EEC, Medical devices;
...
Abstract
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.
Lifecycle
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Original document and degree of correspondence
- EN ISO 11137-2:2007, identical