SS-EN-ISO-11137-2 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

SS-EN-ISO-11137-2 - 2015 EDITION - CURRENT
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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.

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Designation Name

SS-EN ISO 11137-2:2015

Revision Level

2015 EDITION

Status

Current

Publication Date

July 6, 2015

Language(s)

English

Page Count

88

International Equivalent

EN ISO 11137-2:2015(IDT); ISO 11137-2:2013(IDT)