
Sterilization Of Health Care Products - Radiation - Part 1: Requirements For Development, Validation And Routine Control Of A Sterilization Process For Medical Devices
出版:British Standards Institution

专家解读视频
Describes requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
Supersedes 04/30048301 DC. (08/2006) Together with BS EN ISO 11137-2 and BS EN ISO 11137-3, it supersedes BS EN 552. (06/2007) 2006 Edition Re-Issued in August 2013 & incorporates AMD 1 2013. (08/2013)
SN EN ISO 11137-1:2006 - Identical
ONORM EN ISO 11137-1:2013 - Identical
SS EN ISO 11137-1 Ed. 2 (2015) - Identical
EN ISO 11137-1:2015 - Identical
UNE EN ISO 11137-1:2007 - Identical
NBN EN ISO 11137-1:2006 - Identical
NEN EN ISO 11137-1:2015 - Identical