BS EN ISO 11137-2:2015 pdf free

BS EN ISO 11137-2:2015 pdf free.STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE. BS EN ISO 11137-2:2015 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,...
Download

BS EN ISO 11138-2:2017 pdf

BS EN ISO 11138-2:2017 pdf.Sterilization Of Health Care Products - Biological Indicators - Part2:Biological Indicators For Ethylene Oxide Sterilization Processes. Iso 11138-1 specifies production, labelling, test methods and performance requirements for the manufacture of biological indicators including inoculated carriers and suspensions intended for use in validation and monitoring of sterilization processes. This document gives specific requirements for those biological indicators...
Download

BS EN ISO 11137-1:2006 pdf free

BS EN ISO 11137-1:2006 pdf free.Sterilization Of Health Care Products - Radiation - Part1:Requirements For Development, Validation And Routine Control Of A Sterilization Process For Medical Devices. A sterile medical device is one that is free of viable microorganisms. International Standards, which specify requirements for validation and routine control of sterilization processes, require, when it is necessary to supply a...
Download