Useful links and International Standards

LINKS

Association for the Advancement of Medical Instrumentation

International Organisation for Standardisation

BSI Group

RPSMUG – Radiation Process Simulation and Modelling User Group

STANDARDS

ISO 11137-1:2006, Sterilization of health care products — Radiation — Part 1:
Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-2:2006, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 11137-3:2006, Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects

ISO/TS 11135-2:2008, Sterilization of health care products – Ethylene oxide, Part 2:
Guidance on the application of ISO 11135-1
 ANSI/AAMI ST67:2011, Sterilization of health care products – Requirements and guidance for selecting a sterility assurance level (SAL) for products labelled “sterile”