GOST R ISO 11137-1-2008 Sterilization of health care products. Radiation. Part 1. Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 10012-1:1992 Quality assurance requirements for measuring equipment; part 1: metrological confirmation system for measuring equipment
ISO 11137-2:2006 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
ISO 11737-2:1998 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process
ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
GOST R ISO 11137-1-2008 history
2008GOST R ISO 11137-1-2008 Sterilization of health care products. Radiation. Part 1. Requirements for development, validation and routine control of a sterilization process for medical devices