GOST ISO 14160-2011 Sterilization of single-use medical devices incorporating materials of animal origin. Validation and routine control of sterilization by liquid sterilants
ISO 11134:1994 Sterilization of health care products; requirements for validation and routine control; industrial moist heat sterilization
ISO 11135:1994 Medical devices; validation and routine control of ethylene oxide sterilization
ISO 11137:1995 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
ISO 11138-1:1994 Sterilization of health care products - Biological indicators - Part 1: General
ISO 11737-1:1995 Sterilization of medical devices - Microbiological methods - Part 1: Estimation of population of microorganisms on products
ISO 13408-1:1998 Aseptic processing of health care products - Part 1: General requirements
ISO 13485:1996 Quality systems - Medical devices - Particular requirements for the application of ISO 9001
ISO 13488:1996 Quality systems - Medical devices - Particular requirements for the application of ISO 9002
ISO 9001:1994 Quality systems - Model for quality assurance in design, development, production, installation and servicing
ISO 9001:2000 Quality management systems - Requirements
ISO 9002:1994 Quality systems - Model for quality assurance in production, installation and servicing
ISO 9004-1:1994 Quality management and quality system elements - Part 1: Guidelines
GOST ISO 14160-2011 history
2011GOST ISO 14160-2011 Sterilization of single-use medical devices incorporating materials of animal origin. Validation and routine control of sterilization by liquid sterilants