GOST 12.2.091-2012 Safety requirements for electrical equipment for measurement, control and laboratory use. Part 1. General requirements
GOST 15.101-1998 System of product development and launching into manufacture. Procedure of scientific researches and development
GOST 15.311-1990 System of product development and launching into manufacture. Launching of products under foreign companies technical documents
GOST 16504-1981 The state system of testing products. Product test and quality inspection. General terms and definitions
GOST 19126-2007 Medical metallic instruments. General specifications
GOST 25047-1987 Disposable exfusion, infusion and transfusion sets. Specifications
GOST 31214-2003 Medical devices. Requirements for samples and documentation presented for toxicological tests, sanitary and chemical analyses, tests for sterility and pyrogenicity
GOST 31214-2016 Medical devices. Requirements for samples and documentation presented for toxicological tests, sanitary and chemical analyses, tests for sterility and pyrogenicity
GOST ISO 13485-2011 Medical devices. Quality management systems. System requirements for regulatory purposes
GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST R 15.000-1994 System of product development and launching into manufacture. Basic provisions
GOST R 15.000-2016 System of product development and launching into manufacture. Basic provisions
GOST R 15.201-2000 System of product development and launching into manufacture. Products of industrial and technical designation. Procedure of product development and launching into manufacture
GOST R 50444-1992 Medical instruments, apparatus and equipment. General specifications
GOST R 51088-2013 In vitro diagnostic medical devices. Reagents, kits, the test-systems, control materials, culture media. Requirements to devices and to supporting documentation
GOST R 8.674-2009 State system for ensuring the uniformity of measurements. General requirements for measuring instruments and systems and devices with measuring function
GOST R IEC 60601-1-2010 Medical electrical equipment. Part 1. General requirements for basic safety and essential performance
GOST R IEC 878-1995 Graphical symbols electrical equipment in medical practice
GOST R ISO 14937-2012 Sterilization of health care products. General criteria for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
GOST R ISO 15223-1-2014 Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 1. General requirements
GOST R ISO 18113-1-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 1. Terms, definitions and general requirements
GOST R 15.013-2016 history
2016GOST R 15.013-2016 System of products development and launching into manufacture. Medical devices
1994GOST R 15.013-1994 System of product development and launching into manufacture. Medical products