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 12.1.005-1988 Occupational safety standards system. General sanitary requirements for working zone air
GOST 2.114-1995 Unified system for design documentation. Specifications
GOST 2.601-2006 Unified system for design documentation. Exploitative documents
GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST R 1.4-2004 Standardization in Russian Federation. Standards of organizations. General
GOST R 15.013-1994 System of product development and launching into manufacture. Medical products
GOST R 51609-2000 Medical products. Classification in accordance with potential risk of using. General requirements
GOST R 52905-2007 Mеdical laboratories. Requirements for safety*， 2023-12-21 Update
GOST R 53133.3-2008 Medical laboratory technologies. Quality control of clinical laboratory tests. Description of materials for quality control of clinical laboratory investigations
GOST R 54147-2010 Strategic and innovation management. Terms and definitions
GOST R EN 12322-2010 In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media*， 2023-12-21 Update
GOST R 51088-2013 history
2013GOST R 51088-2013 In vitro diagnostic medical devices. Reagents, kits, the test-systems, control materials, culture media. Requirements to devices and to supporting documentation
1997GOST R 51088-1997 Kits of reagents for clinical laboratory diagnostics. General specifications