GOST R 15.013-1994 PDF

Scope: This standard establishes the procedure for the development, testing, and acceptance of samples of new and modernized medical devices.

GOST R 15.013-1994 Referenced Document

GOST 2.103-1968 Unified system for design documentation. Stages of designing
GOST 2.116-1984 Product technical level and quality map
GOST 20790-1993 Medical instruments, apparatus and equipment. General specifications
GOST 22261-1994 Means for measuring electrical and magnetic quantities. General specifications
GOST 30324.0-1995 Medical electrical equipment. Part 1. General safety requirements*， 1995-04-19 Update
GOST 8.009-1984 State system for ensuring the uniformity of measurements. Standardized metrological characteristics of measuring instruments
GOST 8.256-1977 State system for ensuring the uniformity of measurements. Standardization and determination of dynamic characteristics of analogue measuring instruments. Basic principles
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*， 2024-04-19 Update
GOST R 50267.0-1992 Medical electrical equipment. Part 1. General safety requirements
GOST R 50444-1992 Medical instruments, apparatus and equipment. General specifications

2016 GOST R 15.013-2016 System of products development and launching into manufacture. Medical devices
1994 GOST R 15.013-1994 System of product development and launching into manufacture. Medical products