ISO/DIS 13485 : 60.00 (2016)被替代
MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
出版：International Organization for Standardization
專家解讀視頻
Defines requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle including the design and development, production, storage and distribution, installation, or servicing of a medical device and the design, development or provision of associated activities (e.g. technical support).
15/30321131 DC : 0 - Identical
DIN ISO 13485 : 2002 - Identical
02/560598 DC : DRAFT FEB 2002 - Identical
14/30257644 DC : 0 - Identical
14/30257644 DC : 0 - Identical
15/30321131 DC : 0 - Identical
