ISO13485 has no corresponding national standard and is an international standard.
ISO13485 is called "Medical Device Quality Management System for Regulatory Requirements" in Chinese. Since medical devices are special products used to save lives, prevent and treat diseases, it is not enough to just standardize them according to the general requirements of the ISO9000 standard.
For this reason, the ISO organization promulgated ISO13485: 1996 version standard (YY/T0287 and YY/T0288), which puts forward special requirements for the quality management system of medical device manufacturers to ensure the quality of medical devices is safe and effective. Played a very good role in promoting.
Development:
Since its release in 1996, the standard has been widely implemented and applied around the world. The new version of the ISO13485 standard was officially released on July 3, 2003. Different from the ISO9001:2000 standard, ISO13485:2003 is a management standard suitable for regulatory environments: it is clear from the name that it is a quality management system requirement for regulations.
Internationally, medical devices are not just general listed commodities operating in a commercial environment, they are also subject to the supervision and management of national and regional laws and regulations. Therefore, the standard must be legally bound and operate in a regulatory environment. At the same time, the risks of medical device products must be fully considered, requiring risk management throughout the entire process of medical device product realization.