ISO13485医疗器械质量管理体系 何谓ISO13485？
ISO13485 medical equipment quality management system what is a ISO13485?
　　ISO13485是全世界医疗设备制造商（如：美国、日本、加拿大、欧盟）最为接受的标准。
ISO13485 is the whole world medical device manufacturers ( such as: the United States, Japan, Canada, the European Union ) is the accepted standard.
这一标准包括专门针对这一行业的要求，并为诸如医疗设备、主动型医疗设备、主动型移植设备和无菌医疗设备等其他的术语做了定义。
This standard includes specific to this industry requirements, and for such as medical equipment, medical equipment, active active transfer equipment and sterile medical equipment and other terms defined.
　　ISO13485支持那些生产制造或使用医疗产品和服务的企业，帮助这些企业减少不可预期的风险。该体系力图提高企业在顾客及权威组织眼中的声誉。 　　
ISO13485 supports the production or use of medical products and service to the enterprise, help the enterprise to reduce unexpected risk. The system tries to improve business in the customers and the authority of the organization 's reputation.
　　ISO13485:2003已正式颁布，该标准将取消并代替ISO13485:1996和ISO13488:1996（等同于中国医疗器械行业标准YY/T0287:1996和YY/T0288:1996）。
ISO13485: 2003 has been officially promulgated, the standard will be cancelled and instead of ISO13485: 1996 and ISO13488: 1996 ( equivalent to China's medical equipment industry standard YY / T0287 : 1996 and YY / T0288: 1996 ).
中国等同采用的医疗器械行业标准YY/T0287:2003《医疗器械质量管理体系用于法规的要求》(代替YY/T0287:1996)，也于2003年9月17日由国家食品药品监督管理局正式发布了，该标准自2004年4月1日起实施。
Chinese equivalent of medical equipment industry standard YY / T0287: 2003" quality management system for medical equipment regulations" (instead of YY / T0287: 1996 ), also in September 17, 2003 by the State Food and Drug Administration formally issued, the standard is carried out since April 1, 2004.
　　ISO13485:2003是一个独立的标准，对于仅在医疗产品工业领域经营的企业，该标准可以独立于ISO9001:2000使用。
ISO13485: 2003 is an independent standard, for only in medical products industry enterprises, the standard can be independent of ISO9001 : 2000 use.