ISO13485/' target='_blank'>ISO13485标准的发展
The development of ISO13485 standard
随着历史的发展，ISO组织在此基础上又将此标准进行了修订，升级为ISO13485：2003。
With the development of history, the ISO organization on the basis of this, the standard was revised, upgraded to ISO13485: 2003.
目前大多数医疗设备生产厂家在建立质量管理体系时，开始把ISO9001：2000版+ISO13485：2003版+CE认证作为一揽子解决方案来考虑。
Most of the current medical equipment manufacturers in the establishment of quality management system, start to ISO9001 : 2000 + ISO13485 : 2003 + CE certification as a package of solutions to consider.
医疗器械行业一直将ISO 13485标准(我国等同转换标准号为YY/T0287)作为质量管理体系认证的依据。
Medical equipment industry has been the standard ISO 13485 ( Chinese equivalent conversion Standard No. YY / T0287 ) as the certification of quality management system based on.
这个标准是在ISO 9001： 1994标准的基础上，增加了医疗器械行业的特殊要求制定的，也就是所谓1+1的标准。
This standard is the ISO 9001: 1994 on the basis of standards, increase the medical device industry, special requirements, which is also called the 1+1 standard.
因此，满足ISO 13485标准也就符合ISO 9001： 1994标准的要求。ISO 9001：2000标准颁布以后，ISO/TC 210又颁布了新的ISO 13485： 2003标准(我国等同转换的YY/T 0287-200X标准正在报批)。
Therefore, to meet the ISO 13485 standard is in accordance with ISO 9001 : 1994 standard requirements. ISO 9001 : 2000 standard after promulgating, ISO / TC 210 enacted a new ISO 13485 : 2003 standard ( Chinese equivalent conversion of YY / T 0287-200X standards are being submitted for approval).