iso13485新标准对删减的规定。
The new standard on the provisions of the ISO13485.
在新标准的1.2"应用"中，对删减作出了比较详细的规定：
In the new standard 1.2 "applications", for a more detailed deletion of the provisions:
　　"本标准的所有要求是针对提供医疗器械的组织，不论组织的类型或规模。"
" All the requirements of this standard is to provide the medical equipment organization, regardless of tissue type or size. "
　　"如果法规要求允许对设计和开发控制进行删减，则可以在质量管理体系中进行合理的删减。这些法规能够提供另一种安排，这些安排要在质量管理体系中加以说明。组织有责任确保在符合
" If the regulations allow for the design and development of control are deleted, can be in the quality management system to carry out a reasonable cut. These regulations can provide an alternative arrangement, these arrangements in the quality management system described in the. Organizations have a responsibility to ensure that in line with
本标准的声明中反映出对设计和开发控制的删减。"
This standard is the statement reflected on design and development control. "
　"本标准第7章中的任何要求，如果因质量管理体系所涉及的医疗器械的特点而不适用时，组织不需要在质量管理体系中包含这样的要求。对于本标准中所要求的适用于医疗器械的过程，但未在组织内实施，则组织应对这些过程负责并在其质量管理体系中加以说明。"后者指的就是外包过程。
" The seventh chapter of any request, if involved in the quality management system of medical equipment characteristics are not applicable, organizations do not have the quality management system includes such a requirement. The standard for medical equipment required by applicable to the process, but not within the organization to implement, process of these organizations were responsible for its quality management system and to be described. " The latter refers to the outsourcing process.