ISO 22442-2:2015 利用动物组织及其衍生物的医疗设备 第2部分：关于来源、收集和处理的控制

标准编号：ISO 22442-2:2015

中文名称：利用动物组织及其衍生物的医疗设备 第2部分：关于来源、收集和处理的控制

英文名称：Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling

发布日期：2015-11

标准范围

This part of ISO 22442 specifies requirements for controls on the sourcing, collection, and handling(which includes storage and transport) of animals and tissues for the manufacture of medical devicesutilizing materials of animal origin other than in vitro diagnostic medical devices. It applies whererequired by the risk management process as described in ISO 22442?1.The manufacturers should refer to ISO 22442?3 for information on the validation of the eliminationand/or inactivation of viruses and TSE agents.This part of ISO 22442 does not cover the utilization of human tissues in medical devices.This part of ISO 22442 does not specify a quality management system for the control of all stages ofproduction of medical devices.It is not a requirement of this part of ISO 22442 to have a full quality management system duringmanufacture, but it does specify requirements for some of the elements of a quality managementsystem. Attention is drawn to the standards for quality management systems (see ISO 13485) thatcontrol all stages of production or reprocessing of medical devices.The quality management systemelements that are required by this part of ISO 22442 can form a part of a quality management systemconforming to ISO 13485.

标准预览图