ISO 22442-2-2007 医疗设备用动物组织及其衍生物.第2部分_来源控制、采集和处理.pdf

标准号：ISO 22442-2-2007
实施状态：作废
中文名称：医疗设备用动物组织及其衍生物.第2部分:来源控制、采集和处理
英文名称：Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
发布日期：2007-12-01
被替代标准：ISO 22442-2-2015
代替标准：ISO/FDIS 22442-2-2007
采用标准：DIN EN ISO 22442-2-2008,IDT;ANSI/AAMI/ISO 22442-2-2007,IDT;BS EN ISO 22442-2-2008,IDT;EN ISO 22442-2-2007,IDT;NF S97-601-2-2008,IDT;SN EN ISO 22442-2-2008,IDT;OENORM EN ISO 22442-2-2008,IDTN-EN ISO 22442-2-2008,IDT;UNE-EN ISO 22442-2-2008,IDT
起草单位：ISO/TC 194
标准简介：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 devices utilizing
materials of animal origin, other than in vitro diagnostic medical devices. It applies where required by the risk
management process as described in ISO 22442-1.
NOTE 1 Selective sourcing is considered to be especially important for transmissible spongiform encephalopathy
(TSE) risk management.
NOTE 2 Manufacturers should refer to ISO 22442-3 for information on the validation of the elimination and/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 of
production of medical devices.
NOTE 3 It is not a requirement of this part of ISO 22442 to have a full quality management system during manufacture,
but it does specify requirements for some of the elements of a quality management system. Attention is drawn to the
standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of
medical devices. The quality management system elements that are required by this part of ISO 22442 can form a part of
a quality management system conforming to ISO 13485.
NOTE 4 A general principle for the application of ISO 22442 is that it is advisable to give due consideration to the
requirements and recommendations contained in all three parts of the standard.
文件格式：PDF
文件大小：205.42KB
文件页数：24
（以上信息更新时间为：2019-11-22）



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