ISO 14971-2019 医疗器械——风险管理对医疗器械的应用（英文版）.pdf

《ISO 14971-2019 医疗器械——风险管理对医疗器械的应用（英文版）.pdf》由会员上传分享，免费在线阅读，更多相关内容在教育资源-天天文库。

1、INTERNATIONALISOSTANDARD14971Thirdedition2019-12Medicaldevices—ApplicationofriskmanagementtomedicaldevicesDispositifsmédicaux—ApplicationdelagestiondesrisquesauxdispositifsmédicauxReferencenumberISO14971:2019(E)©ISO2019ISO14971:2019(E)COPYRIGHTPROTECTED

2、DOCUMENT©ISO2019Allrightsreserved.Unlessotherwisespecified,orrequiredinthecontextofitsimplementation,nopartofthispublicationmaybereproducedorutilizedotherwiseinanyformorbyanymeans,electronicormechanical,includingphotocopying,orpostingontheinternetoranin

3、tranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbeloworISO’smemberbodyinthecountryoftherequester.ISOcopyrightofficeCP401•Ch.deBlandonnet8CH-1214Vernier,GenevaPhone:+41227490111Fax:+41227490947Email:copyright@iso.org

4、Website:www.iso.orgPublishedinSwitzerlandii©ISO2019–AllrightsreservedISO14971:2019(E)ContentsPageForeword....................................................................................................................................................

5、....................................................................................ivIntroduction...........................................................................................................................................................

6、.....................................................................vi1Scope................................................................................................................................................................................

7、.................................................12Normativereferences......................................................................................................................................................................................1

8、3Termsanddefinitions.....................................................................................................................................................................................14Generalrequirementsforrisk