{"product_id":"yyt0771-2-2020","title":"YY\/T 0771.2-2020 English PDF (YY\/T0771.2-2020)","description":"\u003ch1\u003eYY\/T 0771.2-2020: Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling\u003c\/h1\u003e\u003cb style=\"font-size:16px;\"\u003eDelivery:\u003c\/b\u003e 9 seconds. Download (and Email) true-PDF + Invoice.\u003cbr\u003e\u003cb style=\"font-size:16px;\"\u003eGet Quotation:\u003c\/b\u003e Click \u003ca style=\"color: blue;\" href=\"https:\/\/www.chinesestandard.net\/Cart\/Cart.aspx?YY\/T%200771.2-2020_English\" rel=\"nofollow\"\u003eYY\/T 0771.2-2020\u003c\/a\u003e (Self-service in 1-minute)\u003cbr\u003e\u003cb style=\"font-size:16px;\"\u003eNewer \/ historical versions: \u003c\/b\u003e \u003ca style=\"color: blue;\" href=\"https:\/\/www.chinesestandard.net\/PDF.aspx\/YYT0771.2-2020\"\u003eYY\/T 0771.2-2020\u003c\/a\u003e\u003ch2\u003ePreview True-PDF\u003c\/h2\u003e\u003ciframe src=\"https:\/\/www.chinesestandard.net\/Preview_PDF.aspx\/YYT0771.2-2020\" width=\"445\" height=\"600\" title=\"YY\/T 0771.2-2020 True-PDF\"\u003e\u003c\/iframe\u003e \u003cbr\u003e\u003ch2\u003eScope\u003c\/h2\u003eThis Part of YY\/T 0771 specifies the control requirements for the sourcing, collection \u003cbr\u003eand handling (including storage and transportation) of animals and tissues used to \u003cbr\u003emanufacture medical devices made from animal-derived materials, excluding in vitro \u003cbr\u003ediagnostic medical devices. The risk management process requirements given in YY\/T \u003cbr\u003e0771.1-2020 apply. \u003cbr\u003eNote 1: The selection of animal sources is particularly important for the risk \u003cbr\u003emanagement of transmissible spongiform encephalopathy (TSE). \u003cbr\u003eThis Part of YY\/T 0771 does not cover medical devices using human tissues. \u003cbr\u003eThis Part of YY\/T 0771 does not specify a quality management system for controlling \u003cbr\u003ethe whole process of medical device production. \u003cbr\u003eYY\/T 0771 does not cover the overall quality management system for production, but \u003cbr\u003especifies requirements for certain elements of the quality management system. \u003cbr\u003eAttention is drawn to the standards for quality management systems for controlling the \u003cbr\u003ewhole process of production or reprocessing of medical devices (see YY\/T 0287). The \u003cbr\u003equality management system elements required by this Part may form part of a quality \u003cbr\u003emanagement system conforming to YY\/T 0287. \u003cbr\u003eNote 2: The basic principle for the application of YY\/T 0771 is to give appropriate \u003cbr\u003econsideration to the requirements and recommendations in all three Parts of \u003cbr\u003ethe standard. \u003cbr\u003e\u003cbr\u003e\u003ch2\u003eBasic Data\u003c\/h2\u003e\u003ctable id=\"TableTabAbout0\" rules=\"all\" border=\"1\" style=\"font-family:Arial;font-size:Small;\"\u003e  \u003ctr id=\"TableTabRow10\"\u003e     \u003ctd id=\"TableTabCell110\" align=\"center\" font=\"bold\"\u003e \u003cb\u003eStandard ID\u003c\/b\u003e \u003c\/td\u003e    \u003ctd id=\"TableTabCell120\" align=\"center\"\u003e YY\/T 0771.2-2020 (YY\/T0771.2-2020)\u003c\/td\u003e  \u003c\/tr\u003e\n\u003ctr id=\"TableTabRow20\"\u003e     \u003ctd id=\"TableTabCell210\" align=\"center\" font=\"bold\"\u003e \u003cb\u003eDescription (Translated English)\u003c\/b\u003e \u003c\/td\u003e    \u003ctd id=\"TableTabCell220\" align=\"center\"\u003e Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling\u003c\/td\u003e  \u003c\/tr\u003e\n\u003ctr id=\"TableTabRow30\"\u003e     \u003ctd id=\"TableTabCell310\" align=\"center\" font=\"bold\"\u003e \u003cb\u003eSector \/ Industry\u003c\/b\u003e \u003c\/td\u003e    \u003ctd id=\"TableTabCell320\" align=\"center\"\u003e Medical Device and Pharmaceutical Industry Standard (Recommended)\u003c\/td\u003e  \u003c\/tr\u003e\n\u003ctr id=\"TableTabRow40\"\u003e     \u003ctd id=\"TableTabCell410\" align=\"center\" font=\"bold\"\u003e \u003cb\u003eClassification of Chinese Standard\u003c\/b\u003e \u003c\/td\u003e    \u003ctd id=\"TableTabCell420\" align=\"center\"\u003e C30\u003c\/td\u003e  \u003c\/tr\u003e\n\u003ctr id=\"TableTabRow50\"\u003e     \u003ctd id=\"TableTabCell510\" align=\"center\" font=\"bold\"\u003e \u003cb\u003eClassification of International Standard\u003c\/b\u003e \u003c\/td\u003e    \u003ctd id=\"TableTabCell520\" align=\"center\"\u003e 11.100.20\u003c\/td\u003e  \u003c\/tr\u003e\n\u003ctr id=\"TableTabRow60\"\u003e     \u003ctd id=\"TableTabCell610\" align=\"center\" font=\"bold\"\u003e \u003cb\u003eWord Count Estimation\u003c\/b\u003e \u003c\/td\u003e    \u003ctd id=\"TableTabCell620\" align=\"center\"\u003e 17,156\u003c\/td\u003e  \u003c\/tr\u003e\n\u003ctr id=\"TableTabRow70\"\u003e     \u003ctd id=\"TableTabCell710\" align=\"center\" font=\"bold\"\u003e \u003cb\u003eDate of Issue\u003c\/b\u003e \u003c\/td\u003e    \u003ctd id=\"TableTabCell720\" align=\"center\"\u003e 2020\u003c\/td\u003e  \u003c\/tr\u003e\n\u003ctr id=\"TableTabRow80\"\u003e     \u003ctd id=\"TableTabCell810\" align=\"center\" font=\"bold\"\u003e \u003cb\u003eDate of Implementation\u003c\/b\u003e \u003c\/td\u003e    \u003ctd id=\"TableTabCell820\" align=\"center\"\u003e 2021-04-01\u003c\/td\u003e  \u003c\/tr\u003e\n\u003ctr id=\"TableTabRow90\"\u003e     \u003ctd id=\"TableTabCell910\" align=\"center\" font=\"bold\"\u003e \u003cb\u003eIssuing agency(ies)\u003c\/b\u003e \u003c\/td\u003e    \u003ctd id=\"TableTabCell920\" align=\"center\"\u003e State Drug Administration\u003c\/td\u003e  \u003c\/tr\u003e\n\u003ctr id=\"TableTabRow100\"\u003e     \u003ctd id=\"TableTabCell1010\" align=\"center\" font=\"bold\"\u003e \u003cb\u003eSummary\u003c\/b\u003e \u003c\/td\u003e    \u003ctd id=\"TableTabCell1020\" align=\"center\"\u003e This standard specifies the control requirements for the source, collection and disposal (including storage and transportation) of animals and tissues for medical devices manufactured from materials of animal origin, excluding in vitro diagnostic medical devices. The risk management process requirements given in YY\/T 0771.1-2020 apply. This standard does not cover medical devices using human tissue. This standard does not specify a quality management system that controls the entire process of medical device production. YY\/T 0771 does not deal with the overall quality management system in production, but specifies the requirements for certain elements of the quality management system, paying attention to the quality management system standards for controlling the entire process of medical device production or reprocessing (see YY\/T 0287). The elements of the quality management system required by this standard can form a quality management system that conforms to YY\/T 0287\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/table\u003e\u003cbr\u003e\u003cbr\u003e","brand":"www.ChineseStandard.us -- Field Test Asia Pte. Ltd.","offers":[{"title":"Default Title","offer_id":67783177142586,"sku":null,"price":695.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0821\/5737\/1706\/files\/YYT0771.2-2020EN.1.jpg?v=1792246746","url":"https:\/\/www.chinesestandard.us\/products\/yyt0771-2-2020","provider":"www.ChineseStandard.us (www.ChineseStandard.net)","version":"1.0","type":"link"}