{"product_id":"yyt0771-3-2009","title":"YY\/T 0771.3-2009 English PDF (YY\/T0771.3-2009)","description":"\u003ch1\u003eYY\/T 0771.3-2009: Medical devices utilizing animal tissues and their derivatives. Part 3: Validation of the elimination and\/or inactivation of viruses and Transmissible Spongiform Encephalopathy (TSE) agents\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%200771.3-2009_English\" rel=\"nofollow\"\u003eYY\/T 0771.3-2009\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\/YYT0771.3-2009\"\u003eYY\/T 0771.3-2009\u003c\/a\u003e\u003ch2\u003ePreview True-PDF\u003c\/h2\u003e\u003ciframe src=\"https:\/\/www.chinesestandard.net\/Preview_PDF.aspx\/YYT0771.3-2009\" width=\"445\" height=\"600\" title=\"YY\/T 0771.3-2009 True-PDF\"\u003e\u003c\/iframe\u003e \u003cbr\u003e\u003ch2\u003eScope\u003c\/h2\u003eThis Part of YY\/T 0771 specifies requirements for the validation of the elimination and\/or \u003cbr\u003einactivation of viruses and transmissible spongiform encephalopathy (TSE) agents during the \u003cbr\u003emanufacture of medical devices (excluding in vitro diagnostic medical devices) utilizing animal \u003cbr\u003etissues or derivatives thereof that are rendered non-viable or non-viable through processing. \u003cbr\u003eThis Part applies when required by the risk management process described in YY\/T 0771.1. \u003cbr\u003eThis Part does not address other transmissible or non-transmissible agents. \u003cbr\u003eNOTE 1: YY\/T 0771.1 describes risk analysis and management. Since conventional sterilization \u003cbr\u003eprocesses used for animal tissues in medical devices have not been shown to be fully effective in \u003cbr\u003einactivating TSE agents, the selection of animal sources is of critical importance (see YY\/T 0771.1 and \u003cbr\u003eYY\/T 0771.2). \u003cbr\u003eNOTE 2: Standards relating to bacteria, molds, and yeasts include GB 18279, GB 18280, GB\/T 19973.1, \u003cbr\u003eYY\/T 0567, ISO 14160, GB\/T 19974, and ISO 17665 (see Bibliography). \u003cbr\u003eThis Part of YY\/T 0771 does not cover the use of human tissues in medical devices. \u003cbr\u003eThis Part of YY\/T 0771 does not specify a quality management system for the control of the \u003cbr\u003eentire medical device manufacturing process. \u003cbr\u003eNOTE 3: Implementation of a comprehensive quality management system during production is not a \u003cbr\u003erequirement of this Part; however, this Part specifies requirements for certain elements of a quality \u003cbr\u003emanagement system. Attention shall be paid to quality management system standards (see YY\/T 0287) \u003cbr\u003egoverning all stages of medical device manufacture or reprocessing. The quality management system \u003cbr\u003eelements specified in this Part may serve as part of a quality management system that complies with \u003cbr\u003eYY\/T 0287. \u003cbr\u003eThis Part of YY\/T 0771 does not consider the impact of any elimination and\/or inactivation \u003cbr\u003emethods on the suitability of the medical device for its intended use. \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 0771.3-2009 (YY\/T0771.3-2009)\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 3: Validation of the elimination and\/or inactivation of viruses and Transmissible Spongiform Encephalopathy (TSE) agents\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 23,275\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 2009-12-30\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 2011-06-01\u003c\/td\u003e  \u003c\/tr\u003e\n\u003ctr id=\"TableTabRow90\"\u003e     \u003ctd id=\"TableTabCell910\" align=\"center\" font=\"bold\"\u003e \u003cb\u003eQuoted Standard\u003c\/b\u003e \u003c\/td\u003e    \u003ctd id=\"TableTabCell920\" align=\"center\"\u003e YY\/T 0771.1; YY\/T 0771.2\u003c\/td\u003e  \u003c\/tr\u003e\n\u003ctr id=\"TableTabRow100\"\u003e     \u003ctd id=\"TableTabCell1010\" align=\"center\" font=\"bold\"\u003e \u003cb\u003eAdopted Standard\u003c\/b\u003e \u003c\/td\u003e    \u003ctd id=\"TableTabCell1020\" align=\"center\"\u003e ISO 22442-3-2007, IDT\u003c\/td\u003e  \u003c\/tr\u003e\n\u003ctr id=\"TableTabRow110\"\u003e     \u003ctd id=\"TableTabCell1110\" align=\"center\" font=\"bold\"\u003e \u003cb\u003eIssuing agency(ies)\u003c\/b\u003e \u003c\/td\u003e    \u003ctd id=\"TableTabCell1120\" align=\"center\"\u003e State Food and Drug Administration\u003c\/td\u003e  \u003c\/tr\u003e\n\u003ctr id=\"TableTabRow120\"\u003e     \u003ctd id=\"TableTabCell1210\" align=\"center\" font=\"bold\"\u003e \u003cb\u003eSummary\u003c\/b\u003e \u003c\/td\u003e    \u003ctd id=\"TableTabCell1220\" align=\"center\"\u003e This standard specifies the use of animal tissues or products derived from animal tissue medical equipment (not including in vitro diagnostic medical devices) in the production of the virus and transmissible spongiform encephalopathy (TSE) factor removal and\/or inactivation requirements for confirmation these animal tissues or products derived from animal tissue is non- viable or treated as non- viable. In this section YY\/T 0771. 1 The risk management process need apply. This section does not involve the transmission or non- transmission of other factors. YY\/T 0771 does not consider this part of any removal and\/or inactivation methods used for medical devices is expected to influence the suitability. \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":67783177437498,"sku":null,"price":450.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0821\/5737\/1706\/files\/YYT0771.3-2009EN.1.jpg?v=1792246746","url":"https:\/\/www.chinesestandard.us\/products\/yyt0771-3-2009","provider":"www.ChineseStandard.us (www.ChineseStandard.net)","version":"1.0","type":"link"}