{"product_id":"gb18280-1-2025","title":"GB 18280.1-2025 English PDF","description":"\u003ch1\u003eGB 18280.1-2025: Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices\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?GB%2018280.1-2025_English\" rel=\"nofollow\"\u003eGB 18280.1-2025\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\/GB18280.1-2025\"\u003eGB 18280.1-2025\u003c\/a\u003e\u003ch2\u003ePreview True-PDF\u003c\/h2\u003e\u003ciframe src=\"https:\/\/www.chinesestandard.net\/Preview_PDF.aspx\/GB18280.1-2025\" width=\"445\" height=\"600\" title=\"GB 18280.1-2025 True-PDF\"\u003e\u003c\/iframe\u003e \u003cbr\u003e\u003ch2\u003eScope\u003c\/h2\u003e1.1 This document specifies the requirements for the development, validation and routine \u003cbr\u003econtrol of a radiation sterilization process for medical devices. \u003cbr\u003eThis document applies to irradiation facilities using the following radiation sources. \u003cbr\u003ea) Using radionuclides cobalt-60 or cesium-137; \u003cbr\u003eb) Electron beams emitted from electron accelerators; \u003cbr\u003ec) X-rays emitted from X-ray generators. \u003cbr\u003e1.2 This document does not apply to the sterilization process of inactivated viruses or infectious \u003cbr\u003espongiform encephalopathy pathogens such as scrapie, bovine spongiform encephalopathy, and \u003cbr\u003eCreutzfeldt-Jakob disease. \u003cbr\u003eNOTE. Relevant information can be found in GB\/T 44353.1, GB\/T 44353.2, YY\/T 0771.3, ISO \u003cbr\u003e13022, and ICH Q5A. \u003cbr\u003e1.2.1 This document does not specify requirements for medical devices to be designated \u003cbr\u003e“STERILE”. \u003cbr\u003eNOTE. For China’s requirements for designating medical devices as “STERILE”, refer to YY\/T \u003cbr\u003e0615.1. \u003cbr\u003e1.2.2 This document does not specify a quality management system for controlling all stages of \u003cbr\u003ethe medical device manufacturing process. \u003cbr\u003eNOTE. This document does not require the establishment of a complete quality management \u003cbr\u003esystem in manufacturing, but the elements that need to be controlled in the sterilization \u003cbr\u003eprocess within the quality management system shall refer to the applicable clauses in this \u003cbr\u003edocument (see Clause 4). The application of the reference quality management system \u003cbr\u003estandard (see GB\/T 42061) in the entire medical device manufacturing process, including \u003cbr\u003esterilization, is permitted. \u003cbr\u003e1.2.3 This document does not require the use of biological indicators in the validation and \u003cbr\u003emonitoring of radiation sterilization, nor does it require the use of products listed in the \u003cbr\u003epharmacopoeia for test for sterility and release. \u003cbr\u003e1.2.4 This document does not specify occupational safety requirements related to the design \u003cbr\u003eand operation of irradiation plants. \u003cbr\u003eNOTE. For Chinese occupational safety regulations related to radiation, refer to GB 10252, GB \u003cbr\u003e18871, and HJ 979. \u003cbr\u003e1.2.5 This document does not specify sterilization requirements for used and reprocessed \u003cbr\u003emedical devices. \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 GB 18280.1-2025 (GB18280.1-2025)\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 Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices\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 National Standard\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 C47\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 11.080.01\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 37,344\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 2025-12-02\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 2029-01-01\u003c\/td\u003e  \u003c\/tr\u003e\n\u003ctr id=\"TableTabRow90\"\u003e     \u003ctd id=\"TableTabCell910\" align=\"center\" font=\"bold\"\u003e \u003cb\u003eOlder Standard (superseded by this standard)\u003c\/b\u003e \u003c\/td\u003e    \u003ctd id=\"TableTabCell920\" align=\"center\"\u003e GB 18280.1-2015\u003c\/td\u003e  \u003c\/tr\u003e\n\u003ctr id=\"TableTabRow100\"\u003e     \u003ctd id=\"TableTabCell1010\" align=\"center\" font=\"bold\"\u003e \u003cb\u003eIssuing agency(ies)\u003c\/b\u003e \u003c\/td\u003e    \u003ctd id=\"TableTabCell1020\" align=\"center\"\u003e State Administration for Market Regulation, Standardization Administration of China\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":54048263766330,"sku":null,"price":470.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0821\/5737\/1706\/files\/GB18280.1-2025EN.1.jpg?v=1789211807","url":"https:\/\/www.chinesestandard.us\/products\/gb18280-1-2025","provider":"www.ChineseStandard.us (www.ChineseStandard.net)","version":"1.0","type":"link"}