GB/T 39768-2021 English PDFUS$559.00 · In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 39768-2021: Classification and coding for human biomaterial Status: Valid
Basic dataStandard ID: GB/T 39768-2021 (GB/T39768-2021)Description (Translated English): Classification and coding for human biomaterial Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C40 Word Count Estimation: 30,387 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 39768-2021: Classification and coding for human biomaterial---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.Classification and coding for human biomaterial ICS 07.080 C40 National Standards of People's Republic of China Classification and coding of human biological samples Released on 2021-03-09 2021-10-01 implementation State Administration of Market Supervision and Administration Issued by the National Standardization Management Committee Table of contentsForeword Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Classification rules of human biological samples 2 5 Human biological sample coding rules 2 References 24ForewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard was proposed and managed by the National Standardization Technical Committee for Biological Samples (SAC/TC559). Drafting organizations of this standard. Fudan University, Shanghai National Engineering Research Center for Biochips, Shanghai Xinchao Biotechnology Co., Ltd., National Health Institute of Science and Technology of the Health Commission, Shanghai Fourth People’s Hospital Affiliated to Tongji University, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai Renji Hospital Affiliated to Haijiao Jiaotong University School of Medicine, Fudan University Affiliated Tumor Hospital, Fudan University Affiliated Zhongshan Hospital, Nanjing University School of Medicine Affiliated It belongs to Drum Tower Hospital, Oriental Hepatobiliary Surgery Hospital, Shanghai Changzheng Hospital, Hangzhou Baihan Biotechnology Co., Ltd. The main drafters of this standard. Jin Li, Ma Xu, Gao Hengjun, Yang Yajun, Li Ka, Man Qiuhong, Zhang Xiaoyan, Gao Huafang, Wang Weiye, Zhang Yang, Xu Jingman, Zhang Kehao, Sun Menghong, Xu Midie, Ye Qing, Kang Xiaonan, Wang Xueqi, Yang Yuan, Ge Meiling. Classification and coding of human biological samples1 ScopeThis standard specifies the classification and coding rules for human biological samples. This standard applies to all institutions engaged in the preservation of human biological samples.2 Normative referencesThe following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document. GB/T 37864-2019 General Requirements for the Quality and Capability of Biological Repositories3 Terms and definitionsThe following terms and definitions defined in GB/T 37864-2019 apply to this document. 3.1 Human biomaterial Any substance obtained or derived from the human body, including but not limited to tissue, blood, urine, skin, bone marrow, muscle, hair, secretions and internal Organs, etc. 3.2 Typeofhumanbiomaterial According to the common characteristics and morphology of biological samples, the types of biological samples are divided, which can be divided into tissues, blood, semen, secretions, Cell suspension, excrement, cells or processed biological samples (DNA, RNA, protein, etc.), and other biological materials, etc. 3.3 Whole blood Collect human peripheral blood into a mixture formed in a blood collection tube/bag with an appropriate amount of anticoagulant. Note. All blood components including blood cells and plasma. 3.4 General biomaterial Physical specimens are complete organs or organisms as opposed to sliced samples. Example. Such as a human brain or embryo sample soaked in formalin. 3.5 Circulating-freecelDNA; cf-DNA The extracellular DNA present in body fluids such as plasma or serum is referred to as free DNA. Note. Extracellular DNA is also called circulating DNA or cell-free DNA. 3.6 Circulating tumor DNA; ct-DNA Necrotic or apoptotic tumor cells with tumor-specific mutations or epigenetic changes, which are contained in free DNA (cf-DNA) Tumor DNA fragments released into the peripheral blood are referred to as circulating tumor DNA. Note. Part of cf-DNA in tumor patients. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 39768-2021_English be delivered?Answer: Upon your order, we will start to translate GB/T 39768-2021_English as soon as possible, and keep you informed of the progress. 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