YY/T 0617-2021 English PDFUS$299.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0617-2021: (Enjoy the use of human peripheral blood sample collection) Status: Valid YY/T 0617: Historical versions
Basic dataStandard ID: YY/T 0617-2021 (YY/T0617-2021)Description (Translated English): (Enjoy the use of human peripheral blood sample collection) Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C48 Word Count Estimation: 14,133 Issuing agency(ies): State Drug Administration YY/T 0617-2021: (Enjoy the use of human peripheral blood sample collection)---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.(Enjoy the use of human peripheral blood sample collection) ICS 11.120.20 C48 People's Republic of China Pharmaceutical Industry Standard Replacing YY/T 0617-2007 Disposable human peripheral blood sample collection container Published on 2021-09-06 2022-09-01 Implementation Released by the State Drug Administration forewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY/T 0617-2007 "Disposable Human Peripheral Blood Sample Collection Container". Compared with YY/T 0617-2007, The main technical changes are as follows. --- Modified the scope of application of the standard, and clarified that the collection container for trace peripheral blood samples less than 20 μL is not within the scope of this standard (See Chapter 1, Chapter 1 of the.2007 edition); --- Added normative references GB/T.19973.1-2015, YY/T 0466.1 (see Chapter 2); --- Modified the terms and definitions, deleted the gravimetric analysis method (see 3.7 of the.2007 edition), the nominal filling line (see.2007 edition) Version 3.9), adding main color (see 3.8), filling volume (see 3.10), add-ons (see 3.12), relative centrifugal force (see 3.16); --- Increased the requirements for the tube body (see 4.1); --- Delete the requirements for the capacity part (5.2, 5.3 of the.2007 edition); --- Added relevant requirements for transportation (see 6.5); --- Increased requirements for peripheral blood sample collection containers for coagulation tests (see 9.2); --- Revised the requirements for the recommended color scale (see Appendix D, Table 1 of the.2007 edition). Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents. This standard is proposed by the State Drug Administration. This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Devices (SAC/TC106). This standard was drafted by. Shandong Medical Device Product Quality Inspection Center, Guangzhou Yangpu Medical Technology Co., Ltd., Bidi Medical Instrument (Shanghai) Co., Ltd., Beijing Greiner Jianfeng Biotechnology Co., Ltd., Henan Tuoren Medical Technology Co., Ltd., Shandong Xinhua An De Medical Supplies Co., Ltd. and Liuyang Sanli Medical Technology Development Co., Ltd. The main drafters of this standard. Xia Jie, Sun Bangfu, Zhang Lei, Yu Xiaohong, Yang Qiaoyang, Shi Tong, Chen Pingxuan, Shi Kai, Zhang Luwen. The previous editions of the standard replaced by this standard are as follows. ---YY/T 0617-2007. Disposable human peripheral blood sample collection container1 ScopeThis standard specifies the requirements and test methods for disposable human peripheral blood sample collection containers (peripheral blood sample collection containers). This standard applies to peripheral blood sample collection containers that are expected to be single-use and with a blood collection volume of 20 μL to 1000 μL. This standard does not apply to venous blood sample collection containers, arterial blood sample collectors and micro blood collection pipettes.2 Normative referencesThe following documents are essential for the application of this document. For dated references, only the dated version applies to this article pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 6682 Analysis Laboratory Water Specifications and Test Methods GB/T.19973.1-2015 Microbiological Methods for Sterilization of Medical Devices Part 1.Determination of Total Microorganisms on Products YY/T 0466.1 Medical Devices Symbols for Medical Device Labeling, Marking and Providing Information Part 1.General Requirements3 Terms and DefinitionsThe following terms and definitions apply to this document. 3.1 body tube Part of the peripheral blood sample collection container without a lid, which can contain blood samples. 3.2 Filling instruction filindicator Marked on the tube body or on its label to indicate proper filling. 3.3 Vessels for holding blood samples with any blood collection container additions, additives, and lids. 3.4 The inner surface of the peripheral blood sample collection container, the part in contact with the blood sample. 3.5 blood sample The peripheral blood collected in the peripheral blood sample collection container. 3.6 free space freespace Provides additional volume or headspace for adequate mixing of the contents of the peripheral blood sample collection container. 3.7 lid cap Component that seals the peripheral blood sample collection container. ...... |
