YY/T 0314-2021 English PDFUS$439.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0314-2021: (Huiyong human blood vessel blood sample collector) Status: Valid YY/T 0314: Historical versions
Basic dataStandard ID: YY/T 0314-2021 (YY/T0314-2021)Description (Translated English): (Huiyong human blood vessel blood sample collector) Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C48 Word Count Estimation: 21,225 Issuing agency(ies): State Drug Administration YY/T 0314-2021: (Huiyong human blood vessel blood sample collector)---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.(Huiyong human blood vessel blood sample collector) ICS 11.120.20 C48 People's Republic of China Pharmaceutical Industry Standard Replacing YY/T 0314-2007 Disposable human venous blood sample collection container (ISO 6710.2017, MOD) 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 0314-2007 "Disposable Human Venous Blood Sample Collection Container". Compared with YY/T 0314-2007, The main technical changes are as follows. --- Modified the scope, the scope of application does not include blood culture bottles, because this standard does not describe specific requirements for such tests; --- Modified the content of terms and definitions, deleted the blood sample collection system (see 3.2 of the.2007 edition), closed torque (see the.2007 edition of 3.3), filling capacity (see 3.9 of the.2007 edition), scale marks (see 3.11 of the.2007 edition), gravimetric analysis method (see 3.11 of the.2007 edition) 3.12 of the.2007 edition), maximum filling line (see 3.13 of the.2007 edition), minimum filling line (see 3.14 of the.2007 edition), needle and needle holder assembly (see 3.15 of the.2007 edition), nominal filling line (see 3.17 of the.2007 edition); added filling instructions (see 3.9), main color (see 3.12), relative centrifugal force (see 3.14), tube body (see 3.16); --- Updated the content of "Materials" (see Chapter 4, Chapter 4 of the.2007 edition); --- Delete the scale mark and filling line (see Chapter 6 of the.2007 edition); --- Increase the design should consider related matters (see 6.3); --- Modified the structural requirements and deleted 8.1 of the.2007 edition (see Chapter 7); --- Modified the requirements for sterility and specific microbial status, and clarified that the interior of the vacuum collection container should be sterile (see 8.1, 9.2 of the.2007 edition and Amendment No. 1 of.2013); --- Revised the requirements for the range of additives (see Chapter 9, Chapter 10 of the.2007 edition); --- Change "information provided by the manufacturer" to "marks and labels" (see Chapter 10, Chapter 11 of the.2007 edition); --- Changed "Identification of blood collection tubes and additives" to "Identification of collection containers", Table 1 deleted the recommended color code (see Chapter 11,.2007 Chapter 12 of the year edition); --- Modify the name of Appendix A (see Appendix A); --- Modify the name of Appendix B (see Appendix B); --- Modified the liquid for strength test, replacing water with the test liquid with the same specific gravity as human blood (see Appendix D); --- Modified the informative appendix "Concentration of additives and volume of liquid additives" (see Appendix E, Appendix NC of the.2007 edition); --- Added the informative appendix "Recommended Color Codes for Identifying Additives and Additives" (see Appendix F). This standard adopts the redrafting method to modify and adopts ISO 6710.2017 "Disposable Human Venous Blood Sample Collection Container". Compared with ISO 6710.2017, this standard has structural changes, and appendix G and appendix H have been added. The technical differences between this standard and ISO 6710.2017 and their reasons are as follows. --- Regarding normative reference documents, this standard has made adjustments to specific technical differences to adapt to the technical conditions of our country and the circumstances of the adjustment. The situation is reflected in Chapter 2 "Normative References", and the specific adjustments are as follows. ● Added GB/T 6682 (see A.1.1); ● Replace ISO 15223-1 (see 10.3) with YY/T 0466.1 which is equivalent to adopting international standards. ---Appendix E is modified from normative appendix to informative appendix. 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, Bidi Medical Devices (Shanghai) Co., Ltd., Guangzhou Yangpu Medical Medical Technology Co., Ltd., Henan Tuoren Medical Technology Co., Ltd., Beijing Greiner Jianfeng Biotechnology Co., Ltd., Shandong Xinhua An De Medical Supplies Co., Ltd., Liuyang Sanli Medical Technology Development Co., Ltd., Jiangsu Kangwei Century Biotechnology Co., Ltd. The main drafters of this standard. Sun Jianjun, Xu Yuanmei, Sun Bangfu, Yu Xiaohong, Zhang Limei, Zhang Jing, Shi Tong, Chen Pingxuan, Zhao Changshuai, Liu Wanzong, Yin Jianfeng. The publications of the previous editions of the standard replaced by this standard are as follows. ---YY 0314-1999, YY/T 0314-2007.IntroductionDisposable human venous blood sample collection container (collection container), also known as blood collection container or blood collection tube. There are two scale systems, one of which is the color scale system recommended by ISO 6710.1995.Due to the changes in the production technology of blood collection tubes, mainly in Europe Some of the countries strongly demand revision of ISO 6710.1995.On the one hand, some countries strongly require blood collection tubes for patient safety concerns. Color-coded; on the other hand, since there have been no reports of patient safety impacts due to color-coded differences, any changes by the manufacturer in this regard will Increase the cost of production, which will increase the user purchase price. The majority opinion no longer recommends the color scale. Therefore, the revised ISO 6710 has not reached an agreement due to the color code problem, and the revision work has not been completed. However, in some European countries, it is generally believed that the lack of color code storage In terms of potential safety risks, EN14820.2004 was therefore published, giving a recommended color scale. In.2014, the revision of ISO 6710 was launched again, and in order to avoid heated debate on the color code issue, the content of the color code was used as an informative The appendix is given. If the acceptance level is gradually agreed after the standard is published, the content of the appendix may be moved to the main body of the standard..2017 Year, ISO 6710 was successfully released. In order to make the EN standard consistent with the ISO standard, EN14820 was revised in the same year and equivalently adopted. ISO 6710, the standard number is ENISO 6710-2017, replaces EN14820.2004 and abolishes EN14820.2004. In the process of revision of YY 0314, from the perspective of patient safety, it is believed that a unified color code is the development trend, so the color code has been Give a recommendation. The.1999 edition is equivalent to ISO 6710.1995, and the.2007 edition is revised and adopted EN14820.2004.This revision adopts the Use ISO 6710.2017. For the vacuum blood collection tube, the accuracy of the collected blood sample volume is mainly affected by the vacuum degree in the blood collection tube and the atmospheric pressure of the environment where the blood is collected (mainly affected by altitude) and the volume of the collection needle. In order to make the blood collection tube meet the requirements of clinical use, in addition to requiring the collection container to have good In addition to the vacuum retention, it is recommended that the manufacturer make corrections to the local atmospheric environment at the time during the production process, express the applicable altitude range and stipulate Applicable vein collection needle. Disposable human venous blood sample collection container1 ScopeThis standard specifies the requirements and test methods for vacuum and non-vacuum single-use venous blood sample collection containers (collection containers). This standard applies to vacuum and non-vacuum single-use venous blood sample collection containers. This standard does not include requirements for collection needles and needle holders, and this standard does not apply to blood culture bottles or "arterial" blood gas collections that can be used for venous blood. set container.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 6682-2008, ISO 3696.1987, MOD) YY/T 0466.1 Medical Devices Symbols for Medical Device Labeling, Marking and Providing Information Part 1.General Requirements (YY/T 0466.1-2016, ISO 15223-1.2012, IDT)3 Terms and DefinitionsThe following terms and definitions apply to this document. 3.1 accessories accessory A component that a manufacturer places inside a collection container to aid in the collection, mixing, or separation of a blood sample. NOTE. Examples of add-ons. plastic inert beads or separating gels in serum or plasma containers for separating serum or plasma from cells after centrifugation. 3.2 additive additive A substance placed in the collection container to assist in obtaining the desired sample (excluding non-removable substances for interior surface preparation). 3.3 head cover closure The assembly of the closed collection container, which can be composed of several parts. 3.4 collection container Vacuum or non-vacuum container for blood samples with any add-ons, additives and caps. 3.5 Collection container interior containerinterior The inner surface of the collection container that is in contact with the blood sample. 3.6 drawvolume The volume of the entire blood in the collection container is collected. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0314-2021_English be delivered?Answer: Upon your order, we will start to translate YY/T 0314-2021_English as soon as possible, and keep you informed of the progress. 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