YY 0465-2019 PDF EnglishUS$359.00 · In stock · Download in 9 seconds
YY 0465-2019: Disposable membrane plasmaseparator and plasma component separator Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid YY 0465: Historical versions
Similar standardsYY 0465-2019: Disposable membrane plasmaseparator and plasma component separator---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY0465-2019Disposable membrane plasmaseparator and plasma component separator ICS 11.040.40 C45 People's Republic of China Pharmaceutical Industry Standard Replacing YY 0465-2009 Single-use hollow fiber plasma separator and Plasma component separator Published on.2019-05-31 2020-06-01 implementation State Drug Administration issued ForewordChapter 5 of this standard is mandatory. This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY 0465-2009 "single-use hollow fiber plasma separator", compared with YY 0465-2009, except for editing The main technical changes outside the sexual modification are as follows. --- Increased the requirements and test methods for the particles to fall off the outer cavity (see 5.5 and 6.5); --- Increased bacterial endotoxin requirements and test methods (see 5.10 and 6.10); --- Increased the plasma separator separation of plasma hemoglobin content requirements and test methods (see 5.11 and 6.11); --- Increased the plasma component filtration rate requirements and test methods for plasma component separators (see 5.13.3 and 6.13.3); --- Increased the requirements and test methods for the screening factor of plasma component separator proteins (see 5.13.4 and 6.13.4); --- Increased the validity period requirements and test methods (see 5.15 and 6.15); --- Revised the test method for pyrogens (see 6.9, 6.7.3 for the.2009 edition). Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Extracorporeal Circulation Equipment (SAC/TC158). This standard was drafted. Guangdong Medical Device Quality Supervision and Inspection Institute, Guangzhou Kangsheng Biotechnology Co., Ltd., Foshan Boxin Bio Technology Co., Ltd. The main drafters of this standard. Wu Jingbiao, He Xiaofan, Luo Jiewei, Ye Xiaoyan. The previous versions of the standards replaced by this standard are. ---YY 0465-2003; ---YY 0465-2009. Single-use hollow fiber plasma separator and Plasma component separator1 ScopeThis standard specifies the terms and definitions, type and model nomenclature for single-use hollow fiber plasma separators and plasma component separators. Requirements, test methods, inspection rules, marking and packaging, transportation, storage. This standard applies to single-use hollow fiber plasma separators and plasma component separators. Single-use hollow fiber plasma separation The device (referred to as a plasma separator) is combined with a plasma separation device to treat various immune, metabolic disorders and certain poisoning diseases. One-time Hollow fiber plasma component separator (referred to as plasma component separator) is suitable for performing double filtration plasma exchange therapy with plasma separator In combination, a certain molecular weight substance is separated from the separated plasma by a membrane separation method.2 Normative referencesThe following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 191 packaging storage and transportation icon GB/T 1962.2 syringes, needles and other medical devices 6% (Ruhr) conical joints Part 2. Locking joints GB/T 13074 blood purification terminology GB/T 14233.1-2008 Methods of test for infusions, blood trans GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management GB/T 16886.4 Biological evaluation of medical devices - Part 4. Selection of test for interaction with blood GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test GB/T 16886.10 Biological evaluation of medical devices - Part 10. Stimulation and skin sensitization test GB/T 16886.11 Biological evaluation of medical devices - Part 11. Systemic toxicity test YY/T 0466.1 Medical devices for the labeling, marking and information of medical devices - Part 1. General requirements Pharmacopoeia of the People's Republic of China (2015 Edition)3 Terms and definitionsThe following terms and definitions as defined in GB/T 13074 apply to this document. 3.1 Plasma separation plasmaseparation The process of separating plasma from blood forms a fraction. 3.2 Plasma separation device plasmaaseparationsystem A device consisting of a hemodynamic, monitoring, volume balancing system, and plasma separator. 3.3 Plasma component separation plasmacomponentseparation The process of separating different relative molecular mass substances in plasma. YY 0465-2019 Disposable membrane plasmaseparator and plasma component separator ICS 11.040.40 C45 People's Republic of China Pharmaceutical Industry Standard Replacing YY 0465-2009 Single-use hollow fiber plasma separator and Plasma component separator Published on.2019-05-31 2020-06-01 implementation State Drug Administration issuedForewordChapter 5 of this standard is mandatory. This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY 0465-2009 "single-use hollow fiber plasma separator", compared with YY 0465-2009, except for editing The main technical changes outside the sexual modification are as follows. --- Increased the requirements and test methods for the particles to fall off the outer cavity (see 5.5 and 6.5); --- Increased bacterial endotoxin requirements and test methods (see 5.10 and 6.10); --- Increased the plasma separator separation of plasma hemoglobin content requirements and test methods (see 5.11 and 6.11); --- Increased the plasma component filtration rate requirements and test methods for plasma component separators (see 5.13.3 and 6.13.3); --- Increased the requirements and test methods for the screening factor of plasma component separator proteins (see 5.13.4 and 6.13.4); --- Increased the validity period requirements and test methods (see 5.15 and 6.15); --- Revised the test method for pyrogens (see 6.9, 6.7.3 for the.2009 edition). Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Extracorporeal Circulation Equipment (SAC/TC158). This standard was drafted. Guangdong Medical Device Quality Supervision and Inspection Institute, Guangzhou Kangsheng Biotechnology Co., Ltd., Foshan Boxin Bio Technology Co., Ltd. The main drafters of this standard. Wu Jingbiao, He Xiaofan, Luo Jiewei, Ye Xiaoyan. The previous versions of the standards replaced by this standard are. ---YY 0465-2003; ---YY 0465-2009. Single-use hollow fiber plasma separator and Plasma component separator1 ScopeThis standard specifies the terms and definitions, type and model nomenclature for single-use hollow fiber plasma separators and plasma component separators. Requirements, test methods, inspection rules, marking and packaging, transportation, storage. This standard applies to single-use hollow fiber plasma separators and plasma component separators. Single-use hollow fiber plasma separation The device (referred to as a plasma separator) is combined with a plasma separation device to treat various immune, metabolic disorders and certain poisoning diseases. One-time Hollow fiber plasma component separator (referred to as plasma component separator) is suitable for performing double filtration plasma exchange therapy with plasma separator In combination, a certain molecular weight substance is separated from the separated plasma by a membrane separation method.2 Normative referencesThe following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 191 packaging storage and transportation icon GB/T 1962.2 syringes, needles and other medical devices 6% (Ruhr) conical joints Part 2. Locking joints GB/T 13074 blood purification terminology GB/T 14233.1-2008 Methods of test for infusions, blood trans GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management GB/T 16886.4 Biological evaluation of medical devices - Part 4. Selection of test for interaction with blood GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test GB/T 16886.10 Biological evaluation of medical devices - Part 10. Stimulation and skin sensitization test GB/T 16886.11 Biological evaluation of medical devices - Part 11. Systemic toxicity test YY/T 0466.1 Medical devices for the labeling, marking and information of medical devices - Part 1. General requirements Pharmacopoeia of the People's Republic of China (2015 Edition)3 Terms and definitionsThe following terms and definitions as defined in GB/T 13074 apply to this document. 3.1 Plasma separation plasmaseparation The process of separating plasma from blood forms a fraction. 3.2 Plasma separation device plasmaaseparationsystem A device consisting of a hemodynamic, monitoring, volume balancing system, and plasma separator. 3.3 Plasma component separation plasmacomponentseparation The process of separating different relative molecular mass substances in plasma. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of English version of YY 0465-2019 be delivered?Answer: The full copy PDF of English version of YY 0465-2019 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.Question 2: Can I share the purchased PDF of YY 0465-2019_English with my colleagues?Answer: Yes. The purchased PDF of YY 0465-2019_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. www.ChineseStandard.us -- YY 0465-2019 -- Click this link and select your country/currency to pay, the exact amount in your currency will be printed on the invoice. Full PDF will also be downloaded/emailed in 9 seconds.Question 5: Should I purchase the latest version YY 0465-2019?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 0465-2019 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.How to buy and download a true PDF of English version of YY 0465-2019?A step-by-step guide to download PDF of YY 0465-2019_EnglishStep 1: Visit website https://www.ChineseStandard.net (Pay in USD), or https://www.ChineseStandard.us (Pay in any currencies such as Euro, KRW, JPY, AUD).Step 2: Search keyword "YY 0465-2019". Step 3: Click "Add to Cart". If multiple PDFs are required, repeat steps 2 and 3 to add up to 12 PDFs to cart. Step 4: Select payment option (Via payment agents Stripe or PayPal). Step 5: Customize Tax Invoice -- Fill up your email etc. Step 6: Click "Checkout". Step 7: Make payment by credit card, PayPal, Google Pay etc. After the payment is completed and in 9 seconds, you will receive 2 emails attached with the purchased PDFs and PDF-invoice, respectively. Step 8: Optional -- Go to download PDF. Step 9: Optional -- Click Open/Download PDF to download PDFs and invoice. See screenshots for above steps: Steps 1~3 Steps 4~6 Step 7 Step 8 Step 9 |
