GB/T 39367.1-2020 English PDFUS$374.00 ยท In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 39367.1-2020: In vitro diagnostic test systems. Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens - Part 1: General requirements, terms and definitions Status: Valid
Basic dataStandard ID: GB/T 39367.1-2020 (GB/T39367.1-2020)Description (Translated English): In vitro diagnostic test systems. Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens - Part 1: General requirements, terms and definitions Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C30 Classification of International Standard: 01.040.19; 11.100.01 Word Count Estimation: 20,278 Date of Issue: 2020-11-19 Date of Implementation: 2022-06-01 Quoted Standard: GB 19781-2005; GB/T 22576.1-2018; GB/T 29791.1-2013; GB/T 29791.2-2013; GB/T 29791.3-2013; YY/T 0316-2016; YY/T 1579-2018; ISO 13485-2003; BIPM JCGM 200-2012 Adopted Standard: ISO/TS 17822-1-2014, IDT Regulation (derived from): National Standard Announcement No. 26 of 2020 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration Summary: This standard applies to: in vitro diagnostic medical device manufacturers, medical laboratories, and scientific research laboratories that develop nucleic acid-based qualitative in vitro diagnostic testing procedures for the detection and identification of microbial pathogens in human specimens; and for the detection and identification of human specimens A medical laboratory that performs nucleic acid-based in vitro diagnostic tests for microbial pathogens. This standard does not apply to: nucleic acid testing whose intended use is not in vitro diagnostics; or nucleic acid-based quantitative in vitro diagnostic testing procedures. GB/T 39367.1-2020: In vitro diagnostic test systems. Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens - Part 1: General requirements, terms and definitions---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. In vitro diagnostic test systems - Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens - Part 1.General requirements, terms and definitions ICS 01.040.19;11.100.01 C30 National Standards of People's Republic of China In vitro diagnostic test system pathogenic microorganism detection and Qualitative in vitro testing procedures for nucleic acids for identification Part 1.General requirements, terms and definitions 2020-11-19 released 2022-06-01 implementation State Administration for Market Regulation Issued by the National Standardization Management Committee ForewordGT/T 39367 "In Vitro Diagnostic Test System Pathogenic Microorganism Detection and Identification Nucleic Acid Qualitative In Vitro Test Procedure" is planned as follows Partial composition. ---Part 1.General requirements, terms and definitions; This part is Part 1 of GB/T 39367. This section was drafted in accordance with the rules given in GB/T 1.1-2009. The translation method used in this part is equivalent to the ISO /T S17822-1.2014 "In Vitro Diagnostic Testing System Pathogenic Microorganism Detection and Identification Qualitative in vitro testing procedures for nucleic acids. Part 1.General requirements, terms and definitions. The Chinese documents that have a consistent correspondence with the international documents cited in this section are as follows. ---YY/T 0287-2017 Medical device quality management system is used in regulatory requirements (ISO 13485.2016, IDT). Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This part is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136). Drafting organizations of this section. Beijing Medical Device Inspection Institute, China National Accreditation Center for Conformity Assessment, Shenzhen Huada Yinyuan Pharmaceutical Technology Co., Ltd. Co., Ltd., Sun Yat-sen University Daan Gene Co., Ltd. The main drafters of this section. Dai Leiying, Fu Yue, Gong Yanping, Jiang Xiwen, Wang Ruixia.IntroductionNucleic acid-based in vitro diagnostic test procedures are currently commonly used in the detection and identification of microbial pathogens in laboratory medicine. These inspection procedures It is especially valuable for detecting infectious agents that are not easy to cultivate. Recent developments in in vitro diagnostic testing procedures related to nucleic acid amplification and detection technology (molecular diagnostics) For a review of progress and current practice, see references [35], [36], [37], [38], [39], [41] and [42]. ISO /T S17822-1 compares the in vitro diagnostic nucleic acid qualitative testing procedures for the detection and identification of microbial pathogens in human samples The related concepts are defined and the general principles of its design, development and performance are established. Traditional PCR inspection procedures usually include three steps. (1) sample preparation and nucleic acid extraction; (2) nucleic acid amplification; (3) nucleic acid detection and Identification. Analytical technology continues to evolve. Recent kinetic methods ("real-time PCR") incorporate detection into the amplification step, and multiplex PCR will The entire system has been integrated. Due to the inherent complexity and excellent analytical sensitivity of the nucleic acid test process, special attention needs to be paid to its design, development and use. Matters include the establishment of analysis and clinical performance, documentation of instructions for use, design of medical laboratory facilities, and appropriate quality assurance measures. Implementation, verification of performance characteristics by medical laboratories under actual conditions of use, and risk management. As with all in-vitro diagnostic test procedures, as part of the development process, it is necessary to prove that the nucleic acid-based test procedure is suitable for its expectations The clinical use. In order to detect and identify the target pathogen, it is necessary to determine and verify the analysis performance characteristics. Clinical manifestation characteristics need to be based on clinical Evidence to determine and verify, including assessment of benefits and risks to patients. Instructions for use need to be clearly documented, and effective quality assurance procedures need to be specified. Before testing patient specimens, whether the testing procedures are performed correctly needs to be tested by a medical laboratory under actual conditions of use. certificate. That is, it is proved by objective evidence that the verified inspection procedure has been successfully transplanted from the laboratory or IVD manufacturer to the medical laboratory terminal. After this transfer, any modification to the inspection procedure may require verification to verify whether its analytical performance and/or clinical performance are still applicable Its intended use includes reassessing any risks that may result from the modification. In vitro diagnostic test system pathogenic microorganism detection and Qualitative in vitro testing procedures for nucleic acids for identification Part 1.General requirements, terms and definitions1 ScopeThis part of GB/T 39367 applies to. ---In vitro diagnosis of nucleic acid-based qualitative in vitro diagnostic test procedures for the detection and identification of microbial pathogens in human specimens Medical device manufacturers, medical laboratories and scientific research laboratories; and ---A medical laboratory that conducts nucleic acid-based in vitro diagnostic tests for the detection and identification of microbial pathogens in human specimens. This section does not apply to. ---The intended use is not a nucleic acid test for in vitro diagnostics; or --- Nucleic acid-based quantitative in vitro diagnostic test procedures.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 references, the latest version (including all amendments) applies to this document. GB 19781-2005 Medical laboratory safety requirements (ISO 15190.2003, IDT) GB/T 22576.1-2018 Requirements for the quality and competence of medical laboratories Part 1.General requirements GB/T 29791.1-2013 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 1.Terms, definitions and general requirements GB/T 29791.2-2013 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.Professional in vitro diagnostic reagents GB/T 29791.3-2013 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 3.Professional in vitro diagnostic devices YY/T 0316-2016 Application of medical device risk management to medical devices YY/T 1579-2018 Evaluation of the stability of in vitro diagnostic reagents for in vitro diagnostic medical devices ISO 13485.2003 medical device quality management system for regulatory requirements BIPMJCGM200.2012 International Metrology Vocabulary General, Basic Concepts and Related Terms (VIM), third edition3 Terms and definitionsDefined in GB/T 29791.1-2013, YY/T 0316-2016, ISO 13485.2003 and BIPMJCGM200.2012 and The following terms and definitions apply to this document. Note. The terms and definitions of the source GB/T 29791.1-2013 have priority over other sources. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 39367.1-2020_English be delivered?Answer: Upon your order, we will start to translate GB/T 39367.1-2020_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB/T 39367.1-2020_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 39367.1-2020_English will be deemed to be sold to your employer/organization who actually pays 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. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay. |
