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Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 42080.3-2024: DNA Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA Status: Valid
Basic dataStandard ID: GB/T 42080.3-2024 (GB/T42080.3-2024)Description (Translated English): DNA Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C30 Classification of International Standard: 11.100.10 Word Count Estimation: 18,193 Date of Issue: 2024-09-29 Date of Implementation: 2025-04-01 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 42080.3-2024: DNA Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA---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. ICS 11.100.10 CCSC30 National Standard of the People's Republic of China Molecular in vitro diagnostic testing before frozen tissue testing Specification of the process Part 3.Isolation of DNA (ISO.20184-3.2021, IDT) Released on 2024-09-29 2025-04-01 Implementation State Administration for Market Regulation The National Standardization Administration issued Table of ContentsPreface III Introduction IV 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 General Requirements 4 5 Outside the laboratory 5 5.1 Specimen Collection 5 5.2 Fresh Tissue Shipping Requirements 6 6 Laboratory Interior 6 6.1 Information about specimen receipt 6 6.2 Specimen pathology evaluation and sample selection 7 6.3 Freezing of specimens or samples 7 6.4 Storage requirements 8 6.5 DNA Isolation 9 6.6 Qualitative and quantitative assessment of isolated DNA 10 6.7 Storage of Isolated DNA 10 Reference 11ForewordThis document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents" Drafting. This document is part 3 of GB/T 42080 "Specifications for pre-testing procedures for frozen tissues for molecular in vitro diagnostic testing". The following parts have been published. --- Part 1.Isolation of RNA; --- Part 2.Isolation of proteins; --- Part 3.Isolation of DNA. This document is equivalent to ISO.20184-3.2021 "Specification for pre-testing processes of frozen tissues for molecular in vitro diagnostic tests Part 3 Separation of DNA. Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents. This document is proposed by the State Food and Drug Administration. This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Clinical Testing Laboratories and In Vitro Diagnostic Systems (SAC/TC136). This document was drafted by. Guangdong Provincial People's Hospital, China-Japan Friendship Hospital, Beijing Institute of Medical Device Inspection (Beijing Medical Bioprevention Protective Equipment Inspection and Research Center). The main drafters of this document. Yan Lixu, Chen Huang, Xu Songyan, and Liu Yanchun.IntroductionMolecular in vitro diagnostics (including molecular pathology) have made great progress in medicine. Further progress is expected with the advent of new technologies for the analysis of proteins, acids, and metabolites. However, the integrity and profile of these molecules are limited in specimens. Changes may occur during collection, transportation, storage and processing, thus making the results of diagnosis or research unreliable or even impossible. Because the actual situation of the patient will not be considered in the subsequent test analysis, but the artificial map generated before the test will be used. The entire process from specimen collection to testing is standardized. GB/T 42080 "Specification for pre-testing procedures for frozen tissues for molecular in vitro diagnostic testing" specifies the molecular in vitro diagnostic procedures for frozen tissues. The standardized requirements for pre-inspection operation steps of the inspection are planned to consist of three parts. --- Part 1.Isolation of RNA. The purpose is to standardize the pre-test procedures for RNA testing of frozen tissues and reduce Minimize changes in RNA spectrum and ensure the validity and reliability of subsequent test results. --- Part 2.Protein separation. The purpose is to standardize the pre-test procedures for protein testing of frozen tissues and reduce Fewer protein profile changes and modifications. --- Part 3.Isolation of DNA. The purpose is to standardize the pre-test procedures for DNA testing of frozen tissues. The integrity of DNA in tissues may change during processing and storage. Modifications to DNA molecules can affect test results. Special measures are necessary to minimize changes and modifications in the described DNA for subsequent testing. Therefore, there is a need to standardize the entire process from specimen collection to DNA testing. This document builds on this work by codifying and standardizing the steps involved in DNA testing of frozen tissues at the so-called pre-test stage. Standardization. Molecular in vitro diagnostic testing before frozen tissue testing Specification of the process Part 3.Isolation of DNA1 ScopeThis document specifies the procedures for handling, recording, and analyzing frozen tissue specimens for DNA testing during the pre-test phase prior to molecular analysis. The requirements for storage and material collection are given and corresponding suggestions are provided. This document applies to molecular in vitro diagnostic tests performed by medical laboratories and molecular pathology laboratories on DNA extracted from frozen tissues. This document is also applicable to laboratory customers, in vitro diagnostic developers and manufacturers, biobanks, Institutional and commercial organizations involved in biomedical research and regulatory agencies. This document does not apply to tissues that have been chemically stabilized prior to freezing. NOTE. International, national or regional regulations or requirements may also apply to the specific areas covered by this document.2 Normative referencesThe contents of the following documents constitute essential clauses of this document through normative references in this document. For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document. competence Note. GB/T 22576.1-2018 Requirements for quality and competence of medical laboratories Part 1.General requirements (ISO 15189.2012, IDT) Note. GB 19781-2005 Safety requirements for medical laboratories (ISO 15190.2003, IDT)3 Terms and definitionsFor the purpose of this document, the terms and definitions defined in ISO 15189 and the following apply. ISO and IEC maintain terminology databases used for standardization at the following addresses. ---IEC Electronic Encyclopedia http.//electropedia./org. 3.1 Aliquot The portion of a bulk homogeneous substance when sampling errors are assumed to be negligible. NOTE. This term is usually applied to liquids. Tissues are heterogeneous and cannot be aliquoted. [Source. GB/T 42080.1-2022, 3.1] 3.2 Ambient temperature ambienttemperature The temperature of the unconditioned ambient air. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 42080.3-2024_English be delivered?Answer: Upon your order, we will start to translate GB/T 42080.3-2024_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. 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