GB/T 21919-2022 English PDFUS$174.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 21919-2022: Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures Status: Valid GB/T 21919: Historical versions
Basic dataStandard ID: GB/T 21919-2022 (GB/T21919-2022)Description (Translated English): Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C30 Classification of International Standard: 11.100.99 Word Count Estimation: 10,151 Date of Issue: 2022-10-14 Date of Implementation: 2023-05-01 Older Standard (superseded by this standard): GB/T 21919-2008 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 21919-2022: Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures---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. Laboratory medicine -- Requirements for the competence of calibration laboratories using reference measurement procedures ICS 11.100.99 CCSC30 National Standards of People's Republic of China Replacing GB/T 21919-2008 Laboratory Medicine Running Reference Measurement Procedures Competency requirements for calibration laboratories (ISO 15195.2018, IDT) Published on 2022-10-12 2023-05-01 Implementation State Administration for Market Regulation Released by the National Standardization Administration directory Preface I Introduction II 1 Scope 1 2 Normative references 1 3 Terms and Definitions 2 4 General Requirements 2 5 Structural Requirements 2 6 Resource Requirements 3 6.1 General 3 6.2 Personnel 3 6.3 Laboratory Facilities and Environmental Conditions 3 6.4 Device 3 6.5 Metrological traceability3 6.6 Reference substances 4 6.7 Externally provided products and services4 7 Process Requirements 4 7.1 Review of Requirements, Tenders and Contracts 4 7.2 Reference measurement procedure 4 7.3 Sample processing 4 7.4 Measurement record 4 7.5 Evaluation of measurement uncertainty 5 7.6 Ensuring the validity of the measurement results5 7.7 Reporting measurement results 5 8 Management Requirements 5 8.1 General 5 8.2 Internal Audit5 Appendix A (Informative) Relationship between this document and GB/T 27025-20196 Reference 7 forewordThis document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents" drafted. This document replaces GB/T 21919-2008 "Requirements for Laboratory Medicine Reference Measurement Laboratories", which is consistent with GB/T 21919-2008 The main technical changes are as follows. a) The terms "measurement accuracy", "certified reference material", "measurable", "measurement precision", "reference material", "reference measurement experiment" were deleted laboratory, "traceability", "true value of quantity", "measurement accuracy", "validation", "verification" and their definitions (see 3.1~3.6 of the.2008 edition, 3.8~3.10, 3.12, 3.13); b) Added GB/T 27025-2019 as a normative reference document, deleted the duplicate clauses with GB/T 27025-2019 Content (see Chapters 4 to 8); c) Changed "Management System Requirements" and "Technical Requirements" to "General Requirements", "Structure Requirements", "Resource Requirements" and "Process Requirements" requirements” and “management requirements” (see Chapters 4-8, Chapters 4-5 of the.2008 edition). This document is equivalent to ISO 15195.2018 "Competence requirements for calibration laboratories operating reference measurement procedures in laboratory medicine". Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is under the jurisdiction of the National Standardization Technical Committee for Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136). This document is drafted by. Beijing Institute of Medical Device Inspection (Beijing Medical Bioprotective Equipment Inspection and Research Center), China Qualified The National Accreditation Center, the National Health Commission Clinical Laboratory Center, the Shanghai Clinical Laboratory Center, and the Beijing Jinyu Medical Laboratory have Co., Ltd., Shenzhen Mindray Biomedical Electronics Co., Ltd., and Zhengzhou Antu Biological Engineering Co., Ltd. The main drafters of this document. Kang Juan, Hu Dongmei, Peng Mingting, Ju Yi, Chen Baorong, Shi Xiaoyong, Liu Chunlong. The previous versions of this document and its superseded documents are as follows. ---First published in.2008 as GB/T 21919-2008; ---This is the first revision.IntroductionSee GB/T 27025-2019 for general requirements for the competence of calibration laboratories. This document is a reference to the competence of calibration laboratories in the field of laboratory medicine. Additional requirements, these calibration laboratories are also commonly referred to as "reference measurement laboratories". Results from medical laboratories should be traceable to higher-level reference materials and/or reference measurement procedures (as long as they are available), which are essential for achieving patient outcomes. The comparability of the measurement results of the patient sample at different measurement locations and measurement times is necessary. The level of measurement of results provided by the calibration laboratory should be appropriate to support the medical laboratory in meeting medical requirements. Specific requirements for medical laboratories see ISO 15189. Calibration laboratories should implement reference measurement procedures and issue reports that are accurate and traceable to existing national or international primary reference materials (where applicable). measurement results. Wherever possible, traceability to a reference material that reproduces International System of Units (SI) units should be established (ISO 17511). The calibration laboratory should issue a reference measurement procedure or reference material traceable to the highest level available for the reference material provided by the customer value of. In most cases, the molecular structure of the analyte is unclear and its form in the reference material may be different from that of human origin. For the original sample (such as the glycation state of a certain protein), the properties of the biologically derived material cannot be expressed in SI units. Even if the value of a property of a biologically derived material is not traceable to SI units, refer to each step of the measurement procedure (e.g. gravimetric determination, Capacity determination, temperature measurement, potentiometric measurement) should all have values traceable to the corresponding SI units. The concept of traceability, including its applicability and limitations, is detailed in ISO 17511. The requirements described in this document and in GB/T 27025-2019 are prerequisites for calibration laboratories to perform their tasks adequately. If a calibration laboratory applies for accreditation of the ability to perform a reference measurement procedure, this document may serve as the basis for accreditation. Laboratory Medicine Running Reference Measurement Procedures Competency requirements for calibration laboratories1 ScopeThis document specifies requirements for the competence of medical calibration laboratories to run reference measurement procedures. This document is based on the requirements of GB/T 27025-2019 This is a normative reference listing additional requirements for calibration laboratories to adequately perform their tasks. The relationship between this document and the provisions of GB/T 27025-2019 is summarized in Appendix A. This document does not include measurements of properties that report results on a nominal or ordinal scale. This document is not intended for use in medical laboratories. NOTE. ISO 15189 specifies the requirements for medical laboratories.2 Normative referencesThe contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document. GB/T 27025-2019 General requirements for the competence of testing and calibration laboratories (ISO /IEC 17025.2017, IDT) ISO /IEC Guide 98-3 Measurement Uncertainty Part 3.Guidelines for the Expression of Measurement Uncertainty [Uncertaintyofmea- Note. GB/T 27418-2017 Evaluation and representation of measurement uncertainty (ISO /IEC Guide98-3.2008, MOD) ISO 15193 Requirements for the presentation and content of reference measurement procedures for the measurement of quantities in samples of biological origin for in vitro diagnostic medical devices Note. GB/T 19702-2021 Requirements for the expression and content of reference measurement procedures for the measurement of quantities in biologically derived samples of in vitro diagnostic medical devices (ISO 15193.2009, IDT) ISO 15194 Measurement of quantities in biologically derived samples of in vitro diagnostic medical devices Certified reference materials and requirements for the content of supporting documents Note. GB/T 19703-2020 Requirements for the content of certified reference materials and supporting documents for the measurement of quantities in biologically derived samples of in vitro diagnostic medical devices (ISO 15194.2009, IDT) ISO 17511 Requirements for in vitro diagnostic medical devices to establish traceability of calibrators, correctness control substances and human sample assignments Note. GB/T 21415-2008 Metrological traceability of measurement calibrators and control substance assignments in biological samples of in vitro diagnostic medical devices (ISO 17511.2003, IDT) ISO 18153 Enzyme-catalyzed concentration of calibrators and control substances for the measurement of quantities in biologically derived samples of in vitro diagnostic medical devices ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 21919-2022_English be delivered?Answer: Upon your order, we will start to translate GB/T 21919-2022_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB/T 21919-2022_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 21919-2022_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.Question 5: Should I purchase the latest version GB/T 21919-2022?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version GB/T 21919-2022 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. |
