Search result: GB/T 21919-2022 (GB/T 21919-2008 Older version)
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Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures
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GB/T 21919-2022
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| GB/T 21919-2008 | English | 594 |
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Laboratory medicine -- Requirements for reference measurement laboratories
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GB/T 21919-2008
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| Standard 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Count Estimation | 10,138 | | Date of Issue | 2022-10-14 | | Date of Implementation | 2023-05-01 | | Older Standard (superseded by this standard) | GB/T 21919-2008 | | Issuing agency(ies) | State Administration for Market Regulation, National Standardization Management Committee |
GB/T 21919-2022
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
foreword
This 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.
introduction
See 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 laboratories
1 Scope
This 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 references
The 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
......
GB/T 21919-2008
Laboratory medicine. Requirements for reference measurement laboratories
ICS 11.100
C30
National Standards of People's Republic of China
GB/T 21919-2008/ISO 15195.2003
Laboratory Medicine
Reference measurement laboratory requirements
(ISO 15195.2003, IDT)
Posted 2008-06-11
2009-01-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Table of Contents
Preface Ⅰ
Introduction Ⅱ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 3 Management System Requirements
4.1 Organization and Management 3
4.2 Quality Management System 4
4.3 staff 4
4.4 Measurement documents and records 5
4.5 Contract 5
5 Technical requirements 5
5.1 basic conditions and environmental conditions 5
5.2 Sample Preparation 5
5.3 Equipment 5
5.4 Reference substance 6
5.5 reference measurement procedure 6
Metrological traceability 5.6 Measurement Uncertainty --- 6
5.7 Quality Assurance 6
5.8 report results 7
Appendix A (informative) and GB/T 15481 CROSS-REFERENCE TO 8
Reference 9
GB/T 21919-2008/ISO 15195.2003
Foreword
This standard is identical with ISO 15195.2003 "medical reference measurement laboratories testing requirements."
For ease of use, this standard made the following editorial changes.
--- The "international standard" be replaced by "this standard";
"." --- With a decimal point instead of a comma as the decimal point, "";
--- Delete international standards foreword.
Appendix A of this standard is an informative annex.
This standard was proposed by the State Food and Drug Administration.
This standard by the national medical clinical testing laboratory and diagnostic systems in vitro Standardization Technical Committee.
This standard was drafted. Beijing Medical Device Testing.
The main drafters of this standard. Cong Yu Long, Liu Yi, Hu Dongmei, Zhang Xinmei, Wang.
GB/T 21919-2008/ISO 15195.2003
introduction
GB/T 15481 specifies the general requirements for testing and calibration laboratories. This standard describes the field of laboratory medicine in the real calibration
Specific requirements of the laboratory, in the field, "Calibration Laboratory" is usually referred to as "reference measurement laboratories."
Whenever possible, medical laboratory results obtained should be traceable to reference material and (or) a higher level of reference measurement procedures. This is real
Now the patient sample measurement results from measuring the impact of space and time, thus recognizing the transferability necessary.
To achieve this goal, the first and basic step is to clear the amount measured. Once the volume is measured to establish a clear need
A reference measurement system, comprising.
--- Reference materials;
--- Reference measurement procedures;
--- Reference measurement laboratories.
Reference measurement laboratories should be added by the International Society for Clinical Chemistry and Laboratory Medicine (IFCC) and CIPM (CIPM) and other organizations
International (global) network.
Reference measurement laboratories must ensure that working conditions can be traced to the most advanced existing metrology and has a lower level of routine laboratory
Measurement uncertainty. Reference measurement results provided by the laboratory of metrology level should ensure that conventional medical laboratory can meet the requirements.
ISO 15189 specifies the requirements for medical laboratories in the conventional measured.
Description Description of reference materials and reference measurement procedures corresponding national standards (GB/T 19702/ISO 15193 and GB/T 19703 /
ISO 15194). This standard specifies the performance characteristics of laboratory medicine in the field of reference measurement laboratory requirements. These are highly specialized laboratory
Industry-oriented laboratories, often affiliated with certain institutions or subcontractors in certain institutions, such as national metrology institutes, quality assessment/proficiency testing organizations,
Academic centers or in vitro diagnostic medical devices manufacturer.
Reference measurement laboratories should be possible to implement reference measurement procedures and provide accurate, traceable to national or international reference material
Measurement results. As far as possible and should be traceable to SI units reflect the reference material (GB/T 21415/ISO 17511).
In most cases, due to the molecular structure of the analyte is not clear and its presence in the form of a reference material may be different from human origin
The original sample (for example, a protein glycation state), certain characteristics of biogenic materials can not be expressed in SI units; this time traceability chain
We can only achieve a lower level, such as an agreed international units. However, the reference measurement laboratory reference material should be provided by the customer is given
It can be traced to the highest existing reference measurement procedure or reference material results.
Even if a characteristic value of a material of biological origin can not be traceable to SI units, but the reference measurement procedures at each step (for example, by weight measured
Fixed capacity measurement, temperature measurement) should have all traceable to the value of the corresponding SI units.
The concept of traceability, and the application is limited to GB/T 21415/ISO 17511 "in vitro diagnostic medical devices amounts of samples of biological origin
Measurement calibration and quality control material assignment metrological traceability "is described in detail.
If desired, the reference measurement laboratory can also undertake further work include.
--- Study the accuracy of a new or existing measurement procedures;
--- Is used for calibration, indoor quality control and quality assessment of substances provided with clear and accurate Uncertainty (correct and fine
Secret) assignment;
--- To provide advice to governments, businesses and organizations engaged in external quality assessment programs and professional independent laboratory.
The standards and requirements specified in GB/T 15481 is sufficient for reference measurement laboratories to perform prerequisite tasks. Where a
Reference measurement laboratory is part of a routine laboratory, then the reference measurement laboratory management systems, personnel and equipment should comply with the standard
Registration requirements and independent of routine laboratory.
As reference measurement laboratories can demonstrate its compliance with this standard requirements, this standard can help users to create reference measurement laboratories
Trust.
GB/T 21919-2008/ISO 15195.2003
As reference measurement laboratories apply for government recognition performance of a reference measurement procedure, the approval of this standard can be used as the basis. usually
The case by the National Institute of Metrology, or the national accreditation body for reference measurement laboratories accredited.
NOTE. ISO /IEC Guide 58 specifies the requirements for approval and implementation. International Laboratory Accreditation Cooperation (ILAC) for national accreditation bodies regional organizations,
For example, the European Accreditation Cooperation (EA) coordination and oversight to ensure that its member institutions recognize each other's certificate of accreditation.
This standard can also promote collaboration between reference measurement laboratories interlaboratory comparisons and encourage people need real reference measurement
Establishment of an international network of laboratories.
In summary, the reference measurement procedure should have advanced metrology and measuring the level of applied analysis theory should have a sufficiently low uncertainty
Given degrees. Reference measurements should be traceable to reference material or as a higher reference measurement procedures.
GB/T 21919-2008/ISO 15195.2003
Laboratory Medicine
Reference measurement laboratory requirements
1 Scope
This standard specifies the requirements for inspection and special medical reference measurement laboratories. This standard does not include the name of a scale or ordinal scale report results
Measurement characteristics of fruit.
This standard does not apply to routine medical laboratories.
Note 1. The laboratory is responsible to comply with health and safety requirements of the relevant laws.
Note 2. routine medical laboratory requirements are defined in the ISO 15189.
2 Normative references
Following standard terms of this standard reference and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to reach an agreement the purpose of this standard
Research on whether to use the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
Description GB/T 19702-2005 vitro diagnostic medical devices derived biological sample in an amount of reference measurement procedures
(ISO 15193.2002, IDT)
GB/T 19703-2005 vitro diagnostic medical devices derived biological sample volume measurement reference substance description (ISO 15194.
2002, IDT)
Meter GB/T 21415-2008 vitro diagnostic medical devices samples of biological origin - Measurement of quantities calibrators and control of product value
Dosimetry traceability (ISO 17511.2003, IDT)
Enzymatic YY/T 0638-2008 vitro diagnostic medical devices samples of biological origin quantity measurement calibration and control materials in
Concentration assignment metrological traceability (ISO 18153.2003, IDT)
International Metrology basic and common terminology vocabulary (VIM) BIMP, IEC , IFCC, ISO , IUPAC, IUPAP and OIML, 19931)
Guide to the Expression of Uncertainty in Measurement (GUM) BIMP, IEC , IFCC, ISO , IUPAC, IUPAP and OIML, 19931)
1) This publication is a joint working group of experts from the following bodies assigned to develop.
BIMP BIPM
IEC International Electrotechnical Commission
IFCC International Society of Laboratory Medicine and Clinical Chemistry
ISO International Organization for Standardization
IUPAC International Union Pure and Applied Chemistry
IUPAP International Federation of Theoretical and Applied Physics
OIML International Organization of Legal Metrology
3 Terms and Definitions
Fundamentals of metrology and international generic term vocabulary (VIM) and the following terms and definitions apply to this standard.
3.1
Single measurements and measured the degree of agreement between the true value.
[JJF1001-1998,5.5]
Note 1. According to the accuracy ISO 5725-1, measurement accuracy and precision associated with the measured.
GB/T 21919-2008/ISO 15195.2003
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