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JJF 1937-2021: Calibration Specification for Automated Blood Bacteria Culture Analyzers
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| JJF 1937-2021 | English | 289 |
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Calibration Specification for Automated Blood Bacteria Culture Analyzers
| Valid |
JJF 1937-2021
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Standard similar to JJF 1937-2021 JJF 1033 JJF 1050 JJF 1030 Basic data | Standard ID | JJF 1937-2021 (JJF1937-2021) | | Description (Translated English) | Calibration Specification for Automated Blood Bacteria Culture Analyzers | | Sector / Industry | Metrology & Measurement Industry Standard | | Word Count Estimation | 14,19 | | Date of Issue | 2021-12-08 | | Date of Implementation | 2022-06-08 | | Issuing agency(ies) | State Administration for Market Regulation | JJF 1937-2021: Calibration Specification for Automated Blood Bacteria Culture Analyzers---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.
National Metrology Technical Specifications of the People's Republic of China
Calibration specifications for fully automated blood bacterial culture analyzers
Published on 2021-12-08
2022-06-08 Implementation
Released by the State Administration for Market Regulation
Fully automatic blood bacterial culture analyzer
Calibration specifications
Focal point: National Biometrics Technical Committee
Drafting unit: China Institute of Metrology
Heilongjiang Provincial Metrology Verification and Testing Institute
Jiangsu Institute of Metrology
Beijing Saifu Pharmaceutical Research Institute Co:, Ltd:
The National Biometrics Technical Committee is entrusted with the interpretation of this specification:
Drafter of this specification:
Sui Zhiwei (China Institute of Metrology)
Zhang Ling (China Institute of Metrology)
Zhou Tong (Heilongjiang Provincial Metrology Verification and Testing Institute)
Cui Hongen (Jiangsu Institute of Metrology)
Zhang Yongchen (Heilongjiang Provincial Institute of Metrology, Verification and Testing)
Wang Yu (Beijing Saifu Pharmaceutical Research Institute Co:, Ltd:)
Liu Siyuan (China Institute of Metrology)
Table of contents
Introduction(Ⅱ)
1 Scope(1)
2 Cited documents(1)
3 Terminology and measurement units (1)
3:1 Blood culture(1)
3:2 Positive blood culture(1)
3:3 Negative blood culture(1)
4 Overview(1)
5 Measuring characteristics(2)
6 Calibration conditions(2)
6:1 Environmental conditions(2)
6:2 Equipment for calibration(2)
7 Calibration items and calibration methods (2)
7:1 Temperature indication error and temperature fluctuation (2)
7:2 Temperature uniformity(3)
7:3 Light source illumination uniformity and light source illumination repeatability (3)
8 Calibration result expression (4)
8:1 Calibration result processing(4)
8:2 Measurement uncertainty of calibration results(4)
9 Recalibration time interval (4)
Appendix A Calibration original record (reference) format (5)
Appendix B Calibration Certificate Result Page (Reference) Format (6)
Appendix C Example of uncertainty assessment of temperature indication error calibration results (7)
Introduction
JJF 1071 "Rules for Writing National Measurement Calibration Specifications", JJF 1001 "General Measurement Terms and Definitions" and
JJF 1059:1 "Evaluation and Expression of Measurement Uncertainty" together constitute the basic series of regulations supporting the formulation of this specification:
Fan: The calibration method and measurement characteristics refer to JJF 1101-2019 "Calibration Regulations for Temperature and Humidity Parameters of Environmental Test Equipment"
Specification", JJF 1287-2011 "Calibration Specifications for Clarity Detector", YY/T 0656-2008 "Automated Blood Culture System
System", CNAS-GL028 "Guidelines for the Validation of Clinical Microbiological Testing Procedures", CLSIM47-A "Principles and Procedures for Blood Culture"
This specification provides the temperature indication error based on JJF 1059:1-2012 "Evaluation and Expression of Measurement Uncertainty"
Measurement uncertainty and evaluation examples of calibration results:
This specification is released for the first time:
Calibration specifications for fully automated blood bacterial culture analyzers
1 Scope
This specification is applicable to clinical laboratories using in vitro culture to detect human blood or other sterile organisms using optical principles:
Calibration of fully automated blood bacterial culture analyzers for microorganisms such as bacteria and yeast-like fungi in liquid: Based on pressure sensing and
The calibration of other microbial culture analyzers with similar principle methods can be performed with reference to this specification:
2 cited documents
This specification references the following documents:
JJF 1101-2019 Specification for calibration of temperature and humidity parameters of environmental test equipment
JJF 1287-2011 Calibration Specifications for Clarity Detector
YY/T 0656-2008 Automated blood culture system
CNAS-GL028 Guidelines for Validation of Clinical Microbiology Testing Procedures
BloodCultures;ApprovedGuideline)
For dated references, only the dated version applies to this specification; for undated references, only the dated edition applies:
The latest version (including all modification orders) shall apply to this specification:
3 Terminology and units of measurement
JJF 1101-2019, JJF 1287-2011, YY/T 0656-2008, CNAS-GL028 and CLSI
The terms and definitions defined in M47-A and below apply to this specification:
3:1 Blood culturebloodculture
Clinical laboratories detect microorganisms in human blood or other body fluids through in vitro culture:
[Source: YY/T 0656-2008,3:1]
3:2 Blood culture positivebloodculturepositive
During the culture cycle, the fully automatic blood bacterial culture analyzer detected the presence of microorganisms in the blood culture medium:
exist:
[Source: YY/T 0656-2008, 3:4, modified]
3:3 Blood culture negative blood culture negative
During the culture cycle, the fully automatic blood bacterial culture analyzer failed to detect microorganisms in the blood culture medium:
exist:
[Source: YY/T 0656-2008, 3:5, with modifications]
4 Overview
The fully automatic blood bacterial culture analyzer (hereinafter referred to as the analyzer) is used in clinical laboratories to analyze human blood or other
Continuous in vitro culture of bacteria, yeast-like fungi and other microorganisms in sterile body fluids, automatic detection and judgment of culture results
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