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JJF 1614-2017 English PDF

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JJF 1614-2017: Calibration Specification for Antibiotics Potency Analyzers
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Basic data

Standard ID JJF 1614-2017 (JJF1614-2017)
Description (Translated English) Calibration Specification for Antibiotics Potency Analyzers
Sector / Industry Metrology & Measurement Industry Standard
Classification of Chinese Standard A50
Classification of International Standard 17.020
Word Count Estimation 15,121
Date of Issue 2017-02-28
Date of Implementation 2017-05-28
Quoted Standard JJG 861-2007; JJF 1071-2010; JJF 1101-2003
Regulation (derived from) General Administration of Quality Supervision, Inspection and Quarantine No. 23 of 2017
Issuing agency(ies) General Administration of Quality Supervision, Inspection and Quarantine
Summary This standard is applicable to the calibration of the Antibiotic Potentiometer (hereinafter referred to as "instrument").

JJF 1614-2017: Calibration Specification for Antibiotics Potency 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.
Calibration Specification for Antibiotics Potency Analyzers National Metrological Technical Code of the People's Republic of China Standard for Calibration of Antibiotic Potentiometric Analyzers 2017-02-28 released 2017-05-28 Implementation State Administration of Quality Supervision, Inspection and Quarantine issued Standard for Calibration of Antibiotic Potentiometric Analyzers CalibrationSpecification for Antibiotics Responsible unit. National Biometric Technology Committee The main drafting unit. Henan Institute of Metrology Participated in the drafting unit. China Institute of Metrology Jining City Metrology and Testing Institute This specification entrusts the National Biometric Technology Committee to explain The main drafters of this specification. Ding Fengyuan (Henan Institute of Metrology) Sui Zhiwei (China Institute of Metrology) Xu Jianjun (Henan Institute of Metrology) Lei Junfeng (Henan Institute of Metrology) Participate in the drafters. Sun Wen (Jining City Metrology and Testing Institute) Zhang ling (China Institute of Metrology) Ji xiangjuan (jining city measurement test center)

table of Contents

Introduction (II) 1 Scope (1) 2 References (1) 3 Overview (1) 4 Metering characteristics (1) 5 Calibration conditions (2) 5.1 Environmental conditions (2) 5.2 Calibration equipment (2) 6 Calibration items and calibration methods (2) 6.1 Instrument for disc dish (2) 6.2 Turbidity instrument (3) 7 Calibration results (5) 8 Recurrence time interval (5) Appendix A Calibration Record Format (6) Appendix B Calibration Certificate Inside Page Format (8) Appendix C Examples of Measurement Uncertainty Evaluation (9)

Introduction

This specification is mainly based on JJG861-2007 "ELISA system test procedures", JJF 1101-2003 "environmental test Test equipment temperature, humidity calibration norms ", refer to the" People's Republic of China Pharmacopoeia "to complete the development of this specification. This specification is the first release. Standard for Calibration of Antibiotic Potentiometric Analyzers

1 Scope

This specification applies to the calibration of the Antibiotic Potentiometer (hereinafter referred to as the instrument) for tube disc and turbidity.

2 reference file

This specification refers to the following documents. JJG861-2007 ELISA analyzer Rules for the preparation of national metrological calibration specifications Specification for temperature and humidity calibration for environmental test equipment JJF 1101-2003 Pharmacopoeia of the People's Republic of China For dated references, only the dated edition applies to this specification; references that are not dated , The latest version (including all modifications) applies to this specification.

3 Overview

The instrument is to measure the antibiotic potency by detecting the inhibitory effect of antibiotics on the growth of the test bacteria. According to the original measurement The instrument is divided into two kinds of disc and turbidity method. The disc dish is the use of antibiotics in the solid medium for the proliferation of Used to measure the standard sample and the sample to be tested separately. The test bacteria were inoculated on the solid medium Diameter or area value to calculate the antibiotic potency of the measured sample. Turbidity method is the use of antibiotics on the liquid culture The inhibitory effect of the growth of the test bacteria in the base was measured by measuring the addition of the standard sample and the liquid medium of the test sample Absorbance value to calculate the antibiotic titer of the measured sample.

4 measurement characteristics

Refer to Chapter 3 of JJG861-2007 and Chapter 4 of JJF 1101-2003 for instrument calibration and technical instructions. See Table 1. Table 1 Calibration items and technical requirements Instrument type calibration project technical indicators Tube disc method Diameter indication error ± 0.1mm Diameter measurement Repeatability 0.1mm Turbidity method Absorbance zero drift ± 0.005 Absorbance indication drift ± 0.005 Absorbance indication error ± 0.03 Absorbance measurement repeatability 0.005 Absorbance channel difference 0.03