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JB/T 20203-2022Colorimeters for drug solutions (English PDF)

药物溶液颜色测定仪

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Issued by

MIIT

Level / Type

Industry · Recommended

Issue date

April 8, 2022

Implementation date

October 1, 2022

Scope

JB/T 20203-2022 is the English-translated version of 药物溶液颜色测定仪.

JB/T 20203-2022 is the Chinese machinery industry standard for the colour measuring instrument used on pharmaceutical solutions. It applies to instruments with a transmission measurement function that derive the colour tristimulus values of a sample from its spectral transmission characteristics, and their model code, for instance JRS1 for a single-channel instrument, is written under JB/T 20188-2017 from the drug-testing equipment class and the number of measuring channels. Requirements and test methods draw on GB/T 5698-2001, GB/T 26791-2011, GB/T 14710-2009 and GB/T 36035-2018, with the 2020 Pharmacopoeia behind the colorimetric comparison. A normative annex gives the preparation of the standard colorimetric solutions. Issued on 8 April 2022, it has applied since 1 October 2022.

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Document preview — JB/T 20203-2022

National Standard of the People's Republic of China

ICS: 11.120.30
Classification: C 95

Issued by: Ministry of Industry and Information Technology of the People's Republic of China

Preface
1 Scope
2 Normative references
3 Terms and Definitions
4 Model
5 requirements
6 Test method
7 Inspection rules
8 Signs, instructions for use, packaging, transportation and storage
Appendix A (Normative) Preparation of Standard Colorimetric Solution

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 for Standardization Documents" drafting.

1 Scope

This document specifies the model, requirements, test methods, inspection rules, marks, instructions for use, packaging, transportation, etc. of the drug solution color analyzer. transport and storage.

This document is applicable to those with transmission measurement function, which can quantitatively detect the color tristimulus value of an object by measuring the spectral transmission characteristics of the object Drug solution color measuring instrument (hereinafter referred to as "measuring instrument").

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text. Among them, dated references For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document.

GB/T 191 Packaging, storage and transportation icon marks

GB/T 5698-2001 Color Terminology

GB/T 9969 General Rules for Instructions for Use of Industrial Products

GB/T 10111 Generation of Random Numbers and Its Application in Product Quality Sampling Inspection

GB/T 13384 General Technical Specifications for Packaging of Mechanical and Electrical Products

GB/T 14710-2009 Environmental requirements and test methods for medical electrical appliances

GB/T 26791-2011 Glass cuvette

GB/T 36035-2018 General Requirements for Electrical Safety of Pharmaceutical Machinery

JB/T 20188-2017 Pharmaceutical machinery product model compilation method Pharmacopoeia of the People's Republic of China (2020 Edition)

3 Terms and Definitions

This document does not have terms and definitions that need to be defined.

4 Models

The measuring instrument model is compiled as follows according to the provisions of JB/T 20188-2017.

Category Code. Drug Testing Equipment Function code. drug solution color tester Specification code. Number of measuring channels Example: JRS1 type, which means a drug solution color measuring instrument with one measurement channel.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

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