JB/T 20204-2022Melting point apparatus (English PDF)
熔点测定仪
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Issued by
MIIT
Level / Type
Industry · Recommended
Issue date
April 8, 2022
Implementation date
October 1, 2022
Scope
JB/T 20204-2022 is the English-translated version of 熔点测定仪.
Instruments that determine the melting point of solid drug substances are what JB/T 20204-2022 sets out to control. Alongside its requirements it gives a model naming scheme under JB/T 20188-2017 in which the feature code marks automatic instruments with A and the specification code counts capillary channels, so JRD is a plain single-channel apparatus and JRDA3 an automatic three-channel one. Environmental test methods are taken from GB/T 14710-2009 and electrical safety from GB/T 36035-2018, while metrological performance is aligned with the verification regulation JJG 701-2008. Inspection rules and the clauses on signs, instruction manuals, packaging, transport and storage close the document. Issued on 8 April 2022, it has applied since 1 October 2022.
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Document preview — JB/T 20204-2022
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
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Model
- 5 requirements
- 6 Environmental test method
- 7 Inspection rule
- 8 Signs, instructions for use, packaging, transportation and storage
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, environmental test methods, inspection rules, marks, instruction manual, packaging, transportation and storage.
This document applies to measuring instruments for determining the melting point of solid pharmaceuticals (hereinafter referred to as "melting point 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 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 36035-2018 General Requirements for Electrical Safety of Pharmaceutical Machinery
JB/T 20188-2017 Pharmaceutical machinery product model compilation method
JJG701-2008 Verification Regulations for Melting Point Meter
3 Terms and Definitions
This document does not have terms and definitions that need to be defined.
4 Models
The model of the melting point apparatus is compiled as follows according to the provisions of JB/T 20188-2017.
Category Code. Drug Testing Equipment Function code. melting point tester Feature code. automatic type (A), ordinary type is not marked Specification code. number of capillary channels, single channel is not marked Example 1.JRD type, which means ordinary single-channel melting point apparatus.
Example 2.JRDA3 type means automatic 3 capillary channel melting point apparatus.
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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
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB/T 9969General principles for preparation of instructions for use of industrial products
- GB/T 10111Generation of random numbers and procedures applied to sampling inspection for product quality
- GB/T 13384General specifications for packing of mechanical and electrical product
- GB/T 14710-2009The environmental requirement and test methods for medical electrical equipment
- GB/T 36035-2018Pharmaceutical machinery—General requirements for electrical safety
JJG701-2008
Similar standards
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Related Standards
GB/T 10111-2008 — Generation of random numbers and procedures applied to sampling inspection for product quality
GB/T 13384-2008 — General specifications for packing of mechanical and electrical product
GB/T 14710-2009 — The environmental requirement and test methods for medical electrical equipment
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