JB/T 20205-2022Degassing instruments (English PDF)
脱气仪
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Issued by
MIIT
Level / Type
Industry · Recommended
Issue date
April 8, 2022
Implementation date
October 1, 2022
Scope
JB/T 20205-2022 is the English-translated version of 脱气仪.
JB/T 20205-2022 addresses the degasser that removes dissolved gas from the aqueous dissolution medium before a drug dissolution test is run. Degassers are divided by construction into a water-storage type and an instant-heating type, and the model designation follows JB/T 20188-2017. The standard then sets requirements and matching test methods, with the dissolved oxygen check referred to HJ 925-2017, noise measured to GB/T 3768, environmental behaviour to GB/T 14710-2009 and electrical safety to GB/T 36035-2018; the dissolution testing context itself is that of the 2020 Pharmacopoeia. Inspection rules and clauses on signs, instruction manuals, packaging, transport and storage complete it. Issued on 8 April 2022, it has applied since 1 October 2022.
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Document preview — JB/T 20205-2022
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 Classification and Model
- 5 requirements
- 6 Test method
- 7 Inspection rules
- 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 classification and model of the degasser, requirements, test methods, inspection rules, signs, instructions for use, packaging, transportation and storage.
This document is applicable to the degasser used to degas the dissolution medium with water in the drug dissolution test.
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 3768 Acoustic sound pressure method for measuring sound power level and sound energy level of noise sources adopts the simple method of enveloping the measuring surface above the reflecting surface. easy method
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
HJ925-2017 Technical Requirements and Testing Methods for Portable Dissolved Oxygen Meter 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 Classification and Model
4.1 Classification
The degasser is divided into water storage type and instant heat type according to the structural characteristics.
4.2 Model
The degasser model is prepared according to the provisions of JB/T 20188-2017 as follows. […]
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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
GB/T 3768 · HJ925-2017
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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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