GB/T 39476-2020Testing method of energy efficiency for drug stability test chambers (English PDF)
药品稳定性试验箱能效测试方法
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
November 19, 2020
Implementation date
June 1, 2021
Scope
GB/T 39476-2020 is the English-translated version of 药品稳定性试验箱能效测试方法.
GB/T 39476-2020 is the Chinese standard "Testing method of energy efficiency for drug stability test chambers". Its scope clause reads: This standard specifies the terms and definitions, test conditions, and test methods for energy efficiency testing of drug stability test chambers (hereinafter referred to as test chambers).
This standard applies to the energy efficiency test of test chambers with a rated volume not exceeding 1000L. Its clauses include terms and definitions; test conditions.
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Document preview — GB/T 39476-2020
National Standard of the People's Republic of China
- ICS
- 27.010
- Classification
- N 61
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Test condition
- 4.1 Environmental conditions
- 4.2 Power condition
- 4.3 Test equipment
- 4.3.1 Electric energy measuring instrument
- 4.3.2 Temperature test instrument
- 4.3.3 Stopwatch
- 4.3.4 Thermometer
- 4.3.5 Steel tape measure
- 4.3.6 Relative humidity test equipment
- 4.3.7 Illumination test equipment
- 5 Test method
- 5.1 Working status of the test chamber
- 5.2 Measurement of working space
- 5.3 Measurement of geometric center point temperature and relative humidity
- 5.4 Power consumption test
- 5.5 Energy efficiency calculation method
1 Scope
This standard specifies the terms and definitions, test conditions, and test methods for energy efficiency testing of drug stability test chambers (hereinafter referred to as test chambers).
This standard applies to the energy efficiency test of test chambers with a rated volume not exceeding 1000L.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document.
For undated references, the latest version (including all amendments) applies to this document.
GB/T 10586-2006 Damp heat test chamber technical conditions
3 Terms and definitions
The following terms and definitions defined in GB/T 10586-2006 apply to this document. For ease of use, the following is repeated
Certain terms and definitions in GB/T 10586-2006.
3.1 Drug stability test chamber
Provide a cabinet with environmental test conditions such as temperature, humidity, and light for drug stability research.
Note. This box is suitable for long-term drug testing, intermediate testing, accelerated testing and influencing factor testing by pharmaceutical companies.
3.2 Test chamber energy efficiency
During the test of the test chamber, the unit volume maintains the temperature, relative humidity, and illuminance (if any) of the working space constant and keeps it for 1 hour.
Energy consumption.
Note. The unit is Joule per cubic meter (J/m3).
3.3 Workspace
The part of the test box that can maintain the specified conditions within the specified tolerance range.
[GB/T 10586-2006, definition 3.6]
3.4 Stable temperature
The temperature of the geometric center point of the working space reaches the temperature setting value and is maintained within a given tolerance range.
[GB/T 10586-2006, definition 3.4]
4 Test conditions
4.1 Environmental conditions
The environmental test conditions of the test chamber should meet.
a) Ambient temperature. 25°C±2°C or 32°C±2°C, the temperature gradient in the vertical direction at the ambient temperature measuring point does not exceed 2°C/m, […]
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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
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