YY/T 1641-2018Medical biochemical incubator (English PDF)
医用生化培养箱
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 20, 2018
Implementation date
January 1, 2020
Scope
YY/T 1641-2018 is the English-translated version of 医用生化培养箱.
YY/T 1641-2018 is the Chinese pharmaceutical industry standard for the medical biochemical incubator, the cabinet that holds a stable temperature for culturing bacteria, moulds and other samples of human origin.
It gives the terms and definitions, the requirements, the test methods, the nameplate, the packaging marks and instructions for use, and the rules for packaging, transport and storage, covering the temperature reached and its accuracy, uniformity and stability, the recovery after the door is opened, the temperature display and the alarms, and the electrical safety. Issued on 20 December 2018, it has applied since 1 January 2020.
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Document preview — YY/T 1641-2018
National Standard of the People's Republic of China
- ICS
- 11.100
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Requirements
- 5 Test method
- 6 Nameplate, packaging mark and instructions for use
- 7 Packaging, transportation and storage
- Appendix A (informative) Recommended disinfection/sterilization measures for medical biochemical incubators
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the terms and definitions, requirements, test methods, nameplates, packaging marks, and medical biochemical incubators (hereinafter referred to as incubators). Instructions for use, packaging, transportation and storage.
This standard is applicable to provide an ideal temperature field for the good growth of cultures, and is used for the cultivation of human-derived microorganism samples such as bacteria and mold.
The medical biochemical incubator includes a medical mold incubator, a medical microbial incubator, and a medical constant temperature incubator.
This standard does not apply to medical carbon dioxide incubators and anaerobic incubators.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 packaging storage and transportation icon Safety of electrical equipment for measurement, control and laboratory use - Part 1. General requirements
GB 4793.6 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 6 Special requirements
GB/T 14710 Medical electrical requirements and test methods
GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment - Part 1. General requirements
YY/T 0466.1 Medical devices for the labeling, marking and information of medical devices - Part 1. General requirements
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Temperature control range
The temperature range that can be effectively controlled when the incubator is operated under specified environmental conditions.
3.2 Workspace workingspace
A space area where the specified technical conditions can be achieved in the workroom.
3.3 Constant state steadystate
If an environmental parameter of the working space only changes within the specified range, the environmental parameter is said to be in a constant state.
3.4 Box temperature
The temperature at the geometric center of the workspace.
4 Requirements
4.1 Working conditions
Ambient temperature. 18 ° C ~ 30 ° C;
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB 4793.6Safety requirements for electrical for measurement, control, and laboratory use - Part 6: Particular requirements for laboratory equipment for the heating of materials
- GB/T 14710The environmental requirement and test methods for medical electrical equipment
- GB/T 18268.1Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
- YY/T 0466.1Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
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Related Standards
GB 4793.6-2001 — Safety requirements for electrical equipment for measurement, control and laboratory use Particular requirements for laboratory equipment for the heating of materials
GB 4793.6-2008 — Safety requirements for electrical for measurement, control, and laboratory use - Part 6: Particular requirements for laboratory equipment for the heating of materials
GB/T 14710-1993 — The environmental requirements and test methods for medical electrical equipment
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YY/T 1641-2018
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