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Medical biochemical incubator
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Basic data
| Standard ID | YY/T 1641-2018 (YY/T1641-2018) |
| Description (Translated English) | Medical biochemical incubator |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C44 |
| Classification of International Standard | 11.100 |
| Word Count Estimation | 13,164 |
| Date of Issue | 2018-12-20 |
| Date of Implementation | 2020-01-01 |
| Quoted Standard | GB/T 191; GB 4793.1; GB 4793.6; GB/T 14710; GB/T 18268.1; YY/T 0466.1 |
| Regulation (derived from) | State Drug Administration Announcement No. 97 of 2018 |
| Issuing agency(ies) | State Drug Administration |
| Summary | This standard specifies the terms and definitions, requirements, test methods, nameplates, packaging marks and instructions for use, packaging, transportation and storage of medical biochemical incubators (hereinafter referred to as incubators). This standard is applicable to medical biochemical incubators for the cultivation of human-derived microbial samples such as bacteria, molds, etc. for the good growth of cultures, including medical mold incubators, medical microbial incubators and medical constant temperature incubators. This standard does not apply to medical carbon dioxide incubators and anaerobic incubators. |
YY/T 1641-2018: Medical biochemical incubator
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
(Medical biochemical incubator)
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Medical biochemical incubator
Published on.2018-12-20
2020-01-01 implementation
State Drug Administration issued
Content
Foreword I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements 1
5 Test method 3
6 Nameplate, packaging mark and instructions for use 7
7 Packaging, transportation and storage 8
Appendix A (informative) Recommended disinfection/sterilization measures for medical biochemical incubators 9
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Drug Administration.
This standard is determined by the National Technical Committee for Measurement, Control and Laboratory Electrical Equipment Safety Standardization Technical Committee (SAC/
TC338/SC1) is under the jurisdiction.
This standard was drafted. Beijing Medical Device Inspection Institute, Shanghai Lishen Scientific Instrument Co., Ltd., Shanghai Yuejin Medical Devices Co., Ltd.
Division, Qingdao Haier Special Electric Co., Ltd., Jinan Xin Beisi Biotechnology Co., Ltd., Peking University Third Hospital.
The main drafters of this standard. Liang Zhenshi, Li Wen, Yang Chao, Wu Jun, Yang Yufeng, Cui Jiehui, Yuan Wenhu, Wang Dong, Zhan Yi, Huang Yanchun.
Medical biochemical incubator
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 article.
Pieces. 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 temperaturecontrolrange
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 chambertemperature
The temperature at the geometric center of the workspace.
4 requirements
4.1 Working conditions
Ambient temperature. 18 ° C ~ 30 ° C;
...
