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YY/T 1621-2018: Medical carbon dioxide incubator
Status: Valid YY/T 1621: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1621-2018 | English | 235 |
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Medical carbon dioxide incubator
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YY/T 1621-2018
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| YY/T 1621-2018 | English | 235 |
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Medical carbon dioxide incubator
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YY/T 1621-2018
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PDF similar to YY/T 1621-2018
Standard similar to YY/T 1621-2018 YY/T 1652 YY/T 1582 YY/T 1200 YY/T 1183 Basic data | Standard ID | YY/T 1621-2018 (YY/T1621-2018) | | Description (Translated English) | Medical carbon dioxide incubator | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 15,146 | | Date of Issue | 2018-09-28 | | Date of Implementation | 2020-04-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the terms and definitions, requirements, test methods, labels, packaging marks and instructions for use, packaging, transportation and storage of medical carbon dioxide incubators. This standard applies to medical carbon dioxide incubators for culturing human-derived samples such as biological cells, tissues and bacteria in clinical tests. The upper limit of the cultivation temperature of the incubator applicable to this standard is 55��C, the lower limit of the temperature is 3��C to 5��C higher than the ambient temperature, the control range of carbon dioxide concentration is 0% to 20%, and the internal volume is 100L to 300L. | YY/T 1621-2018: Medical carbon dioxide 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.
ICS 11:100
C44
Pharmaceutical Industry Standard of the People's Republic of China
YY 1621-2018
Medical carbon dioxide incubator
According to the State Drug Administration medical device industry
Standard Announcement (No: 76 of 2022), this standard is from
From September 7, 2022, it will be converted into a recommended standard, no
Enforce it again:
Released on:2018-09-28
2020-04-01 Implementation
Released by the State Drug Administration
table of contents
Preface I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements 1
5 Test method 3
6 Labels, packaging labels and instructions for use 5
7 Packaging, transportation and storage 6
Appendix A (Normative Appendix) Temperature Control Performance Test Method 7
Appendix B (Normative) Carbon dioxide concentration control performance test method 10
YY 1621-2018
foreword
All technical contents of this standard are mandatory:
This standard is drafted in accordance with the rules given in GB/T 1:1-2009:
Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying these patents:
This standard was proposed by the State Drug Administration:
This standard is prepared by the National Measurement, Control and Laboratory Electrical Equipment Safety Standardization Technical Committee Medical Equipment Sub-Technical Committee (SAC/
TC338/SC1) centralized:
This standard was drafted by: Beijing Institute of Medical Device Inspection, Shanghai Lishen Scientific Instrument Co:, Ltd:, Thermo Fisher Scientific (China) Co:, Ltd:
Co:, Ltd:, Qingdao Haier Special Electric Co:, Ltd:, Bidi Medical Devices (Shanghai) Co:, Ltd:, Peking University Third Hospital:
The main drafters of this standard: Liu Pei, Wu Jun, Shen Ping, Li Chunjing, Peng Xuguang, Cao Qing, Jiang Ahong, Xu Heng:
YY 1621-2018
Medical carbon dioxide incubator
1 Scope
This standard specifies the terms and definitions, requirements, test methods, labels, and packaging labels for medical carbon dioxide incubators (hereinafter referred to as incubators):
identification and instructions for use, packaging, transport and storage:
This standard applies to medical carbon dioxide incubators for culturing human-derived samples such as biological cells, tissues and bacteria in clinical tests: Book
The upper limit of the culture temperature of the standard applicable incubator is 55°C, the lower limit of the temperature is 3°C~5°C higher than the ambient temperature, and the carbon dioxide concentration is controlled
The range is 0%~20%, and the internal volume is 100L~300L:
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
pieces: For undated references, the latest version (including all amendments) applies to this document:
GB/T 191 Packaging, storage and transportation icon marks
GB 4793:1 Safety requirements for 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: Characteristics of laboratory material heating equipment
special request
GB/T 14710 Environmental requirements and test methods for medical electrical appliances
GB/T 18268:1 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1: General Requirements
YY/T 0466:1 Symbols for Medical Device Labeling, Marking and Information Provision for Medical Devices Part 1: General Requirements
3 Terms and Definitions
The following terms and definitions apply to this document:
3:1
The temperature range within which the incubator can be effectively controlled when operating under specified environmental conditions:
3:2
working space working space
The space area in the studio that meets the specified technical conditions:
3:3
chamber temperature
The temperature at the geometric center of the workspace:
4 requirements
4:1 Working environment conditions
If the manufacturer has no special working environment requirements, the working environment of the incubator shall meet the following requirements:
a) Ambient temperature: 18°C~30°C;
YY 1621-2018
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