YY 1621-2018 Medical carbon dioxide incubator
1 Scope
This standard specifies the terms and definitions, requirements, test methods, labels, packaging markings, instructions for use, packaging, transportation and storage for medical carbon dioxide incubators (hereinafter referred to as "incubators").
This standard is applicable to medical carbon dioxide incubators for culturing human-derived samples including biological cells, tissues and bacteria for clinical examination. The incubators covered by this standard shall have a maximum incubation temperature of 55°C, a minimum incubation temperature ranging from 3°C to 5°C above the environmental temperature, a carbon dioxide concentration control range from 0% to 20%, and an internal volume ranging from 100L to 300L.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 191 Packaging - Pictorial marking for handling of goods
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: Particular requirements for laboratory equipment for the heating of materials
GB/T 14710 Environmental requirement and test methods for medical electrical equipment
GB/T 18268.1 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
temperature control range
temperature range that can be effectively controlled by the incubator when operating under specified environmental conditions
3.2
working space
spatial area within the working chamber where the specified technical conditions are achieved
3.3
chamber temperature
temperature at the geometric center of the working space
4 Requirements
4.1 Working environmental conditions
If no special working environmental requirements are specified by the manufacturer, the working environment of the incubator shall meet the following requirements:
a) Environmental temperature: 18°C to 30°C;
b) Relative humidity: ≤80%;
c) Atmospheric pressure: 86kPa to 106kPa;
d) The surroundings shall be free from severe vibration and corrosive gas;
e) Direct sunlight or influences from other cold and heat sources shall be avoided;
f) Supply voltage: 220V±22V;
g) Voltage frequency: 50Hz±1Hz.
4.2 Appearance and structure
4.2.1 The surface of the incubator shall be clean and smooth, without obvious scratches, burrs or unevenness. Text and symbol markings shall be clearly distinguishable.
Contents
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Labels, packaging markings and instructions for use
7 Packaging, transportation and storage
Annex A (Normative) Test method for temperature control performance
Annex B (Normative) Test method for carbon dioxide concentration control performance
YY 1621-2018 Medical carbon dioxide incubator
1 Scope
This standard specifies the terms and definitions, requirements, test methods, labels, packaging markings, instructions for use, packaging, transportation and storage for medical carbon dioxide incubators (hereinafter referred to as "incubators").
This standard is applicable to medical carbon dioxide incubators for culturing human-derived samples including biological cells, tissues and bacteria for clinical examination. The incubators covered by this standard shall have a maximum incubation temperature of 55°C, a minimum incubation temperature ranging from 3°C to 5°C above the environmental temperature, a carbon dioxide concentration control range from 0% to 20%, and an internal volume ranging from 100L to 300L.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 191 Packaging - Pictorial marking for handling of goods
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: Particular requirements for laboratory equipment for the heating of materials
GB/T 14710 Environmental requirement and test methods for medical electrical equipment
GB/T 18268.1 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
YY/T 0466.1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
temperature control range
temperature range that can be effectively controlled by the incubator when operating under specified environmental conditions
3.2
working space
spatial area within the working chamber where the specified technical conditions are achieved
3.3
chamber temperature
temperature at the geometric center of the working space
4 Requirements
4.1 Working environmental conditions
If no special working environmental requirements are specified by the manufacturer, the working environment of the incubator shall meet the following requirements:
a) Environmental temperature: 18°C to 30°C;
b) Relative humidity: ≤80%;
c) Atmospheric pressure: 86kPa to 106kPa;
d) The surroundings shall be free from severe vibration and corrosive gas;
e) Direct sunlight or influences from other cold and heat sources shall be avoided;
f) Supply voltage: 220V±22V;
g) Voltage frequency: 50Hz±1Hz.
4.2 Appearance and structure
4.2.1 The surface of the incubator shall be clean and smooth, without obvious scratches, burrs or unevenness. Text and symbol markings shall be clearly distinguishable.
Contents of YY 1621-2018
Contents
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Labels, packaging markings and instructions for use
7 Packaging, transportation and storage
Annex A (Normative) Test method for temperature control performance
Annex B (Normative) Test method for carbon dioxide concentration control performance
