This standard specifies the classification requirements, test methods, marking, packaging, transportation and storage of medical freezer.
This standard is applicable to medical freezer (hereinafter referred to as “freezer”) driven by closed motors, including medical cryogenic storage box. Medical cryopreservation equipment in other temperature ranges can refer to this standard.
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 (including any amendments) applies.
GB 4793.1 Safety requirements for electrical equipment for measurement, control, and laboratory use — Part 1:General requirements
GB/T 14710 Environmental requirement and test methods for medical electrical equipment
GB/T18268.1 Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 1:General requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
medical freezer
an insulated box with proper volume and device, the temperature in which can be controlled within -25°C to -164°C, refrigerated by means of consuming electric energy, and with one or more compartments Under the specified conditions, when the freezer reaches the set temperature, it will be used by medical institutions to store the deposits, which will reach set temperature after a period and be stored reliably within the required temperature fluctuation range.
3.2
deposit
such articles for medical or similar purposes as plasma, tissues, cells to be stored in freezers
3.3
top-opening type freezer
freezer where deposits are put in and taken out of via the top door or lid
3.4
upright type freezer
freezer where deposits are put in and taken out of via the front door or lid
3.5
overall dimensions
the space occupied by the freezer when the door or cover is closed, expressed in the form of H×W×D
3.6
volume
the space inside the freezer measured by the test method in 6.2, L
3.7
load limit
limit used to indicate the storage space
Foreword i 1 Scope 2 Normative references 3 Terms and definitions 4 Product classification 5 Requirements 6 Test methods 7 Marking 8 Packaging, transportation and storage
Medical freezer
1 Scope
This standard specifies the classification requirements, test methods, marking, packaging, transportation and storage of medical freezer.
This standard is applicable to medical freezer (hereinafter referred to as “freezer”) driven by closed motors, including medical cryogenic storage box. Medical cryopreservation equipment in other temperature ranges can refer to this standard.
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 (including any amendments) applies.
GB 4793.1 Safety requirements for electrical equipment for measurement, control, and laboratory use — Part 1:General requirements
GB/T 14710 Environmental requirement and test methods for medical electrical equipment
GB/T18268.1 Electrical equipment for measurement, control and laboratory use — EMC requirements — Part 1:General requirements
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
medical freezer
an insulated box with proper volume and device, the temperature in which can be controlled within -25°C to -164°C, refrigerated by means of consuming electric energy, and with one or more compartments Under the specified conditions, when the freezer reaches the set temperature, it will be used by medical institutions to store the deposits, which will reach set temperature after a period and be stored reliably within the required temperature fluctuation range.
3.2
deposit
such articles for medical or similar purposes as plasma, tissues, cells to be stored in freezers
3.3
top-opening type freezer
freezer where deposits are put in and taken out of via the top door or lid
3.4
upright type freezer
freezer where deposits are put in and taken out of via the front door or lid
3.5
overall dimensions
the space occupied by the freezer when the door or cover is closed, expressed in the form of H×W×D
3.6
volume
the space inside the freezer measured by the test method in 6.2, L
3.7
load limit
limit used to indicate the storage space
Contents of YY/T 1757-2021
Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Product classification
5 Requirements
6 Test methods
7 Marking
8 Packaging, transportation and storage
