【CODEX翻译】YY-T 1757-2021 医用冷冻保存箱标准-英文版PDF
YY-T 1757-2021 医用冷冻保存箱标准
General Requirement for Label and Instruction Book of Disinfection Products
This standard specifies the product classification, requirements, test methods, labeling, and packaging, transportation, storage of medical freezer.
This standard is applicable to compression medical freezer (hereinafter referred to as freezer) driven by enclosed type motor, including low temperature freezer for medical use, etc. Cryopreservation equipment of other temperature range may refer to this standard.
2 Normative References
The following documents are indispensable for the application of this document. For dated references, only the dated version is applicable to this document. For undated references, the latest version (including all 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/T 18268.1 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
3 Terms and Definition
The following terms and definitions are applicable to this standard.
An insulated box with an appropriate volume and device, in which the temperature can be controlled within -25 °C ~ -164 °C. It is cooled by means of power consumption, and has one or more compartments. When the temperature in the freezer reaches the specified temperature under specified conditions, the medical institutions can store the deposits in the freezer, where the deposits shall reach the specified temperature over a period of time and be reliably stored within the required temperature fluctuation range.