The temperature of the cold storage should be 2~10℃; the temperature of the cool storage should not exceed 20℃; the temperature of the room temperature storage is 0~30℃; the relative humidity of each warehouse should be maintained between 45~75%.
The temperature requirement range of each warehouse (area) is as follows: general instruments are stored in the room temperature warehouse, room temperature warehouse 0~40℃ (internal control standard: 1~39℃); shade warehouse 0~20℃ (internal control standard: 1~20℃); others need to be stored in other temperature and humidity storage in accordance with the requirements.
The temperature and humidity meter in the warehouse should be checked once a year or re-replace the new one, and have a record. Check the standard temperature and humidity meter can be used in the year the latest production of the specifications of the variety of temperature and humidity meter or sent to the local statutory inspection department after the inspection of the temperature and humidity meter.
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Expanded Information
Medical Device Operation Quality Management Standards" has clear provisions, as follows:
Article 25 of the warehouse temperature, humidity should be in line with the operation of medical equipment instructions or labeling requirements. For medical devices with special temperature and humidity storage requirements, should be equipped with effective control and monitoring of temperature and humidity equipment or instruments.
Article 26 of the business needs refrigeration, freezing storage and transportation of medical devices, should be equipped with the following facilities and equipment:
(a) the scale and variety of its business with an independent cold storage or cold cabinet;
(b) for cold storage temperature monitoring, display, recording, regulation, alarm equipment;
(c) to ensure that the refrigeration equipment normal operation of the Standby generator sets or double circuit power supply system;
(d) the need for transportation enterprises should be equipped with refrigerated trucks, refrigerated containers, or insulated trucks, insulated containers and other equipment;?
(v) for medical devices with special low-temperature requirements, should be equipped with facilities and equipment to meet its storage requirements.
/m.baidu.com/from=1086k/bd_page_type=1/ssid=0/uid=0/pu=usm%401%2Csz%40320_1002%2Cta%40iphone_2_9.0_2_12137.1/baiduid= 847E9EAEAF6FDEA7D562915088DFAF7C/w=0_10_/t=iphone/l=1/tc?ref=www_iphone&lid=10962127112480664635&order=1&waplogo=1& ;fm=alop&isAtom=1&is_baidu=0&dict=-1&tj=bk_polysemy_1_0_10_l1&wd=&eqid=98214c876a16b000100000005d5ba9e1&&w_qd=Itc? amp;w_qd=IlPT2AEptyoA_yk5wBkarROxFktVcHIpzToNpOjQxf18Oe15RTJcsH4ipRR8j2jWp45nQLl1BnW42uA_&bdver=2&tcplug=1&sec=40880& amp;di=4dec3bf668c681cb&bdenc=1&tch=124.0.314.185.0.0&nsrc=iic9cjI881AfZuKg7mKubm0QI1DQsd% 2FqoD2fse3kxnicrzQ4UVGUItEHgvdkT0ELXm6hstFK5SYGSy9Yi83joHLM% 2F3FXEQlzq4bNB8vN0jQPwqDgHqZeayaxwU3UvUhHoSE1TVIUU0rFY6ToBzYhbQYiXahvbmIzVO%2FgULnhD% 2BXyJWGQerBocCeEB7m3xaRvrHnd01nV7bqxK47wwuCNgz6PkJAeXZWr5GhWwTCxRXNeODLjA7wQdPgwbeqpV%2BuvU74TTTJNKh2Kt4vUs9VLxraMy%2BY%2B%. 2ByuUAccBDc0XD8Y%3D" target="_blank "title="Baidu Encyclopedia - Medical Device Business Quality Management Code">Baidu Encyclopedia - Medical Device Business Quality Management Code