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JJF 1676-2017: Calibration Specification for Temperature Parameter of Passive Medical Cold Boxes
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Calibration Specification for Temperature Parameter of Passive Medical Cold Boxes
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JJF 1676-2017
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Basic data | Standard ID | JJF 1676-2017 (JJF1676-2017) | | Description (Translated English) | Calibration Specification for Temperature Parameter of Passive Medical Cold Boxes | | Sector / Industry | Metrology & Measurement Industry Standard | | Classification of Chinese Standard | A54 | | Classification of International Standard | 17.200 | | Word Count Estimation | 19,110 | | Date of Issue | 2017-11-20 | | Date of Implementation | 2018-02-20 | | Regulation (derived from) | AQSIQ Notice 2017 No. 103 | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine | | Summary | This standard is applicable to the calibration of temperature parameters of passive medical refrigerators that have a temperature range of (-20 to 20)��C, temperature display and temperature sensor probe exposed, and the temperature parameters of passive medical refrigerators in other insulation temperature zones. The calibration can also refer to this standard. | JJF 1676-2017: Calibration Specification for Temperature Parameter of Passive Medical Cold Boxes
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Calibration Specification for Temperature Parameter of Passive Medical Cold Boxes
People's Republic of China National Metrology Technical Specifications
Passive medical refrigerator temperature parameter calibration specification
Published on.2017-11-20
2018-02-20 Implementation
The State Administration of Quality Supervision, Inspection and Quarantine issued
Passive medical refrigerator
Temperature parameter calibration specification
Key units. National Temperature Measurement Technical Committee
The main drafting units. Central Military Commission Logistics Department of Health Bureau of Drugs and Equipment Inspection
Beijing Institute of Metrology and Detection
Participated in drafting. Shanghai Institute of Metrology and Measurement Technology
China Testing Technology Research Institute
Dalian Metrology and Inspection Institute
This specification entrusts the National Temperature Measurement Technical Committee to explain
The main drafters of this specification.
Li Yuxue (Institute of Drug and Equipment Inspection, Department of Health, Logistics Administration Department, Central Military Commission)
Zhang Qiushi (Center for Drug and Equipment Inspection, Department of Health, Central Military Commission Logistics Department)
Wang Yuanyuan (Beijing Institute of Metrology and Detection)
Participating drafters.
Huang Chengfeng (Certified by the Institute of Drugs and Equipment, Health Bureau, Central Military Commission Logistics Department)
Yao Lifang (Shanghai Measurement and Measurement Technology Research Institute)
Zhang Conghua (China Testing Technology Institute)
Li Ying (Dalian Metrology and Inspection Institute)
table of Contents
Introduction (II)
1 Scope (1)
2 Terms (1)
2.1 Passive Medical Refrigerator (1)
2.2 Coolant (1)
3 Overview (1)
4 Metrological characteristics and other requirements (1)
4.1 Metrological characteristics (1)
4.2 Other Technical Requirements (1)
5 Calibration Conditions (2)
5.1 Environmental Conditions (2)
5.2 Measurement Standards and Other Equipment (2)
6 Calibration Items and Calibration Methods (2)
6.1 Calibration Items (2)
6.2 Calibration Methods (2)
6.3 Data Processing (3)
7 Expression of Calibration Results (3)
7.1 Calibration Record (3)
7.2 Processing of Calibration Results (3)
8 Re-school interval (4)
Appendix A Tests for Holding Time of Vaccine Refrigerated Containers and Vaccine Carrying Cases (5)
Appendix B Test for Holding Time of Refrigerator (without Refrigerant Load) (8)
Appendix C Calibration Record Format (9)
Appendix D Example of Evaluation of Uncertainty in Measurement of Temperature Indicator Errors in Refrigerators (11)
Appendix E Internal Format of Calibration Certificate (14)
Introduction
This specification was drafted in accordance with JJF 1071-2010 "Rules for the preparation of national metrological calibration specifications", in which measurement uncertainty
The degree of assessment was conducted in accordance with JJF 1059.1-2012 Evaluation and Expression of Measurement Uncertainty.
This specification is the first release.
Passive medical refrigerator temperature parameter calibration specification
1 Scope
This specification applies to the temperature range of the insulation in the (-20~20) °C range, there is a temperature display and thermometer outside the temperature probe
The calibration of the temperature parameters of the passive medical refrigerator and the calibration of the temperature parameters of the passive medical refrigerator in other temperature zones
Also refer to this specification.
2 Terms
2.1 passive medical refrigerator box passivemedicalcoldbox
Applied to the medical industry, relying solely on cold storage and insulation structure refrigerated insulation device.
2.2 Coolant Coolant
It can absorb and store a large amount of cold at low temperatures, and at the higher temperatures it can release a large amount of cold, which can be longer
The substance that maintains a low temperature environment in and around itself.
3 Overview
Passive medical refrigerators are heat-insulating boxes made of highly efficient heat-insulating materials, and a certain amount of cold storage agent is placed inside.
In a closed state, it is possible to effectively maintain the device at a relatively low temperature in the case for a long time. Refrigerated boxes are usually used to save
Items such as medicines, reagents, samples, blood and biological products stored and transported under low temperature conditions have different uses.
Also known as vaccine refrigerated containers, vaccine carrying cases, blood transport containers, drug refrigerated containers, specimen receiving containers, biosafety
All transport freezer and so on.
The passive medical refrigerated box with its own temperature display consists of an incubator, a cooling agent and a digital thermometer.
The internal volume is usually not more than 60L and the ambient temperature is not higher than 55°C. The insulation temperature zone of the refrigerator is due to its expectation
Different from the requirements and the type of coolant, the temperature range of the passive medical refrigerator is usually no more than (-20~
20) °C, wherein the most commonly used temperature range is (2 ~ 8) °C.
The domestic refrigerator manufacturers claim that the temperature of the cold storage box is usually a multiple of 12h, such as 12h, 24h, 48h,
72h or 96h, etc., the test is usually carried out with reference to the vaccine refrigerated box or vaccine provided by the World Health Organization (WHO).
The test method for the box holding time (see Appendix A). Some refrigerator manufacturers provide free storage of cooling agent with the tank
For the preservation time of the refrigerator, see Appendix B for the test method. The manufacturer's stated holding time is usually not when the coolant is not loaded.
6h or more.
4 Metrological characteristics and other requirements
4.1 Measurement Characteristics
Temperature indication error. no more than ±1°C (or meet product specification requirements).
4.2 Other technical requirements
4.2.1 Passive medical refrigerator (hereinafter referred to as refrigerator) logo should be complete, clear, and has the following information.
Manufacturer name or trademark, model/specification, serial number, etc.; vaccine refrigerated containers and vaccine carrying containers should be in obvious positions
(Box Cover or Box Front) Give an open box warning sign.
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