YY/T 0086-2020 in English
VALIDMedical refrigerator
- Issued on:2020-02-21
- Implemented on:2022-01-01
- File Format:PDF
- Delivery:Via email within 5 business days
$330.00
本标准规定了医用冷藏箱的术语和定义、产品分类、要求、试验方法、标志、包装、运输、贮存。
本标准适用于箱内温度范围在2℃～8℃以内，由工厂装配，采用电机驱动压缩机方式制冷，内部采用空气自然对流或强制对流方式进行冷却的用于存放存品的医用冷藏箱，包括医用血液冷藏箱。
Introduction
Background of Standard Revision and Technological Evolution
| Revision Dimensions | 2007 Edition of the Standard | 2020 Edition of the Standard |
|---|---|---|
| Temperature Range | Limited Volume Range | Cancel Volume Limitation |
| Technical Requirements | Basic Performance Indicators | New Electromagnetic Compatibility (5.14) |
| Test Methods | 7 Chapters and 39 Articles | Expanded to 15 Chapters and 82 Articles |
Analysis of Core Performance Indicators
Comparison of Temperature Control Requirements
| Parameters | Blood Refrigerator | Ordinary Medical Refrigerator |
|---|---|---|
| Set Temperature | 4℃(non-adjustable) | 5℃(adjustable) |
| Allowable Fluctuation | ≤2.5℃ | ≤4.5℃ |
| Uniformity Limit | 3℃(±1.5℃) | 4℃(±2℃) |
Note: Temperature uniformity calculation formula: (highest measuring point temperature - set value) - (lowest measuring point temperature - set value)
Description of key test methods
1. Temperature measurement specifications
- Use T-type thermocouple, and place the temperature sensing head at the center of a 25±1.25g copper cylinder
- 9-point layout method in test space (3 layers × 3 points)
- Data collection interval ≤ 1 minute
2. Definition of valid data samples
Must meet the following requirements
- Stable operating state
- Integer multiples of 3 hours in a row
- Exclude defrosting process
- Each measuring point collects data at least once per minute
Implementation suggestions
Key points for equipment selection
- Blood storage must use medical blood refrigerator (temperature locked at 4℃)
- For tropical areas, choose T-type climate type products (ambient temperature 16-43℃)
- The noise level of equipment with a volume of more than 600L must be ≤60dB(A)
Acceptance inspection process
- Verify the nameplate information (including climate type identification)
- Conduct 24-hour continuous temperature monitoring
- Test the temperature recovery performance of the door opening and closing
- Check the alarm system function (high/low temperature, power failure)
Daily maintenance requirements
- Check the airtightness of the door seal every month (0.08mm paper test method)
- Calibrate the temperature display deviation every quarter (≤1.5℃)
- Annual electromagnetic compatibility re-inspection
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