GB/T 36066-2018 in English
SUPERSEDEDCleanrooms and associated controlled environments—Analysis and application of test technology
- Issued on:2018-03-15
- Implemented on:2018-07-20
- File Format:PDF
- Delivery:Via email within 1~3 business days
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《GB/T 36066-2018洁净室及相关受控环境 检测技术分析与应用》由TC319（全国洁净室及相关受控环境标准化技术委员会）归口，主管部门为国家标准化管理委员会。
Introduction
National Standard of the People's Republic of China GB/T 36066—2018 Analysis and Application of Cleanroom and Related Controlled Environment Testing Technology
1. Background of Standard Formulation and Analysis of Technology Evolution
GB/T 36066—2018 "Analysis and Application of Cleanroom and Related Controlled Environment Testing Technology" is to standardize the testing technology requirements of cleanrooms and related controlled environments to ensure their applicability in the fields of electronics, pharmaceuticals, medical and scientific laboratories. With the advancement of science and technology and changes in industry needs, the design and testing technology of cleanrooms are also evolving.
This standard was drafted based on the GB/T1.1—2009 rules and formulated in combination with international advanced experience. The standard covers comprehensive requirements from test items to instrument configuration to ensure the accuracy and reliability of test data.
2. Comparison of testing technology requirements and frameworks
| Testing items | Electronics industry | Pharmaceutical industry | Medical industry | Scientific laboratory |
|---|---|---|---|---|
| Cleanliness level (ISO1~ISO9)/(Pc/m²) | - | - | - | Nano laboratory |
| Colony count (floating bacteria, settling bacteria)/CFU | - | - | Biosafety laboratory | - |
| Air volume Q/(m²/h) | Unidirectional flow | Unidirectional flow | Class I operating room work area | Unidirectional flow of biological safety cabinet |
3. Requirements for testing instrument configuration
The basic requirements for commonly used testing instruments are shown in Table 2, including anemometers, aerosol photometers, particle counters, etc. These instruments must meet the requirements of range, sensitivity and accuracy, and be calibrated regularly.
| Test items | Equipment/Instrument | Requirements | Calibration interval |
|---|---|---|---|
| Wind speed and uniformity test | Anemometer | Measurement limit/range: 0.1m/s～1.0m/s, duct detection 0.5m/s～20m/s | No more than 12 months |
4. Detection condition analysis and implementation suggestions
The accuracy of the test data is affected by many factors, including equipment accuracy, operating norms and environmental conditions. Table 3 lists the main reasons for the deviation of the test items from the target value, providing a reference for practical application.
| Test items | Abnormal working conditions | Main reasons |
|---|---|---|
| Temperature T | Temperature value is too high | a) Insufficient cooling capacity, including insufficient output of the refrigerator and insufficient cooling capacity added to the system. |
5. Implementation suggestions
To ensure the detection effect of clean rooms and related controlled environments, it is recommended that:
- Configure the detection instruments strictly in accordance with the standard requirements and calibrate them regularly.
- Detectors need to undergo professional training and be familiar with the clean room grade and operating specifications.
- Select a suitable combination of detection items according to the application field to ensure the representativeness and accuracy of the data.
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