GB/T 33419-2016 in English
VALIDTest method of biological indicator for ethylene oxide sterilization processes
- Issued on:2016-12-30
- Implemented on:2017-07-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$224.00
《GB/T 33419-2016环氧乙烷灭菌生物指示物检验方法》由628（国家疾病预防控制局）归口，主管部门为国家疾病预防控制局。
Introduction
Interpretation of the Standard for Biological Indicator Test Methods for Ethylene Oxide Sterilization
1. Background and Significance of the Standard
GB/T33419-2016 "Biological Indicator Test Methods for Ethylene Oxide Sterilization" is intended to standardize the detection of biological indicators in the process of ethylene oxide sterilization to ensure the accuracy of the sterilization effect. This standard was proposed and managed by the National Health and Family Planning Commission of the People's Republic of China and is applicable to the inspection work in the field of sterilization of medical and health products.
2. Core content of the standard
| Clause number | Description of content | Key requirements |
|---|---|---|
| 4.1 | Indicator microorganisms | Strain:Bacillus subtilis var. niger spores (ATCC 9372); Bacterial count:≥1.0×10⁶ CFU/piece, the recovered bacterial count should be within the range specified by the manufacturer. |
| 4.2 | Carrier requirements | The carrier should not be deformed or damaged under conditions of high temperature, high humidity, ethylene oxide concentration, etc. |
| 5.1 | Live bacteria counting method | By colony forming unit (CFU) detection, it is applicable to the situation where the expected recovered bacteria amount is ≥50 CFU. |
3. Technical requirements and implementation suggestions
Explanation of professional terms and application cases
Survivor curve:Used to describe the changes in the survival of microorganisms during the sterilization process. By plotting the relationship between survival time and sterilization factor, the D value can be determined.
Partial Negative Analysis Method:Applicable to D value determination, by observing the sterile growth of samples under different exposure times, calculating the average sterile time UH SK, and finally obtaining the D value.
4. Comparison of standard frameworks
| Standard dimensions | GB/T33419—2016 | Differences between international standards |
|---|---|---|
| Definition of terms | Specifies terms such as biological indicators and colony forming units in detail. | Consistent with ISO 18281 series of standards. |
| Technical requirements | Specifies the resistance determination of indicator microorganisms and culture medium requirements. | Some technical parameters are more stringent, such as the requirement for the D value determination range of ±20%. |
5. Implementation suggestions
In actual application, the appropriate method should be selected in strict accordance with the standard requirements for inspection:
- Equipment selection:Equipped with a biological indicator resistance tester that meets the requirements of GB/T24628.
- Operation specification:Sterilization should be completed under high temperature and high humidity to ensure precise control of test conditions.
- Data recording:Use a structured table to record the experimental results for subsequent analysis and comparison.
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