4.4 环氧乙烷的测定 (环氧乙烷) and ECH Residuals
Expert summary and technical interpretation of the 2026 更新的灭菌残留分析方案.
4.4.1 General Procedure
The procedure to determine conformity with Allowable Limits (AL) consists of four critical pillars:
- Extraction: Removing residuals from representative samples.
- Determination: Quantifying the amount of residual (EO/ECH).
- Surface Analysis: Determining the contact surface area of the device.
- Data Interpretation: Analyzing results against Annex A, 乙, C, and J of ISO 10993-7:2026.
4.4.2 Test Method Validation
A valid method for extraction and measurement is mandatory to ensure patient safety. 气相色谱法 (气相色谱) remains the gold standard for EO and ECH analysis (see Annex H and I).
| Requirement Category | Minimum Validation Parameters |
|---|---|
| System Suitability | Demonstration of accuracy, 精确 (重复性 & reproducibility), and specificity (sensitivity & selectivity). |
| Analytical Range | Verification of detection limits (LOD), quantification limits (LOQ), linearity, and range. |
| Guideline Alignment | Validation must align with ICH Harmonized Tripartite Guidelines to meet minimum international requirements. |
4.4.3 Product Sampling & Worst-Case Conditions
Samples must be representative of the finished product. 国际标准化组织 10993-7:2026 emphasizes the Worst-Case Scenario, which includes:
- Allowed double or triple sterilization cycles.
- Minimum specified aeration times.
- Retrieval and handling factors described in Annex A and B.
4.4.5 Product Extraction Strategy
The aim is to determine the worst-case amount delivered to the patient during actual use. The choice of method depends on exposure duration:
模拟使用提取
Evaluates the cumulative dose based on how the device is used in clinical practice. Recommended if exhaustive extraction exceeds AL.
彻底提取
Total removal of residuals. If exhaustive results are within AL limits, further simulated-use testing is not required.
4.4.6 多设备系统 & Kits
Multi-device systems: Must be assessed to determine if components should be tested individually or as an assembled unit (Clause A.8).
Convenience kits: For products used independently, limits may be applied using the appropriate CEF or calculated for the entire kit. If the device count differs from the default (5 devices), the CEF must be adjusted accordingly.
Achieve Compliance with ISO 10993-7:2026
BOCON’s advanced aeration and sterilization systems are designed to help you meet the most stringent EO residual limits efficiently.
