ISO 终极指南 11135 合规医用 ETO 灭菌器
In the highly regulated medical device manufacturing sector, 最终目标是在保持材料完整性的同时实现可重复的无菌状态. 对于超过 20 年, Hangzhou Bocon has been at the forefront of designing and manufacturing comprehensive 工业环氧乙烷灭菌机 系统. With hundreds of successful installations across 44 国家, we provide complete, life-long turnkey solutions—including preconditioning rooms, 曝气室, conveyors, and EO waste gas scrubbers.
Global Milestone: The United States enforces the strictest controls over Ethylene Oxide (排队) sterilization globally. Hangzhou Bocon is proud to be the only Chinese supplier that successfully exports fully compliant sterilizers to the US market.
1. Strict Regulatory Compliance & Certification
A reliable sterilization cycle is built on a foundation of uncompromised quality standards. Bocon’s equipment undergoes rigorous quality control to meet the stringent demands of international regulatory bodies. Our systems guarantee:
- 国际标准化组织 11135 遵守: Full support for the parametric release of medical devices.
- Global Certifications: Equipment is certified under CE, 国际标准化组织 13485, 和ISO 9001.
- 安全 & Design Codes: Full compliance with EN 1422, Pressure Equipment Directive (PED), and ATEX explosion protection standards where applicable.
- Data Integrity: Electronic records and data management functions comply with global data integrity requirements, ensuring complete traceability.
2. Chamber Construction & Leak Testing Beyond Standards
The structural integrity of an ETO sterilization chamber dictates both workplace safety and sterilization efficacy. All Bocon sterilization chambers are constructed utilizing medical-grade, corrosion-resistant materials designed for a service life exceeding 30 年.
| Technical Parameter | BOCON Standard Specification |
|---|---|
| Chamber Material | Premium Stainless Steel 316L |
| Material Thickness | 8毫米 (δ=8mm) |
| Design Lifespan | Over 30 年 |
| Chamber Leak Rate | At 80Kpa pressure, deviation is < 2Kpa after 12 小时. |
Note on Leakage: The leakage standard outlined in ISO 11135 is considered a minimum baseline. Bocon strictly adheres to a much higher internal standard, ensuring that after stabilization at 80Kpa, the pressure change will not exceed 2Kpa over a full 12-hour period.
3. Precision Environmental Control (温度 & 湿度)
An effective ETO process relies on penetrating all medical products (excluding non-metallic ones, which are suitable for surface sterilization). To achieve this, precise control over the microclimate is required. We utilize optimized heating, vacuum, and circulation systems that not only reduce utility consumption but also ensure absolute uniformity.
- Precondition Room Accuracy: 控温精度±3℃, 温度均匀度±3℃, 湿度均匀度±5%RH.
- 灭菌室精度: 控温精度±2℃, 温度均匀度±2℃, 湿度均匀度±5%RH.
- 空气流通: 内循环系统运行于 > 60 次/小时, 在整个周期中保持完美的均匀性.
- 地图支持: 综合温度, 相对湿度 (相对湿度), 和气体浓度测绘支持完全可用.
4. 模块化设计 & 交钥匙供货范围
制造设施需要可扩展的解决方案. Bocon 系统设计有模块化扩展选项. 完整的交钥匙环氧乙烷灭菌解决方案包括主灭菌器, 先进的预处理室, 曝气室, 自动输送机, 和环保洗涤器.
每个项目都有全面的技术文档支持 (完全以英文提供) 和强大的验证支持. 我们执行一个 工厂验收测试 (胖的) 装运前和全面的 现场验收测试 (SAT) 安装后.
5. 无与伦比的售后服务 & 维护
医疗器械制造中的停机成本高昂. 凭借二十年的工程经验, Bocon 系统的设计易于维护. 我们提供终身维护, 专门的预防性维护 (下午) 日程, 及相关技术咨询.
我们的承诺得到了有保证的服务响应时间的支持 之内 12 小时 以及与商定的规格直接一致的性能保证.
