ETO 멸균기 검사 & Test Methods: Complete Validation Guide
Detailed step-by-step inspection procedures for ethylene oxide sterilizers – covering visual checks, dimensional measurements, material verification, door safety, instrumentation tests, cycle validation, and regulatory compliance.
WhatsApp을 통해 문의하세요 ? View ETO Sterilizer ProductRigorous testing of ethylene oxide sterilizers is essential to ensure they meet the strict performance criteria defined in the ETO sterilizer performance specifications. The following inspection methods apply under controlled environmental conditions: temperature 5–40°C, relative humidity ?80%, atmospheric pressure 70 kPa–106 kPa, and power supply AC380V, 50Hz.
모습 & Structure (3.1)
Perform visual observation, tactile checks, and operational tests. The exterior must be smooth, uniform, and free from defects, as required in 모습 & 구조.
Chamber Dimensions (3.2)
Use standard measuring tools to verify chamber length, width, height, diameter, and volume. Results must comply with 챔버 치수.
Material Verification (3.3)
Review manufacturer’s material certificates and test connection documentation. Visually inspect test ports and seals. All must conform to 재료 호환성 그리고 Test Connections.
Vaporizer Cleaning (3.4)
Follow the manufacturer’s cleaning procedure and verify that the heating surface can be maintained as specified in Vaporizer Cleaning.
관 & Fittings (3.5)
Visually inspect seamless construction, welded joints (except cylinder connections), insulation, and flow direction labels. Flexible tubing materials are verified. Must meet 관 & 사이.
Door & Interlock Test (3.6)
Examine design drawings, operate doors manually and automatically, measure operating force with a push-pull gauge. Seals, locking mechanisms, and double-door interlocks must satisfy Door Systems & 안전 인터록.
Service Supply Verification (3.7)
Confirm steam humidification method (Steam Humidification), compressed air/gas dryness and filtration (Compressed Air & Inert Gas Supply), filter ratings ?99.5% for 0.3?m (Air & Inert Gas Filtration), and EO supply integrity including scale accuracy (±5% of 0.5 kg/m³ dose) as per Sterilant Supply & Dosing.
Noise Level (3.8)
Run a complete sterilization cycle. Measure A-weighted sound pressure at 1 m height and 1 m distance from the main noise source (front, rear, left, right). The maximum value must be ?65 dB(A), in line with Noise Level.
Thermal Insulation (3.9)
Visually and manually check that asbestos-free insulation covers all surfaces exceeding 55°C, except those essential for function. Requirements align with Thermal Insulation.
Instrumentation verification covers indicators, recorders, and automatic controllers per Instrumentation & 자동제어.
- Temperature: accuracy ±1%, compare with reference sensors (Temperature Accuracy)
- Pressure: indication error <±5 kPa, leak test resolution 0.1 kPa (압력 정확도)
- Relative humidity: sensor accuracy verification (Relative Humidity Accuracy)
- Timer: test 10 min with stopwatch, error ?2.5% (Timing Accuracy)
- Cycle phase & counter indicators
- Recorder: permanent records, sampling ?2s, tamper-proof (Recording Instruments)
- Auto controller: software validation, over-temp protection (Automatic Cycle Control)
- Override control: dedicated key/code access (Override Control)
Fault Simulation (3.10.6)
Induce each fault condition (sensor break, over-temperature, pressure deviation) and confirm visual/audible alarms, safe state, and door lock. Must behave as defined in Fault Handling.
- 표면 온도 - Annex C.1에 따른 시험은 ? 설정값 +5°C(표면 온도 균일성).
- 사용 가능한 공간 온도 – 부속서 C.2에 따른 시험, 균일성 ±3°C(사용 가능한 공간 온도 균일성).
- 진공 능력 – -75kPa 이하 달성, -50kPa 및 -75kPa까지 기록 시간(진공 성능).
- 누출율 – 부록 D에 따라 테스트, ø1m³ 챔버에 대해 ø0.1kPa/min(누출율).
- 살균효능 – 생물학적 지표를 사용하여 부록 E에 따라 테스트합니다. 클래스 B는 성장이 없어야 합니다(생물학적 지표 효능).
- 전기 안전 – GB4793.1 및 IEC 61010-2-040에 따름(전기 안전).
- 전자기 호환성 – GB/T18268.1에 따라 테스트됨(전자기 호환성).
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WhatsApp에서 채팅Disclaimer: This article outlines general inspection procedures for educational purposes. Always refer to applicable standards and manufacturer documentation for specific testing protocols.