Residual Ethylene Oxide Gas Chromatograph
The ethylene oxide residual gas chromatograph is a professional analytical instrument for detecting the residual amount of ethylene oxide in medical-related products.
Applicable standards:
The testing of ethylene oxide residuals is subject to strict international and national regulations and pharmacopoeial requirements to ensure patient and user safety:
ISO 10993-7:2021: "Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals." This is the definitive international standard specifying allowable limits for EO, ECH, and EG based on product contact duration and patient exposure, and outlines test methods.
United States Pharmacopeia (USP): Various chapters, notably those related to chromatography (e.g., USP ) and biocompatibility, which often reference ISO 10993-7.
European Pharmacopoeia (Ph. Eur.): Contains monographs and general chapters (e.g., 2.2.28 Gas Chromatography) that specify methods for the determination of residues of sterilizing agents.
Japanese Pharmacopoeia (JP): Also includes methods for testing residual solvents and sterilizing agents.
National Standards (e.g., GB/T 16886.7 in China): Many countries have adopted or developed national standards that are equivalent to or aligned with ISO 10993-7.
Product Advantages:
High Accuracy and Sensitivity: Capable of detecting trace amounts of EO, ECH, and EG (often in the parts per million or µg/g range), essential for regulatory compliance.
Compliance Assurance: Designed to meet the requirements of key international standards and pharmacopoeias (ISO 10993-7. USP, Ph. Eur.), ensuring validity of test results for regulatory submissions.
Reliable Detection: Utilizes the highly sensitive Hydrogen Flame Ionization Detector (FID) for robust and consistent detection of carbon-containing compounds.
Automated Sample Preparation: Often features automated headspace samplers, reducing manual labor, improving reproducibility, and enhancing safety by minimizing exposure to EO.
Comprehensive Data Analysis: Advanced software provides detailed chromatograms, quantitative results, and reporting capabilities, simplifying data interpretation and compliance documentation.
Ensures Product Safety: Directly contributes to reducing medical risks by controlling residual toxins in sterilized medical supplies, protecting patients and healthcare workers.
Send product request
Other supplier products
 |
System of Spinal Pedicle Screw-Rod System Torsional Fatigue Tester | Standard YY/T 0857-2011 (China): Specifies torsional fatigue testing protocols for spinal pedicle screw-rod systems, including load ratios, freq... |
 |
Mechanical Property Testing Machine for Metallic Cables and Wire Ropes | Product Information: - Evaluating material properties: Evaluate the mechanical properties of metallic cables and wire ropes, such as tensile stren... |
 |
Creep testing machine with full incision | Standard ISO 16770: Exclusively designed for full-notch creep testing (FNCT) of thermoplastics under sustained stress. ASTM D2990: Configurable f... |
 |
Multi-function Burling Machine | Basic characteristics： Fabric inspecting width: 1800/2000/2400mm Maximum batching diameter: 500mm Power supply voltage:AC220V±50Hz Rolli... |
 |
Microbial Barrier Tester | Product Introduction: Y/T 0471.5-2017 is a newly updated standard, which specifies the experimental method for evaluating the bacteria-inhibiting ... |
Same products
 |
pH-2398 pH/EC/ORP/Temperature multi-parameter Water Quality Tester | Seller: Kelilong Electron Co.,Ltd | Feature Large display screen, capable of simultaneously measuring water quality pH, redox potent... |
 |
ORP-2026S Waterproof Soil ORP and Temperature Meter | Seller: Kelilong Electron Co.,Ltd | 范围 ORP -999～999mV Temp 0～50℃ 分辨率 ORP 1mV... |
 |
TDS-2616 Waterproof EC/TDS/Temperature Meter | Seller: Kelilong Electron Co.,Ltd | Range EC ～19.9mS TDS Temp 0～50℃ R... |
 |
EC-98330 CF ECOstick - Nutrient Tester | Seller: Kelilong Electron Co.,Ltd | Ideal for hydroponics and agriculture applications, theNutrient Tester accurately measures the el... |
 |
PH-808 Waterproof Soil PH Meter | Seller: Kelilong Electron Co.,Ltd | Model PH-808 Range PH ～14.00PH Temp 0～50℃ ... |
