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Medical devices are products or equipment intended generally for a medical use and are regulated at Member State level The Medical Devices and the In-Vitro Diagnostic Devices Regulations have introduced new responsibilities for the European Medicines Agency (EMA) and national competent authorities in the assessment of certain categories of medical device

Ethylene Oxide Sterilization

For details of the requirements in OSHA's ETO standard for occupational exposures see Title 29 of the Code of Federal Regulations (CFR) Part 1910 1047 873 Several personnel monitoring methods (e g charcoal tubes and passive sampling devices) are in use 814 OSHA has established a PEL of 5 ppm for ethylene chlorohydrin (a toxic by-product of ETO) in the workplace 876 Additional

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