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Information update Ethylene oxidesterilised medical devices in neonatology and paediatrics: Implementation of standard NF EN ISO 109937 Ethylene oxide is a widely used steri lising agen t, especially

How to fill out ethylene oxide-sterilised medical devices

How to fill out ethylene oxide-sterilised medical devices

1. Gather the necessary documents and information about the medical devices.
2. Ensure all devices are clean and free from any contaminants.
3. Check the compatibility of the materials used in the devices with ethylene oxide sterilization.
4. Package the devices in appropriate sterilization containers or wraps that allow gas penetration.
5. Place indicators and labels on the packages for tracking and identification.
6. Load the packages into the ethylene oxide sterilizer according to the manufacturer's instructions.
7. Set the appropriate sterilization parameters such as temperature, humidity, and exposure time.
8. Begin the sterilization process and monitor it until completion.
9. Once sterilization is finished, allow the packages to aerate in a controlled environment to remove residual ethylene oxide.
10. Finally, inspect the sterilized devices before they are released for use.

Who needs ethylene oxide-sterilised medical devices?

1. Healthcare facilities requiring sterile surgical instruments and devices.
2. Manufacturers of medical devices that need to meet regulatory sterilization standards.
3. Research laboratories working with sterile equipment.
4. Dental clinics needing sterilized tools for procedures.
5. Emergency medical services that require ready-to-use sterile devices.

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What is ethylene oxide-sterilised medical devices?

Ethylene oxide-sterilised medical devices are medical instruments or products that have been disinfected and sterilised using ethylene oxide gas. This process is effective for sterilising heat-sensitive and moisture-sensitive devices.

Who is required to file ethylene oxide-sterilised medical devices?

Manufacturers and importers of ethylene oxide-sterilised medical devices are typically required to file regulatory documentation with health authorities to ensure compliance with safety and efficacy standards.

How to fill out ethylene oxide-sterilised medical devices?

Filling out documentation for ethylene oxide-sterilised medical devices generally involves providing information such as device specifications, sterilisation validation data, packaging details, and any applicable regulatory submissions to the relevant health authorities.

What is the purpose of ethylene oxide-sterilised medical devices?

The purpose of ethylene oxide-sterilised medical devices is to eliminate all viable microorganisms, including bacteria, viruses, and spores, ensuring that the devices are safe for patient use and free from contamination.

What information must be reported on ethylene oxide-sterilised medical devices?

Information that must be reported typically includes the device name, manufacturer's details, sterilisation cycle parameters, safety data, validation results, expiration dates, and any specific usage instructions.