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Knowledge Base

Ethylene Oxide Residual Analysis

Ethylene Oxide (EtO or EO) is used to sterilize medical devices. Ethylene oxide gas (usually under pressure) may penetrate container boxes and packaging pauch made of certain material and practically dissolve in medical devices which are generally made of various polymers such as plastic and rubber. 

ISO 10993-7 -

Categories of Medical Devices

ISO 10993-7  group medical devices into 3 major categories depending on the duration of contact with the patient.

A) Limited Exposure Devices are those that are used within 24 hours.

B) Prolonged Exposure Devices are medical devices which in contact with patients between 24 hours to 30 days.

C) Permanent Contact devices are those that are placed on a patients for more than 30 days.

Sterility Test

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Bioburden Test

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