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Decision Rules -
ISO 17025:2017 requires that a decision rule should be applied to any statement of conformity to a specification or standard in a test report when it is requested by customers. The decision rule applied should also takes into account the level of risk associated with the decision, primarily in term of incorrect decision. Measurement uncertainty should be incorporated in any decision rule applied to the reported result.
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.
Test for sterility for medical devices is regulated internationally under ISO 11737-2 as well as in USP <71> beside a few other country standard. Under ISO 11737-2, test for sterility is prescribed for aerobic sterility while in USP <71>, both aerobic and anaerobic sterility are tested using two different growth media. Aerobic sterility using SCDB growth media will detect the presence of aerobic bacteria and fungi. Anaerobic sterility tests will detect the presence of both aerobic and anaerobic bacteria and fungi using SCDB and FTM growth media. Two methods of sterility tests ...
Bioburden test is to determine the number of viable microorganism (bacteria and fungi) which may be present in/on a medical device. Guideline on the bioburden test is described in ISO 11737-1 where the most common test method is the membrane filtration method. The microorganism is dislodged from the sample and extracted onto a membrane filter. The filter is then placed on a suitable agar plate and incubated for a specified period. Number of colonies observed after incubation is completed will represent the number of viable organisms extracted from the device. Efficiency of extracting the organism must be determined prior to performing the bioburden test...