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As a medical device, the G-VIR® glove meets the corresponding
Essential Requirements of the 93/42/EEC Directive: conformity
to these requirements is based on the direct application of
harmonized standards. In fact, Hutchinson Santé possesses
data record attesting conformity to the following major harmonized
standards:
- EN 455-1: medical gloves for single use,
specification for freedom from holes.
- EN 455-2: medical gloves for single use,
specification for physical properties.
- the EN 868 series of standards: packaging
material and systems for medical devices to be sterilized.
- the ISO 10993 series of standards: biological
evaluation of medical devices.
- the EN 1174 series of standards : estimation
of the population of micro-organisms on a device.
- EN ISO 14971: application of risk management
to medical devices.
- EN 14155-1 and EN 14155-2: clinical investigation
of medical devices for human subjects.
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