Transcription of CLASSIFICATION CRITERIA Definitions for the classification ...
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CLASSIFICATION CRITERIA Definitions for the classification ...
BANNEX IXCLASSIFICATION CRITERIAI. for the CLASSIFICATION intended for continuous use for less than 60 termNormally intended for continuous use for not more than 30 termNormally intended for continuous use for more than 30 devicesInvasive deviceA device which, in whole or in part, penetrates inside the body, eitherthrough a body orifice or through the surface of the orificeAny natural opening in the body, as well as the external surface of theeyeball, or any permanent artificial opening, such as a invasive deviceAn invasive device which penetrates inside the body through the surface ofthe body.
B ANNEX IX CLASSIFICATION CRITERIA I. DEFINITIONS 1. Definitions for the classification rules 1.1. Duration Transient Normally intended for continuous use for less than 60 minutes.
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