41Rule 18 - Blood bagsGeneral explanation of the ruleThis is a special rule that covers only blood bags.RULE 18 EXAMPLESBy derogation from other rules, blood bags are in Class IIb. - Blood bags (inclu40Rule 17 - Devices utilizing animal tissues or derivativesExplanation of the ruleThis rule covers devices that contain or are made of animal tissues that have been rendered non-viable or derivatives 39Rule 16 - Non-active devices to record X-ray diagnostic imagesRULE 16 EXAMPLESNon-active devices specifically intended for recording of X-raydiagnostic images are in Class II a.X-ray films, photosti38Rule 15 - Specific disinfecting, cleaning and rinsing devicesGeneral explanation of the ruleThis rule is principally intended to cover various contact lens fluids. It also covers substances used pr37Rule 14 - Devices used for contraception or prevention of sexually transmitted diseasesGeneral explanation of the ruleThese intended uses relate to special cases of human vulnerability that cannot b364. Special rulesRule 13 - Devices incorporating a medicinal substance (See MEDDEV. 2.1/3 rev. 1)General explanation of the ruleThis rule is intended to cover combination devices that contain a medi35Rule 12 All other active devicesGeneral explanation of the ruleThis is a fallback rule to cover all active devices not covered by the previous rules.RULE 12 EXAMPLESAll other active devices are in C34Rule 11 - Active devices to administer, remove medicines and other substances to or from the bodyGeneral explanation of the ruleThis rule is intended to cover primarily drug delivery systems and ane
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