iBoske | Classification of medical devices other than in vitro diagnostic medical devices

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Arnab Bandhu

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What kind of medical device do you have? Active medical Devices. Medical devices incorporating medicinal products.. Medical devices incorporating animal or human cells, tissues or derivatives.. Medical devices for sterilization or disinfection.. Medical devices for contraceptive use.. Non Invasive medical device. Invasive medical Device.
Choose further details. Contact with Injured Skin. Channeling or storing substances. Modifying composition of substances. Others not mentioned before..
Class A.
Breached dermis? NO. It is used as a mechanical barrier, for compression or for absorption of exudates only.. Yes.
Class A.
Choose further. It is intended to be used principally with wounds which have breached the dermis, or is principally intended for the management of the microenvironment of a wound.. It is intended to be used principally with wounds which have breached the dermis and cannot heal by primary intention.
Class B.
Class C.
Is it a blood bag that does not incorporate a medicinal product? No..
Is it intended to be connected to an active medical device which is in Class B, C or D or for channeling blood or storing or channeling other body liquids or storing organs, parts of organs or body tissues? The safety and performance of the active medical device is influenced by the non-invasive medical device or vice versa.. Yes. No.
Class B.
Class A.
Is it intended for modifying the biological or the chemical composition of blood or other body liquids or other liquids intended for infusion into the body by filtration? Yes.. filtration. No. Not using filtration..
Class B.
Class C.
Body Orifice or Surgically Invasive? Body Orfice. Surgically Invasive or implantable devices.
Is it connected to an active medical device? No. Yes.
What is the duration of use? Transient ( upto 60 mins ). Short term (upto 30 days). long term (more than 30 days ).
Is it intended for use on the eyeball or to be absorbed by mucous membrane? Yes. No.
Class B.
Is it connected to a class B, C or D device? No. Yes.
Class A.
Start again to find relevant classification..
Is it liable to be absorbed by mucous membrane? Yes. No.
Is it connected to a class B, C or D device? No. Yes.
Class B.
Start again to find relevant classification..
Is it intended for use in an oral cavity as far as the pharynx or in an ear canal up to the ear drum or in a nasal cavity? No. Yes.
Class A.
Is it connected to a class B, C or D device? No. Yes.
Class B.
Start again to find relevant classification..
Is it liable for absorption by the mucous membrane? No. Yes.
Is it intended for use in an oral cavity as far as the pharynx or in an ear canal up to the ear drum or in a nasal cavity? Yes. Answer.
Class B.
Is it connected to a class B, C or D device? No. Yes.
Class C.
Start again for relevant classification..
Is it connected to a class B, C or D device? No. Yes.
Class C.
Start again for relevant classification..
What is the class of the active nedical device? Class B, C, D.
Class B.
Is it a long term (more than 30 days) or an implantable or an active device? No. Yes.
What is the duration of use? Transient ( upto 60 mins ). Short term ( upto 30 days ).
Is it intended to be used specifically in direct contact with the central nervous system or for the diagnosis, monitoring or correction of a defect of the heart or of the central circulatory system through direct contact with these parts of the body? Yes. No.
Class D.
Is it intended for the administration of any medicinal product by means of a delivery system and such administration is done in a manner that is potentially hazardous? Yes. No.
Class C.
Is it intended to have a biological effect or to be wholly or mainly absorbed by the human body? Yes. No.
Class C.
Is it intended for the supply of energy in the form of ionising radiation? Yes. No.
Class C.
Is it connected to an active medical device? Yes. No.
What is the class of the active medical device? Class B. Class C. Class D.
Classified as class B.
Classified as class C.
Classified as class D.
Is it a reusable surgical instrument? Yes. No.
Class A.
Class B.
Is it intended to have a biological effect or to be wholly or mainly absorbed by the human body or to be used specifically in direct contact with the central nervous system or for the diagnosis, monitoring or correction of a defect of the heart or of the central circulatory system through direct contact with these parts of the body? Yes. No.
Class D.
Is it intended for the administration of any medicinal product or the supply of energy in the form of ionising radiation? Yes. No.
Class C.
Is it intended to be placed into any tooth? Yes. No.
Class B.
Is it intended to undergo a chemical change in the body? Yes. No.
Class C.
Class B.
Is it intended to undergo chemical change in the body? Yes. No.
Is it intended to be placed into any tooth? No. Yes.
Class D.
.
Class B.
Is it any of these?- (1) to be used in direct contact with the heart, the central circulatory system or the central nervous system; (2) to be life supporting or life sustaining; (3) to be an active medical device; (4) to be wholly or mainly absorbed by the human body; (5) for the administration of any medicinal product; or (6) to be a breast implant.. Yes. No.
Class D.
Is it intended to be placed into any tooth? Yes. No.
Class B.
Class C.
Choose the type of active device.. Therapeutic medical devices for administering or exchanging energy.. Diagnostic medical devices.. Other active medical devices..
Class A.
Is it intended for the control or monitoring, or to be used to directly influence the performance, of a Class C active therapeutic device? Yes. No.
Class C.
Is it intended for the administration or exchange of energy to or with a human body in a potentially hazardous way (such as through the emission of ionising radiation), taking into account the nature, density and site of application of the energy and the type of technology involved? Yes. No. It is just intended for the administration or exchange of energy to or with a human body..
Class C.
Class B.
Is it intended for the administration, or removal of, any medicinal product, body liquid or other substance to or from a human body in a manner that is potentially hazardous, taking into account, (1) the nature of the medicinal product, body liquid or substance; (2) the part of the body concerned; and (3) the mode and route of the administration or removal? Yes. No. It is intended for the administration, or removal of, any medicinal product, body liquid or other substance to or from a human body.. No.
Class C.
Class B.
Is it intended for the emission of ionising radiation and to be used in diagnostic or interventional radiology? Yes. No.
Class C.
Is it intended for the control or monitoring, or to be used to directly influence the performance, of any active medical device intended for the emission of ionising radiation and to be used in diagnostic or interventional radiology? Yes. No.
Class C.
Is it intended,- (1) to be used to supply energy which will be absorbed by the human body; (2) to be used to capture any image of the in vivo distribution of radiopharmaceuticals; or (3) for the direct diagnosis or monitoring of vital physiological processes? Yes. It is specifically for (1) the monitoring of vital physiological parameters, where the nature of any variation is such that it could result in immediate danger to the patient (such as any variation in cardiac performance, respiration or activity of the central nervous system); or (2) diagnosing in a clinical situation where the patient is in immediate danger. . Yes, it is intended to be used solely to illuminate a patient's body with light in the visible or near infrared spectrum. . Yes, but not the cases mentioned at this stage..
Class C.
Class A.
Class B.
Does it incorporates as an integral part a substance which,- (1) if used separately, may be considered to be a medicinal product; and (2) is liable to act on a human body with an action ancillary to that of the medical device? Yes, bu the incorporated substance is a medicinal product exempted from the licensing requirements of the Drugs and Cosmetics Act, 1940 (23 of 1940) and the rules made thereunder.. Yes.
Class B.
Class D.
Is it is manufactured from or incorporates,- (1) cells, tissues or derivatives of cells or tissues, or any combination thereof, of animal or human origin, which are or have been rendered non-viable; or (2) cells, tissues or derivatives of cells or tissues, or any combination thereof, of microbial or recombinant origin? No, it is manufactured from or incorporates non-viable animal tissues, or their derivatives, that come in contact with intact skin only. . Yes.
Class A.
Class D.
Is it intended to be used specifically for,- (1) the sterilization of any other medical device; (2) the end-point disinfection of any other medical device; or (3) the disinfection, cleaning, rinsing or hydration of contact lenses? Yes, but it is intended for the disinfection of any other medical device before the latter is sterilized or undergoes end-point disinfection, i.e., the disinfection of a medical device immediately before its use by or on a patient. . Yes.
Class B.
Class C.
Is it an implantable medical device or an invasive medical device intended for long term use for contraception or the prevention of the transmission of any sexually transmitted disease? Yea. It is not an implantable medical device or an invasive medical device intended for long term use..
Class D.
Class C.