Cavalcanti, Silvio

English

Almae Matris Studiorum Campus

93/42/CEE - ANNEX IX

93/42/CEE - ANNEX IX  CLASSIFICATION CRITERIA  1. DEFINITIONS   1. Definitions for the classification rules 1. 1. Duration Transient Normally intended for continuous use for less than 60 minutes.  Short term Normally intended for continuous use for not more than 30 days.  Long term Normally, intended for continuous use for more than 30 days. 1.2. Invasive devices Invasive device A device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body. Body orifice Any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma. Surgically invasive device An invasive device which penetrates inside the body through the surface of the body, with the aid or in the context of a surgical operation. For the purposes of this Directive devices other than those referred to in the previous subparagraph and which produce penetration other than through an established body orifice, shall be treated as surgically invasive devices. Implantable device Any device which is intended: - to be totally introduced into the human body or, - to replace an epithelial surface or the surface of the eye, by surgical intervention which is intended to remain in place after the procedure. Any device intended to be partially introduced into the human body through surgical intervention . and intended to remain in place after the procedure for at least 30 days is also considered an implantable device. 1.3. Reusable surgical instrument Instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without connection to any active medical device and which can be reused after appropriate procedures have been carried out. 1.4. Active medical device Any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to he active medical devices. 1.5. Active therapeutical device Any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or handicap. 1.6. Active device for diagnosis Any active medical device, whether used alone or in combination with other medical devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities. 1.7. Central circulatory system For the purposes of this Directive, 'central circulatory system' means the following vessels. Arteriae pulmonales, aorta ascendens, arteriae coronariae, arteries carotis communis, arteries carotis externa, arteries carotis interna, arteriae cerebrates, truncus brachicephalicits, venae cordis, venae pulmonales, vena cava superior, vena cava inferior. 1.8. Central nervous system For the purposes of this Directive, 'central nervous system' means brain, meninges and spinal cord.  II. IMPLEMENTING RULES  2. Implementing rules 2.1. Application of the classification rules shall be governed by the intended purpose of the devices. 2.2. If the device is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices. Accessories are classified in their own right separately from the device with which they are used.   2.3. Software, which drives a device or influences the use of a device, fails automatically in the same class. 2.4. If the device is not intended to be used solely or principally in a specific part of the body, it must be considered and classified on the basis of the most critical specified use.   2.5. If several rules apply to the same device, based on the performance specified for the device by the manufacturer, the strictest rules resulting in the higher classification shall apply.   III. CLASSIFICATION  1. Non-invasive devices 1.1. Rule 1 All non-invasive devices are in Class I, unless one of the rules set out hereinafter applies. 1.2. Rule 2 All non-invasive devices intended for channelling or storing blood, body liquids or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body are in Class IIa: - if they may be connected to an active medical device in Class IIa or a higher class, - if they are intended for use for storing or channelling blood or other body liquids or for storing organs, parts of organs or body tissues, in all other cases they are in Class 1. 1.3. Rule 3 All non-invasive devices intended for modifying the biological or chemical composition of blood, other body liquids or other liquids intended for infusion into the body are in Class llb, unless the treatment consists of filtration, centrifugation or exchanges of gas, heat, in which case they are in Class Iia. 1.4. Rule 4 All non-invasive devices which come into contact with injured skin: - are in Class I if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates, - are in Class Ilb if they are intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent,  - are in Class Ila in all other cases, including devices principally intended to manage the micro-environment of a wound. 2. Invasive devices 2.1. Rule 5 All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device: - are in Class I if they are intended for transient use, - are in Cla!s lla if they are intended for short-term use, except if they are used in the oral cavity as far as the pharvnx, in an car canal up to the car drum or in a nasal cavity, in which case they are in Class I, - are in Class IIb if they are intended for long-term use, except if they are used in the oral cavity as far as the phar).nx, in an ear canal up to the car drum or in a nasal caviry and are not liable to be absorbed by the mucous membrane, in which case they are in Class IIa. All invasive devices with respect to body orifices, other than surgically invasive devices, intended for connection to an active medical device in Class lla or a higher class, are in Class IIa. 2.2. Rule 6 All surgically invasive devices intended for transient use are in Class lIa unless they arc: - intended specifically to diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III, - reusable surgical instruments, in which case they are in Class I, - intended to supply energy in the form of ionizing radiation in which case they are in Class llb, - intended to have a biological effect or to he wholly or mainly absorbed in which case they are in Class IIb, - intended to administer medicines by means of a delivery system, if this is done in a manner that is potentially hazardous taking account of the mode of application, in which they are in Class lIb. 2.3. Rule 7 All surgically invasive devices intended for short-term use are in Class IIa unless they are intended: - either specifically to diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III, - or specifically for use in direct contact with the central nervous system, in which case they are in Class III, - or to supply energy in the form of ionizing radiation in which case they are in Class IIb, - or to have a biological effect or to be wholly or mainly absorbed in which cast they are in Class III, - or to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in Class lIb. 2.4. Rule 8 All implantable devices and long-term surgically invasive devices are in Class IIb unless they are intended: - to be placed in the teeth, in which cast they are in Class Ila, - to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are in Class Ill, - to have a biological effect or to be wholly or mainly absorbed, in which cast they are in Class Ill, - or to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in Class 111. 3. Additional rules applicable to active devices 3.1. Rule 9 All active therapeutic devices intended to administer or exchange energy are in Class lIa unless their characteristics are such that they may administer or exchange energy to or from the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which cast they are in Class lIb. All active devices intended to control or monitor the performance of active therapeutic devices in Class Iib, or intended directly to influence the performance of such devices are in Class llb. 3.2. Rule 10 Active devices intended for diagnosis are in Class IIa: - if they are intended to supply energy which will be absorbed by the human body, except for devices used io illuminate the patient's body, in the visible spectrum, - if they are intended to image in vivo distribution of radiopharrnaccuticals, - if they are intended to allow direct diagnosis or monitoring of vital physiological processes, unless they are specifically intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activiry of CNS in which case they are in Class IIb. Active devices intended to emit ionizing radiation and intended for diagnostic and therapeutic interventional radiology including devices which control or monitor such devices, or which directly influence their performance, are in Class lIb.   Rule 11 All active devices intended to administer and/or remove medicines, body liquids or other substances to or from the body are in Class lIa, unless this is done in a manner: - that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are in Class IIb. 3.3. Rule 12 All other active devices are in Class I. 4. Special Rules 4.1. Rule 13 All devices incorporating, as an integral part, a substance which, if used separately, can he considered to be a medicinal product, as defined in Article 1 of Directive 65165/EEC, and which is liable to act on the human body with action ancillary to that of the devices, are in Class Ill. 4.2, Rule 14 All devices used for contraception or the prevention of the transmission of sexually transmitted diseases are in Class lIb, unless they are implantable or long term invasive devices, in which case they are in Class III. 4.3. Rule 15 All devices intended specifically to be used for disinfecting, cleaning, rinsing or, when appropriate, hydrating contact lenses are in Class IIb. All devices intended specifically to be used for disinfecting medical devices are in Class IIa. Tnis rule does not apply to products that are intended to clean medical devices other than contact lenses by means of physical action. 4.4. Rule 16 Non-active devices specifically intended for recording of X-ray diagnostic images are in Class Ila. 4.5. Rule 17 All devices manufactured utilizing animal tissues or derivatives rendered non-viable are Class 111 except where such devices are intended to come into contact with intact skin only. 5. Rule 18 By derogation from other rules, blood bags are in Class Ilb.     

http://campus.unibo.it/11112/1/Direttiva9342CEEAnnexIX.pdf

93/42/CEE - ANNEX IX

Abstract

Similar works

Full text

Available Versions

Almae Matris Studiorum Campus

Almae Matris Studiorum Campus