Council Directive 93/42/EECDangos y teitl llawn

I. DEFINITIONS U.K.

1. Definitions for the classification rules U.K.

1.1. Duration U.K.

Transient U.K.

Normally intended for continuous use for less than 60 minutes.

Short term U.K.

Normally intended for continuous use for not more than 30 days.

Long term U.K.

Normally intended for continuous use for more than 30 days.

1.2. Invasive devices U.K.

Invasive device U.K.

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 U.K.

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 U.K.

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 U.K.

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 U.K.

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 U.K.

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 be active medical devices.[F1 Stand alone software is considered to be an active medical device.]

Textual Amendments

F1 Inserted by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance).

1.5. Active therapeutical device U.K.

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 U.K.

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.

[F2 1.7. Central circulatory system U.K.

For the purposes of this Directive, ‘ central circulatory system ’ means the following vessels:

arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, vena cava inferior.]

Textual Amendments

F2 Substituted by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance).

1.8. Central nervous system U.K.

For the purposes of this Directive, ‘central nervous system’ means brain, meninges and spinal cord.