(2a) ‘device for aesthetic purposes’ means any instrument, apparatus, appliance, software, implant, material, substance or other article, intended by the manufacturer to be used, alone or in combination, for the purposes of modifying the physical appearance of human beings, without any therapeutic or reconstructive intent, by implanting it in the human body, attaching it to the surface of the eye or using it to induce a tissue or cell reaction on external or non-external parts of the human body.

(a) to verify that, under normal conditions of use, devices are designed, manufactured and packaged in such a way that they are suitable for one or more of the specific purposes of a medical device referred to in number (1) of Article 2(1), and achieve the performances intended as specified by the manufacturer;

(a) to verify that, under normal conditions of use, devices are designed, manufactured and packaged in such a way that they are suitable for one or more of the specific purposes of a medical device referred to in number (1) of Article 2(1), and achieve the performances intended as specified by the manufacturer or sponsor ;

(i) interference with medical electronic equipment and devices (including cardiac pacemakers and other implanted devices as referred to in point (c));

This Regulation establishes the conditions under which the instructions for use of medical devices referred to in point 15 of Annex 1 to Directive 90/385/EEC and in point 13 of Annex I to Directive 93/42/EEC may be provided in electronic form instead of in paper form.

Notification concerning the granting, refusal, withdrawal or extension of EEC component type-approval with regard to the strength of a protection structure (rear-mounted rollbar, frame or cab) and to the strength of its attachment to the tractorEEC component type-approval No: extension (¹)1.Trade name or mark and type of protection structure: 2.Name and address of manufacturer of protection structure: 3.If applicable, name and address of authorized representative of manufacturer of protection structure: 4.Trade mark or name, type and commercial description of tractor for which protection structure is intended: 5.Extension of EEC component type-approval for tractors of the following type(s) and, where appropriate, commercial descriptions: 5. ...[+++]1.The mass of the unballasted tractor, as defined in 1.4 of Annex II, exceeds/does not exceed (²) the reference mass used for the test by more than 5 %.5.2.The method of attachment and points of attachment are/are not (²) identical.5.3.All the components likely to serve as supports for the protection structure are/are not (²) identical.6.Submitted for EEC component type-approval on: 7.Test station: 8.Date and number of the report of the test station: 9.Date of granting/refusal/withdrawal of EEC component type-approval (²): 10.Date of granting/refusal/withdrawal of the extension of EEC component type-approval (²): 11.Place: 12.Date: 13.The following documents, bearing the component type-approval number shown above, are annexed to this certificate (e.g. report of the test station).