CEI UNI EN ISO 14971/A11:2022

CEI UNI EN ISO 14971/A11:2022 Dispositivi medici - Gestione dei rischi dispositivi medici (Variante A.11 RESS / P. Norma)
ID 18043 | 10.11.2022 / In allegato
La Variante A11 (2022 IT) della Norma CEI ...
ID 12018 | 11.11.2020
ADCO MED EU DECLARATION OF CONFORMITY TEMPLATE
(to be used for marine equipment within the scope of DIRECTIVE 2014/90/EU)
1. N°… (unique identification of the product): [Give type, batch or serial number(s) as appropriate]
2. This declaration of conformity is issued under the sole responsibility of the manufacturer:
3. Name and address of the manufacturer (and his authorised representative, if applicable):
4. Object of the declaration (identification of product allowing traceability. It may include a photograph, where appropriate): [Give MED entry number and description (e.g. MED/1.11 Linethrowing appliances), current version of implementing act and model and brand names, etc., Product description as given for EC type examination certificate]
5. The object of the declaration described above is in conformity with Directive 2014/90/EU
6. References to the relevant performance requirements and test standards - specifying also year of issue, version, dates - in relation to which conformity is declared: [Typically references to IMO documents and IEC, ISO, EN standards given in the relevant item in the implementing act and the Notified Body’s EC type examination certificate]
7. The notified body/bodies [give name(s) and number(s)] performed a [as appropriate indicate the used modules: B+D, B+E, B+F, G] conformity assessment procedure and issued the certificate(s): …[Indicate the certificate numbers, validity of Modules D and E].
8. Additional Information - Application and / or limitations (if any), as specified in EC Type Examination Certificate (Module B or G): [ Any limitations on the acceptance or use of the product or specific requirements stipulated in the relevant section of SOLAS, MARPOL, LSA, etc. or any other condition of validity - such as life rafts height of stowage, …].
9. Signature:
Signed for and on behalf of: …………………………………
(place and date of issue):
(name, function) (signature):
__________
Fonte: EU
Collegati:

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