This technical operating documentation shall be part of the technical file.
This technical operating documentation shall be part of the technical file.
Parameters to be recorded in the technical file
The technical file shall comprise the following
Information concerning the certificate and the technical file
the references of the documents contained in the technical file
The technical file shall contain at least the following parameters
the documents necessary for the compilation of the technical file
references of the documents contained in the technical file
Accordingly, the manufacturer of record has the responsibility to develop a technical file, also called a technical construction file.
Technical file of the machine (the Technical book of the machine):
Administrative processing and evaluation of the technical file takes 14 days
documented in the technical file accompanying the EC declaration of verification.
four months after submission of the technical file referred to in paragraph 2
The application shall include a technical file compiled in accordance with Annex II.
a summary of the technical dossier
It shall provide a technical dossier specifying
It shall provide a technical dossier specifying
The technical dossier referred to in paragraph 1(b) shall contain
a new complete summary of the technical dossier in a standardised form.
A technically complete dossier is one that satisfies all the requirements of Annex IIIB.
the design and manufacturing schedule referred to in point 3 of Annex II.
The person authorised to compile the technical file:
The person authorised to compile the technical file:
Dental implant systems — Contents of technical file
Dental implant systems — Contents of technical file
Dental implant systems — Contents of technical file
1. the manufacturer’s technical file consisting of:
Development of the technical file (industrialization).
1. the manufacturer's technical file consisting of:
The technical file accompanying the EC certificate of verification shall be lodged with the applicant.
The technical file accompanying the EI declaration of demonstration is lodged with the applicant.
The compatibility with these requirements shall be set out in the technical file for the vehicle.
Each notified body compiles a technical file in respect of the verifications they have carried out.
The technical file accompanying the declaration of verification must be made up as follows
Requêtes fréquentes français :1-200, -1k, -2k, -3k, -4k, -5k, -7k, -10k, -20k, -40k, -100k, -200k, -500k, -1000k,
Requêtes fréquentes anglais :1-200, -1k, -2k, -3k, -4k, -5k, -7k, -10k, -20k, -40k, -100k, -200k, -500k, -1000k,
Traduction Translation Traducción Übersetzung Tradução Traduzione Traducere Vertaling Tłumaczenie Mετάφραση Oversættelse Översättning Käännös Aistriúchán Traduzzjoni Prevajanje Vertimas Tõlge Preklad Fordítás Tulkojumi Превод Překlad Prijevod 翻訳 번역 翻译 Перевод