Article R5221-10
All in vitro diagnostic medical devices imported, placed on the market or put into service must bear the CE mark. However, CE marking is not required for devices undergoing a performance evaluation or…
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Showing 721–730 of 13025 articles for “Art. Euronext Harmonised Market Rules — derivatives”
All in vitro diagnostic medical devices imported, placed on the market or put into service must bear the CE mark. However, CE marking is not required for devices undergoing a performance evaluation or…
The CE marking is affixed under the responsibility of the manufacturer or his authorised representative, in a visible, legible and indelible manner on the in vitro diagnostic medical device where this…
…tro diagnostic medical devices which comply with the standards relating to them and transposing the harmonised European standards, the references of which have been published in the Journal officiel d…
The provisions of articles R. 5211-15, R. 5211-17, R. 5211-19 and R. 5211-20 are applicable to in vitro diagnostic medical devices.
Equipment routes and accesses, passenger compartments accessible to people and spaces in shafts where checking and maintenance operations take place are equipped with appropriate lighting.
The equipment is installed or equipped in such a way as to prevent any risk of contact between persons present in the vicinity of the installation and the moving carrier or any other moving part. As s…
Checks and maintenance operations are carried out from a safe location allowing easy and secure access to the components concerned, by opening a guard. A stop device allows safe access to the passenge…
…in space, or along a substantially vertical guided path, when they are not subject to the technical rules in Annex I provided for in Article R. 4312-1: 1° Goods lifts which are inaccessible to persons…
The equipment is installed or equipped in such a way as to prevent any risk of a person falling into the shaft when the carrier is not at the landing, by means of guards fitted with a device preventin…
Where equipment is provided for the access or movement of persons, it must be installed or equipped in such a way as to avoid: 1° any risk of the persons concerned falling when the carrier is at rest…
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