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CE marking Fire doors

ceAs of September 1, 2016 will mark the EC can fire doors and smoke seal according to product standard EN 16034: 2014 Pedestrian doors, industrial, commercial garage and windows that open - Product standard, performance characteristics - resistance Features fire and / or smoke leakage.
The CE marking according to EN 16034: 2014 will become mandatory as from 1 September 2019.
The CE marking according to EN 16034: 2014 will introduce several innovations on the Italian territory where until now the approval of the fire doors was regulated by mechanisms defined by the Interior Ministry. A major novelty is that the dispersion of the smoke control performance becomes an essential requirement.
The introduction of this new type of doors finally meet the demands of the industry, which for years have called for fire prevention measures that involve the use of smoke leakage ports.





Unannounced audits for Medical Device Manufacturers


Following the recommendation 2013/473 / EU the European Union introduced the mandatory audits without notice for manufacturers of medical devices have CE Certificate according to the Medical Device Directive 93/42 / EEC.

Unannounced inspection is unannounced used to monitor continued compliance with the legal obligations of the manufacturers or their outsourced suppliers.

These inspections must be carried out according to schedule established.

The unannounced audit is in addition to the three assessment meetings canons - initial audit, surveillance audits and recertification audit - and, in cases where the device under certification presents a serious risk, appears frequently not in compliance, or under specific reason to suspect non-compliance, can be repeated.

It is important to be ready at any time: this new obligation of unannounced audits requires good planning and document preparation, accurate and updated periodically.



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