Perimetra CE Marking Process is the service we provide to collect all the relevant documentation for CE marking as per Machinery Directive requirements which in turn allows machinery to be placed on the market or to be put into service.
The certification process is made up of a number of steps to be carried out in a sequence during which all pertinent documentation is drafted.
Article 5 of the Machinery Directive 2006/42/CE demands that the manufacturer or his authorised representative shall:
- ensure that it satisfies the relevant essential health and safety requirements set out in Annex I
- ensure that the technical file referred to in Annex VII, part A is available c
- provide, in particular, the necessary information, such as instructions and User and Maintenance Manual
- carry out the appropriate procedures for assessing conformity in accordance with Article 12
- draw up the EC declaration of conformity
- affix the CE marking
HOW TO DRAFT THE TECHNICAL FILE
The technical file must prove the machinery conformity to the requirements of the current directive relatively to design, manufacturing and machinery operation.
More in detail, the technical file includes the manufacturing file composed by:
- a general description of the machine
- documentation regarding the risk assessment which must report the procedures which have been followed, including:
- List of essential safety requirements and health protection relative to the machinery
- Implemented protection measures to eliminate the identified hazards or to reduce risks
- Report of residual risks connected to the machinery, if they exist
- report of health & safety tests carried out (noise- vibration -AOR -electromagnetic fields – electromagnetic compatibility – electric safety 60204-1)
- validation of software with safety functions as required by UNI EN ISO 13849-1:2016 and UNI EN ISO 13849-2:2013 standards.
- (if present) copy of the CE declaration of conformity of machines or other products incorporated in the machine
- machinery layout and control circuit drawings Also the necessary description and explanation to understand how the machinery operates.
- standards e and technical specifications applied which report the essential safety requirements and health protection described in such standards.
- analysis and testing of control circuits with safety functions(PL UNI EN ISO 13849-1:2016 & SIL – IEC 61508)
- machinery instructions (user and maintenance manual)
- detailed and complete drawings, including calculation notes, testing results, certification. All documentation must allow for machinery conformity verification regarding essential safety requirements and health protection.
- any technical report which provides test results carried out by the manufacturer himself or any external appointed by the manufacturer or his authorised representative
- validation of control circuits with safety functions according to UNI EN ISO 13849-1:2016 and UNI EN ISO 13849-2:2013 (e.g. carried out with WS System)
- (if present) declaration of incorporation for the included partly-completed machinery with the pertinent assembly instructions
In the case of serial production, the manufacturer must carry out all the necessary research and testing on the components and accessories or on the entire machine.
This process establishes if the machinery can be assembled and put into service in appropriate safety conditions after its design or production.
The technical files must include all reports and pertinent results.
WE FOLLOW ALL STAGES OF THE PROJECT FROM RISK ANALYSIS TO SAFE PLANT COMMISSIONING.
PERIMETRA
MACHINERY DUE DILIGENCE
PERIMETRA
RISK ASSESSMENT
PERIMETRA
SAFETY DESIGN
PERIMETRA
UPGRADING REMEDIATION
PERIMETRA
CE MARKING PROCEDURE
PERIMETRA
MACHINERY DUE DILIGENCE
PERIMETRA
RISK ASSESSMENT
PERIMETRA
SAFETY DESIGN
PERIMETRA
UPGRADING REMEDIATION
