DECLARATION AND CE MARKING OF PROCESS MACHINES
Thanks to the experience gained over the years, Brentech stands out for its technical consultancy activity in the field of CE Declaration and Marking of process machines.
We mainly address the industrial, medical and sports sectors, and support the customer in preparing the machine technical file which certifies compliance with European safety requirements. Once produced, the documentation allows the company to draw up the CE Declaration and proceed with the consequent CE marking of its machine.
How Brentech supports companies
1. Risk analysis
Risk analysis is a primary phase in the CE marking process of a machine. Our work consists of analyzing all the risks associated with the machine, also through an analysis of the probability of occurrence which therefore defines the level of risk. If the level of risk is not acceptable, one or more actions must be taken to contain it.
The reference standard for this service that we offer to our customers is UNI EN ISO 12100 which defines the risk analysis procedure. The risk assessment process, in each phase of the machine’s life, consists of a series of activities:
- Hazard recognition
- Risk estimation
- Risk assessment
- Verification of current regulations.
2. Three types of regulations
The current regulations to which we refer are divided into three types:
Basic safety type A standards covering the fundamental concepts, design principles and general aspects applicable to machines. EN ISO 12100 is an example of a standard of this type.
Type B safety standards that deal with aspects related to safety or protective devices that can be used for a series of machines. They are further divided into type B1 standards for certain safety aspects and type B2 standards for protection devices. EN ISO 13849-1/2 and EN ISO 13855 are examples of type B1 standards relating respectively to the parts of the control systems related to safety and the positioning of protective devices. EN ISO 13851 and DIN EN ISO 14120 are examples of type B2 standards relating respectively to two-hand controls and fixed guards.
Type C standards for machine safety with detailed safety requirements relating to a specific machine or group of machines. In order to proceed with the CE marking, the manufacturer must comply with the regulations in force for the type of machine made.
The reference standard for this service that we offer to our customers is UNI EN ISO 12100 which defines the risk analysis procedure. The risk assessment process, in each phase of the machine’s life, consists of a series of activities:
- Hazard recognition
- Risk estimation
- Risk assessment
- Verification of current regulations.
3. Safety operating procedures
This type of procedures is composed by the operations that the operator must carry out on the machine in order to work safely. Therefore they must be defined together with the people involved in order to allow the correct execution of the work without putting the operator at risk.
These operational and safety procedures are an output of the risk analysis and are fundamental to limit or avoid certain risks associated with the operator’s work.
4. Drafting of manuals and maintenance
The use and maintenance manual is a primary document for the technical file. Here are reported the functions of the machine, the residual risks associated with its use, the operating procedures for use, installation and handling, the ordinary and extraordinary maintenance.
The manual therefore aims to give all the necessary information to the user to be able to operate safely throughout the life of the machine, from installation to demolition. It is the only document in the technical file in addition to the declaration of conformity that is delivered to the user so that he can execute the CE Declaration and proceed with the consequent CE Marking of the machine.
