Question 1

Tried, tested and proven: Our modular process for flexible collaboration

Accepted Answer

The path to CE labelling first leads you to the product analysis and determination of the limits of use. The appropriate legal bases, in particular standards, must then be researched according to the nature of the product. CE labelling of certain product classes then requires in particular a risk assessment, which may be carried out in accordance with various extended directives such as ATEX. easyCE relies on collaboration and communication in the conformity assessment procedure. You have the option of organising our collaboration flexibly and providing the elements of the conformity assessment procedure that you require yourself. Our modular approach to collaboration has been tried and tested in dozens of projects and has proven itself over decades.

Question 2

Analyse product and define limits of use?

Accepted Answer

The specific application/use of the product is of particular importance. The use or application and the limits of use are determined by the manufacturer. This is his duty. It also determines the limits of claims in terms of product liability. The clear definition of the limits of use is particularly important if the expected application by the user/operator cannot always be clearly recognised by the manufacturer or is even unknown to him or if the product is installed in another product or system. The required level of user safety must be maintained so that the manufacturer of the product is not placed at a disadvantage due to "foreseeable misuse" by the user in the life phases (e.g. transport, assembly, installation, operation, cleaning and maintenance, disposal). The manufacturer, its authorised representative or the "distributor" is responsible for all these measures, and the use/application of a product always has consequences in terms of product safety and the associated product liability. (See ProdSG §3, §7 and ProdHaftG §3, as well as BGB §434 liability for material defects)

Question 3

Identify applicable directives, laws and standards?

Accepted Answer

These requirements are specified in EC directives (RL), implemented in national laws, e.g. in the national Product Safety Act (ProdSG), and laid down in harmonised European standards (EN) as an implementation aid and, when the standards are applied, as a presumption of conformity. The manufacturer confirms the conformity of the product with the requirements of the directives/laws and the EN - also for products for own use - by means of the declaration of conformity and by affixing the CE mark. This is mandatory. If other directives apply to the product, these must also be applied in the conformity assessment procedure. (e.g. ATEX Directive 2014/34/EU, Pressure Equipment Directive 2014/68/EU and EMC Directive 2014/30/EU) etc. In addition, the relevant harmonised standards applied during design and construction must be stated in the documents (operating instructions and CE declaration). Harmonised standards are published in the Official Journal of the EU. However, this simple and straightforward description of the legal requirements harbours considerable demands on the quality and properties of machinery.

Question 4

Identify, assess and mitigate risks during use

Accepted Answer

Products/machines must have certain design characteristics in order to reduce hazards to people, animals and objects to an acceptable level in all life cycles. To this end, manufacturers must carry out a risk assessment (RA) for their products to "determine the residual hazards and to select and apply suitable and appropriate means to reduce the risks". If products are used in potentially explosive atmospheres, an ignition source analysis must be carried out to identify potential ignition sources.

Question 5

Operating instructions and operator responsibility resulting from the BetrSichV

Accepted Answer

The operator/user of an equipment, in turn, is obliged by the requirements of the Industrial Safety Ordinance (BetrSichV) and the ArbSchG, as well as the ArbSG to let his personnel work only on such equipment. to provide its employees with only those resources that meet the requirements of the EC directives and laws.The operator/user/employer is responsible for providing safe work equipment for the entire life cycle (see section 4 BetrSichV and section 5 ArbSchG). For this purpose, the employer carries out a risk assessment at the workplace and prepares an operating instruction for the work on or. with these resources.

Question 6

Why use support for the conformity assessment procedure?

Accepted Answer

Speed up the entire process with expert advice and additional external capacity. You also reduce your uncertainty and thus your risk of exposure to product liability. By allowing your employees to focus on their core competences, they concentrate on the essentials and the flow of work is not interrupted.

Information	Produkt-analyse	Risk-assesment	Operation-instructions
Ambient conditions under which the machine/product may be used	✔️	✔️	✔️
Operation: User interface of panel, control panel, remote control, etc.: screenshots, graphics, etc.	❌	❌	✔️
Detailed views (graphics) of the machine/product with all operator-machine/product interfaces (What does the operator need to know? Where does the operator need to go?)	❌	❌	✔️
Documents/drawings that should/must be included in the operating instructions (circuit diagrams, flow charts, component lists, system architecture, etc.)	✔️	✔️	✔️
Area of application (commercial, private)	✔️	✔️	✔️
Emissions, especially from machinery (noise, dust, heat, cold, vibrations, electromagnetic fields, etc.) with test reports	✔️	✔️	✔️
Disposal: Are there components that require special disposal (radioactivity, hazardous substances, etc.)	✔️	✔️	✔️
Spare parts list with article numbers	❌	❌	✔️
If available: Information about comparable devices	✔️	✔️	✔️
Manufacturer's company logo	✔️	✔️	✔️
How it works/functional description	✔️	✔️	✔️
For the cover page: Photo or graphic of the product	❌	❌	✔️
Danger areas	✔️	✔️	✔️
Exact contact details of the manufacturer, including for service, maintenance, etc.	✔️	✔️	✔️
Overall view (graphics) of the machine/product	✔️	❌	✔️
If applicable, operating modes (Automatic, Expert User, etc.)	✔️	✔️	✔️
If applicable, variants of the machine/product	✔️	✔️	✔️
Information on operation (procedure, steps, consequences, dangers)	❌	✔️	✔️
Components of the machine/product with precise designations of the components that the operator must access	✔️	✔️	✔️
Service life of the machine/product	✔️	✔️	✔️
Scope of delivery	✔️	❌	✔️
List of (error) messages, meaning of the message, measures	✔️	✔️	✔️
Take as many photos/videos as possible on site (not for the documents, but for better understanding)	❌	❌	❌
Pictograms/instructions attached to the machine/product by the manufacturer	✔️	✔️	✔️
Safety devices (emergency stop, etc.)	✔️	✔️	✔️
Technical data (weight, dimensions, power supply, performance, additional connections such as compressed air, etc., materials, accuracies, interfaces, etc.)	✔️	✔️	✔️
terminology	✔️	✔️	✔️
Transport/assembly/commissioning: What does the manufacturer do? What does the operator do?	❌	✔️	✔️
Nameplate: Where is it located? What information does it contain?	✔️	❌	✔️
Environmental conditions under which the machine/product may be used	✔️	✔️	✔️
Maintenance: what may/must the operator do, what must the manufacturer (service) do?	✔️	✔️	✔️
Maintenance intervals	❌	❌	✔️
What materials does the machine/product require/process?	✔️	✔️	✔️
Is a quick start guide required? For what purpose (format, waterproof, weatherproof, etc.)?	❌	❌	✔️
Target group of the product/instruction manual (previous knowledge)	✔️	✔️	✔️
Supplier information	✔️	✔️	✔️

easyCE CE project checklist: You need this data for CE labelling and technical documentation.

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Declaration of conformity done!

Risk assessment completed!

Applicable standards & guidelines applied!

Technical documentation created!

CE mark attached!

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