The list of harmonised standards according to the machinery directive published in the Official Journal of the EC is divided into three different types of standards: Types A, B and C. Type A represents basic standards, i.e. standards that are applicable to all products governed by the machinery directive. Only one standard of this type, EN ISO 12100:2010, currently deals with the creation of a risk assessment. Standards of type B are applicable to a group of machines. Standards of type C, by contrast, define more closely the protection targets of the machinery directive for very specific types of machines.
Occupational safety and health
The multidisciplinary framework directive on occupational safety and health 89/391/EEC was enacted in 1989 for the working environment with the following directives:
Workplace requirements directive 89/654/EEC
Use of work equipment 89/655/EEC
Manual handling of loads 90/269/EEC
Biological agents at work 90/679/EEC
Safety and/or health signs 92/58/EEC
Construction products (89/106/EEC, superseded by the EU Construction Products Regulation 305/2011 from 1 July 2013)
Construction products refers to products that are permanently integrated in structures built above or below ground, e.g. building materials and components, systems and equipment and their components for heating, air-conditioning, ventilation, sanitary purposes, electrical supply, storage of environmentally hazardous substances as well as prefabricated structures sold as such, e.g. prefabricated housing, prefabricated garages and silos.
Designated bodies assume the duties mandated in the directives for the conformity assessment procedure if it is deemed necessary to appoint a neutral body. This is the case for e.g. medical products and for many types of machine. Designated bodies are appointed nationally by the European Commission in a “naming procedure”. A directory listing all designated bodies is included in our CE-CON Safety software.
Operating instructions form part of a machine’s technical documentation and must be compiled in the local language. The following information must be included as a minimum requirement:
Workstations that can be occupied by maintenance personnel;
Information sufficient to ensure the hazard-free performance of maintenance, usage, handling etc.;
Personnel induction information if necessary;
Essential properties of tools that can be attached to the machine if necessary.
The instructions must provide information on improper use if necessary.
Possible operating states of the machine include standard operation, i.e. the machine performs the designated function. A deviation from this state may apply if the machine fails to perform its designated function, i.e. malfunctions, for various reasons. Reasons can include, for instance:
A change to the properties or dimensions of the material processed or workpiece;
The failure of one (or more) of its components or supply instruments;
Disruption from an external source (e.g. impacts, vibration, electromagnetic interference);
Structural faults or deficiencies (e.g. software bugs);
Interruption of energy supply;
Environmental conditions (e.g. damaged flooring);
Accidental actions on the part of operating personnel or reasonably foreseeable misuse of the machine, e.g.:
Loss of control of the machine by operating personnel (particularly with hand-held or moving machinery);
Knee-jerk reactions by personnel in the case of malfunction, interruption or failure while the machine is in use;
Actions due to a lack of concentration or attentiveness;
Actions due to taking the easiest option when handling a task;
Actions due to pressure to keep the machine operating under all circumstances;
Actions by specific persons (e.g. children, disabled persons).
This term is defined in machinery directive 2006/42/EC under article 2 (j). This is defined as any natural person or legal entity local to the community that has been authorised by the manufacturer in writing to fulfil, in its name, some or all of the duties and formalities that are associated with this directive.
The list of harmonised standards according to the machinery directive published in the Official Journal of the EC is divided into three types of standards: types A, B and C. Type A represents basic standards, i.e. standards that are applicable to all products governed by the machinery directive. Standards of type B are applicable to a group of machines and deal with general topics such as options to prevent crushing hazards. Standards of type C, by contrast, define more closely the protection targets of the machinery directive for very specific types of machines. Only one A standard, EN ISO 12100:2010, currently deals with the creation of a risk assessment.
The CE marking declares “that the product satisfies the applicable requirements defined in the harmonisation legislation of the European Community governing its attachment.” The CE marking is an administrative mark that documents that the product has been subject to the provisions harmonised in the EU.
Associations founded according to Belgian civil law:
CEN (Comité Européen de Normalisation)
CENELEC (Comité Européen de Normalisation Electronique)
The list of harmonised standards according to the machinery directive published in the Official Journal of the EC is divided into three types of standards: types A, B and C. Type A represents basic standards, i.e. standards that are applicable to all products governed by the machinery directive. Currently only one A standard exists that deals with the creation of a risk assessment. C standards define more closely the protection targets of the machinery directive for very specific types of machines, e.g. sawing machines for the cold working of metal. Standards of type B, by contrast, are applicable to a group of machines and deal with general topics such as preventing access to danger areas.
Documentation according to EN ISO 12100:2010
Documentation on risk assessment must illustrate the applied procedure and the results achieved. This documentation comprises, if relevant:
Specifications, thresholds, intended usage of the machine
All underlying assumptions such as loads, strengths, safety assessments
All information produced and identified during the iterative process for risk analysis.
The results of the risk assessment, and of all forms completed along the way.
EC declaration of conformity
The EC declaration of conformity according to machinery directive 2006/42/EC appendix IIA, 1.) must contain the following information:
− Name and address of the manufacturer or of its authorised person established in the community (2);
− Description of the machine (3);
− All relevant provisions with which the machine complies;
− If applicable, the name and address of the reported body and number of the EC type examination certificate;
− If applicable, the name and address of the reported body to which the documentation was transmitted according to article 8 para. 2 (c), first indent;
− If applicable, the name and address of the reported body that performed the review according to article 8 para. 2 (c), second indent;
− If applicable, the sources of the harmonised standards;
− If applicable, national technical standards and specifications that were applied;
− Information on the signatory that is authorised to sign the declaration with legal effect on behalf of the manufacturer or of its authorised person established in the community.
The following hazards must be considered in the construction of machinery:
Hazards due to noise
Hazards due to vibration
Hazards due to radiation
Hazards due to materials and substances
Hazards due to neglect of ergonomic principles in the construction of machinery
Hazards due to slipping, tripping, falling
Combinations of hazards
Hazard analysis and risk assessment
Quotation from notes on appendix I of machinery directive:
“The manufacturer of a machine or its authorised person must ensure that a risk assessment is performed in order to determine the safety and health protection requirements applicable
to the machine. The machine must then be designed and built in due consideration of the results of the risk
The performance of a risk assessment is mandatory!
All hazards must be identified!
Design and construction of the machine should not be commenced until the hazards have been determined.
A danger area is the point of origin of a hazard. A danger area is the point of origin of a mechanical hazard. A danger area is where an accident occurs. “An accident is understood to mean the spatial coincidence of a person with hazardous movements in connection with a danger area.”
Adherence to specific limits must be verified as part of the risk assessment. These include usage limits, spatial limits and time limits.
Standards are deemed to be harmonised if produced under a mandate of the European Commission by institutions under private law and published in the Official Journal of the EC.
85A/B standards, 245C standards for machines and 100 other C standards. Household electric refrigerators, freezers (96/57/EC)
“Manufacturer” means any natural or legal person who designs and/or manufactures machinery or partly completed machinery covered by this directive and is responsible for the conformity of the machinery or the partly completed machinery with this directive with a view to it being placed on the market, under his/her own name or trademark or for his/her own use. In the absence of a manufacturer as defined above, any natural or legal person who places on the market or puts into service machinery or partly completed machinery covered by this directive shall be considered a manufacturer.
A manufacturer declaration was the EC declaration that had to be issued according to the former machinery directive 98/37/EC for incomplete, non-usage-ready machines. According to the new machinery directive 2006/42/EC, an installation declaration must be issued for non-usage-ready machines according to appendix II.
IEC and ISO standards
These standards apply worldwide. Harmonised European standards are being increasingly converted to international standards. This automatically gives them presumption of conformity with the same content.
E.g. DIN EN ISO 12100-1/-2 “Safety of machinery”
E.g. EN ISO 14121 “Risk assessment”
Category signifies the design of a safety related protective function. The various design forms are described in EN ISO 13849-1. Together with component data, this allows conclusions to be drawn concerning the “performance level” of a safety function.
Declaration of conformity
The EC declaration of conformity is issued by the manufacturer of a complete machine and must contain the following information according to EC machinery directive 2006/42/EC appendix IIA:
Name and address of the manufacturer or of its authorised person established in the community (2);
Description of the machine (3);
All relevant provisions with which the machine complies;
If applicable, the name and address of the reported body and number of the EC type examination certificate;
If applicable, the name and address of the reported body to which the documentation was transmitted according to article 8 para. 2 (c), first indent;
If applicable, the name and address of the reported body that performed the review according to article 8 para. 2 (c), second indent;
If applicable, the sources of the harmonised standards;
If applicable, national technical standards and specifications that were applied;
Information on the signatory that is authorised to sign the declaration with legal effect on behalf of the manufacturer or of its authorised person established in the community.
A machine passes through various life phases over the course of its full service life, in which accidents can happen through human intervention:
Transport, assembly and installation;
Setup, teach-in / programming or conversion;
Decommissioning, disassembly and, where safety is concerned, disposal.
As defined by machinery directive 2006/42/EC, the term “machine” designates the products listed in “article 1 para. 1 (a) to (f)”.
The term is more closely defined, however, in article 2 (a):
• an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application;
• an assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion;
• an assembly referred to in the first and second indents, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure;
• assemblies of machinery referred to in the first, second and third indents or partly completed machinery
referred to in point (g) which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole;
• an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort;
Standards are documents that are produced by consensus with the collaboration of interested parties.
Standards are not considered the current state of scientific knowledge or technology as defined by the German Law on Liability for Defective Products (PrdHG)!
Definition according to standard EN 13849-1: “Discreet level that specifies the capability of the safety-related parts of a controller to perform a safety function under predictable conditions.”
In other words, this means that the Performance Level (PL) indicates how reliable a safety function is.
Prospective hazard determination
Prospective means the predictive determination of possible hazards and the associated creation of the corresponding documentation.
RAPEX stands for Rapid Exchange of Information System and was launched by the EU as a rapid alert system for consumer protection. Via this system, information concerning hazardous or potentially hazardous consumer goods is made available from EU member states, with the exception of foodstuffs, medicines and pharmaceutical products. The system allows for EU-wide information sharing with the aim of facilitating rapid product recalls. RAPEX has been established based on product safety directive 2001/95/EC (RaPS).
Retrospective hazard determination
Retrospective means the subsequent determination of hazards that are systematically identified on the basis of incidents such as accidents, work-related illnesses and work-related damage to health.
(Product observation as manufacturer obligation according to German Product Safety Act (ProdSG))
Directives define minimum requirements that machine manufacturers must consider for their products. These include e.g. the following directives: Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, EMC Directive 2014/30/EU, Gas Appliances Directive 2009/142/EC, Product Safety 2001/95/ EC and others
According to EN ISO 13849-2, the purpose of validation is to confirm the definitions and standard of the safety-related parts of controllers.
A validation plan describes the requirements for performing validation of the defined safety functions.
Validation must be documented with the following documents:
Drawings, construction documents
If a machine is modified, the question arises as to whether or not the change is considered significant. The German Federal Ministry of Labour and Social Affairs (BMAS) issued guidelines in this respect on 9 April 2015.
If the change is classified as a significant modification, the modified machine is to be regarded as a new machine and the CE certification process must be undertaken according to the machinery directive. If the modification is not significant, the change must be documented in accordance with German industrial safety legislation and the German Ordinance on Industrial Safety and Health. Read more about this in our “Machine life cycle” white paper
Certification process signifies the structured and progressive, iterative procedure to achieve the applicable Europe-wide safety standard. There are seven stages to the certification process:
1. Investigation of directives
2. Investigation of standards
3. Hazard analysis and risk assessment
4. Constructive implementation of targets from 3.)
5. Design and construction of machine
6. Checking and determining compliance with the machinery directive
7. Creation of technical documentation, issue of manufacturer declaration or declaration of conformity