Terminology directory

The terminology directory provides a comprehensive collection of terms, expressions and abbreviations used in the context of CE-CON Safety. It serves to ensure the uniform use and definition of terms.

Term	Description
Project	A project refers to the phase in which a product is designed, manufactured, or modified. During the project, the legal requirements are determined, such as whether a product is intended for the European market. There are different types of projects that have different goals.
Product	The product is the actual object of consideration that is processed with the software. When all projects for a product are completed, an end product is created that fulfills the relevant legal requirements for the respective market. Difference between project and product A project refers to the activity of designing or testing a product. The type of project determines, among other things, the legal framework and the documents to be created. The product itself is the final result of the process, which is available on the market and must meet the requirements of the respective project. It is possible that multiple projects are performed for a single product. Similarly, later tests represent separate projects for the same product.
Component	A component represents a specific part or group of parts within your product. These parts can be considered as a whole or as separate units, depending on how they are structurally and functionally integrated into the overall product. For example, a gearbox can be considered a component that consists of a housing and two shafts. Each shaft can then be considered a separate component that consists of the shaft itself and several gears. This detailed capture enables a comprehensive analysis and evaluation of the individual parts in the context of the overall product.
Danger point	A product typically harbors hazards that originate from specific points - the danger points. A danger point can simultaneously affect multiple components and can be the source of hazards of different kinds. Differences between component and danger points Components describe the structure of a product, while danger points describe where a hazard can occur. Components build a hierarchical structure, where each component can consist of further subcomponents. A danger point can be defined on a single component, but can also be located at the transition between two or more components and then be linked to several components. The linking of multiple components does not build on a hierarchy.
Hazard	A hazard is defined as a potential source of harm. Furthermore, a distinction is made between relevant and significant hazards. Relevant hazards are those that originate from a machine. Significant hazards are addressed with corresponding measures to reduce the risk.
Measure	A measure refers to a specific action or step taken to reduce or eliminate the risk associated with an identified hazard. Measures may include, for example, adjusting work processes, using personal protective equipment, installing safety devices, or training employees.
Risk assessment	A risk assessment is a structured process aimed at systematically identifying, evaluating and implementing measures to reduce potential hazards emanating from a machine or installation. The goal of this process is to reduce the identified risks to an acceptable level, ensuring the safety and health of operators and other parties involved and compliance with legal requirements and standards.
Type-A standard	The harmonized list of standards of the Machinery Directive in the EC is divided into the types A, B and C. Type A comprises basic standards that are applicable to all products under the Directive. Type B applies to a group of machines, while type C specifies the safety objectives for specific types of machinery. An example of type A is the EN ISO 12100:2010 standard, which deals with risk assessment.
Occupational safety	In 1989, the interdisciplinary Occupational Health and Safety Framework Directive 89/391/EEC was issued for the working environment. This resulted in the following directives: Workplace Directive 89/654/EEC, Use of Work Equipment 89/655/EEC, Handling of Heavy Loads 90/269/EEC, Carcinogenic Substances 90/394/EEC, Biological Agents 90/679/EEC and Health and Safety Signs 92/58/EC.
Construction products (89/106/EEC, replaced by the EU Construction Products Regulation 305/2011 as of July 1, 2013)	Construction products are products that are permanently incorporated into civil engineering works. These include building materials, building components, installations for heating, air conditioning, ventilation, sanitary purposes, electrical supply, storage of environmentally hazardous substances and prefabricated structures such as prefabricated houses, prefabricated garages and silos.
Notified Body	A Notified Bodies takes on tasks for conformity assessment procedures in accordance with directives if a neutral body is required, e.g., for medical devices and many machines. The European Commission designates these bodies nationally, in the so-called designation procedure. A list of all Notified Bodies is available in our CE-CON Safety software.
Instruction manual	The instruction manual are part of the technical documentation for machinery and must be written in the national language. They must contain the machine identification, intended use, workplaces of the operating personnel, safe maintenance, use and handling and, if applicable, instructions for familiarization and the main features of the tools. The instruction manual must also warn against improper use, if applicable.
Operating condition	The possible operating conditions of a machine include normal operation, in which the machine functions as intended, as well as deviations from this if the machine fails for various reasons. Reasons for deviations can be: changes in material or workpiece, component failure, external faults, design faults, power supply faults, environmental conditions and unintentional behavior by the operator. This can be caused, for example, by loss of control, reflexive behavior, carelessness, pressure to keep the machine running or the behavior of specific persons, such as, children or disabled persons.
Authorized Representative	The term is defined in the Machinery Directive 2006/42/EC under Article 2, letter j. It means any natural or legal person established within the Community who has been authorized in writing by the manufacturer to act on his behalf in relation to all or part of the obligations and formalities imposed by this Directive.
Type-B standard	The harmonized list of standards according to the EC Machinery Directive is divided into types A, B and C. Type A comprises basic standards that are applicable to all products under the directive. Type B applies to a group of machines and deals with general topics such as the prevention of crushing hazards. Type-C standards specify the safety objectives for specific types of machinery. There is currently exactly one type-A standard, EN ISO 12100:2010, which deals with the preparation of a risk assessment.
CE marking	The CE marking confirms that the product complies with the applicable requirements in accordance with EU harmonization legislation. It documents that the product has been subjected to the harmonized regulations of the EU.
CEN/CENELEC	The CEN (Comité Européen de Normalisation) and CENELEC (Comité Européen de Normalisation Electronique) associations are established under Belgian civil law.
Type-C standard	The harmonized list of standards according to the EC Machinery Directive is divided into types A, B and C. Type A comprises basic standards that are applicable to all products under the directive. There is currently only one type-A standard, which deals with the preparation of risk assessments. Type-C standards specify the safety objectives for specific types of machinery, such as sawing machines for cold metalworking. Type-B standards deal with general topics, such as how to avoid reaching danger points, and are applicable to a group of machines.
Documentation according to EN ISO 12100:2010	The risk assessment documentation must describe the process used and the results achieved. This includes specifications, limits, intended use of the machine, underlying assumptions, such as, loads, strengths, safety assessments and all information provided and identified during the risk analysis process. The result of the risk assessment and all completed forms must also be included.
Three-step procedure	During the risk assessment, risk-reducing protective measures are defined. The protective measures should be selected according to the three-step procedure: Stage 1: Measures of the inherently safe design type that can already be taken during and exclusively during design. Stage 2: Technical protective measures and/or supplementary protective measures that are applied externally to a product. Stage 3: User information, such as pictograms, personal protective equipment and instructions in the instruction manual.
EC Declaration of Conformity	The EC Declaration of Conformity according to MRL 2006/42/EC Annex IIA, 1. must contain the following information: Company name and full address of the manufacturer and, where applicable, his Authorized Representative Name and address of the person authorized to compile the technical documentation; that person must be established in the Community a description and identification of the machinery, including the general designation, function, model, type, serial number and commercial description an explicit declaration that the machinery complies with all the relevant provisions of this Directive and, where appropriate, a similar declaration for other Directives and/or relevant provisions with which the machinery complies the name, address and identification number of the Notified Body that carried out the EC type-examination procedure referred to in Annex IX, and the number of the EC type-examination certificate, if applicable the name, address and identification number of the Notified Body that approved the full quality assurance system referred to in Annex X, if applicable the references of the harmonized standards referred to in Article 7(2) applied, if applicable the references of the other technical standards and specifications applied, if applicable the place and date of the declaration the details of the authorized person and his signature .
Declaration of Incorporation	In contrast to the declaration of conformity, the manufacturer of partly completed machinery must submit a “Declaration of Incorporation of partly completed machinery”. This declaration must contain the following information: company name and full address of the manufacturer of the partly completed machinery and, where applicable, of his authorized representative name and address of the person authorized to compile the relevant technical file; this person must be established in the Community a description and identification of the partly completed machinery, including the generic name, function, model, type, serial number and commercial description a statement of the essential requirements of this Directive that apply and are met, a statement that the relevant technical documentation has been drawn up in accordance with Annex VII, Part B, and, where appropriate, a statement that the partly completed machinery complies with other relevant Directives. The references as published in the Official Journal of the European Union shall be indicated The obligation to provide national bodies with the specific documentation relating to the partly completed machinery upon reasoned request. This obligation must also specify how the documentation will be transmitted; without prejudice to the industrial property rights of the manufacturer of the partly completed machinery an indication that the partly completed machinery may not be put into service until the machinery into which the partly completed machinery is to be incorporated has been declared in conformity with the provisions of this Directive the place and date of the declaration the identity and signature of the person empowered to make the declaration on behalf of the manufacturer or his authorized representative .
Functional safety	Protective measures that have an influence on the function of a product when actuated or triggered are often referred to as functional safety. These include light grids, safety mats, two-hand controls or similar devices that stop or reverse dangerous movements in a safety-oriented manner.
Hazard analysis and risk assessment	The quote from the preliminary notes to Annex I of the Machinery Directive states that the manufacturer or his Authorized Representative must ensure that a risk assessment is carried out to determine the applicable health and safety requirements for the machinery. The machinery must then be designed and constructed taking into account the results of the risk assessment. This means that carrying out a risk assessment is mandatory and all hazards must be identified before the design and construction of the machinery begins.
Limits	As part of the risk assessment, compliance with certain limits must be checked, including the limits of use, spatial limits and time limits.
Harmonized standards	Standards are considered harmonized if they have been drawn up by private-law institutions under a mandate from the European Commission and published in the Official Journal of the European Union. There are 85 type-A/type-B standards and 245 type-C standards for machinery, as well as 100 other type-C standards. Specific standards apply to household refrigerators and freezers (96/57/EC).
Manufacturer	Manufacturer means any natural or legal person who designs and/or constructs machinery or partly completed machinery covered by this Directive and is responsible for the conformity of the machinery or partly completed machinery with this Directive with regard to marketing the product under their own name or their own trademark or for their own use. In the absence of a manufacturer within the meaning of this definition, 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 to be a manufacturer.
Manufacturer's Declaration	The Manufacturer's Declaration was the EC declaration under the old Machinery Directive 98/37/EC for partly completed machinery not ready for use. According to the new Machinery Directive 2006/42/EC, a Declaration of Incorporation must be issued for machinery that is not ready for use in accordance with Annex II.
IEC and ISO standards	These standards apply worldwide. More and more European harmonized standards are being converted into international standards. If they have the same content, they automatically have a presumption of conformity. An example of this are the standards DIN EN ISO 12100-1/-2 “Safety of machinery” and EN ISO 14121 “Risk assessment”.
Category	Category is the design of a safety-related protective function. The various designs are described in EN ISO 13849-1. Together with component data, conclusions can be drawn about the so-called performance level of a safety function.
Declaration of Conformity	In accordance with the EC Machinery Directive 2006/42/EC Annex IIA, the EC Declaration of Conformity issued by the manufacturer of a complete machine must contain the following information: the name and address of the manufacturer or his authorized representative established in the Community a description of the machinery all the relevant provisions that the machinery complies with where applicable, the name and address of the Notified Body and the number of the EC type-examination certificate where applicable, the name and address of the Notified Body to which the documents referred to in the first indent of Article 8 (2) (c) have been sent where applicable, the name and address of the Notified Body that carried out the verification referred to in the second indent of Article 8(2)(c) Where applicable, the references of the harmonized standards Where applicable, the national technical standards and specifications that have been applied Details of the signatory authorized to sign the declaration on behalf of the manufacturer or his Authorized Representative established within the Community.
Life stages	Throughout its lifetime, machinery passes through various phases during which accidents may occur as a result of human intervention: Manufacture Transportation, assembly and installation Putting into service Use: Set-up, teaching / programming or retooling Operation Cleaning Troubleshooting Maintenance Decommissioning, disassembly and, if safety is affected, disposal
Machine	According to the Machinery Directive 2006/42/EC, the term “machinery” refers to the products listed in “Article 1(1)(a) to (f)”. Article 2 (a) defines the term more precisely: An assembly of linked parts or components, at least one of which is movable and which are joined together for a specific application. An assembly which lacks only the parts connecting it to its place of use or to its sources of power and propulsion. A ready-to-install assembly which is functional only after being mounted on a means of transport or installed in a building or structure. An assembly of machinery or partly completed machinery which, in order to work together, is arranged and operated so as to function as a unit. An assembly of linked parts or devices, at least one of which is movable and which are joined together for lifting operations and whose sole source of power is directly applied human power.
Standard	Standards are documents that have been developed by consensus with the participation of interested parties. They reflect the prevailing professional opinion and are therefore considered to be generally recognized rules of technology. However, it is important to note that standards are not considered to be the state of the art in science and technology within the meaning of the Product Liability Act.
Performance Level	The definition according to standard EN 13849-1 is: “Discrete level that specifies the ability of safety-related parts of a control system to perform a safety function under foreseeable conditions.” In simpler terms, this means that the Performance Level (PL) indicates how reliable a safety function is.
Prospective risk assessment	Prospective refers to the forward-looking determination of possible hazards and the creation of corresponding documentation.
Retrospective risk assessment	Retrospective refers to the retrospective recording of hazards that are systematically determined on the basis of incidents such as accidents, occupational illnesses and work-related health hazards. This also includes product monitoring as a manufacturer obligation in accordance with the Product Liablity Act.
RAPEX List	RAPEX stands for Rapid Exchange of Information System and was set up by the EU as a rapid alert system for consumer protection. This system provides information from the EU member states on dangerous or potentially dangerous consumer goods, with the exception of food, medicines or pharmaceutical products. This enables an EU-wide exchange of information with the aim of rapid recall actions. The basis for the establishment of RAPEX is the Product Safety Directive 2001/95/EC (GPSD).
Directives	Directives define minimum requirements that machine manufacturers must take into account for their products. These include, for example, the Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, EMC Directive 2014/30/EU, Gas Appliances Directive 2009/142/EC, Product Safety Directive 2001/95/EC, and others.
Validation	According to EN ISO 13849-2, the purpose of validation is to confirm the specifications and levels of the safety-related parts of the control systems.
Validation plan	A validation plan describes the requirements for carrying out the validation of the specified safety functions. The validation must be documented with the following documents: Specifications, drawings, design documents, block diagrams and failure analysis.
Significant change	When a machine is modified, the question arises as to whether the change is significant or not. The German Federal Ministry of Labor and Social Affairs (BMAS) published a guideline on this on 2015-04-09. If it is a substantial modification, the modified machine must be treated as a new machine and the CE certification procedure must be carried out in accordance with the Machinery Directive. If the change is not substantial, the change must be documented in accordance with occupational health and safety law and the Ordinance on Industrial Safety and Health. Further information can be found in our white paper “Machine life cycle”.
Certification procedure	The certification procedure is the structured, step-by-step, iterative procedure for achieving the safety standard applicable throughout Europe. The seven steps of the certification procedure include: Research in directives Research in standards Hazard analysis and risk assessment Constructive implementation of the objectives from step 3 Design and construction of the machine Check of and declaration of compliance with the Machinery Directive Drafting of the technical documentation and issuing of the Manufacturer's Declaration or Declaration of Conformity.