2006/42/EC Machinery Directive Requirements
Machinery Directive is a wide ranging document and applies to the following products;
- machinery;
- interchangeable equipment;
- safety components;
- lifting accessories;
- chains, ropes and webbing;
- removable mechanical transmission devices;
- partly completed machinery.
- safety components intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery;
- specific equipment for use in fairgrounds and/or amusement parks;
- machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity;
- weapons, including firearms;
- the following means of transport:
- — agricultural and forestry tractors for the risks covered by Directive 2003/37/EC, with the exclusion of machinery mounted on these vehicles,
- — motor vehicles and their trailers covered by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers (1), with the exclusion of machinery mounted on these vehicles,
- — vehicles covered by Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles (2), with the exclusion of machinery mounted on these vehicles,
- — motor vehicles exclusively intended for competition, and
- — means of transport by air, on water and on rail networks with the exclusion of machinery mounted on these means of transport;
- seagoing vessels and mobile offshore units and machinery installed on board such vessels and/or units;
- machinery specially designed and constructed for military or police purposes;
- machinery specially designed and constructed for research purposes for temporary use in laboratories;
- mine winding gear;
- machinery intended to move performers during artistic performances;
- electrical and electronic products falling within the following areas, insofar as they are covered by Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (3):
- — household appliances intended for domestic use,
- — audio and video equipment,
- - information technology equipment,
- - ordinary office machinery,
- — low-voltage switchgear and control gear,
- — electric motors;
- the following types of high-voltage electrical equipment:
- — switch gear and control gear,
- — transformers.
Machinery means:
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;
To comply with 2006/42/EC, the following standards are typically applied;
EN ISO 12100:2010 – Safety of Machinery – General requirements for design – Risk Assessment & Risk Reduction
This International Standard specifies basic terminology, principles and a methodology for achieving safety in the design of machinery. It specifies principles of risk assessment and risk reduction to help designers in achieving this objective. These principles are based on knowledge and experience of the design, use, incidents, accidents and risks associated with machinery. Procedures are described for identifying hazards and estimating and evaluating risks during relevant phases of the machine life cycle, and for the elimination of hazards or the provision of sufficient risk reduction. Guidance is given on the documentation and verification of the risk assessment and risk reduction process.
This International Standard is also intended to be used as a basis for the preparation of type-B or type-C safety standards.
This is the only TYPE A standard quoted in the Machinery Directive Harmonized Standard List. This standard specifies the principles of risk assessment and identifies hazards that must be considered.However it does not specify how to conduct a risk assessment and the potential pitfalls to avoid. It only considers potential injury to the operator and persons in and around the machine. Risk Assessment is mandatory for each machine.
To conduct a successful risk assessment another non-harmonized standard; ISO/TR 14121-2:2012 - Safety of machinery -- Risk assessment -- Part 2: Practical guidance and examples of methods, details a number of methods that could be used to conduct the mandatory risk assessment.
n order to correctly risk assess a machine it is necessary to consider the use of other TYPE B or TYPE C Harmonized Standards to justify the acceptable risk.
The risk assessment is the fundamental document that demonstrates compliance with the Machinery Directive.
To mitigate the risks identified by the risk assessment, a number of Type B standards would be used to demonstrate that the risk had been reduced to an acceptable level. The use of EU Harmonized standards would be the most appropriate route, the EU is in agreement and has published the standards to address specific risk reduction philosophies.
The application of the standard must be in full, with all clauses being covered. It is never appropriate to “cherry pick” a standard and only apply agreeable clauses.
Electrical Risks
EN 60204-1:2018 - Safety of machinery - Electrical equipment of machines - Part 1: General requirements
If you manufacture a machine, this is the electrical safety standard to use form the harmonized standards list for Machinery Directive.
This part of IEC 60204 is applicable to the electrical equipment or parts of the electrical equipment that operate with nominal supply voltages not exceeding 1 000 V for alternating current (AC) and not exceeding 1 500 V for direct current (DC), and with nominal supply frequencies not exceeding 200 Hz.
The coverage area deals with more than strictly the electrical/electronic circuit. Button labels, Functional safety, Emergency Stop function, Marking etc. It does reference the other EN standards for detail.
This standard also has mandatory test requirement for each and every machine, therefore a test results/report is required.
EN60204 has been updated to be very similar to NFPA 79 (wiring regulations for machines in the USA). Both standards have the same (EN 60204) content format but differ in some of the clauses. It is not possible to say that NFPA 79 compliance meets the requirements of EN60204.
Guarding
EN ISO 13857 – Safety of Machinery – Safety Distances to prevent hazard zones being reached by upper and lower limbs
This International Standard establishes values for safety distances in both industrial and non-industrial environments to prevent machinery hazard zones being reached. The safety distances are appropriate for protective structures. It also gives information about distances to impede free access by the lower limbs.
The distances apply when adequate safety can be achieved by distance alone. Because safety distances depend on size, there will be some people of extreme dimensions who will be able to reach hazard zones even when the requirements of this International Standard are complied with.
This international standard publishes tables that determine the height and separation distances of guarding structures. It also determines the maximum gap size dependent on separation distance.
As an international standard under the “ISO” banner, it is now the appropriate standard for all markets including North America.
It is very easy to apply during an audit. A large proportion of North American manufacturers fail to meet this standard and need modifications.
Type of Guard
EN ISO 14120:2015 – Safety of Machinery – Guards – General requirements for the design and construction of fixed and movable guards
This International Standard specifies general requirements for the design, construction, and selection of guards provided to protect persons from mechanical hazards.
The appropriate guard for use in specified situations. A few instances of applying the wrong type of guard has been experienced in the past. Measures you MUST use when attaching guards to your machine.
Interlocks and safeguarding
EN ISO 14119:2013 - Safety of machinery - Interlocking devices associated with guards - Principles for design and selection
This International Standard specifies principles for the design and selection — independent of the nature of the energy source — of interlocking devices associated with guards. This International Standard covers the parts of guards which actuate interlocking devices.
Specifies the type of interlock to be used for specific guarding situations. With four types identified, it is an easy standard to apply using an audit process.
EN ISO 13855:2010 - Safety of machinery - Positioning of protective equipment with respect to the approach speeds of parts of the human body
This International Standard establishes the positioning of safeguards with respect to the approach speeds of parts of the human body. It specifies parameters based on values for approach speeds of parts of the human body and provides a methodology to determine the minimum distances to a hazard zone from the detection zone or from actuating devices of safeguards. The values for approach speeds (walking speed and upper limb movement) in this International Standard are time tested and proven in practical experience. This International Standard gives guidance for typical approaches. Other types of approach, for example running, jumping or falling, are not considered in this International Standard.
This standard considers four different safeguards;
- electro-sensitive protective equipment, including:
light curtains and light grids (AOPDs);
laser scanners (AOPDDRs) and two-dimensional vision systems; - pressure-sensitive protective equipment, especially pressure-sensitive mats;
- two-hand control devices;
- interlocking guards without guard locking.
Safety related Parts of the Control System (SRS/CS)
EN ISO 13849-1:2015 - Safety of machinery - Safety-related parts of control systems - Part 1: General principles for design
This part of ISO 13849 provides safety requirements and guidance on the principles for the design and integration of safety-related parts of control systems (SRP/CS), including the design of software. For these parts of SRP/CS, it specifies characteristics that include the performance level required for carrying out safety functions. It applies to SRP/CS for high demand and continuous mode, regardless of the type of technology and energy used (electrical, hydraulic, pneumatic, mechanical, etc.), for all kinds of machinery.
Details the requirements of the Functional Safety System (SRP/CS) and how to validate the overall performance level of the circuits. In order to complete your Risk Assessment a validation against EN ISO 13849-1 is required.
EN ISO 13850:2015 - Safety of machinery - Emergency stop function - Principles for design
This International Standard specifies functional requirements and design principles for the emergency stop function on machinery, independent of the type of energy used.
Defines different designs and the correct components to use.
Pneumatic System
EN ISO 4414:2010 - Pneumatic fluid power - General rules and safety requirements for systems and their components
This International Standard specifies general rules and safety requirements for pneumatic fluid power systems and components used on machinery as defined by ISO 12100:2010, 3.1. It deals with all significant hazards associated with pneumatic fluid power systems and specifies principles to apply in order to avoid those hazards when the systems are put to their intended use.
Hydraulic System
EN ISO 4413:2010 - Hydraulic fluid power — General rules and safety requirements for systems and their components
This International Standard specifies general rules and safety requirements for hydraulic fluid power systems and components used on machinery as defined by ISO 12100:2010, 3.1. It deals with all significant hazards associated with hydraulic fluid power systems and specifies the principles to apply in order to avoid those hazards when the systems are put to their intended use.
Acoustic Measurements
Section 1.7.4.2 – Contents of the instructions (under point “u”)
the following information on airborne noise emissions:
- the A-weighted emission sound pressure level at workstations, where this exceeds 70 dB(A); where this level does not exceed 70 dB(A), this fact must be indicated,
- the peak C-weighted instantaneous sound pressure value at workstations, where this exceeds 63 Pa (130 dB in relation to 20 μPa),
- the A-weighted sound power level emitted by the machinery, where the A-weighted emission sound pressure level at workstations exceeds 80 dB(A).
These values must be either those actually measured for the machinery in question or those established on the basis of measurements taken for technically comparable machinery which is representative of the machinery to be produced.
It is usually necessary to conduct acoustic measurements of the finished machine (or a machine that is comparable), so the above values can be included in the machine manual. If the measurements exceeds the quoted values, additional ear protection may be advised.
Acoustic measurement requires the use of an integrating sound meter. The necessary equipment is not inexpensive and requires a certain amount of acoustic knowledge to measure the required values correctly.
The above list of standards are an example of the Type B standards that need to be applied. It is not intended to be an exhaustive list, as many more may be applied depending on the machine and its application. It does however represent the most common standards that are applied to the majority of machines.
EU Standards are not the easiest to comprehend, every published standard has a list of Normative References (detailed in part 2 of the standard). Understanding any one applicable EN standard may require reference the one or more of the Normative References.
I would always advise the client to have the latest copy of the main standards in their library. This however is not an inexpensive undertaking, especially if sourced in North America. The most affordable source of “EN” standards is;
This is the Estonia national standard website. EN Standards are approx. a tenth of the cost in North America. Electronic copies can be downloaded immediately, once payment has been made via credit card in Euro. The website supports the English language.