Directives and Standards

Directives and standards are of great importance for manufacturers of machines and safety components. EU Directives giving requirements for the minimum level of health and safety are mandatory for manufacturers to fulfill. In every member country the Directives are implemented in that country's legislature.

The objectives of the Machinery Directive, 98/37/EC, are to maintain, increase and equalize the safety level of machines within the members of the European Community. Based on this, the free movement of machines/products between the countries in this market can be achieved. The Machinery Directive is developed according to "The New Approach" which is based on the following principles.

Harmonized Standards

Harmonized standards give support on how to fulfill the requirements of the Machinery Directive. The relationship between the Machinery Directive and the Harmonized standards is illustrated by the diagram below.

Within ISO (The International Organization for Standardization) work is also going on in order to harmonize the safety standards globally in parallel with the european standardization work. One consequence of this is that many existing EN-standards will, when revised, change number. For example, EN 954-1 will- when revised-change number to EN ISO 13849-1.

JOKAB SAFETY takes an active part in the working groups both for the ISO and EN standards.

98/37/EC

Giving basic concepts, principles for design and general aspects that can be applied to all machinery.

B1: Standards on particular safety aspects (e.g. safety distances, surface temperature, noise)

B2: Standards on safeguards, e.g. two-hand controls, interlocking devices, pressure sensitive devices, guards)

Dealing with detailed safety requirements for a particular machine or group of machines.

The Machinery Directive for Machines and Safety Components

From the Machinery Directive 98/37/EC

2. For the purposes of this Directive:

(a) ‘machinery’ means:

- an assembly of linked parts or components, at least one of which moves, with the appropriate actuators, control and power circuits, etc., joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material

- an assembly of machines which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole

- interchangeable equipment modifying the function of a machine, which is placed on the market for the purpose of being assembled with a machine or a series of different machines or with a tractor by the operator himself in so far as this equipment is not a spare part or a tool.

The definition of a machine can cover everything from hand-held portable machines to production lines. There are exclusions- e.g. machinery for medical use used in direct contact with patients, means of transport, i.e. vehicles and their trailers intended solely for transporting passengers and agricultural and forestry tractors.

The Machinery Directive is valid also for

2. ...‘safety components’ means:

- a component, provided that it is not interchangeable equipment, which the manufacturer or his authorized representative established in the Community places on the market to fulfill a safety function when in use and the failure or malfunctioning of which endangers the safety or health of exposed persons.

Safety components are e.g. light curtains, safety relays and safety PLCs.

CE-Marking and Declaration of Conformity

Machines manufactured or put on the market from January 1, 1995 shall be CE-marked and fulfill the requirements according to the Machinery Directive 98/37/EC. This is also valid for old machines (manufactured before January 1, 1995) if they are manufactured in a country outside the EEA and imported to be used in a country in the EEA.

Note: The point in time when the Machinery Directive was implemented in each Member Country varies. Machines have to be accompanied by a Declaration of Conformity (according to 98/37/EC, Annex IIA) that states which directive and standards the machine fulfills. It also shows if the product has gone through EC Type Examination.

Safety components have to be accompanied with a Declaration of Conformity (according to 98/37/EC, annex IIC). According to the requirements in the Machinery Directive, safety components should not be CE-marked. But many safety components fall under the requirements in other directives such as the Low Voltage Directive and the EMC Directive that require CE-marking. This means that a CE-mark will anyway be found on most safety components.

Requirements for the Use of Machinery

For a machine to be safe it is not enough that the manufacturer has been fulfilling all valid/necessary requirements. the user of the machine also has requirements to fulfill. for the use of machinery there is a Directive, 89/655/EEC (with amendment 96/63/EC).

About CE-marked machinery the Directive gives the following requirement:

From the Machinery Directive 89/655/EEC
(with Amendment 96/63/EC)

1. Without prejudice to Article 3, the employer must obtain and/or use:

(a) work equipment which, if provided to workers in the undertaking and/or establishment for the first time after December 31, 1992, complies with:

(i) the provisions of any relevant Community directive which is applicable

(ii) the minimum requirements laid down in Annex I, to the extent that no other Community directive is applicable or is so only partially

This means that when repair/changes are made on the machine it shall still fulfill the requirements of the Machinery Directive. this doesn’t have to mean that a new CE-marking is required. (Can be required if the changes are extensive.)

“Old” Machines

For machines delivered or manufactured in the EEA before January 1, 1995 the following is valid.

(b) work equipment which, if already provided to workers in the undertaking and/or establishment by December 31, 1992, complies with the minimum requirements laid down in Annex I no later than four years after that date.

(c) without prejudice to point (a)(i), and not with standing point (a)(ii) and point (b), specific work equipment subject to the requirements of point 3 of annex I, which, if already provided to workers in the undertaking and/or establishment by December 5, 1998, complies with the minimum requirements laid down in Annex I, no later than four years after that date.

Annex I contains minimum requirements for health and safety. There can also be additional national specific requirements for certain machines. NB the point in time when the Machinery directive was implemented in each Member Country varies. Therefore, it is necessary to check with the national authorities in one’s own country to find out what is considered as “old” and respectively “new” machines.

"Old" Machines

"New"Machines

Risk Assessment - An important tool when constructing a new machine and when assessing risks on older machines.

A well thought-out risk assessment supports manufacturers/users of machines to develop production friendly safety solutions. One result of this is that the safety components will not be a hindrance. This minimizes the risk of the safety system being defeated.

New Machines

The following requirement is given by the Machinery Directive:

The manufacturer is under an obligation to assess the hazards in order to identify all of those which apply to his machine; he must then design and construct it taking account of his assessment.

The standard EN 1050 gives guidance on the information required to allow risk assessment to be carried out. the standard does not point out a specific method to be used. It is the responsibility of the manufacturer to select a suitable method.

Machines in Use

Risk assessment must be carried out on all machines that are in use; CE-marked as well as not CE-marked:

To fulfill the requirements from Directive 89/655/EEC (concerning the minimum safety and health requirements for the use of work equipment by workers at work) risk assessment has to be made.

Documentation of Risk Assessment

The risk assessment shall be documented. In the assessment the actual risks shall be analyzed as well as the level of seriousness.

Protection or Warning

How is it possible to choose safety measures that are production friendly and in every way well balanced? The Machinery Directive gives an order of priority for the choice of appropriate methods to remove the risks. Here it is further developed in a 5-step method.

The further from the middle of the circle, the greater the responsibility for the safety is put onto the user of the machine. If full protection is not effectively achieved in one step, one has to go to the next step and find complementary measures.

What is possible is dependent on the need for accessibility, the seriousness of the risk, appropriate safety measures, etc.

5-Step Method to Prioritize Safety Measures

1. Eliminate or reduce risks by design and construction.
2. Move the work tasks outside the risk area.
3. Use guards/safety devices.
4. Develop safe working routines, information, education
5. Use warnings as pictograms, light, sound, etc.

Example of Prioritizing according to the 5-Step Method

Combine the 5-Step Method with Production Friendly Thinking

The possibilities will increase to achieve a well thought-through safety system if each risk is handled according the described prioritizing. This can give you:

• Fast and easy restart of machines after a stop from a safety device
• Enough space to safely program a robot
• Places outside the risk area to observe the production

• Electrically interlocked doors, instead of guards attached with screws, to be able to take the necessary measures for removing production disturbances
• A safety system that is practical for all types of work tasks, even when removing production disturbances