The Design of Technical Equipment*

Executive Order No. 561 of 24 June 1994 with subsequent amendments, issued by the Danish Working Environment Authority – unofficial version

THE COMPILATION OF EXECUTIVE ORDERS comprises the following:
  • No. 561 of 24 June 1994, which entered into force on 1 January 1995;
  • No. 669 of 7 August 1995, which entered into force on 16 August 1995; and
  • No. 831 of 27 November 1998, which entered into force on 5 December 1998.
Pursuant to sections 35(1), 46, 74, 84 and 86 of the Danish Working Environment Act, cf. Consolidated Act No. 184 of 22 March 1995, and as authorised under section 73 of the said Act, it is laid down as follows:

Part 1 – Scope and definitions

1.-(1) This Executive Order shall apply to the design, marking, instructions for use, examination and marketing of technical equipment.

(2) The Executive Order shall not apply to the following, cf. section 3 of the Danish Working Environment Act:
  1. Technical equipment used in aviation, apart from that which is used for work on the ground.
  2. Technical equipment on board ships and fishing vessels. The Executive Order shall, however, apply to
    a) equipment used in loading and unloading, apart from the vessel’s hoisting equipment and other permanently installed equipment; and
    b) equipment used in shipbuilding work on board ships and other equivalent work.
2. For the purposes of this Executive Order, the term “technical equipment” shall mean:
  1. machines, containers, apparatus, tools and any other similar devices that
    a) are used in the processing of a product,
    b) are used in the production of a work result, including transport and storage, or
    c) serve in the performance of a technical process; and
  2. parts of such devices, prefabricated structures, or any other worked object that is intended to be combined with other objects to form a complete unit.
General provisions

3. Technical equipment must be so designed that it does not present a risk to health or safety when installed and maintained in an appropriate manner and used in accordance with its intended purpose.

4. The obligations arising from this Executive Order shall rest upon manufacturers and other suppliers, designers, repairers, etc., as well as employers, company managers, supervisors, other employees, and users, in accordance with the general rules specified in the Danish Working Environment Act, cf. section 2 and Part 4 of the said Act.

Part 2 – CE marked machines and safety components

5. The rules in this Part shall apply to machines and separately marketed safety components as defined and delimited in Annex VIII.

6. When a machine or safety component is required to satisfy the provisions contained in this Part, cf. the second item in Annex VIII, the same shall also apply to its marketing in other Member States.

Construction, manufacture, ancillary equipment and design

7.-(1) The design of machinery and safety components shall satisfy the essential health and safety requirements specified in Annex I.

(2) However, a machine or safety component may be shown at trade fairs, exhibitions, etc., without satisfying subsection (1) hereof provided (a) clear notice(s) is/are displayed stating that the machine or safety component does not satisfy the legal requirements and cannot be acquired before it has been brought into conformity therewith. During demonstrations of its operation, adequate safety measures must have been taken to ensure the protection of persons.

8.-(1) A machine or safety component that is constructed in conformity with a harmonised standard that covers one or more of the requirements referred to in section 7(1) of this Executive Order shall be presumed to comply with the requirements concerned.

(2) For the purposes of this Executive Order, the term “harmonised standard” shall mean a European standard adopted by CEN or CENELEC on the basis of a remit from the Commission, and the reference number of which has been published in the Official Journal of the European Communities. The reference numbers of the Danish standards implementing a harmonised standard are published by the Danish Standards Association.

Marking and instructions for use

9. Every machine or safety component shall bear markings that comply with the requirements set out in Annex I.

10. Every machine or safety component shall be provided with instructions for use that at least satisfy the requirements set out in Annex I. The instructions for use must accompany the individual machine or safety component on delivery.

Documentation etc. for marketing

11.-(1) Before a machine or safety component is placed on the market, the manufacturer or his authorised representative established in the Community shall provide each individual machine or safety component with an EC declaration of conformity in accordance with the rules set out in sections 12-15 of this Executive Order, as evidence that the machine or safety component complies with the requirements set out in Annex I. The declaration of conformity must accompany the machine or safety component on delivery.

(2) Each individual machine shall also be provided with the CE mark in accordance with the rules set out in section 18 of this Executive Order. If the machine is covered by other regulations that prescribe the CE mark, the CE mark shall only be placed on the machine if the machine also satisfies the other regulations.

(3) It shall be incumbent upon any person who markets the machine or safety component to check and if necessary take steps to ensure that the documentation, etc. referred to in subsections (1) and (2) hereof is in order before the machine or safety component is placed on the market. A similar obligation shall apply to any person assembling machinery or parts thereof of various origins or constructing machines for his own use.

EC declaration of conformity

12.-(1) The EC declaration of conformity for a machine shall be drawn up in accordance with part A of Annex II, cf. however subsection (2) hereof.

(2) In the case of a machine that is intended to be incorporated into machinery or assembled with other machinery, the EC declaration of conformity shall be drawn up in accordance with part B of Annex II, unless the machine can function independently.

(3) In the case of a safety component, the EC declaration of conformity shall be drawn up in accordance with part C of Annex II.

13.-(1) The EC declaration of conformity for a machine or safety component cannot be drawn up until the requirements laid down in Annex V concerning the technical file and other documentation have been satisfied. See, however,  subsection (2) hereof.

(2) The EC declaration of conformity for a machine or safety component that is covered by Annex IV cannot be drawn up until the provisions set out in sections 14 and 15 of this Executive Order have been satisfied.

14. In cases where a machine or safety component covered by Annex IV has been constructed in conformity with harmonised standards, one of the following procedures shall be followed:
  1. A technical file is produced and sent to a notified certifying body within the Community in accordance with Annex VI, see item 5 (first sentence) and item 7 of that Annex. The certifying body confirms receipt of the file.
  2. A technical file is produced and submitted in accordance with Annex VI to a notified certifying body within the Community, which will verify that the relevant standards have been correctly applied and if so will draw up a certificate of adequacy for the file.
  3. A specimen of the machine or safety component is submitted to a notified certifying body within the Community for EC type-examination in accordance with Annex VI.
15. In cases where a machine or safety component covered by Annex IV has not been constructed - or has only partly been constructed - in conformity with harmonised standards, a specimen must be submitted for EC type-examination in accordance with Annex VI.

EC type-examination

16.-(1) The Director General of the Danish Working Environment Authority will approve one or more certifying bodies to undertake type-examination in Denmark in accordance with the provisions contained in this Executive Order.

(2) The certifying bodies mentioned in subsection (1) hereof shall satisfy the minimum requirements laid down in Annex VII.

(3) Approval under subsection (1) may be granted subject to conditions or limitations.

(4) Approval under subsection (1) hereof will be revoked by the Director General of the Danish Working Environment Authority if the body concerned no longer satisfies the requirements laid down in Annex VII.

17.-(1) The certifying body shall undertake type-examinations and issue EC type-examination certificates in accordance with the directions laid down in Annex VI.

(2) The certifying body concerned shall be informed of any change to the machine or safety component to which the certificate applies, cf. Annex VI. The certifying body shall determine whether the magnitude of the change is such in relation to the certificate granted as to require the machine or safety component to undergo a new type-examination.

(3) The certifying body shall have the power to revoke a type-examination certificate in cases where it is later found that the machine or safety component submitted as a basis for the type-examination certificate does not satisfy the requirements set out in Annex I.

CE marking

18.-(1) The CE mark shall be of the form specified in Annex III and shall be affixed to the machine so that it is distinct, visible and durable.

(2) No marks or inscriptions may be affixed to the machine that would diminish the visibility or legibility of the CE mark, or which might be misleading as regards the meaning or graphic design of the CE mark.

Part 3 - Other machines and technical equipment

Construction, manufacture, ancillary equipment and design

19.-(1) The rules in this Part apply to technical equipment that is not covered by Part 2 of this Executive Order, including machines delivered for use before the entry into force of Part 2, cf. Annex VIII.

(2) The construction, manufacture, ancillary equipment, design and instructions for use of technical equipment shall be subject to the general provisions set out in sections 20–34. In addition, special provisions shall apply to certain types of technical equipment. These provisions are specified in Annex X and in the executive orders mentioned in Annex IX.

20.-(1) Technical equipment must be properly designed and properly made of suitable materials, having regard to the conditions to which it can be anticipated that it will be exposed, so that it has the requisite strength and durability to satisfy health and safety considerations.

(2) Any item of technical equipment in which there occur or may occur pressures, temperatures, stresses or other conditions that could give rise to dangerous states must be designed and constructed in such a way, or so provided with equipment to limit such conditions, that neither the safe limits nor any maximum values that have been specified for such conditions are exceeded. If necessary, the equipment shall be provided with a warning device that automatically comes into action if such limits are exceeded.

21.-(1) The design of technical equipment must incorporate protection against any hazards presented by the equipment, ensuring that:
  1. persons cannot come into contact with dangerous machine parts or substances;
  2. tools, workpieces or parts thereof, splashes, etc., cannot be ejected so as to present a health or safety hazard; and
  3. heat, cold, radiation, noise, vibrations, dust, humidity, smoke, vapours, gases, etc., developed when the technical equipment is used, are not emitted in a way that presents a health or safety hazard.
(2) If the requisite protection cannot be achieved through the design, it shall be effected in a reliable manner by means of screens/guards, extraction ventilation, other safety equipment or other safety measures.

(3) Screens and other protection devices
  1. must be of robust construction;
  2. must not give rise to any additional hazard;
  3. must not be easily removed or rendered inoperative;
  4. must be situated at sufficient distance from the danger zone;
  5. must not restrict more than necessary the view of the operating cycle of the equipment; and
  6. must allow operations necessary to fit or replace parts and for maintenance work, restricting access only to the area where the work is to be carried out and, if possible, without removal of the screen or protection device.
22. Power supply equipment must be so designed, constructed and fitted that it does not present a danger to health or safety.

23.-(1) Technical equipment must be designed, constructed and equipped in such a way that it can be operated without risk to health or safety and without other persons being exposed to danger.

(2) Subsection (1) hereof shall apply correspondingly to all other work connected with the equipment to the maximum extent permitted by the nature of the equipment concerned.

24.-(1) The way in which power to technical equipment is connected, controlled and disconnected and the means by which other forms of control over its functions or working processes are exercised, shall to the greatest extent possible ensure that no risk to health or safety arises. It must be ensured that operation takes place under the best possible conditions of visibility and control, and if necessary the equipment must be provided with devices that automatically give a signal before starting, stopping or other control functions. It must be possible to start the equipment only by deliberate action performed on a control system designed for the purpose.

(2) It must be possible to stop functions or working processes rapidly from suitable positions on or close to the equipment, unless such interruption might be dangerous. Where considerations of safety render it appropriate, automatic stopping must be provided. If necessary, stopping must be combined with a braking action. Stop commands must have higher priority than start commands.

(3) If abnormal conditions during operation, including variations or interruptions in the supply of power to the equipment, may present a danger, the equipment must be effectively protected against such conditions. If necessary, the equipment must be provided with an automatic and suitably acting alarm device.

25. Lighting that is built into or mounted on technical equipment must be suitably designed and not give rise to dazzle.

26.-(1) Control devices and control systems must be so designed and constructed that any risk of potentially dangerous inadvertent or erroneous actuation, changing or stopping of functions is prevented or counteracted.

(2) Control systems must be safe and must be chosen making due allowance for the failures, faults and constraints to be expected in the planned circumstances of use.

(3) Controls must be well illuminated, easily accessible, clear, easy to see, suitably marked, and designed and mounted in accordance with ergonomic principles.

Special equipment

27.-(1) Automatically driven, controlled or monitored technical equipment must, to the extent relevant for safety, be provided with devices to cut back the power to the processes and disconnect the automatic control, and furnished with equipment for manual control and, if appropriate, emergency stopping.

(2) Such equipment must also be provided with instructions, diagrams, plans or similar material that can, in the event of failure of the automatic systems or other exceptional situations, serve as a basis for a full assessment of the safety implications and for the putting into effect of such measures or interventions as may be necessary to avert danger to health and safety.

(3) The text of the written material and associated instructions shall be in Danish, unless otherwise specified by special rules or decision of the Director General of the Danish Working Environment Authority.

(4) The material must be located on the equipment or close to it in a way that is appropriate for its use.

28.-(1) Technical equipment the safety of which is dependent on its operating state, must be provided with devices for the monitoring, control and regulation of its operating state.

(2) The monitoring and control devices must be properly designed and properly made of suitable materials so that they operate reliably and in a manner to afford due protection of health and safety.

(3) The monitoring and control devices must be so designed and mounted that their settings cannot be unintentionally disturbed. Their displays must be correct, clear and well illuminated. It must be possible to read and set them from an easily accessible position, and it must be possible to perform necessary adjustments or replacements.

29. In cases where it is necessary for persons to move about or remain by or on technical equipment for the purpose of operation, maintenance, inspection or other attention, access routes and work platforms must be installed to the extent necessary. These must so be designed, constructed, made safe and illuminated that health and safety in connection with their use are properly safeguarded.

Design

30. Where the form or colour of technical equipment or parts thereof may be relevant to health and safety, this shall be taken into account to the greatest extent possible.

31. Marking colours and symbols must be clear and durable, and having regard to considerations of visual perception it shall generally be endeavoured to achieve an appropriate form and colouring of the equipment.

32.-(1) To the extent permitted by its intended use, accessible parts of the equipment must be so designed that there are no sharp corners, edges, rough surfaces, etc., that could cause personal injury.

(2) The design shall ensure as far as possible that the equipment is easy to clean and that cleaning of and near it can take place without risk to health or safety.

33. Technical equipment which it can be anticipated will be moved, transported, installed and assembled must be designed with this in view, and, if necessary, furnished with devices to allow moving, etc., to take place in a manner that affords due protection of health and safety.

Instructions for use

34.-(1) When technical equipment is delivered it must be accompanied by the necessary instructions for use to allow it to be used, transported and set up in a manner that affords due protection of health and safety, and maintained in the prescribed condition. The instructions should contain requisite information, plans, diagrams, etc., describing the equipment and its operation, and information about any hazards or other special matters connected with it, including limitations as to use that may be relevant to health and safety in the working environment and which are not generally known. It must also contain information about any special safety precautions that are necessary in connection with the use, transport, setting up and maintenance of the equipment. In cases where personal protective equipment is necessary, the instructions for use must give information about its type and use that accords with any relevant existing regulations.

(2) The instructions for use must be adequate, and easily understood by the anticipated users. They must be in Danish, unless otherwise specified by special rules or unless the Director General of the Danish Working Environment Authority permits or requires another language.

(3) To the extent that it may be relevant to health and safety to do so, the instructions for use, important parts thereof, or references to them, must be displayed directly on the equipment, or by means of a plate, notice, or similar, to be set up near it.

Part 4 – Detailed rules

35.-(1) The Director General of the Danish Working Environment Authority may lay down detailed rules for individual types of technical equipment, in accordance with the foregoing provisions.

(2) References to norms or standards may be used in such rules, provided they are given unambiguously and include the date of the norm or standard referred to.

36. The Director General of the Danish Working Environment Authority may issue guidelines explaining how to comply with the provisions contained in this Executive Order and the detailed rules.

Part 5 – Exemptions and appeals

37. The Director General of the Danish Working Environment Authority may permit derogations from the provisions of this Executive Order in individual cases where the specific design and use of equipment or other special circumstances render it reasonable and appropriate to do so. However, this shall not apply to technical equipment covered by Part 2.

38. Appeals can be made against decisions based on the Executive Order under section 81 of the Danish Working Environment Act.

Part 6 – Penalty provisions

39.-(1) Unless a more severe penalty is prescribed by the Danish Working Environment Act or other legislation, anyone who
  1. contravenes section 3, sections 6–7, sections 9–15, section 17(2), or sections 18–34;
  2. fails to comply with an improvement notice or prohibition notice issued pursuant to the provisions of this Executive Order; or
  3. disregards the terms of authorisations under this Executive Order
shall be punished with a fine or imprisonment.

(2) If a public limited company, a private limited company, cooperative or similar body contravenes these provisions, the company as such may be held liable to pay a fine. If the Government, a municipality or a municipal community in accordance with section 60 of the Danish Local Government Act contravenes these provisions, the Government, the municipality or the municipal community may be held liable to pay a fine.

40. Detailed rules issued under this Executive Order may specify penalties for contravention of the provisions contained in them in accordance with section 84 of the Danish Working Environment Act.

Part 7 – Entry into force and transitional provisions

41.-(1) This Executive Order shall enter into force on 1 January 1995.

(2) Executive Order No. 694 of 7 August 1992 on the Design of Technical Equipment, as amended by Executive Order No. 564 of 24 June 1994, shall at the same time be repealed, cf. however subsections (3) and (4) hereof.

(3) Compliance with Part 2 of this Executive Order is not required before 1 January 1997 for machinery for raising or moving persons or for separately marketed safety components, provided they satisfy the regulations formerly in force.

(4) Machines covered by Part 2 of this Executive Order that are delivered for use new before 1 January 1997 are not required to be marked as specified in section 18 if they bear the EC mark in accordance with the Executive Order referred to in subsection (2) hereof.

42.-(1) Part 2 of this Executive Order shall not apply to machines covered by Executive Order No. 15 of 9 January 1989 on the EC Directive on self-propelled industrial trucks, as amended by Executive Order No. 43 of 24 January 1990, until 1 July 1995. The said Executive Order shall at the same time be repealed, but shall retain validity in the period 1 July 1995 – 31 December 1995, as specified in subsection (2) hereof.

(2) Machines as referred to in subsection (1) hereof that are marketed or delivered for use in Denmark in the period 1 July 1995 – 31 December 1995 must satisfy either the requirements laid down in Part 2 of the present Executive Order or the requirements laid down in the Executive Order referred to in subsection (1) hereof and in Part 3 of the present Executive Order.

(3) For protective structures covered by Executive Order No. 47 of 26 January 1990 on the EC Directive on falling-object protective structures (FOPS) for certain construction plant or by Executive Order No. 48 of 26 January 1990 on the EC Directive on roll-over protective structures (ROPS) for certain construction plant, Part 2 of the present Executive Order shall enter into force on 1 January 1995. The said executive orders shall at the same time be repealed, but shall retain validity in the period 1 January 1995 – 31 December 1996, as specified in subsection (4) hereof.

(4) Protective structures as referred to in subsection (3) hereof that are marketed or delivered for use in Denmark in the period 1 January 1995 – 31 December 1996 must satisfy either the requirements relating to safety components contained in Part 2 of the present Executive Order or the requirements laid down in the executive orders referred to in subsection (3) hereof and in Part 3 of this Executive Order.

The Danish Working Environment Authority, 24 June 1994

Erik Andersen/Charlotte Skjoldager

* The Executive Order contains provisions implementing Council Directive No. 89/392, Official Journal of the European Communities 1989, L 183, p. 9, as amended by Directive No. 91/368, Official Journal of the European Communities 1991, L 198, p. 16, Directive No. 93/44, Official Journal of the European Communities 1993, L 175, p. 12 and Directive No. 93/68/EEC, Official Journal of the European Communities 1993, L 220, p. 1; and provisions implementing Council Directive No. 89/655/EEC, Official Journal of the European Communities 1989, L 393, p. 13, as amended by Directive No. 95/63/EC, Official Journal of the European Communities 1995, L 335, p. 28.