Machinery

Technická inšpekcia, a.s. is a “Notified Body (NB)” with identification code 1354, which was notified by the Slovak Republic (the Slovak Office of Standards, Metrology and Testing – ÚNMS SR) to the European Community authorities and all EU member states as a body authorized to perform conformity assessments—including, among others, the conformity assessment of machinery under Directive 2006/42/EC of the European Parliament and of the Council of May 17, 2006, on machinery, transposed into Slovak legislation by Government Regulation of the Slovak Republic No. 436/2008 Coll.

Conformity assessment of machinery under Government Regulation of the Slovak Republic No. 436/2008 Coll.

Conformity assessment of machinery not listed in Annex IV of the aforementioned Government Regulation

Technická inšpekcia (TI) performs the activity in question (procedure according to Section 8, paragraph 2 or 3, letter a) of the aforementioned Government Regulation) within the scope of machinery assessment as an “accredited inspection body” if the manufacturer, authorized representative, or operator requests testing of certain machine safety parameters or groups of machines, or if they request an assessment of whether the technical documentation—on the basis of which the manufacturer or importer intends to declare conformity—is sufficient, or whether all safety aspects of the machine comply with the requirements of relevant harmonized STN EN or STN standards suitable for conformity assessment.

As part of this activity, TI can assess the conformity of a new machine (type sample), including its technical design documentation (hereinafter referred to as “DD”).

The activity is performed based on a written application, which must include:

  1. name, address, and identification number of the applicant
  2. description of the machine (e.g., name, brand, type, serial number – if available; for imported products, also identification data of the manufacturer), including the intended purpose of the equipment specified by the manufacturer or importer
  3. whether it concerns:
  • type assessment of a newly manufactured or imported machine or a safety component of a machine,
  • assessment of an individual piece of equipment or a group of machines,
  • assessment of part or all of the machine’s DD,
  • assessment of part or all of the equipment, including inspection and testing of the machine in question
  1. the relevant DD (technical design documentation) of the machine in the attachment,

The DD of the assessed machine (or part thereof) must be submitted to the relevant TI workplace in one copy, at a minimum scope and level of detail that allows for the assessment of compliance with the technical requirements established for the machine in question, within the recommended scope of Annex VII of the Government Regulation. The submitted DD file should specifically include:

  • a general drawing of the machine along with drawings of the control circuits,
  • complete detailed drawings supplemented by various records of calculations, test results, etc., necessary for checking the machine’s conformity with essential health and safety requirements,
  • a list of
    • essential requirements of this regulation,
    • standards, and
    • other technical specifications used during the design of the machinery,
  • a description of the methods chosen to eliminate risks caused by the machine (machine risk analysis),
  • if necessary, any technical report or certificate obtained from a competent person or laboratory; a person or laboratory is considered competent if they meet the evaluation criteria set out in the relevant harmonized standards,
  • if the manufacturer declares conformity with a harmonized STN standard relating to their product, any technical report containing the results of tests performed at the choice of either the manufacturer or a competent person or laboratory,
  • a copy of the machine’s operating instructions.
  1. information on whether the applicant has also requested an assessment from another authorized/notified body or TI workplace regarding the same matter.

In the case of series production, the internal measures that the manufacturer will implement to ensure that the machines maintain conformity with the provisions of the Government Regulation. TI will assess the conformity of the submitted machine DD (or part thereof) in terms of technical requirements and design principles established in related generally binding legal and technical regulations (in Annex I of the Government Regulation):

  • through the relevant harmonized STN EN type C (if it exists) specifying detailed safety requirements (measures) for the design and manufacture of the given machine or group of machines (taking into account the design principles stated in STN EN ISO 12100 – 1, – 2 (83 3001): 2004 for the elimination of non-significant hazards),
  • if the aforementioned STN EN does not exist – through related harmonized STN EN (type A and B – B1, B2) or STN standards suitable for conformity assessment.

In the case of a request for a comprehensive inspection and testing of the machine, if no deficiencies were found during the inspection and testing, or if the identified deficiencies were eliminated by the applicant within the agreed deadline, TI will prepare and issue an output document stating that the document serves the applicant as a basis for their “EC Declaration of Conformity.”

Conformity assessment procedure for machinery listed in Annex IV of the aforementioned Government Regulation, where technical characteristics comply with harmonized STN EN standards

If the applicant has decided to proceed according to Section 8, paragraph 3, letter b) or paragraph 4, letter a) of the Government Regulation and Annex IX (and has requested an EC type-examination), TI, as a notified body, verifies and certifies that a representative model of the machinery listed in Annex IV of the Government Regulation complies with the provisions of the Government Regulation (Directive) applicable to it. TI proceeds by subjecting a type sample of the machine to testing via the prescribed procedure. The course of the inspection and/or testing of the machine is documented in an “INSPECTION REPORT” and serves as the basis for issuing an “EC TYPE-EXAMINATION CERTIFICATE.”

Conformity assessment procedure for machinery listed in Annex IV of the Government Regulation, where technical characteristics do not comply with related harmonized STN EN standards

If the applicant (manufacturer, authorized representative) has decided to proceed according to Section 8, paragraph 3, letter c) or paragraph 4, letter b) of the Government Regulation, TI will perform the assessment and approval of the manufacturer’s quality assurance system based on an application.

The application must include:

  1. the name and address of the manufacturer and, where appropriate, their authorized representative,
  2. the location of design, manufacture, inspection, and storage of the machinery,
  3. the technical documentation file described in Annex VII, Part A (Directive) of the Government Regulation for one model from each category of machinery in Annex IV that they plan to manufacture,
  4. in the case of series production, internal measures that will be implemented to ensure that the machinery maintains conformity with the provisions of the Government Regulation (Directive),
  5. quality system documentation:
  • quality manual,
  • quality objectives and quality policy,
  • organizational structure and responsibilities at individual management levels,
  • description of technical design conditions, including the standards used,
  • description of procedures for managing and verifying the design, processes, and measures used in the design of the machinery,
  • description of manufacturing processes, management, and quality assurance procedures,
  • description of inspections and tests performed before, during, and after production, etc.

Most frequently identified assessment deficiencies

  1. When assessing the conformity of technical design documentation (DD) for a machinery type sample (during the assessment of separate design documentation or during an “EC type-examination”): The submitted technical design documentation file for machinery under Annex IX “EC type-examination” of Government Regulation of the Slovak Republic No. 436/2008 Coll. often does not include:
  1. complete detailed drawings – sketches and diagrams, as well as other significant information, especially information regarding safety, supplemented by various records of calculations, test results, etc., necessary for checking the machine’s conformity with essential health and safety requirements,
  2. a description of the methods chosen to eliminate hazards caused by the machinery (machine risk analysis),
  3. in the case of series production, internal company measures implemented to ensure that the machines are in conformity with the provisions of Government Regulation of the Slovak Republic No. 436/2008 Coll.
  1. When assessing the conformity of machinery not listed in Annex IV of Government Regulation of the Slovak Republic No. 436/2008 Coll., the submitted design and accompanying technical documentation for machines under Annex VII of Government Regulation of the Slovak Republic No. 436/2008 Coll., or Article 1.7.4 “Instructions for Use” of Annex I of Government Regulation of the Slovak Republic No. 436/2008 Coll. and Chapter 6.5 of STN EN ISO 12100 – 2 (83 3001): 08.04, does not include:
  1. a general drawing of the machine along with drawings of the control circuits.
  2. complete detailed drawings – sketches and diagrams, as well as other significant information, especially information regarding safety, supplemented by various records of calculations, test results, etc., necessary for checking the machine’s conformity with essential health and safety requirements.
  3. a list of:
    1. essential requirements of the Government Regulation applicable to the machinery
    2. standards, and
    3. other technical specifications used during the design of the equipment.
  4. a description of the methods chosen to eliminate hazards caused by the machinery (machine risk analysis).
  5. a complete copy of the machine’s instructions for use containing instructions for safe commissioning, use, maintenance, inspection, repair, installation, assembly, disassembly, etc., including information regarding noise generated by the machinery (actual value or value obtained based on measurement on an identical device).
  6. in the case of series production, internal company measures implemented to ensure that the machines are in conformity with the provisions of the Government Regulation.

Related pages: Certification (conformity assessment) of machinery, ATEX – equipment for potentially explosive atmospheres

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