Harmonized standards

  • They are technical Standards conceived to meet the essential requirements of the Directives
  • They are written by the various technical committees on a mandate by the Commission of the European Union
  • They are approved and adopted: by the CEN (European Committee for Standardization) or the CENELEC (European Committee for Electrotechnical Standardization)
  • Then they are translated and published in the Official Journal of the European Committee and the Official Gazette of each Member State

Compliance with a harmonized standard confers on the products or services the presumption of compliance with the Directives. In most cases, the use of harmonized standards is optional. It is also possible to choose another technical solution. However, the Essential Safety Requirements of the applicable directives must be guaranteed.

Steps for the development of a Standard

  • A draft standard (NP, New work item proposal) is prepared that will be examined by the various concerned national Committees, for comments, proposals and subsequent approval
  • Upon approval of the NP, a Working Group (WG) made of experts on the subject beeing discussed is set up. Experts (industry experts, experts from test laboratories, representatives of workers’ organizations, consumer representatives) are appointed by the Member States
  • Production of a first WD (Working Draft).
  • Through subsequent processing of the text of the WD the following document are produced:
    • In IEC organization: CD (Committee Draft), CDV (Committee Draft for Voting), FDIS (Final Draft International Standard)
    • In ISO organization: CD (Committee Draft), DIS (Draft International Standard), FDIS (Final Draft International Standard).
  • Upon reaching the consensus (expressed by a positive majority vote on the FDIS document expressed by Member States), the final text of the Standard is finalized, officially published and implemented by each Member State.

A published Standard remain in force for five years unless there is a need to review its contents.

Structure of a safety-related Product Standard

To facilitate use and reading, the majority of technical product standards have the following structure:

  • Preface
  • Index
  • Introduction
  • Field of application
  • Standard references
  • Terms and Definitions (symbols and abbreviations)
  • Safety requirements (risk reduction measures)
  • Tests (test methods by testing or analysis for verifying safety requirements)
  • Marking (for correct identification)
  • Information for safe use
  • Optional Annexes (they provide additional provisions beyond those found in the sbody text of theStandard)
  • Optional information annexes (provide additional information intended to improve understanding and use of the document) and only for European Harmonized Standards
  • Annex ZA (regulatory): regulatory references between International Publications and the corresponding European Publications (this annex lists international or European documents that are essential for the application of the standard)
  • Annex ZZ (informative): correspondence between the paragraphs, sub-paragraphs of the Standard and the Essential Safety Requirements of the applicable Directives. Once the standard is refer to in the Official Journal of the European Union, compliance with the clauses of the Standard that are reported in the Table of Annex ZZ confers, within the limits of the scope of the Standard, a presumption of conformity with the corresponding requirements of the Directive.

The European Standards concerning safety are subdivided into 3 groups:

They specify the general design principles applying to all types of machine:
EN ISO 12100 Safety of machinery – General principles for design – Risk assessment and risk reduction
They are divided into two classes:

Type B1 Standards: concerning a specific aspect of safety

  • EN ISO 13855 Positioning of safeguards with respect to approach speeds of parts of the human body
  • EN ISO 13857 Safety distances for the protection of the upper limbs
  • EN 60204-1 Safety of machinery. Electrical equipment of machine
  • EN ISO 13849 – 1,2 Safety related parts of control systems

Type B2 Standards: concerning safety devices

  • EN 61496-1 Electrosensitive protective equipment – general requirements and tests
  • EN 61496-2 Electrosensitive protective equipment-Particular requirements for equipment using active optoelectronics protective devices (i.e. light curtains)
  • EN 61496-3 Electrosensitive protective equipment-Particular requirements for Active Optoelectronics. Devices responsive to diffuse reflection (i.e. laser scanner)
  • EN ISO 13850 Emergency stop – Principles for design
  • EN ISO 14119 Safety of machinery – Interlocking devices associated with guards – Principles for design and selection
They concern specific types of machine:
  • EN 692 Mechanical presses
  • EN 693 Hydraulic presses
  • EN 415 Packaging machines
  • EN 415-4 Palletizing and de-palletizing systems
  • EN ISO 10218 Industrial robot
A type C Standard takes priority over type A and B Standards.
The type C standard identifies the significant hazards generally associated with the category of machinery and provides the protective measures to address them. However, the application of harmonized standards does not completely 
exempt the machine manufacturer from the obligation to carry out a risk assessment. The manufacturer must ensure that the harmonized standard is suitable for the particular machine and covers all the risks it presents.
If the machine presents hazards that are not covered by a type C standard, a full risk assessment is required for those hazards and adequate protective measures must be taken to face them. In this case, type A and B standards can help