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Harmonized standards

This section contains all important information about Serbian standards representing the adoptions of European harmonized standards in the field of machinery.

Serbian machinery standards, as well as European harmonized machinery standards, are classified into three types: A, B, and C. The purpose of this classification is to enable the authors of standards for specific categories of machinery to use horizontal standards that provide proven technical solutions. Type A and B horizontal standards can also help manufacturers designing machines for which type C standards are not available.

It is important to note that the presumptions of conformity resulting from the application of Serbian standards included in the List of Serbian Standards in the Field of Machinery differ in nature among these three types (see: Structure of a Machinery Safety Standard).

  1. Serbian standards for machinery are standards representing the adoptions of European harmonized standards under the Directive on Safety of Machinery (MD).

Serbian standards in this field, as well as all other fields in Serbia, are adopted by the Institute for Standardization of Serbia (ISS). The list of Serbian standards in the field ofmachinery (MD) representing the adoptions of European harmonized standards (hEN) is under the jurisdiction of the Ministry of Economy of the Republic of Serbia. The latest updated list of Serbian standards for the safety of machinery (MD) was published in the „Official Gazette of the Republic of Serbia“, No.  3/20 of 17 January 2020. See: List of Serbian standards for MD (privreda.gov.rs).

Serbian standards provide technical requirements and specifications that enable machinery manufacturers to fulfill the essential health and safety requirements.

In this context, the level of safety provided by applying Serbian standards establishes a benchmark against which all manufacturers of the machinery category covered by the standard must adhere, including those who choose to employ alternative technical solutions. A manufacturer opting for alternative solutions must demonstrate that these solutions comply with the essential health and safety requirements of the Rulebook, taking into account the state of the art. Accordingly, such alternative solutions must provide a minimum level of safety equal to the level of safety provided by applying the specifications of the relevant Serbian standard.

Application of standards from the The List of Serbian standards in the field of machinery

A machine is considered to comply with the essential health and safety requirements of Annex 1 to the Rulebook on Safety of Machinery if it is constructed in accordance with Serbian machinery standards representing the adoptions of the corresponding harmonized standards. The list of such standards is compiled and published in accordance with the law governing technical requirements for products and conformity assessment and with the regulations adopted on the basis of that law.

If a machine is listed in Annex 4 to the Rulebook and is not constructed in accordance with the Serbian standards referred to in Article 7 of this Rulebook, or is only partially in compliance with such standards, or those standards do not cover all the essential health and safety requirements, or if there are no such standards for the machine in question, the manufacturer shall apply one of the following procedures:

  1. The type examination procedure set out in Annex 9 to the Rulebook and the internal production control for machinery set out in Annex 8, Clause 3;
  2. The full quality assurance procedure set out in Annex 10 to the Rulebook.

In conclusion, the use of Serbian standards from the list of standards is the simplest and fastest tool in the process of demonstrating product compliance with the essential requirements.

2. Harmonized standard (hEN) – The Regulation (EU) No 1025/2012 on European standardization defines hEN as „a European standard adopted at the request of the European Commission for implementation within the framework of harmonised legislation of the European Union“. These harmonized European standards hEN within the framework of the Directive on Safety of Machinery, whose reference is cited in the Official Journal of the European Union (OJEU), provide a presumption of conformity for products conforming to such European standards. According to the data from the Q1 2024, there are approximately900 harmonized standards (hEN) under the Directive on Safety of Machinery (MD) cited in OJEU.

While the application of Serbian machinery standards representing the adoptions of harmonized standards is voluntary, the use of these standards carries a presumption of conformity with the essential health and safety requirements to which they relate. Additionally, these Serbian standards provide a good basis for the state of the art, which should be taken into account when applying the essential health and safety requirements of Annex 1 to the Rulebook.

Specificities of hEN standards under MD

1. Safety of machinery standards structure – Harmonized machinery standards represent a series of standards with the following structure: 

– standards type А (basic safety standards) provide basic concepts, design principles and general aspects so that they can be applied to all machinery. 

While applying only Serbian standards representing the adoptions of  harmonized standards (hEN) provides a significant framework for the proper implementation of the Rulebook, it is not sufficient to ensure compliance with the relevant essential health and safety requirements of the Rulebook and therefore does not provide a full presumption of conformity;

– standards type B (group safety standards) refer to one aspect of security or one type of security protection, so they can be used for a wide range of machinery: 

 – standards type B1 refer to one aspect of safety (for example, safety distances, surface temperature, noise); 

 – standards type B2 refer to safety protections (for example, two-handed steering devices, locking devices, pressure sensitive devices, protectors); 

Applying the specifications of Serbian standards representing the adoptions of harmonized standards (hEN) of type B creates a presumption of conformity with the essential requirements of the Rulebook to which they relate. This presumption applies in cases where a type C standard or the manufacturer's risk assessment indicates that the technical solution prescribed by the type B standard is adequate for a specific category or model of the given machinery.

– standards type C (machine safety standards) refer to detailed safety requirements for individual machines or groups of machines. 

Type C standards may refer to type A or type B standards, specifying which specifications of the type A or type B standard apply to the particular category of machinery. When a type C standard deviates from the specifications of a type A or type B standard for a specific aspect of machinery safety, the specifications of the type C standard have precedence over the specifications of the type A or type B standard.

Applying the specifications of Serbian standards representing the adoptions of harmonized standards (hEN) of type C on the basis of the manufacturer's risk assessment creates a presumption of conformity with the essential health and safety requirements of the Rulebook.

For users seeking more information on the rules for drafting harmonized standards (hEN) related to machinery safety, CEN Guide 414: Safety of Machinery - Rules for the Drafting and Presentation of Safety Standards, cen_414.pdf, serves as a valuable resource. This guide primarily aims to achieve consistency and acceptable quality among the various standards being developed. This Guide was developed based on the principles given in EN ISO 12100 and deals mainly with the type C machinery.

2. Annex ZA/ZZ – All harmonized standards (hEN) for machinery must include Annex ZA (Annex ZZ – for standards developed by CENELEC), that explains the relation among the Clauses of the standards and the requirements of the EU Directive, i.e. national Rulebook in Serbia. 

3. Risk analysis and risk assessment – Machinery design and manufacturing must incorporate the results of a risk assessment to ensure the safety of users and bystanders. Risk assessment is an iterative process, as each risk reduction measure implemented to address a specific hazard must be evaluated to determine its effectiveness and potential for introducing new hazards.

Both the risk assessment process and its outcomes must be documented in the technical file for the machinery. Serbian standard SRPS EN ISO 12100:2014_, Safety of machinery - General principles for design - Risk assessment and risk reduction_, provides guidance on the general principles of risk assessment for machinery.

The risk assessment process can be facilitated by applying Serbian standards listed in the List of Serbian Standards in the field of machinery. This is because type C standards for machinery can identify significant hazards commonly associated with the specific category of machinery and determine appropriate protective measures. However, applying Serbian standards does not absolve the machinery manufacturer from the responsibility of conducting a risk assessment.

A manufacturer using type C standard specifications must ensure that the Serbian standard is applicable to the specific machinery in question and addresses all the risks posed by the machinery. If the machinery presents a hazard not covered by the standard, a full risk assessment is required for those hazards, and appropriate protective measures must be implemented.

Furthermore, if the Serbian standard identifies multiple alternative solutions without providing selection criteria, the choice of the appropriate solution for the specific machinery must be based on a specific risk assessment. This is particularly important when applying type B standards.

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