Basic information about standards
What is a standard?
A standard is a set of regulations approved by the technical committees of standardisation bodies. It should be stressed that standards must comply with the law, science and technical knowledge. In addition, compliant products can only be certified by bodies that have been designated for this purpose, e.g. from the Polish Committee for Standardization or entities it authorized.
What is a harmonized standard?
In the search for information on standards, someone may come accross the term “harmonized standard”.
It refers to standards developed by the European standardization organisations and published in the Official Journal of the EU. In order to become a harmonized standard, a standard must satisfy both of these conditions. As a result, the candidate standards for the harmonized standards title are adopted after consultation with the EU Member States. Only then will they become part of European law, as evidenced by their publication in the Official Journal of the EU. Without this publication, the standard does not qualify as a harmonized standard.
The use of harmonised standards is not mandatory, but doing so often significantly facilitates the certification process. Harmonized standards are subordinate to the essential requirements set out in the relevant Directives, e.g. in the Machinery Directive.
What are the properties of standards?
It can be said that standards are a measuring system for a product, thanks to which the relevant authorities are able to confirm its quality and safety. For this reason, the provisions of a standard have to:
- be repeatable,
- be verifiable,
- be feasible,
- take into account the current or imminent state of knowledge and technology,
- be based on scientific grounds and data checked for state of the art, economic and utility values.
What are the standards for?
Standards are used to standardize products and processes, i.e. their unification. This gives a number of benefits to both producers and consumers:
- guarantees the safety of people, the environment and property;
- removes trade barriers;
- allows to consolidate the achievements of the technique;
- disseminationes technical progress;
- increases economical efficiency;
- provides a solid basis for the settlement of disputes between the supplier and the client;
- facilitates contract subject matter definition when entering into civil law contracts.
Is standard compliance mandatory?
The use of standards is not mandatory, but they will often significantly facilitate and, in the case of safety systems, even condition the implementation of the certification process (conformity assessment, including CE marking and issuing the EC declaration of conformity). It should be taken into account that certain markets may be closed to uncertified products. So, let’s cut to the chase: what is the process of certification of safety systems?
Certification of safety systems for industry
Where to begin with safety system certification?
1. Becoming familiar with the Machinery Directive
The certification of a safety system should begin by reviewing the Machinery Directive and the harmonized standards that apply to the device. It is best to do this before designing the system itself, at the conceptual stage. Otherwise, it may turn out that the device does not meet the basic requirements and should be modified..
2. Designing the safety system
The next step, design, consists of two stages:
- the stage of detection and assessment of machine hazards,
- the stage of developing ways to eliminate the identified risk factors.
During the first stage, i.e. detection and assessment of machine hazards, an iterative process of risk analysis and assessment is carried out. This means that this process is repeated several times, until all potential hazards are detected and each of them is assessed.
Then, in the second stage, it is necessary to demonstrate how the risks associated with a potentially hazardous situation can be reduced or even eliminated. It is worth noting that not every risk can be eliminated immediately. Since the primary objective of this stage is to diagnose and evaluate them, the remaining unaddressed risk will be carefully examined in the next step of preparing for certification, i.e. developing a safety concept.
3. Developing the safety concept
The premise of the safety concept is to eliminate or reduce the remaining risk associated with the operation of the machine, which could not be eliminated during its design and construction. This reduction is mainly achieved through the application of technical safety measures, i.e. ‘safety components’. It is worth knowing that according to the Machinery Directive, a ‘safety component’ means an element:
- which serves to fulfil a safety function, and
- which is independently placed on the market, and
- the failure and/or malfunction of which endangers the safety of persons, and
- • which is not necessary in order for the machinery to function, or for which normal components may be substituted in order for the machinery to function.
4. Conducting the EC type-examination
The certification of safety systems for industry requires the manufacturer to carry out an EC type-examination by a notified body. After the body has found that the device complies with the Machinery Directive, an EC Declaration of Conformity is issued. It is a document necessary to obtain the CE certificate.
5. Transmission of documentation to the notified body
At this point, the manufacturer already has all the documentation gathered. They may send it to the relevant notified body together with the tested device. On this basis, the body certifies that the submitted machine model meets the safety requirements.
What documents are needed to obtain the CE certificate for a safety system?
Safety systems recognizing people are eligible for certification on the basis of the requirements set out in the Machinery Directive. Therefore, it will be necessary to include:
- the design documentation (including a copy of the EC Declaration of Conformity);
- information on in-house measures which will ensure the correctness of batch production, if planned;
- reports on tests and technical examinations.
Contrary to appearances, the documentation is extensive and detailed, so its preparation is time-consuming.
How long does the CE certification process take?
The duration of the certification process is not strictly regulated. It can last from a few months to even a few years. Much depends on the efficiency of the organization applying for the certificate, that is, how quickly it is able to prepare the full documentation.
Certification of innovative products – is it possible?
Most often, the law does not keep up with changes in technology. The same is true for setting standards for products – they are usually a few steps behind technological progress. Therefore, a major challenge for innovative systems designed to detect people (other than optoelectronic barriers, scanners, stereovision systems, etc.) is the lack of appropriate standardisation documents. In particular, this is the case where system sensors are not covered by the relevant safety standards or where machine learning is used for data analysis. Then the notified body carries out or orders to carry out appropriate inspections, measurements and tests in order to determine whether the adopted solutions meet the essential requirements of the Machinery Directive (and Journal Of Laws No. 199, item 1228 as amended zm. on health and safety), including relevant harmonized standards.
Thus, certification of products qualifying as innovative can be difficult (time-consuming and expensive), but it is not impossible. In order for the process to run smoothly, it is good to ensure that the product components comply with applicable standards. At the same time, membership in local standarization commitee’s technical committee is a good idea. In this way, one can not only keep up with changes in the regulations, but also influence the shape of the standards.
In conclusion, the certification of safety systems designed to detect the presence of persons is a complex process. Due to the importance of the task of protecting human health and life, certification is necessary before the product is placed on the market. For this reason, it is worth investing the company’s resources to carry out the certification process – even if it is an innovative solution.