Ah, the wonderful world of standards… numbers, codes, dates, and always the same doubt: “Have I found the right standard, of the right edition, and from the right standardization body?”
In this article, a series of concepts to approach the problem of how to search for and choose standards to apply with greater confidence.
Additionally, considering the cost of standards, this is also an excellent guide to saving money.
Standardization Bodies
Anyone who has dealt with a standard has encountered the series of acronyms that precede the identification number. Their purpose is to indicate the standardization body of origin and all other bodies that have adopted and reworked it.
The standardization body is the organization that develops documents that set standards for manufacturing or processing a product or process, the standards.
The main players are:
Telecommunications
- ITU (international)*
- ETSI (European)
- CEI – UNI (national)
* Intergovernmental body whose recommendations are used by governments for regulatory purposes.
Electronics and electrotechnics
- IEC (international)
- CENELEC (European)
- CEI (national)
Other fields
- ISO (international)
- CEN (European)
- UNI (national)
Therefore, when we encounter a standard like UNI CEI EN ISO 13485, it means that it was developed internationally by ISO, adopted in Europe by CEN, and at the national level by CEI and UNI.
In most cases, the adoptions do not generate any changes to the content. If this is not the case, the adopted standard will provide clear indication of the points reworked for adoption.
Harmonized Standards
Harmonized standards are developed by standardization bodies on mandate from the European Commission with the aim of attesting compliance with specific points of directives or regulations (mandatory requirements).
When a harmonized standard is published in the Official Journal of the European Union, it guarantees presumption of conformity for the specific mandatory requirement identified.
Publication in the Official Journal is a long process, but the waiting time is a fundamental condition. Without a latency between the issuance of a regulatory update and its subsequent publication, manufacturers would constantly find themselves forced to subject their devices to additional tests, or to spend their time developing rationales to support the non-execution of these.
Searching for and Choosing Standards
The starting point for searching for and choosing standards to apply is the European Commission’s website. The relevant Official Journal document, listing the harmonized and published standards, is associated with the directive or regulation of interest.
Through the use of keywords, it is possible to verify the presence of relevant standards and choose them accordingly.
Stopping at this stage, although formally correct, is not always the most technically consistent solution; this is the case with these exceptions:
- Harmonized and published standard but excessively outdated, resulting in misalignment with the state of the art technology (standards dating back to the 90s are still cited);
- Absence of harmonized or published standards fully consistent with one’s product;
- Need to apply harmonized standards to other directives or regulations.
In the first two cases, the solution is to verify if at the national, European, and international levels (in this order), there are more consistent editions or standards. The search must be conducted directly on the websites of standardization bodies, and a rationale supporting this choice must be drafted in the technical file.
In the third case, it is sufficient to analyze the list of harmonized and published standards related to the specific directive or regulation, and provide, always in the technical file, due justification for use.
Given the above, it is clear that a manufacturer is required not to accept any non-conformities identified by a notified body that impose the application of updated but not harmonized or published standards (and the consequent performance of tests).
The application of a non-harmonized or unpublished standard must always be justified. In the above case, the body is therefore required to provide a clear and technically consistent explanation in support.
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