In my last article "Inspection of the HAS assessment forms", I explained our right to inspect the results of the HAS assessment and how this access to the documents is methodically managed.
We have now submitted a further request for inspection and have thus received the HAS assessment documents for EN IEC 62368-1:2024 + A11:2024.
Specifically, two draft versions were evaluated by the HAS consultant.
- prEN IEC 62368-1 Ed. 4 2021
- FprEN IEC 62368-1:2022/FprAA:2023
Eleven weaknesses were identified in the first-mentioned main standard. Two of these weaknesses relate to the violation of the "neutrality requirement" (4.1), whereby manufacturers are able to define test conditions themselves. The remaining nine weaknesses relate to unspecific or unverifiable requirements that leave it up to the manufacturer to apply the requirements.
Five weaknesses were identified in the second mentioned EU-specific amendment document. One of these weaknesses relates to an inadequate "Annex Z", which has too little granularity in relation to the EU harmonization legislation (2014/35/EU).
All of the weaknesses mentioned are understandable and justified. The commissioned HAS consultant completed the HAS evaluation form provided to him as requested. Our criticism does not relate to the persons carrying out the assessment!
Economic operators are expected to take into account the current state of safety technology. In practice, this means applying the latest available standard. As standard users, we would like to have unbureaucratic access to the HAS assessment forms.
A version of this standard from 2014 is currently listed in the Official Journal of the EU. This corresponds to Edition 2 of IEC 62368-1. The EU version for Edition 3 has already not made it into the Official Journal and now the EU version for Edition 4 has not either. We are at least 10 years behind!
Globalnorm recommends using the latest available standard for the EU conformity assessment, taking into account the HAS assessment sheet. By knowing the weaknesses, possible conflicts with market surveillance authorities can be prevented.
We will keep you up to date and will be happy to provide you with further details.
Author's note
This article has been machine translated into English.
DEFINITIONS AND ABBREVIATIONS
A HAS (Harmonized Standards Assessment) is an assessment procedure for harmonized standards (hEN) carried out by the European Commission. The aim is to determine whether a standard meets the requirements for publication in the Official Journal of the European Union (OJEU). HAS consultants check whether the standard complies with the underlying standardization mandate.
All documents containing requirements for products, processes, services, persons, systems, and bodies must be written in accordance with the “neutrality requirement” so that conformity can be assessed by a manufacturer or supplier (first party), the user or purchaser (second party), or an independent body (third party). These documents shall not contain any requirements relating to conformity assessment, except those requirements that are necessary to achieve repeatable and traceable conformity assessment results.
(Source: CENELEC Rules of Procedure)
