We perform tests of face masks in accordance with EN 14683
We perform all required tests of medical masks in accordance with the harmonized standard EN 14683.
Certification of filtering half masks
Certification of protective masks is a process where the manufacturer has an obligation to involve an independent third party (notified body) to assess the conformity of the product with modules B and C2 or D. After obtaining the certificates from modules B and C2 or D, the manufacturer then obtains the CE mark.
The technical requirements for protective masks are confirmed by testing in accordance with the harmonized standard EN 149.
ACCREDITATION DOCUMENTS
LOTRIČ Metrology is accredited by Slovenian Accreditation with accreditation number CP-016 in the field of certification of products, processes and services (ISO/IEC 17065).
EU type-examination is the part of the conformity assessment procedure in which the notified body examines the technical design of the PPE, and verifies and attests that the technical design of the PPE meets the requirements of the Regulations that apply to it.
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Module B: EU type-examination certificate
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EN 149
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EU type-examination certificateRegulation (EU) 2016/425 on personal protective equipment, Annex V
Provided the initial assessment procedure is successfully completed, a certificate of approval of the internal production control system and controlled testing of products at random intervals shall be issued. This is valid for three years from the beginning of the assessment process, if all the conditions satisfy the requirements of the Regulation (EU) 2016/425.
If the initial assessment is successfully completed, the certificate of approval of the quality system is issued. It is valid for three years from the beginning of the assessment process, if all the conditions satisfy the requirements of the Regulation (EU) 2016/425.
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Module C2: Certification of internal production control system
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EU type-examination certificateRegulation (EU) 2016/425 on personal protective equipment, Annex VII
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Module D: Certification of approval of the quality system
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EU type-examination certificateRegulation (EU) 2016/425 on personal protective equipment, Annex VIII
For the purpose of confirming valid certificates issued by the certification/notified body LOTRIČ.
From certification to testing – all in one place
We are one of only 5 laboratories in the EU which can offer such a wide range of services.
All tests are performed in brand new laboratories equipped with modern testing equipment.
The reason we have such a great case study here
is that we are professional and flexible.
And we are able to deliver results
in a very short period of time.
Today we will talk about personal responsibility
About the integrity of an individual
who has signed the papers.
To either sell or buy or use
a piece of standardized equipment
such as the face masks.
We don’t just contribute to our safety.
WE CERTIFY IT!
From certification to testing – all in one place
Technical report on masks
Choosing the right mask is a daunting task.
For the purpose of expert review of the documentation of medical or protective masks, we in LOTRIČ Metrology prepare a Technical Report with detailed descriptions of all established facts.