Dear All!
Our region Lombardy asking to the firm to convert the production to produce sanitary elements or to find sanitary elements.
Notice to companies:
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We are looking for companies that are able to produce masks and / or PPE (Personal Protective Equipment) suitable also in light of the provisions of articles 15 and 16 of Legislative Decree 18/2020 and with the following technical characteristics:
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SURGICAL MASKS Surgical masks must simultaneously meet the UNI EN ISO 14683 and UNI EN ISO 10993 standards and be produced by companies that have a quality management system, in accordance with ISO 13485 or Good Manufacturing Practices (GMP), in order to correspond to the derogation from the CE mark.
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FFP2 MASKS the FFP2 masks must be manufactured according to the N95 NIOSH criteria which comply with the EN 149: 2001 + A1: 2009 standard.
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WATER REPELLENT COATS Water repellent coats must be manufactured according to UNI EN 13795 and UNI EN 14126 criteria.
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PROTECTIVE SUITS Third class yvec suits
Obviously, all the PPE of the type indicated above are provided which bear the CE marking (which certifies the response to the provisions of Directive 93/42 / EEC in the field of medical devices), pursuant to Legislative Decree 2 March 2020 and subsequent amendments.
In fact, technical tests are underway, in collaboration with the Milan Polytechnic, to verify which other materials and devices can be further considered suitable by the Istituto Superiore di Sanità or INAIL and, therefore, in compliance with current regulations.
In this regard, the Politecnico di Milano has provided us with very useful technical details that you can find in the Note to the manufacturers and in Annex 2 to this document and which contain addresses that we invite you to carefully consider to produce suitable devices.
In addition, in Annex 3 we provide a "Checklist for face masks for medical use without CE marking" with additional information.
With reference to the water-repellent gowns and protective suits, also in this case, if you had adequate materials and potentially destined for this type of products, we ask you to submit them to the suitability check of the Politecnico di Milano.
To protect the health of all, we inform you that, for the masks intended for the use of citizens not included in the health categories or workers, the Lombardy Region will still recommend the use of products with suitable characteristics reported by the Milan Polytechnic.
We also ask you to inform us of your possible availability to supply these additional devices, which are also necessary to deal with the Covid19 emergency:
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Protective visors;
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Safety goggles;
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Protective mask goggles;
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Socks / overshoes;
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Headgear headphones;
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Hydroalcoholic solution in liters;
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Respirators;
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Intensive care units.
Maybe do you know some firms that produce these elements in Poland? Thank you very much and I wish to you best regards and have a nice day.
Abramo BALDUZZI
SIMAP Srl
E.
M. +39 348 8513120
