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Medical Masks

Coronavirus: request for availability to companies and technical indications for the manufacturing of masks and personal protective equipment (PPE)

Notice for companies: 


We are looking for companies able to manufacture masks and / or PPE (Personal Protective Equipment) suitable also considering the provisions of articles 15 and 16 of Law Decree 18/2020 and with the following technical characteristics:


SURGICAL MASKS   - In order to comply with the derogation to the CE mark, surgical masks need to simultaneously comply with UNI EN ISO 14683 and UNI EN ISO 10993 standards and be produced by companies having a quality management system, in accordance with ISO 13485 or Good Manufacturing Practices (GMP).


FFP2 MASKS  - FFP2 masks must be manufactured according to N95 NIOSH criteria which correspond to the technical standard EN 149:2001 + A1:2009.

WATER-REPELLENT GOWNS   - Water repellent gowns must be manufactured according to the UNI EN 13795 and UNI EN 14126 criteria.

PROTECTIVE SUITS  - third-class yvec suits


Clearly, all the PPE included in the types indicated above having the CE marking (certifying the compliance with the provisions of Directive 93/42/EEC in the field of medical equipment) are considered adequate, pursuant to Law Decree of 2 March 2020 and subsequent amendments and additions.
If you can supply PPE with the characteristics indicated above, please inform us of the production times per equipment, the amount, the unit price (with delivery to Milan) and the methods of payment by using the following address DPIcoronavirus@regione.lombardia.it 


If you are not able to promptly supply us with masks and/ or PPE with the certified specifications indicated above, also in relation to the derogations provided for in Law Decree 18/2020 (Articles 15 and 16), better specified in Annex 1 to this notice, we are in any case interested in evaluating other equipment having technical and protective characteristics indicated below, even if manufactured with different and innovative materials or processes: such materials and devices can be further considered suitable by the Istituto Superiore di Sanità or INAIL and, therefore, compliant with current regulations.


In particular, the Politecnico di Milano has provided us with very useful technical details that you can find in the Instructions for sending samples and in Annex 2 to this document and which contain instructions that we invite you to carefully consider when manufacturing suitable equipment.


Moreover, Annex 3 contains a "Checklist for medical face masks without CE marking" with additional information.


With reference to lab coats, Headgear caps and overshoes; for hospital / health use, useful indications and technical specifications are shown in Annex 4 - Technical Note Coats.


To protect the health of the whole community, we would like to inform you that for the masks intended to be used by citizens not included in the health categories or workers, Lombardy Region will still recommend the use of products with the characteristics provided by the Politecnico di Milano.

 

We would also like ask you to inform us of your availability to supply this additional equipment, also necessary to deal with the Covid19 emergency:

 

Protective visors; 

Safety goggles

Protective mask goggles;

Water-alcohol mixture in litres;

Respirators;

Intensive care units.

 

If the equipment you propose are deemed suitable for the current needs, we will transfer the report to the regional purchasing centre (Aria S.p.a.) for the related procedures, and inform all the interested parties of this availability.

For further information on the technical standards for the manufacturing of face masks and personal protective equipment, public administrations and companies can also check the UNI – Ente Italiano di Normazione website. On this page, the site provides for free, upon registration, the technical standards defining the safety and quality requirements and test methods of the equipment essential to prevent contagion from COVID-19.

Annex 1 - Regulatory Framework

Documento PDF - 37 KB

How to send Samples

Documento PDF - 147 KB

Annex 4 - Technical Note Gowns- v 3.0 of 4 April 2020

Documento OpenOffice - 129 KB

08/04/2020