Elenco e breve descrizione dei criteri di selezione
All economic operators wishing to participate in this tender must produce, together with the remaining documentation provided for in this call for tender and in the tender specification, under penalty of exclusion from this procedure, the quality certification relating to the ISO 9001 quality management system, in validity course, issued by ACCREDIA accredited body or other body in mutual recognition. In the case of R.T.I. (constituting or constituting) said certification must be in the possession of all the economic operators gathered.
Furthermore, with reference to the manufacturer of the surgical masks that the competitor intends to offer, the following documentation must be produced — under penalty of exclusion from the tender:
(a) certification relating to the UNI CEI EN ISO 13485: 2016 quality management system, currently valid, regarding requirements that allow an organization to demonstrate its ability to provide medical devices and related services that comply with the regulatory requirements applicable to such medical devices;
(b) certification of conformity to UNI EN 14683: 2019, currently valid, relating to the product to be offered, which certifies the possession of the following performance requirements provided by the aforementioned standard for Type IIR (ref. UNI EN 14683: 2019 para 5.2 .7):
Test requirement
Bacterial filtration efficiency (BFE) (%)> 98
Differential pressure (Pa / cm2) <60
Splash resistance pressure (kPa)> 16
Microbial cleaning (cfu / g) <30
The aforementioned certification of compliance with UNI EN 14683: 2019 must be accompanied by the official test report issued by a notified body, verifiable by accessing the ‘NANDO’ system of the European Commission, which registers all the bodies notified for EU Regulation 425/2016. at the link:
https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=country.notifiedbody&cou_id=380 or through the website of the Italian Accreditation Accredia Body (
www.accredia.it), pursuant to Directive 89/686 / EEC and Regulation (EU) 2016/425 on Personal Protective Equipment (PPE). In addition, the aforementioned test report must include the results of the following biocompatibility tests pursuant to EN ISO 10993-1: 2019 (ref. UNI EN 14683: 2019 para. 5.2.6):
TEst reference regulation
Cytotoxicity (ref. UNI EN 10993-1: 2009 para. 6.2.2.2) ISO 10993-5
Awareness (ref. UNI EN 10993-1: 2009 para. 6.2.2.3) ISO 10993-10
Intracutaneous irritation or reactivity (ref. UNI EN 10993-1: 2009 para. 6.2.2.4) ISO 10993-10
The official test report must also include the photographic reproduction of the objects being analyzed.
All the above mentioned certifications and related test reports must be:
— registered to the manufacturer of the masks,
— referring to the template model supplied.
In particular, certification certificates must also:
— report the number of the corresponding test report,
— be valid.
In compliance with the Legislative Decree 17 March 2020, n. 18, the masks eventually delivered by 31 July 2020 (unless extended) and without the CE mark, or in possession of an invalid mark, must first obtain authorization from the Istituto Superiore di Sanità (ISS), as required art. 15, co. 2 of the aforementioned Decree, referring to the template template to be provided and to the proposing economic operator (producer/importer) in line with the procedures
https://www.iss.it/procedure-per-richiesta-production-mascherine. The outcome of the production, marketing and use authorization process can be consulted in the appropriate column of the card on the authorizations issued available on the ISS website.