Public procurement notice: Additional Information
Published: 2020-06-24
Buyer: Comando Generale dell'Arma dei Carabinieri — Centro Unico Contrattuale
Country: IT
Contract type: Supplies
Procedure: Open procedure
CPV classification: 33141000: Disposable medical supplies
Submission deadline: 2020-07-08
Award criteria: Lowest price

Technical requirements: Медицински консумативи, с изключение на химическите и хематологични консумативи, за еднократна употреба
Niet-chemische medische gebruiksgoederen voor eenmalig gebruik en verbruiksartikelen voor hematologie
Accelerated open procedure for the conclusion of a maximum of two ‘framework agreements’ lasting 12 months, each with only one or a plurality of economic operators usefully classified in the ranking, for the supply of surgical masks in the context of the health emergency by Covid-19.
b. certification of compliance with the UNI EN 14683: 2019 standard, currently valid, relating to the product to be offered, which certifies the possession of the following performance requirements envisaged by the aforementioned standard for Type IIR (ref. UNI EN 14683: 2019 for 5.2 0.7):
The aforementioned certification of compliance with the UNI EN 14683: 2019 standard will be accompanied by the official test report issued by a notified body, verifiable through access to the ‘NANDO’ system of the European Commission, which records all the notices notified for EU Regulation 425/2016 at the link: https://ec.europa.eu/growth/tools-d database/nando/index.cfm? Fuseaction=country.notifiedbody&cou_id=380 or via the website of the Italian Accreditation Accreditation 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 par. 5.2.6):
The official test report (test report) must also include the photographic reproduction of the objects being analyzed.
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 trade mark obtained, preliminarily, the authorization by the Istituto Superiore di Sanità (ISS), as required art. 15, co. 2 of the aforementioned Decree, referring to the model of mask to be provided and all the economic operator proposing (producer/importer) in the procedure with line https://www.iss.it/procedure-per-richiesta-production-mascherine. The outcome of the production, use and use authorization process can be consulted in the appropriate column of the authority sheet issued on the ISS website.
b. Declaration of conformity to directive 93/42/EEC issued by the manufacturer, in possession of the performance requirements provided for by UNI EN 14683: 2019 for Type IIR (ref. UNI EN 14683: 2019 para. 5.2.7):
The aforementioned declaration of conformity must be accompanied by the official test report on the aforementioned requirements issued by centers/bodies/bodies/certification institutes accredited by the ACCREDIA Certification body, or other body, even foreign, in silent recognition. 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):
The official test report must also include the photographic reproduction of the objects being analyzed.
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 (manufacturer/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.
Procedura aperta accelerata per la conclusione di massimo due «accordi quadro» della durata di 12 mesi, ciascuno con uno solo o una pluralità di operatori economici utilmente classificati in graduatoria, per la fornitura di mascherine chirurgiche nell’ambito dell’emergenza sanitaria da COVID-19.
b) certificazione di conformità alla UNI EN 14683:2019, in corso di validità, relativa al prodotto che si intende offrire, che attesti il possesso dei seguenti requisiti di prestazione previsti dalla predetta normativa per il tipo IIR (rife. UNI EN 14683:2019 para 5.2.7):
La suddetta certificazione di conformità alla UNI EN 14683:2019 dovrà essere corredata dal rapporto ufficiale di prova rilasciato da un organismo notificato, verificabile mediante accesso al sistema «NANDO» della Commissione europea, che registra tutti gli organismi notificati per il regolamento UE 425/2016 al link: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=country.notifiedbody&cou_id=380 o tramite il sito dell’ente italiano di accreditamento Accredia (www.accredia.it), ai sensi della direttiva 89/686/CEE e il regolamento (UE) 2016/425 sui dispositivi di protezione individuale (DPI). Inoltre, il suddetto rapporto di prova dovrà includere i risultati delle seguenti prove inerenti la biocompatibilità di cui alla EN ISO 10993-1:2019 (rife. UNI EN 14683:2019 para. 5.2.6):
Il rapporto ufficiale di prova (test report) dovrà includere, altresì, la riproduzione fotografica dei manufatti oggetto di analisi.