Elenco e breve descrizione dei criteri di selezione
All economic operators wishing to compete in this tender must produce, together with the remaining documentation provided for in this announcement and in the tender regulations, under penalty of exclusion from this procedure, the quality certification inherent to the ISO 9001 quality management system, in course of validity, issued by an accredited ACCREDIA body or another body in mutual recognition. In the case of R.T.I. (constituting or constituting) said certification must be in possession of all the economic operators gathered.
In addition, with reference to the manufacturer of the nitrile gloves that the competitor intends to offer, the following documentation must be produced — under penalty of exclusion from the tender
(a) certification relating to the quality management system UNI CEI EN ISO 13485: 2016/AC: 2018 regarding the requirements that allow an organisation to demonstrate its ability to provide medical devices and related services that comply with the regulatory requirements applicable to such devices doctors.
(b) CE certification pursuant to UNI EN 374: 2016, currently valid, relating to the product to be offered, issued by a notified body, verifiable by accessing the ‘NANDO’ system of the European Commission, which registers all the notified bodies for the 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 Accredia Accreditation Body (
www.accredia.it), pursuant to Regulation (EU) 2016/425 on personal protective equipment (PPE).
In particular, the aforementioned certification must be issued in compliance with:
— UNI EN 374-1 (resistance to chemical products and dangerous microorganisms), Type B — the permeation characteristics must be at least level 2 with respect to a minimum of three test chemicals among those listed below:
Code Letter Chemical Cas Number Class
J n-Heptane 142-82-5 Saturated hydrocarbon
K Sodium hydroxide 40 % 1310-73-2 Inorganic base
P Hydrogen peroxide 30 % 7722-84-1 Peroxide
T Formaldehyde 37 % 50-00-0 Aldehyde.
— UNI EN 374-5 (resistance to the passage of viruses).
(c) EN 455 certification, in particular:
— EN 455-1 (LQA of 1.5) — absence of holes;
— EN 455-2 with reference to surgical gloves, both for the parameters of dimensions and breaking load before aging — physical properties requirements and tests;
— EN 455-3 - biological evaluation;
— EN 455-4 - determination of shelf life.
(d) declaration of conformity according to Annex IX of Reg. (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment.
All the aforementioned certifications required and the related test reports must be:
— in the name of the manufacturer;
— referring to the model of gloves supplied.
In particular, the certification certificates must also bear the number of the corresponding test report.