Italy - Miscellaneous medical devices and products

Description

Acquisition of personal protective equipment to be distributed to the territorial and foreign branches (OFCN - Operations outside national borders) of the Air Force Health Service.
Disposable non-woven fabric, three or four layers. Tie-down or elastic fastening system. Type II. Standard: UNI EN 14683:2019 and UNI EN 13485:2016. Can be used with other PPE (goggles, headphones, etc). Must cover the nose, mouth and chin and adhere to the face. Must be equipped with double elastic. Standard: UNI EN 149:2001+A1:2009. Can be used with other PPE (goggles, earphones, etc). Semi-face masks suitable to cover the nose, mouth and chin and adhere to the face. Filtering FFP3 without suction valve, at least homologated EN 149:2001+A1+2009 "Respiratory protective devices-filtering half masks to protect against particles - Requirements, testing, marking" and suitable for protection against airborne biological agents. Must be fitted with double elasticated band Standard: UNI EN 149:2009. PPE Category III: with a wide field of vision, it must allow for the use of corrective glasses and a mask to protect the respiratory tract. The frontal system must be comfortable and anti-decubitus. Optical class 1. Resistance against projected particles S. Protection against liquids and splashes 3. Anti-fog treatment N. Anti-reflection. Standard: UNI EN 166:2004. PPE Category III: Unlimited field of vision, wrap-around fit and stackable with prescription glasses, with ventilation system, anti-fog lens, adjustable and breathable headband. The glasses must be washable and chemically disinfectable. Standard: UNI EN 166:2004. - Protective suit made of Tyvek material for protection against liquids, dust, chemical agents and particles, with hood. EN 14126 / EN 13034 / EN 1073-2 / EN 1149-5 / EN 13982-1.Quantity and sizes: 1) no. 20,000 XXL;2) no. 4,900 XL;3) no. 2,000 L;4) no. 100 M.- Tyvek protective footwear (or similar material) DPI category III: one size only (adults) with elastic at the calf, minimum height cm 48 with non-slip PVC sole in white colour. Standard: UNI EN 14126:2004. "Tychem coverall (or similar material) DPI Category III: coverall with reinforced and covered seams, double self-adhesive flap covering zip, elasticated cuffs, ankles and waist, 100% impermeable to particles, resistant to liquid splashes with pressure up to two bars, excellent barrier against inorganic chemical agents and biological risks. EN 14126 / EN 13034 / EN 1073-2 / EN 1149-5 /EN 13982-1.Quantities and sizes: - No. 10 000 XL,- No. 3 000 L. "Tychem protective socks" (or similar material) Knee-high socks with non-slip sole and laces. Partially stitched sole: splash-proof, not completely waterproof, flat seams and covered with tape. Standard: antistatic treatment (EN 1149-5) - internal only Conforms to EN 14126 (barrier against infectious agents). Non-sterile nitrile examination gloves, single-use, minimum length 240 mm with tolerance + or -10 %, ambidextrous, latex free with adequate thickness.Packaging: boxes of 100 pcs - standard: UNI EN ISO 374-1:2018 and UNI EN ISO 374-5:2017Quantities and sizes: - n. 18 000 XL,- n. 11 000 L,- n. 1 000 M. Hydroalcoholic gel solution (100 ml package)In a concentration of not less than 70 % V/V. The percentage is specified in Min. Sal. 0005443 of 22.2.2020 as being necessary and sufficient to inactivate the SARS-CoV-2 virus and therefore binding for procurement. Standard: Authorization Ministry of Health "Hydroalcoholic gel solution" (5 l package) In a concentration of not less than 70 % V/V. The percentage is specified in the Ministry of Health Directive. The percentage is specified in the directive Min. Sal. 0005443 of 22.2.2020 as being necessary and sufficient to inactivate the Sars-Cov-2 virus and thus binding for procurement. Standard: Authorization Ministry of Health. Filter for protection against infectious agents and solid and liquid aerosols, classified as P3 for protection against dust. Can be used with full-face and half-face masks with universal threaded connection EN 148/1. Mechanical filtration. The filter must have the following technical characteristics:- weight 100 g each,- made of Latex Free material,- individually wrapped.Standard: CE certification as Category III PPE in compliance with Directive 89/686/CE (transposition of Legislative Decree 4.12.1992 n. 475);Certificate for protection from infective agents of groups 2 and 3 listed in Annex III of Directive 54/2000/CE.Certified for protection against solid and liquid aerosols in compliance with EN 143 which classifies it as P3.Equipped with a fitting with EN148/1 threading.The expiry date, if any, allows the filter to be used for at least five years;Certification (EU) 2016/425; Cat III, Type PB [6-B]; EN 14126 is clearly indicated on the packaging and on the accompanying documentation.Reference product: Filter GVS BIO P3 Manufacturer code SFF00301 or equivalent with comparable or superior characteristics. For thorough disinfection and cleaning of sensitive areas in the medical and food industries. The fine perforated structure of the wet wipes should ensure even surface distribution of the disinfectant. Easy to handle thanks to the perforated tear-off. After cleaning, the lid of the dispensing bin can be closed and the wipes remain moist for more than 30 days, ensuring constant cleaning and disinfection.Dispensing bin: for one roll of wipes. Made of plastic, resealable and reusable.Disinfectant wipes: viscous, white, fine, tear-resistant, absorbent and residue-free cloth. Dimensions: 300 mm x 320 mm 1 roll of 90 sheets.Reference product: LLG Wiper Bowl® Safe & Clean Dispenser + LLG- Multitex® DR Wipes or equivalent with comparable or superior characteristics. Canvas tape, highly adhesive, resistant and waterproof in rolls of 50 mm X 10 mt. Neutral or transparent colour; its sturdiness must allow heavy and wearing treading; flexible; resistant to corrosive and acid chemical substances; waterproof; high thermal resistance; 6 m wide; 50 m long. Sanitizing and sanitizing aerosol can for environments, objects and surfaces to be used with an automatic timed diffuser.Standard: certified effective on coronavirus. Authorized by the Ministry of Health.

Opportunity closing date

14 July 2021

Value of contract

£1m-5m