Labels for Use on Medical Devices
Product Information
These labels are UL Recognized under category PGJI2, file MH16635
* This information was provided by FLEXcon and may contain additional information outside the scope of this Claim Verification.
Applicable To:
MEDFLEX PLUS PMCGS(b), MEDFLEX PLUS PMWGS(b), MEDFLEX PLUS MMSMGS(b), MEDFLEX PLUS PMCMMS(b), MEDFLEX PLUS PMWMS(b), and MEDFLEX PLUS MMSMMS(b)
Marketing Claim Verified by UL Solutions
Exceeds marking durability requirements with 6 additional cleaning agents per IEC 60601-1
Verification Method
Samples were evaluated in accordance with IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance, Edition 3, AMD 2, Revision Date 08/2020, Clause 7.1.3 Durability of Markings. Additional solutions were evaluated as described below: - Anti-bacterial cleaning spray containing triclosan – 1 minute resting time after application, 30s rubbing duration. - Disinfecting wipe containing benzalkonium chloride – 2 minutes rubbing duration. - 32% Hydrogen peroxide (H2O2) Food Grade – 1 minute rubbing duration. - 0.1% Benzyldimethyldodecylammonium Chloride – 1 minute rubbing duration - 12.5% Sodium Hypochlorite – 30s rubbing duration. - Phenol Disinfectant – 10 minutes resting time after application, 30s rubbing duration. Markings were clearly legible after each solution was applied and the adhesive labels did not work loose or become curled at the edges. The process was repeated for each label when applied to each surface selected for testing. Samples were printed with IIMAK SP330, IIMAK SP575, RICOH B125CS, Inkanto Armor AXR8, and Inkanto Armor AXREL thermal transfer inks in black color only. Samples were applied to Aluminum, Stainless Steel, Galvanized Steel, Polypropylene, Polyethylene, Polystyrene, Acrylic Plastic, Polyethylene Terephthalate (Laminated on Aluminum), Polyvinyl chloride, and Nylon – Polyamide surfaces.
About the Company
About FLEXcon
FLEXcon Global is a leader in coated and laminated films and adhesives used as functional components in manufactured goods and in graphics applications. A family-owned company for over 65 years, FLEXcon serves as a development partner to engineers and designers to bring their innovative ideas from concept to reality, for markets such as sustainable packaging, consumer durables, transportation, electronics, industrial, healthcare, retail & advertising and construction & energy, with a focus on improving human lives through sustainable & emerging technology. Headquartered in Spencer, MA, USA, the company has operations and distribution throughout North America, Europe and Asia.
For more information, visit FLEXcon.com, see MedFLEX - FLEXcon, FLEXcon Healthcare and follow FLEXcon on LinkedIn, or call +1-508-885-8200.
What is UL Verification?
UL Verification is an objective, science-based assessment that confirms the accuracy of marketing claims. Our independent assessment process scrutinizes the validity of specific advertising or promotional statements, giving you a way to separate verified fact from fiction.
