Trendwatch™ Overcoming 5G Component Challenges (English)

Trendwatch™ Overcoming 5G Component Challenges (English)

Trendwatch™ Overcoming 5G Component Challenges (English)

Trendwatch™ Overcoming 5G Component Challenges (English)

Microsoft Word - 55324 Letter of Conformity RCMS Option 2 .docx ABS Quality Evaluations Letter Of Conformity This is to confirm that the Environment, Health, Safety and Security Management System of: PolyOne Corporation 2400 East Devon Elk Grove, IL 60007 U.S.A. WITH ADDITIONAL FACILITIES LISTED ON THE ATTACHED ANNEX) has been assessed by ABS Quality Evaluations, Inc. and found to be in conformance with the requirements set forth by: RCMS®:2013 (Option 2) The Environment, Health, Safety and Security Management System is applicable to: Design and Manufacture of Colorants for Plastics Certificate No: 55324 Effective Date 21 December 2017 ABS Quality Evaluations, Inc. 16855 Northchase Drive, Houston, TX 77060, U.S.A.

CATEGORY DETAIL EC Number 215-175-0 CAS Number 1309-64-4 Name Subclass 1 Antimony Trioxide (ATO) Structural Formula CHEMICAL IDENTITY PROPERTY DETAIL Physical State Solid Form Powder Color White Odor Odorless Melting Point 656°C Boiling Point 1425°C Bulk Density 5.20 g/cm3 Water Solubility Slightly Soluble PHYSICAL/ CHEMICAL PROPERTIES HEALTH EFFECTS HUMAN HEALTH SAFETY ASSESSMENT Consumer It is very unlikely that consumers would be exposed to ATO in its concentrated form because it is only sold for industrial use to make polymers and other products and is not sold directly to consumers. EXPOSURE HUMAN HEALTH SAFETY ASSESSMENT Human Health Consumers are not likely to be exposed to because it is not sold directly to consumers nor are sales to consumer markets endorsed.

These customizable color solutions enhance brand value and promote product differentiation for medical device, cosmetic, or pharmaceutical polymer applications. OnColor HC Plus Colorants have been tested across a wide range of medical polymers to provide added confidence in meeting these critical bio- compatibility standards. KEY CHARACTERISTICS • Polymer colorants formulated specifically for healthcare product applications • Meets and exceeds various material performance requirements including FDA 21 CFR, ISO 10993 and USP Class VI • HC Plus colorants certified for bio-compatibility • Available as pre-color, concentrate, masterbatch or Smartbatch™ combined colorant/additive solution • Wide range of colors, striking special effects and custom color matching MARKETS AND APPLICATIONS OnColor™ HC and HC Plus Colorants are an excellent choice for medical devices and parts, pharmaceutical or cosmetic packaging, and many other healthcare related polymer applications.

It is the responsibility of the medical device manufacturer and the person placing the medical device on the market to ensure compliance of the medical device with all applicable laws and regulations, including the suitability of all raw materials and components used for its manufacture.

MEDICAL DEVICE DISINFECTION—HOW TO PREVENT CRACKING AND CRAZING Understanding polymer performance is key to minimizing disinfectant-related failures DISINFECTANT-RELATED DAMAGE ON POLYMER HOUSINGS Strong chemicals used to reduce hospital- acquired infections can damage equipment and result in material failures, such as: • Stress cracking • Crazing • Discoloration CHEMICAL RESISTANCE REQUIREMENTS VARY BY ENVIRONMENT • Patient/exam rooms • Operating and radiology rooms • Reception areas • Home (patient equipment & devices) Healthcare devices must perform flawlessly in a myriad of challenging environments and engineers must be certain their devices can withstand increasingly potent disinfectants, which have begun to outstrip the performance of traditional polymers. Additionally, the wide variability of environments that medical devices might see, which can range from home to hospital, mean devices must be able to withstand varying disinfectant strengths, exposure levels and frequencies. Whether you are designing for a medical device housing or a surgical device in the operating room, we offer solutions to meet a wide variety of performance specifications and application needs.

 Consider environmental, health and safety impacts into product design, manufacture, use, reuse, recycling and disposal  Promote openness and two-way communication with key stakeholders regarding environmental, health and safety measures and risks associated with use, storage, transportation and disposal of our products.