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Growing safety requirements for respiratory medical devices - ISO 18562 standards

For many, a deep relaxing breath is not possible without a respiratory medical device. These people rely on it to a great extent – and any contamination of these airpath components could pose health hazards. Such devices are being regulated under the ISO 18562(biocompatibility evaluation of breathing gas pathways in healthcare applications) which is recognized by the FDA for biocompatibility evaluation of breathing gas pathways applications.

Tests under ISO 18562 aim to secure respiratory tract safety

The ISO 18562 standards outlines the biocompatibility evaluation of breathing gas pathways in healthcare applications. 
The parts or accessories which are intended to provide respiratory care or supply medicines via the respiratory tract to a patient in all environments are subject to biological evaluation detailed in ISO 18562. The standards cover ISO 18562-1: evaluation and testing within a risk management process, ISO 18562-2: tests for emissions of particulate matter , ISO 18562-3: tests for emissions of (VOCs) and ISO 18562-4: Tests for leachables in condensate.

Covestro offers material solutions that help device manufacturers meet ISO18562

The Covestro medical grade Polycarbonate M2858 was evaluated the biocompatibility according to ISO 18562 and specifically tested according to ISO 18562-3 (tests for emissions of volatile organic compounds or VOCs) and ISO 18562-4 (tests for leachables in condensate) and was found to meet the requirements.
 
We offer medical polycarbonate Makrolon® grades complying to ISO18562. 
 
Successful applications can be found in gas pathway components used in CPAP (Continuous positive airway pressure) equipments, ventilators and other respiratory devices. For more product information and regulatory support, please contact us at plastics@covestro.com.

Covestro provides material solutions that meet the growing safety requirements for respiratory medical devices. This enables our customers to enhance device safety and compliance, further supporting the medical industry’s advancement.

Marina Lee

Senior Marketing Manager, Healthcare, Asia Pacific Engineering Plastics, Covestro

Key Benefits

  • Biocompatibility Biocompatibility according to ISO 10993and ISO 18562
  • Transparency Glass-like transparency for visual monitoring
  • Overmolding adhesion Self-adhesive liquid silicone rubber for air-tight components
  • Sterilization Versatile sterilization by EtO, gamma & e-beam
  • Physical properties Impact resistant, robust & lightweight

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