Growing safety requirements for respiratory medical devices - ISO 18562 standards
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
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.
- 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