Submit
respiratory medical devices
Story

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.
Contact expert Request a sample Request a quote

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 Makrolon® 2858 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

Contact us

Contact Partner

오늘 문의해주신 주제는 무엇입니까?

자신을 어떻게 설명하시겠습니까?

귀하는 어떤 유형의 자료에 관심이 있으십니까?

귀하는 어떤 유형의 산업에 관심이 있으십니까?

이것은 어떤 유형의 조회입니까?

귀하에게 연락할 수 있는 방법은 무엇입니까?

요청 주제는 무엇입니까

우리에게 보내는 메시지

*필수 필드

데이터 처리에 대한 자세한 내용은 개인정보 처 리방침에 서 확인할 수 있습니다.

Request a sample
{"FieldName":"ProductName","Endpoint":"https://covestro-prod-ffm.apimanagement.eu2.hana.ondemand.com/hybrispim/products_typeahead?identKey=GB6LiyNSG0YYxXXEpmO8EyoUdFLN0Roi&CLIENTID=DHLTHP&CLIENTSECRET=2DNknMSM9HF5ubP2qdBg&extended=true","Language":"ko","PermissionQuery":"","BrandLabel":"Brand","ProductLabel":"Product","NoResultLabel":"No results for","MaxItem":5}

Request a quote
{"FieldName":"ProductName","Endpoint":"https://covestro-prod-ffm.apimanagement.eu2.hana.ondemand.com/hybrispim/products_typeahead?identKey=GB6LiyNSG0YYxXXEpmO8EyoUdFLN0Roi&CLIENTID=DHLTHP&CLIENTSECRET=2DNknMSM9HF5ubP2qdBg&extended=true","Language":"ko","PermissionQuery":"","BrandLabel":"Brand","ProductLabel":"Product","NoResultLabel":"No results for","MaxItem":5}

Compare