ISO 18562 Testing for Medical Respiratory Devices

Recently, China's JJRLAB laboratory successfully obtained the CNAS (China National Accreditation Service for Conformity Assessment) accreditation certificate for ISO 18562 standard testing, based on ISO/IEC 17025 standards.

Scope of Accreditation Includes:

- ISO 18562-2:17: Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter.

- ISO 18562-3:17: Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs).

JJRLAB had already received ISO/IEC 17025 accreditation from the International Accreditation Service (IAS) in 2018 for these testing capabilities. This new CNAS accreditation further underscores JJRLAB’s professional assessment capabilities. We provide diverse testing solutions for respiratory gas pathway products in medical devices, aiding clients in accelerating their entry into global target markets.

ISO 18562 Testing Reports:

ISO 18562 series testing evaluation reports are essential for respiratory medical device manufacturers applying for US FDA registration and EU MDR certification. The ISO 18562 standards outline risk management processes for the biocompatibility assessment of medical devices used in respiratory care or for delivering anesthesia or other substances via the respiratory tract, along with corresponding test methods for particulate release, volatile organic compound release, and leachables. Applicable products include ventilators, oxygen concentrators, anesthesia machines, nebulizers, respiratory tubing, and masks.

Our Testing and Services:

Our tests, including particulate matter (PM), volatile organic compounds (VOCs), and extractable condensates, and toxicological exposure assessments, are designed to evaluate medical device compliance according to ISO 18562 standards.

Our Services and Advantages:

- JJRLAB offers a wide range of ISO 18562-related services, helping medical device manufacturers understand and meet market and regulatory requirements efficiently, thereby facilitating international market expansion.

- Our medical device team has extensive experience in biocompatibility assessment, providing services to Chinese medical device manufacturers since 2018.

- We possess a global laboratory network capable of performing ISO 18562 testing for respiratory and ventilation devices and their accessories.

- By understanding device operating conditions, usage instructions, and operating modes, we help manufacturers develop testing plans that adequately cover adverse situations to identify potential contaminants.

- We provide evaluations of the release of VOCs, particulate matter, and inorganic gases (such as carbon monoxide and ozone) from medical devices and assess risk levels, aiding in FDA 510(k) applications.

- We offer biocompatibility assessments for respiratory and ventilation devices and their accessories, including various exposure risk assessments covered by ISO 18562 standards.

- JJRLAB is well-versed in the EU MDR and US FDA 510(k) submission processes, with extensive practical experience, enabling us to help companies identify necessary testing and compliance requirements early on. This significantly reduces the risk of application rejection and minimizes costly retesting, thus shortening the time to market.

Additional Services:

JJRLAB also provides the following one-stop global market access services for medical devices:

- Medical device regulatory compliance services

- Quality Management System (QMS) certification for medical device manufacturers

- Medical Device Single Audit Program (MDSAP) certification

- EU Medical Device Regulation (MDR 2017/745) conformity assessment services

- UKCA certification

- Brazil INMETRO certification

- Medical device testing and certification services

- Electrical safety and usability testing for active medical devices and UL, CB certification

- Electromagnetic compatibility (EMC) testing/wireless RF testing and regulatory certification

- Non-clinical testing (biocompatibility, chemical characterization, etc.)

- Cybersecurity testing and certification services

- Packaging and transportation testing

- Optical testing and certification services.