How can ISO 18562 protect patients with COVID-19?

ISO 18562 protects patients that require ventilators

There has been a lot of news about the lack of ventilators in hospitals to support an increase in patients with severe COVID-19 symptoms.

It is fantastic to see so many great manufacturing companies rising to the challenge of increasing the numbers of ventilators available to our hospitals. Not only do companies need to design, engineer, and manufacture ventilators quickly; they also need to ensure that ventilators meet strict national and international standards required to ensure that they and do not cause further harm to patients. ISO 18562 is one of a number of guidelines that does this.

ISO 18562 focuses on the biocompatibility evaluation of breathing gas pathways in healthcare applications (e.g. ventilators). It is in place so that any materials used in the breathing gas don’t pose a risk to human safety due to compounds which may migrate from materials such as plastics and rubbers.

This standard is built around a risk management framework and is split into four parts focused on determining the risk to patient safety.

  • ISO 18562-1: Evaluation and testing within a risk management process. It defines the general principles for the biocompatibility evaluation of medical devices and the testing which may be required.
  • ISO 18562-2: Tests for emissions of particulate matter generated by respiratory medical devices. Required for materials which are in the breathing gas pathway.
  • ISO 18562-3: Tests for emissions of volatile organic compounds (VOCs). Required for materials which are in the breathing gas pathway. The aim of this test is to detect and quantify potential contamination of the breathing pathway due to volatile compounds from the medical device and/or accessories.
  • ISO 18562-4: Tests for leachables in condensate. Recommended for devices where there is a potential for expired air to be recirculated to the patient. The aim of this test is to detect and quantify potential water-soluble compounds.

It is vital to understand the identity and level at which compounds migrate from the materials used in ventilators. Depending on the materials used, compounds which are harmful may migrate from the material and be inhaled by patients, causing them harm.

Identifying and quantifying these potential compounds can be challenging, particularly at the low levels (2 µg per m3) which may have a toxicological effect.

Hall Analytical have over 20 years’ experience in material analysis for extractables and leachables. With an extensive range of analytical equipment (UV/IR/HPLC(HRMS)/GC(MS)/ICP-MS) and sample preparation equipment, Hall have a long history of supporting customers with trace analytical identification and quantification. We have performed thousands of tests on a range of products and materials as well as a knowledge base with over 25,000 entries.

Hall Analytical is well placed to support your testing needs. For more information, contact us at [email protected]