Element provides biocompatibility analysis and toxicology services as per ISO 18562 for respiratory and ventilation devices. We work closely with customers to help identify all necessary testing and compliance requirements to support global device approval from relevant regulatory bodies.
ISO 18562 testing to support your product compliance journey
Element operates a global network of medical device testing facilities with extensive experience in ISO 18562 testing for breathing gas pathways including respiratory and ventilation devices and accessories.
Our ISO 18562 studies test for hazards associated with breathing gas pathway devices to determine the product’s biocompatibility for medical use, test include;
- leachable condensates,
- particulate matter,
- Volatile Organic Compounds (VOCs).
These studies are designed to assess the compliance of breathing gas pathway devices to support U.S. FDA or EU MDR device requirements helping to ensure global compliance and reduce the likelihood of delays to market.
What is ISO 18562 testing?
ISO 18562 studies comprise of a series of standards that outlines the general principles for the evaluation of breathing gas pathways of medical devices.
We support our customers with ISO 18562 standards across four parts, as shown below. Our laboratories utilize state-of-the-art equipment such as thermal desorption gas chromatography mass spectrometry (GC-MS), direct injection GC-MS, Inductively coupled plasma mass spectrometry (ICP-MS).
ISO 18562-1: Evaluation and testing within a risk management process
A flow diagram of the risk management process is available in our free to download whitepaper titled: ISO 18562 Biocompatibility Evaluation of Breathing Gas Pathways
ISO 18562-2: Testing for emissions of particulate matter
The standard describes testing methodology and acceptance criteria for the quantitation of particles ranging from 0.2 μm to 10 μm in diameter. The acceptable levels of particulate matter generated by respiratory medical devices are based on worldwide published health data.
ISO 18562-3: Testing for emissions of VOCs
The potential contamination of the gas stream in a respiratory medical device due to the presence of VOCs presents a significant risk in terms of patient safety. These compounds often cause irritation to the eyes, nose and throat and can have toxic, carcinogenic, mutagenic and / or genotoxic effects on humans.
ISO 18562-4: Testing for leachables in condensate
The final part of the standard is only applicable where a medical device has the potential to form a condensate during clinical use.
A simulated use extraction study of the device is performed and any potential inorganic or organic leachables are characterised using a combination of Inductively Coupled Plasma (ICP) and Gas Chromatography-Mass Spectrometry (GC-MS) techniques.
The Element advantage
With one of the largest and most experienced Extractables & Leachables practices in the world, in addition to unparalleled experience testing a breadth of products that extend from pharmaceuticals, biologics, and devices, to consumer products and more, as your regulatory and scientific partner, Element will help you to navigate the most efficient path to regulatory approval.
Element Materials Technology Analytical Services conducts all studies with the highest degree of scientific integrity, under our Quality Management System. Our analytical laboratories feature the latest state-of-the-art equipment that we operate in compliance with Good Laboratory Practice (GLP) quality systems.
Read our blog post in response to the FDA class 1 recall of 2 million medical devices
Demand for ISO 18562 medical device testing has accelerated as the result of class 1 medical device recall (MDR).
The recall involves various types of mechanical ventilators, including bi-level airway pressure (BiPAP) and, continuous positive airway pressure (CPAP).
White paper: Download our paper on ISO 18562-Biocompatibility Evaluation of Breathing Gas Pathways
This paper explains the importance of biocompatibility studies in the R&D stages of product development, and the significance of ISO 18562 as the framework to assess the risks associated with the breathing gas pathway products used for within healthcare.
This white paper was authored by Mike Ludlow, Market Development Manager for extractables & leachables studies in Manchester.
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Your global partner from discovery to market
Still researching? Here are a handful of our many services to help achieve regulatory approval quickly and efficiently.
Extractables and Leachables Studies
Our extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.
Pharmaceutical and Biopharmaceutical Unknown Identification and Impurity Testing
Our experts work closely with customers at every stage of the product lifecycle to identify unwanted compounds and ensure products are pure, safe, and quality.
Troubleshooting and Updating Analytical Methods
Element provides troubleshooting and updating analytical methods services to help you achieve more consistent product quality, more efficient manufacturing, reduce cost and save money.
Excipient Raw Materials and Container Testing
Element has comprehensive capabilities that can be applied to the testing of excipient, raw materials, and pharmaceutical containers, enabling you to ensure the quality and safety of your product.
Forced Degradation Studies
Element’s forced degradation, stress testing services per ICH Q1A guidelines assess the stability of drug substances or drug products with effects on purity, potency, and patient safety.
Pharmaceutical Stability Storage and Testing
Element offers advanced pharmaceutical stability testing and ICH storage services to ensure the maintenance of product quality, safety and efficiency throughout the shelf life.
Elemental Impurity Testing and Analysis
Element’s trace metal laboratories provide expert elemental impurities testing and analysis in compliance with USP and ICH Q3D guidelines to ensure the safety of drugs and drug products.
CMC Product Development Services
Our CMC product development services include formulation development, parenteral and topical product development, microbiology testing services, and consultancy.