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.
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.
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:
- 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 volatile organic compounds (VOCs)
- ISO 18562-4: Tests for leachables in condensate
Using 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).
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).
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
Element's extractables and leachables studies offer tailored solutions that ensure patient safety and compliance with industry standards.
Extractables & Leachables Training Services
Element’s extractables and leachables training services address a wide range of topics in the industry to keep you up-to-date with the ever-changing regulations.
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.