Learn about US FDA 510(K), a premarket notification program that helps demonstrate the safety and effectiveness of a medical device in support of its intended use in the U.S.
In this webinar recording delivered live on June 6 2017, Scott Steady, a UL expert in the area of Environmental testing, provided an overview of the series of standards, the scope, testing required and best practices.
Presenter
Scott Steady: senior product manager, UL Environment
Scott Steady graduated from Louisiana State University with a bachelor’s degree in chemical engineering. He has worked as an air quality consultant helping industrial facilities comply with the EPA’s Clean Air Act regulations. For the past 15 years, Scott has been working with product manufacturers to help them understand their products impact on chemical exposure and health. He participated in the development of chemical emissions test methods for UL’s GREENGUARD Certification Program, the BIFMA furniture emissions standards and many other product related sustainability initiatives.
Overview of ISO 18562
US FDA 510(k) submissions must include data regarding the biocompatibility of any patient contacting (directly or indirectly) materials on all medical devices. For respiratory and ventilation devices, a key component of the biocompatibility evaluation is measuring chemicals and particles that may be released into the breathing gas pathway.
Previously only general guidance was provided to define how manufacturers should measure and assess biocompatibility of the breathing gas pathway. The series of standards ISO 18562, Biocompatibility Evaluation of Respiratory Gas Pathways in Healthcare Applications, were formed to provide additional guidance and standardization for evaluating respiratory and ventilation devices.
What’s covered by ISO 18562
The test methods and risk assessment requirements in these standards apply to all medical devices, parts and accessories that may contact the breathing gas pathway. The scope of products effected by these standards include:
- Ventilators
- Anesthesia workstations (including gas mixers)
- Breathing systems
- Oxygen conserving equipment
- Oxygen concentrators
- Nebulizers
- Low pressure hoses
- Humidifiers
- Heat and moisture exchangers
- Respiratory gas monitors
- Respiration monitors
- Masks
- Mouth pieces
- Resuscitators
- Breathing tubes
- Breathing systems filters
- Y-pieces
What you will learn in this ISO 18562 webinar
In this webinar, Scott Steady, a UL expert in environmental testing, will provide:
- An overview of the ISO 18562 series of standards and the scope
- Testing procedure and requirements
- Best practices for testing medical devices to the standard
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