ISO 18562: Biocompatibility of Breathing Gas Pathways
This course provides a comprehensive and practice oriented introduction to the biological evaluation of gas pathways according to ISO 18562. Participants learn how perform a risk assessment related to particulate matter emissions, volatile organic compound (VOCs) emissions and leachable substances in condensate, and how to integrate these assessments into a risk based process aligned with ISO 14971. The training explains the regulatory expectations under the MDR, the interface with ISO 10993, and the role of biocompatible materials within design verification. Through practical guidance and structured methodologies, participants gain the skills needed to prepare robust biological evaluations that withstand scrutiny from Notified Bodies.
Course Outline
- Regulatory framework for gas pathway devices under MDR
- Structure and application of ISO 18562 1 to 4
- Interface with ISO 10993 and ISO 14971
- Material characterization and hazard identification
- Assessment of particles, VOCs, and leachables
- Biological risk assessment and gap analysis
- Testing strategies and justification
- Compilation of biological evaluation plans and reports
- Communication with Notified Bodies
Learning Outcomes
Apply Regulatory Requirements with Confidence
- Regulation (EU) 2017/745 (MDR)
- ISO 18562 1 to 4
- ISO 10993 series and its complementary role
- ISO 14971 and the risk based approach
Implement Biological Evaluation in Practice
- Understanding terminology, scope, and applicability of ISO 18562
- Assessing emissions of particles, VOCs, and leachable substances in condensate
- Conducting material characterization and literature review
- Performing biological risk assessment and gap analysis
- Defining and justifying additional analytical or biological testing
- Compiling results into a structured biological evaluation
Manage Interfaces and Responsibilities
- Effective collaboration across R&D, Quality, Regulatory Affairs, and suppliers
- Documentation requirements for technical documentation
- Integrating biological evaluation into design verification
- Communicating effectively with Notified Bodies during conformity assessment
Use Data and Scientific Evidence
- Evaluating existing data and scientific literature
- Incorporating PMS/PMCF findings into biological risk assessment
- Using analytical results to support safety and performance claims
Who Should Attend
- Medical device manufacturers
- Technical documentation authors
- Regulatory Affairs professionals
- Quality Management specialists
- Research & Development teams
- Service providers supporting biological evaluations
Why You Should Attend
This course is ideal for professionals responsible for biocompatibility evaluation of breathing gas pathways in healthcare applications. It provides a clear understanding of ISO 18562, its regulatory context, and its practical application within a risk based evaluation process. Participants learn how to identify information gaps, determine testing needs, and prepare biological evaluations. The training strengthens confidence when interacting with Notified Bodies and supports the development of compliant, well structured technical documentation.
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