ISO 22679:2021

Overview

ISO 22679:2021 - Cardiovascular implants - Transcatheter cardiac occluders defines performance requirements, testing considerations, and documentation expectations for intracardiac occluders intended for transcatheter implantation. The standard focuses on in vitro functional and durability characteristics of the occluder system, its delivery systems and accessories. It provides requirements and recommendations for performance tests without prescribing exact test methods. Surgical occluders, degradable or animal tissue components, active components (e.g., sensors), and some other device types are explicitly excluded.

Key topics and technical requirements

• Scope and applicability
  • Applies to intracardiac transcatheter occluders (e.g., atrial septal, ventricular septal, patent foramen ovale, left atrial appendage, paravalvular leak occluders) and may inform testing for patent ductus arteriosus occluders.
  • Covers both newly developed and modified devices, including accessories, packaging, and labelling.
• Fundamental requirements
  • Emphasis on risk management, device description, design inputs and outputs, and manufacturability.
• Design verification and validation
  • In vitro assessments: material property evaluation, structural performance, fatigue/durability, corrosion, visibility (imaging), dimensional verification, and simulated use testing.
  • Device MRI compatibility and visual inspection requirements.
  • Usability engineering and training considerations for implantation procedures.
• Preclinical and clinical evaluation
  • Preclinical in vivo testing guidelines and reporting expectations.
  • Clinical investigation planning: study design, endpoints, imaging protocols, sample size and ethical considerations.
• Supporting elements
  • Packaging, labelling, sterilization guidance, and adverse-event classification during clinical investigations.
  • Informative annexes addressing pediatric devices, fatigue assessment, delivery system evaluation, imaging protocols, and physician/staff training.

Practical applications and who uses this standard

• Medical device manufacturers developing or modifying transcatheter cardiac occluders and associated delivery systems.
• Design and QA/RA teams preparing verification/validation plans, clinical investigation protocols, and technical documentation for regulatory submissions.
• Test laboratories executing in vitro and preclinical testing to demonstrate device safety and performance.
• Clinical investigators, hospitals, and training teams implementing implantation procedures, imaging follow-up, and adverse-event reporting.
• Regulatory bodies and notified bodies assessing conformity and clinical evidence for cardiovascular implant devices.

Related standards (if applicable)

• ISO 22679 complements other ISO standards and guidance on sterilization, packaging, biocompatibility, and medical device risk management. For device-specific test methods and regulatory compliance, consult applicable national and international standards and regulatory guidance.

ISO 22679:2021 is a practical framework for evaluating safety, performance, and usability of transcatheter cardiac occluder systems, helping ensure consistent testing, documentation, and clinical evaluation across product life cycles.