ISO 14155
Also written as: ISO — International Organization for Standardization
International standard governing good clinical practice for medical device clinical investigations.
Full Definition
ISO 14155 is the international standard that specifies requirements for the design, conduct, recording, and reporting of clinical investigations conducted to assess the safety and performance of medical devices. For cardiac device manufacturers, compliance with ISO 14155 is essential for clinical studies supporting regulatory approvals. The standard covers protocol development, investigator qualifications, data management, adverse event reporting, and quality assurance requirements specific to medical device research.
Usage
Usage note: Always include the numerical designation; ISO alone is insufficient.
In Context
- "The clinical investigation protocol was developed in accordance with ISO 14155 requirements." — Regulatory submission
- "ISO 14155 compliance ensures international acceptance of clinical data for device approvals." — Quality manual