Standard: AAMI 14155-1

CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS

This standard is available for individual purchase.

or unlock this standard with a subscription to IHS Standards Expert

IHS Standards Expert subscription, simplifies and expedites the process for finding and managing standards by giving you access to standards from over 370 standards developing organizations (SDOs).

FEATURES & BENEFITS
  • Maximize product development and R&D with direct access to over 1.6 million standards
  • Discover new markets: Identify unmet needs and discover next-generation technologies
  • Improve quality by leveraging consistent standards to meet customer and market requirements
  • Minimize risk: Mitigate liability and better understand compliance regulations
  • Boost efficiency: Speed up research, capture and reuse expertise
For additional product information, visit the IHS Standards Expert page.

HOW TO SUBSCRIBE
For more information or a custom quote, visit the IHS Contact Us page for regional contact information.
Scope:

This part of ISO 14155 defines procedures for the conduct and performance of clinical investigations of medical devices. It specifies general requirements intended to

— protect human subjects,

— ensure the scientific conduct of the clinical investigation,

— assist sponsors, monitors, investigators, ethics committees, regulatory authorities, and bodies involved in the conformity assessment of medical devices.

This part of ISO 14155

a) specifies requirements for the conduct of a clinical investigation such that it establishes the performance of the medical device during the clinical investigation intended to mimic normal clinical use, reveals adverse events under normal conditions of use, and permits assessment of the acceptable risks having regard to the intended performance of the medical device,

b) specifies requirements for the organization, conduct, monitoring, data collection, and documentation of the clinical investigation of a medical device,

c) is applicable to all clinical investigation(s) of medical devices whose clinical performance and safety is being assessed in human subjects.

This part of ISO 14155 is not applicable to in vitro diagnostic medical devices.

Organization: Association for the Advancement of Medical Instrumentation
Document Number: aami 14155-1
Publish Date: 2003-01-01
Page Count: 30
Change Type: REAF
Available Languages: EN
DOD Adopted: NO
ANSI Approved: YES
Most Recent Revision: YES
Current Version: NO
Status: Inactive

This Standard References

Showing 4 of 4.


Advertisement
Advertisement
Advertisement
Advertisement