Page 258 - Safety Risk Management for Medical Devices

APPENDIX A: GLOSSARY

ADE Adverse Device Effect
AE Adverse Event
AFAP As Far As Possible; equivalent to ALAP
ALAP As Low As Possible; equivalent to AFAP
ALARP As Low As Reasonably Practicable
Benefit In the context of risk management, benefit refers to Clinical Benefit and is defined as: positive
impact or desirable outcome of a diagnostic procedure or therapeutic intervention on the health of
an individual or a positive impact on patient management or public health. Benefits can be described
in terms of magnitude, probability, and duration, among others [3]
BRA Benefit Risk Analysis
CAPA Corrective and Preventive Actions
CCF Common Cause Failure
CFR Code of Federal Regulation
CHL Clinical Hazards List
CIP Clinical Investigation Plan
CRC Cyclic Redundancy Check
DFMEA Design Failure Modes and Effects Analysis
DMR Device Master Record
EMBASE Database published by Elsevier, contains over 11 million records with over 500,000 citations
added annually. EMBASE’s international journal collection contains over 5000 biomedical journals
from 70 countries
Essential Design Output (EDO) Those design outputs that are essential to the proper functioning of
the device those functions that are related to safety and efficacy [21 CFR y820.30]
Essential Performance Performance of a clinical function, other than that related to basic safety, where
loss or degradation beyond the limits specified by the manufacturer results in an unacceptable risk
Essential Requirements MDD/AIMDD Annex I. Requirements having to do with safe and effective
performance of medical devices
EUDAMED The European information exchange system on Medical Devices
Failure Inability of an entity to achieve its purpose. This could be with no faults
Failure Mode The manner in which a product (system, subsystem, or component) can fail to perform
its desired function, or meet its process or design requirements
Fault An anomalous condition for a part. Could result in failures
FMEA Failure Modes and Effects Analysis
FT Fault Tree
FTA Fault Tree Analysis
GUI Graphical User Interface
HAL Harms Assessment List
HHA, HHE Health Hazard (Analysis, Appraisal, Evaluation)
HiPPO Highest Paid Person in the Office
HS Hazardous Situation
IB Investigator’s Brochure
IFU Information for Use
ISAO Information Sharing Analysis Organization
KOL Key Opinion Leader

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