ANSI TIR-19218-1-2011 pdf download Medical devices — Hierarchal coding structure for adverse events — Part 1 : Event-type codes
1 Scope
This part of ISO/TS 19218 specifies requirements for a hierarchical coding structure for describing adverse events relating to medical devices. The codes are intended for use by medical device users, manufacturers, regulatory authorities, health care facilities and other organizations. The codes can be used for coding events that are not related to death or serious injury, or malfunctions that could lead to death or serious injury.
This part of ISO/TS 19218 is not intended to be used to decide whether an incident is reportable or not.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
adverse event
event associated with a medical device that led to death or serious injury of a patient, user or other person, or that might lead to death or serious injury of a patient, user or other person if the event recurs
NOTE 1 This definition is consistent with guidance in GHTF/SG2/N54/R8:2006 [7] .
NOTE 2 This definition includes malfunction or deterioration of a device which has not yet caused death or serious injury, but which could lead to death or serious injury.
2.2
serious injury
serious deterioration in a state of health that constitutes either a life-threatening illness or injury, or a permanent impairment of a body function or permanent damage to a body structure, or a condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure
NOTE 1 The term “permanent” means irreversible impairment or damage to a body structure or function,
excluding minor impairment or damage.
NOTE 2 This definition is consistent with guidance in GHTF/SG2/N21/R8:1999 [5] .
2.3
intended use
intended purpose
objective intent of the manufacturer regarding the use of a product, as reflected in the specifications,instructions or information provided by the manufacturer
NOTE This definition is consistent with GHTF/SG1/N41/R9:2005 [4] .
ANSI TIR-19218-1-2011 pdf download
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