Example 1 'Default' Configuration (ISO 14971)
This configuration maps most closely to the terms of the ISO 14971 as below:
Code
JS
{
"mitigationTypes": [
{ "type": "SPEC", "name": "Specification", "required": "false" }
],
"maxGreen": 23,
"maxYellow": 35,
"method": "*",
"factors": [
{
"type": "hazard",
"label": "Hazard",
"weights": [
{
"type": "exposure",
"label": "Probability of Occurrence",
"help": "Exposure to Hazard",
"values": [
{ "shortname": "Almost never", "help": "Will almost never happen", "factor": 1 },
{ "shortname": "Not often", "help": "Will not happen often", "factor": 2 },
{ "shortname": "Occasional", "help": "Might happen sometimes", "factor": 3 },
{ "shortname": "Often", "help": "Might happen every time device is used", "factor": 4 },
{ "shortname": "Always", "help": "Always happens", "factor": 5 }
]
}
]
},
{
"type": "sequence",
"label": "Sequence of Events",
"inputType": "textarea",
"weights": []
},
{
"type": "situation",
"label": "Hazardous Situation",
"weights": [
{
"type": "probability",
"label": "Probability of Harm",
"help": "Probability of Harm",
"values": [
{ "shortname": "Not likely", "help": "0-20%", "factor": 1 },
{ "shortname": "Probable", "help": "20-80%", "factor": 2 },
{ "shortname": "Very likely", "help": "80-100%", "factor": 3 }
]
}
]
},
{
"type": "harm",
"label": "Harm",
"weights": [
{
"type": "severity",
"label": "Severity",
"help": "Severity of Harm",
"values": [
{ "shortname": "Negligible", "help": "No harm to patient or user", "factor": 1 },
{ "shortname": "Minor", "help": "Results in temporary injury or impairment not requiring professional medical intervention", "factor": 2 },
{ "shortname": "Serious", "help": "Results in injury or impairment requiring professional medical intervention", "factor": 3 },
{ "shortname": "Critical", "help": "Results in permanent impairment or life-threatening injury", "factor": 4 }
]
}
]
}
],
"reductions": [
{
"name": "00",
"options": [
{ "shortname": "no effect", "by": 0 },
{ "shortname": "reduces exposure to hazardous situation by 1", "changes": "exposure", "by": -1 },
{ "shortname": "reduces exposure to hazardous situation by 2", "changes": "exposure", "by": -2 },
{ "shortname": "reduces exposure to hazardous situation by 3", "changes": "exposure", "by": -3 },
{ "shortname": "reduces probability of harm by 1", "changes": "probability", "by": -1 },
{ "shortname": "reduces probability of harm by 2", "changes": "probability", "by": -2 }
]
}
]
}