Example 1 'Default' Configuration (ISO 13485)
- Wolfgang Huber
- Yves Berquin [Matrix Requirements]
Owned by Wolfgang Huber
This configuration maps most closely to the terms of the ISO 13485 as below:
Code Expand source
{ "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 } ] } ] }