Example 1 'Default' Configuration (ISO 13485)

This configuration maps most closely to the terms of the ISO 13485 as below:  



Code
{
  "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 }
      ]
    }
  ]
}