{
  "url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-2/paragraph-8",
  "json_url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-2/paragraph-8.json",
  "legislation": "uksi/1992/3146",
  "legislation_title": "The Active Implantable Medical Devices Regulations 1992",
  "legislation_url": "https://openlegislation.uk/active-implantable-medical-devices-regulations-1992",
  "path": "schedule/2/paragraph/8",
  "kind": "paragraph",
  "number": "8",
  "heading": "Requirements as to design and construction",
  "text": "The device shall be designed and manufactured in such a way as to remove or minimise so far as is possible—\n(a) the risk of physical injury arising out of its physical features (including its dimensions);\n(b) risks connected with the use of sources of energy, including, in the case of a device which uses electricity, risks arising from lack of adequate insulation, from leakage currents and from overheating;\n(c) risks connected with reasonably foreseeable environmental conditions such as magnetic fields, external electrical influences, electrostatic discharge, pressure, variations in pressure and acceleration;\n(d) risks connected with medical treatment, in particular those resulting from the use of defibrillators or high—frequency surgical equipment;\n(e) risks connected with ionising radiation from any radioactive substance included in the device in compliance with the protection requirements laid down in Directive 80/836/Eurotom as amended by Directives 84/467/Euratom and 84/466/Euratom;\n(f) risks which may arise where maintenance and calibration are impossible, including—\n(i) excessive increase of leakage currents,\n(ii) ageing of the materials used,\n(iii) excess heat generated by the device, and\n(iv) decreased accuracy of any measuring or control mechanism.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "OJ No. L246, 17.9.80, p. 1."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "OJ No. L265, 5.10.84, p. 4."
    },
    {
      "type": "footnote",
      "label": "f3",
      "text": "OJ No. L265, 5.10.84, p. 1."
    }
  ],
  "outstanding_effects": [
    {
      "type": "words substituted",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    },
    {
      "type": "words substituted",
      "affecting": "uksi/2002/236",
      "affecting_title": "The Medicines (Codification Amendments Etc.) Regulations 2002"
    }
  ],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1992/3146/schedule/2/paragraph/8",
    "retrieved_at": "2026-10-29T14:09:16.889291+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}