{
  "node": {
    "id": "term:iso-13485",
    "type": "Term",
    "label": "ISO 13485",
    "properties": {
      "id": "iso-13485",
      "name": "ISO 13485",
      "aka": [
        "ISO 13485:2016",
        "medical device quality management"
      ],
      "section": "topic-standards-stationary",
      "definition": "The quality-management standard for designing and making medical devices, current edition 2016. Built on ISO 9001 but stricter on risk management, design control, supplier control and traceability of every component and lot, it is what battery-pack makers supplying medical manufacturers are expected to hold; the US FDA’s quality rule has incorporated it since 2026.",
      "related": [
        "iso-management-systems",
        "medical-device-batteries",
        "iec-60601-1",
        "traceability"
      ],
      "url": "https://lemonergy.com/learn/glossary/iso-13485/",
      "mentions": []
    }
  },
  "edges": [
    {
      "id": "edge:belongsTo/term:iso-13485/topic:topic-standards-stationary",
      "source": "term:iso-13485",
      "target": "topic:topic-standards-stationary",
      "type": "belongsTo",
      "properties": {
        "sourceFile": "terms.json"
      }
    },
    {
      "id": "edge:relatedTo/term:iso-13485/term:iso-management-systems",
      "source": "term:iso-13485",
      "target": "term:iso-management-systems",
      "type": "relatedTo",
      "properties": {
        "sourceFile": "terms.json",
        "meaning": "Related context; not a causal claim"
      }
    },
    {
      "id": "edge:relatedTo/term:iso-13485/term:medical-device-batteries",
      "source": "term:iso-13485",
      "target": "term:medical-device-batteries",
      "type": "relatedTo",
      "properties": {
        "sourceFile": "terms.json",
        "meaning": "Related context; not a causal claim"
      }
    },
    {
      "id": "edge:relatedTo/term:iso-13485/term:iec-60601-1",
      "source": "term:iso-13485",
      "target": "term:iec-60601-1",
      "type": "relatedTo",
      "properties": {
        "sourceFile": "terms.json",
        "meaning": "Related context; not a causal claim"
      }
    },
    {
      "id": "edge:relatedTo/term:iso-13485/term:traceability",
      "source": "term:iso-13485",
      "target": "term:traceability",
      "type": "relatedTo",
      "properties": {
        "sourceFile": "terms.json",
        "meaning": "Related context; not a causal claim"
      }
    }
  ],
  "neighbors": [
    {
      "id": "topic:topic-standards-stationary",
      "type": "Topic",
      "label": "Stationary, industrial and product standards",
      "properties": {
        "id": "topic-standards-stationary",
        "name": "Stationary, industrial and product standards",
        "lede": "Safety and performance standards for portable, industrial and grid batteries, their electronics and their installation.",
        "context": "Match scope to product and installation.",
        "example": "A cell-level test does not establish fire performance or commissioning requirements for a complete installation.",
        "lesson_url": "https://lemonergy.com/learn/fundamentals/battery-basics/",
        "lesson_label": "Open battery basics"
      }
    },
    {
      "id": "term:iso-management-systems",
      "type": "Term",
      "label": "ISO 9001, ISO 14001 and ISO 45001",
      "properties": {
        "id": "iso-management-systems",
        "name": "ISO 9001, ISO 14001 and ISO 45001",
        "aka": [
          "ISO 9001",
          "ISO 14001",
          "ISO 45001",
          "IATF 16949"
        ],
        "section": "topic-standards-stationary",
        "definition": "The three certifiable management-system standards that cell and pack makers are expected to hold: ISO 9001 for quality, ISO 14001 for environmental management and ISO 45001 for occupational health and safety. Automotive suppliers add IATF 16949, the industry’s quality-system standard built on ISO 9001.",
        "related": [
          "cell-production",
          "gigafactory",
          "traceability",
          "fmea",
          "yield"
        ],
        "url": "https://lemonergy.com/learn/glossary/iso-management-systems/",
        "mentions": []
      }
    },
    {
      "id": "term:medical-device-batteries",
      "type": "Term",
      "label": "Medical device batteries",
      "properties": {
        "id": "medical-device-batteries",
        "name": "Medical device batteries",
        "aka": [
          "implantable battery",
          "medical battery pack"
        ],
        "section": "topic-applications",
        "definition": "Batteries for devices from infusion pumps and portable monitors to pacemakers. External equipment uses rechargeable packs tested to IEC 62133 and approved as part of the device under IEC 60601-1, built under ISO 13485 with full traceability; implants use hermetic primary cells such as lithium–iodine and lithium–silver vanadium oxide, chosen for years of predictable life.",
        "related": [
          "iec-60601-1",
          "iso-13485",
          "lithium-iodine-cell",
          "lithium-silver-vanadium-oxide",
          "iec-62133",
          "traceability"
        ],
        "url": "https://lemonergy.com/learn/glossary/medical-device-batteries/",
        "mentions": []
      }
    },
    {
      "id": "term:iec-60601-1",
      "type": "Term",
      "label": "IEC 60601-1",
      "properties": {
        "id": "iec-60601-1",
        "name": "IEC 60601-1",
        "aka": [
          "ANSI/AAMI ES60601-1",
          "EN 60601-1",
          "medical electrical equipment standard"
        ],
        "section": "topic-standards-stationary",
        "definition": "The general safety standard for medical electrical equipment, adopted in the US as ANSI/AAMI ES60601-1. It treats the battery as part of the device: clause 15.4.3 covers battery housings and venting, connection, protection against overcharge and excessive current, and requires lithium batteries to meet IEC 62133 or, for primaries, IEC 60086-4.",
        "related": [
          "medical-device-batteries",
          "iec-62133",
          "iec-60086",
          "iso-13485"
        ],
        "url": "https://lemonergy.com/learn/glossary/iec-60601-1/",
        "mentions": [
          "overcharge"
        ]
      }
    },
    {
      "id": "term:traceability",
      "type": "Term",
      "label": "Traceability",
      "properties": {
        "id": "traceability",
        "name": "Traceability",
        "section": "topic-manufacturing",
        "definition": "Recording for each cell which material lots, machines and process conditions produced it, so a field failure can be traced to a batch and a recall limited to it. The EU battery passport extends this record to the cell’s whole life.",
        "related": [
          "battery-passport",
          "yield",
          "end-of-line-testing",
          "iso-management-systems"
        ],
        "example": {
          "title": "Connect records to identity",
          "text": "A cell record can link its material lots and electrode rolls. A lot identifier joins records; it is not a measured quality value."
        },
        "url": "https://lemonergy.com/learn/glossary/traceability/",
        "mentions": []
      }
    }
  ]
}