{ "model": { "rank": 13633, "code": "thing-q6554101", "model_id": "vr.tr.medical-device", "name": "medical device", "purpose": "Let an agent explain medical device regulation, classification and safety, help people check approvals and report problems, and support safe use of home devices without personal medical advice.", "family": "Thing Registry", "category": "Physical world and living systems", "status": "research-draft", "kind": "thing", "plane": "PHY", "domain": "PHY.OBJ", "industry": "", "version": "", "url": "/models/thing/q6554101/", "tier": 2, "score": 37, "payload": { "layer": "wikidata", "aliases": [ "anaesthetic machine", "anesthetic vaporizer", "cauter", "Syringe driver", "KD Scientific Legato 100", "Barton's forceps", "Snook hook", "viewing box", "nebulizer", "Analytical nebulizer", "medical forceps", "obstetrical forceps", "orthopedic brace", "dental instrument", "respiratory mask", "mouth opener", "digger dentin", "dental tray", "glass plate (dentist)", "rotating dental instruments", "dental material", "periodontal scaler", "matrix bands", "medical glove", "leg prosthesis", "pulp capping and pulpectomy agents", "dental photoinitiator", "root canal filling materials", "dental casting investment", "dental impression materials", "transfemoral prosthesis", "robotic leg", "Flex-Foot Cheetah", "surgical suture", "umbilical cord clamp", "Vertical mattress stitch", "Allgower-Donati suture", "barbed suture", "catgut suture", "Horizontal mattress stitch" ], "aliasCount": 190, "merged": 190, "knownIn": 37, "facets": null, "markers": [], "lexicalClass": "", "senseRank": null, "alsoRegisteredAs": null, "source": { "dataset": "wikidata", "item": "Q6554101", "url": "https://www.wikidata.org/wiki/Q6554101", "license": "CC0 1.0" } }, "research": { "vercy": "1.0-draft", "publication": { "status": "research-draft", "adjudicationStatus": "unreviewed", "publishableCanonical": false, "generatedAt": "2026-09-11T15:19:38Z", "providers": [ "Claude" ], "breadth": "written by Claude from model knowledge without web access - no source was read, every claim is a lead to verify", "pass": 2, "wave": 1, "engine": "claude" }, "metaModel": { "id": "THING-Q6554101", "registryId": "vr.tr.medical-device", "name": "medical device", "version": "0.2.0-wave.1", "entryKind": "thing", "family": "Thing Registry", "domain": [ "PHY.OBJ" ], "status": "research-draft" }, "canonicalUrl": "https://ver.cy/models/thing/q6554101/", "model": { "registry_id": "vr.tr.medical-device", "name": "medical device", "purpose": "Let an agent explain medical device regulation, classification and safety, help people check approvals and report problems, and support safe use of home devices without personal medical advice.", "definition": "An instrument, apparatus, implement, software or other article intended for medical purposes such as diagnosis, monitoring, treatment or alleviation of disease or injury, from syringes, forceps and thermometers to anaesthetic machines, implants and diagnostic software, regulated for safety and performance by classes of risk.", "what_it_is_for": "Diagnosing, monitoring and treating health conditions.", "affordances": [ "check whether a device is approved or registered", "understand risk classes and marking", "report adverse incidents", "use home medical devices safely" ], "distinguishing_features": [ "Intended medical purpose", "Risk-classified", "Regulated before and after market", "Requires incident reporting" ], "appearance": "Instruments, machines, implants, consumables and software with regulatory markings.", "visual_identification": [ "CE or other conformity marks", "Unique device identifiers", "Wellness gadgets may not be medical devices" ], "physical_properties": [], "families_and_kinds": [ "diagnostic devices", "surgical instruments", "implants", "therapeutic machines such as anaesthetic machines", "software as a medical device" ], "related_models": [ { "relation": "is a kind of", "target": "medical product", "why": "category" }, { "relation": "is regulated by", "target": "medical device regulator", "why": "regulator" }, { "relation": "is used in", "target": "medical imaging", "why": "application" }, { "relation": "is related to", "target": "medication", "why": "related product class" } ], "identifiers": [ { "scheme": "UDI", "value_or_pattern": "unique device identifier", "note": "device identifier" } ], "standards_and_regulation": [ "EU Medical Device Regulation 2017/745", "ISO 13485 quality management", "IEC 60601 electrical medical equipment safety" ], "failure_modes_and_hazards": [ "Device failures and recalls", "Counterfeit or unapproved devices", "Misuse of home devices" ], "in_scope": [], "out_of_scope": [], "characteristics": [] }, "sources": [], "structure": { "bundles": [ { "id": "regulation", "name": "Regulation", "description": "Approval.", "rationale": "Regulation protects patients.", "layers": [ { "id": "class", "name": "Class", "description": "Risk class.", "findings": [ { "id": "class-finding", "name": "Class", "description": "Risk class.", "questions": [ { "text": "Which risk class does this device fall into, and what does that require?", "kind": "provenance" }, { "text": "Is it a medical device at all?", "kind": "boundary" } ] } ] }, { "id": "check", "name": "Check", "description": "Approval check.", "findings": [ { "id": "check-finding", "name": "Check", "description": "Approval check.", "questions": [ { "text": "Is the device registered or approved, according to the regulator database?", "kind": "provenance" }, { "text": "Who is the manufacturer?", "kind": "provenance" } ] } ] } ] }, { "id": "safety", "name": "Safety", "description": "Incidents.", "rationale": "Report problems.", "layers": [ { "id": "incident", "name": "Incident", "description": "Adverse events.", "findings": [ { "id": "incident-finding", "name": "Incident", "description": "Adverse events.", "questions": [ { "text": "Has a device malfunctioned or caused harm?", "kind": "boundary" }, { "text": "How can it be reported to the regulator and manufacturer?", "kind": "action" } ] } ] }, { "id": "recalls", "name": "Recalls", "description": "Safety notices.", "findings": [ { "id": "recalls-finding", "name": "Recalls", "description": "Recalls.", "questions": [ { "text": "Are there recalls or field safety notices for this device?", "kind": "provenance" }, { "text": "What should users do?", "kind": "provenance" } ] } ] } ] }, { "id": "use", "name": "Use", "description": "Home devices.", "rationale": "Safe use matters.", "layers": [ { "id": "home", "name": "Home", "description": "Using at home.", "findings": [ { "id": "home-finding", "name": "Home", "description": "Home use.", "questions": [ { "text": "How should this home device, such as a blood pressure monitor, be used and maintained according to the instructions?", "kind": "provenance" }, { "text": "Is the user asking to interpret their own readings?", "kind": "boundary" } ] } ] }, { "id": "buying", "name": "Buying", "description": "Buying safely.", "findings": [ { "id": "buying-finding", "name": "Buying", "description": "Buying safely.", "questions": [ { "text": "Is this seller offering genuine, approved devices?", "kind": "boundary" }, { "text": "What are the risks of counterfeit devices?", "kind": "provenance" } ] } ] } ] }, { "id": "industry", "name": "Industry", "description": "Development.", "rationale": "Development is regulated.", "layers": [ { "id": "development", "name": "Development", "description": "Bringing to market.", "findings": [ { "id": "development-finding", "name": "Development", "description": "Development.", "questions": [ { "text": "What steps are needed to bring a device to market, in general terms?", "kind": "provenance" }, { "text": "Which standards apply?", "kind": "provenance" } ] } ] }, { "id": "software", "name": "Software", "description": "Software devices.", "findings": [ { "id": "software-finding", "name": "Software", "description": "Software as a medical device.", "questions": [ { "text": "When does software count as a medical device?", "kind": "provenance" }, { "text": "Which guidance applies?", "kind": "provenance" } ] } ] } ] } ] }, "openQuestions": [ "Should device types be separate entries?", "How should device databases be linked?", "How should recalls be tracked?" ], "statistics": { "bundles": 4, "layers": 8, "findings": 8, "questions": 16 } }, "draft": { "generator": "vr.draft.v3", "status": "draft-generated", "researched": false, "archetype": "device, machine or tool", "method": "Written from the archetype playbook - what this kind of thing needs beyond identity and provenance - and from the structure that recurred across 6,333 models already researched by two engines. Applied to this entry by rule. No source was read for this thing and no claim here is researched. This entry carries no facets of its own, so they were inferred from its domain - a guess about a whole domain applied to one thing.", "facetsInferred": true, "nextPass": "A researcher replaces this draft with a sourced specification. Treat every sentence below as a proposal to argue with.", "purpose": "Give an agent a durable, checkable way to recognise a medical device, record what state it is in, and decide what may be done with it.", "whatItIs": "Let an agent explain medical device regulation, classification and safety, help people check approvals and report problems, and support safe use of home devices without personal medical advice.", "characteristics": { "substance": "material", "origin": "manufactured", "agency": "inert", "mobility": "varies" }, "whatYouCanDoWithIt": [ "observed and measured" ], "distinguishingFeatures": [ "Names folded into this entry, which a task may need to split apart again: anaesthetic machine, anesthetic vaporizer, cauter, Syringe driver, KD Scientific Legato 100, Barton's forceps, Snook hook, viewing box, nebulizer, Analytical nebulizer, medical forceps, obstetrical forceps.", "190 finer distinctions are held as aliases rather than separate entries, because telling them apart needs a task that asks for it.", "Described in 37 Wikipedia languages, which is a measure of how widely the thing is known, not of how important it is." ], "openQuestionsForResearch": [ "Which of the bundles below does a real task actually need, and which are ceremony?", "What does this thing have that the facets do not capture at all?", "Which neighbouring kind is most often confused with a medical device, and on what evidence are they told apart?" ], "whatItIsMadeOf": "matter you can touch", "physicalCharacter": [ "Mobility varies between examples.", "Does nothing on its own; everything it does, something else did to it.", "These come from the domain this entry sits in rather than from the entry itself, so treat them as a first guess about the whole domain applied to one thing." ], "whatCanBeDoneWithIt": [ "observe it, measure it, record its state" ], "howItIsRecognised": [ "Recognised by form, by the arrangement of its controls, and by markings - a plate, a model number, a certification mark. Form alone rarely separates two models that do very different things." ], "relatedModels": [ { "relation": "covers", "note": "Finer kinds folded into this entry because telling them apart needs a task that asks for it. Each is a model waiting to be split out when one does.", "targets": [ "anaesthetic machine", "anesthetic vaporizer", "cauter", "Syringe driver", "KD Scientific Legato 100", "Barton's forceps", "Snook hook", "viewing box", "nebulizer", "Analytical nebulizer", "medical forceps", "obstetrical forceps" ] } ], "standing": "Described in 37 Wikipedia languages, which measures how widely it is written about rather than how important or how common it is. 190 finer distinctions are held inside this entry as names rather than as separate models.", "structure": { "bundles": [ { "id": "identity-and-classification", "name": "Identity, naming and classification", "description": "How an agent tells one medical device from another, and a medical device from things that resemble it.", "rationale": "Recognition comes before every other claim. Without stable identity nothing else in the model can be trusted to be about the same thing twice.", "layers": [ { "id": "naming-and-identifiers", "name": "Names and identifiers", "description": "The names this thing goes by and the identifiers that survive translation and time.", "findings": [ { "id": "preferred-name-and-aliases", "name": "Preferred name, aliases and local names", "description": "Which name to use, which names mean the same thing, and which merely sound similar.", "questions": [ { "id": "preferred-name-and-aliases-q01", "text": "What identifies and describes the name of a medical device, and in what units or vocabulary?", "kind": "definition", "answer_data": [ "identifiers", "types and classes", "values with units", "explicit unknowns" ] }, { "id": "preferred-name-and-aliases-q02", "text": "Who or what asserted this about the name of a medical device, by which method, and when was it true?", "kind": "provenance", "answer_data": [ "authority", "method", "evidence", "event time", "knowledge time" ] }, { "id": "preferred-name-and-aliases-q03", "text": "What may an agent decide or do once the name of a medical device is known, and what must it refuse?", "kind": "action", "answer_data": [ "permitted actions", "preconditions", "refusals", "escalation" ] } ] }, { "id": "stable-identifiers", "name": "Stable identifiers and external keys", "description": "Identifiers that keep pointing at this kind of thing across systems and languages.", "questions": [ { "id": "stable-identifiers-q01", "text": "What identifies and describes an identifier for a medical device, and in what units or vocabulary?", "kind": "definition", "answer_data": [ "identifiers", "types and classes", "values with units", "explicit unknowns" ] }, { "id": "stable-identifiers-q02", "text": "Who or what asserted this about an identifier for a medical device, by which method, and when was it true?", "kind": "provenance", "answer_data": [ "authority", "method", "evidence", "event time", "knowledge time" ] }, { "id": "stable-identifiers-q03", "text": "What may an agent decide or do once an identifier for a medical device is known, and what must it refuse?", "kind": "action", "answer_data": [ "permitted actions", "preconditions", "refusals", "escalation" ] } ] } ] }, { "id": "classification-and-granularity", "name": "Classification and granularity", "description": "Where a medical device sits among kinds, and how finely a task needs to cut it.", "findings": [ { "id": "kind-and-parents", "name": "Kind, parents and neighbouring kinds", "description": "The classes this thing belongs to and the ones it is next to.", "questions": [ { "id": "kind-and-parents-q01", "text": "What identifies and describes the kind of a medical device, and in what units or vocabulary?", "kind": "definition", "answer_data": [ "identifiers", "types and classes", "values with units", "explicit unknowns" ] }, { "id": "kind-and-parents-q02", "text": "Who or what asserted this about the kind of a medical device, by which method, and when was it true?", "kind": "provenance", "answer_data": [ "authority", "method", "evidence", "event time", "knowledge time" ] }, { "id": "kind-and-parents-q03", "text": "What may an agent decide or do once the kind of a medical device is known, and what must it refuse?", "kind": "action", "answer_data": [ "permitted actions", "preconditions", "refusals", "escalation" ] } ] }, { "id": "distinguishing-features", "name": "Distinguishing features", "description": "What separates a medical device from the things most often confused with it.", "questions": [ { "id": "distinguishing-features-q01", "text": "What identifies and describes what distinguishes a medical device, and in what units or vocabulary?", "kind": "definition", "answer_data": [ "identifiers", "types and classes", "values with units", "explicit unknowns" ] }, { "id": "distinguishing-features-q02", "text": "Who or what asserted this about what distinguishes a medical device, by which method, and when was it true?", "kind": "provenance", "answer_data": [ "authority", "method", "evidence", "event time", "knowledge time" ] }, { "id": "distinguishing-features-q03", "text": "What may an agent decide or do once what distinguishes a medical device is known, and what must it refuse?", "kind": "action", "answer_data": [ "permitted actions", "preconditions", "refusals", "escalation" ] } ] } ] } ] }, { "id": "form-and-composition", "name": "Form, composition and condition", "description": "What a medical device is made of, what shape and size it takes, and what state it is in.", "rationale": "A physical thing can be measured, and a model that cannot record its measurements cannot support any decision that depends on them.", "layers": [ { "id": "form-and-dimensions", "name": "Form and dimensions", "description": "Shape, size, mass and the ranges these take across examples.", "findings": [ { "id": "measurable-dimensions", "name": "Measurable dimensions and their units", "description": "The quantities worth recording and the units they are recorded in.", "questions": [ { "id": "measurable-dimensions-q01", "text": "What identifies and describes the dimensions of a medical device, and in what units or vocabulary?", "kind": "definition", "answer_data": [ "identifiers", "types and classes", "values with units", "explicit unknowns" ] }, { "id": "measurable-dimensions-q02", "text": "Who or what asserted this about the dimensions of a medical device, by which method, and when was it true?", "kind": "provenance", "answer_data": [ "authority", "method", "evidence", "event time", "knowledge time" ] }, { "id": "measurable-dimensions-q03", "text": "What may an agent decide or do once the dimensions of a medical device is known, and what must it refuse?", "kind": "action", "answer_data": [ "permitted actions", "preconditions", "refusals", "escalation" ] } ] } ] }, { "id": "material-and-composition", "name": "Material and composition", "description": "Materials, parts and how they are put together.", "findings": [ { "id": "parts-and-materials", "name": "Parts and materials", "description": "What a medical device is built from and which parts are replaceable.", "questions": [ { "id": "parts-and-materials-q01", "text": "What identifies and describes the composition of a medical device, and in what units or vocabulary?", "kind": "definition", "answer_data": [ "identifiers", "types and classes", "values with units", "explicit unknowns" ] }, { "id": "parts-and-materials-q02", "text": "Who or what asserted this about the composition of a medical device, by which method, and when was it true?", "kind": "provenance", "answer_data": [ "authority", "method", "evidence", "event time", "knowledge time" ] }, { "id": "parts-and-materials-q03", "text": "What may an agent decide or do once the composition of a medical device is known, and what must it refuse?", "kind": "action", "answer_data": [ "permitted actions", "preconditions", "refusals", "escalation" ] } ] } ] }, { "id": "condition-and-integrity", "name": "Condition and integrity", "description": "Wear, damage, health and the difference between working and broken.", "findings": [ { "id": "condition-assessment", "name": "Condition, damage and health", "description": "How the condition of a medical device is judged and by whom.", "questions": [ { "id": "condition-assessment-q01", "text": "What identifies and describes the condition of a medical device, and in what units or vocabulary?", "kind": "definition", "answer_data": [ "identifiers", "types and classes", "values with units", "explicit unknowns" ] }, { "id": "condition-assessment-q02", "text": "Who or what asserted this about the condition of a medical device, by which method, and when was it true?", "kind": "provenance", "answer_data": [ "authority", "method", "evidence", "event time", "knowledge time" ] }, { "id": "condition-assessment-q03", "text": "What may an agent decide or do once the condition of a medical device is known, and what must it refuse?", "kind": "action", "answer_data": [ "permitted actions", "preconditions", "refusals", "escalation" ] } ] } ] } ] }, { "id": "place-and-movement", "name": "Place and movement", "description": "Where a medical device is, how it got there and where it may go (varies).", "rationale": "A thing that can move needs its position recorded with a time, or every later claim about it is about a place it has left.", "layers": [ { "id": "location-and-placement", "name": "Location and placement", "description": "Position, containment and the reference frame the position is given in.", "findings": [ { "id": "position-and-frame", "name": "Position, container and reference frame", "description": "Where a medical device is, and what that position is measured against.", "questions": [ { "id": "position-and-frame-q01", "text": "What identifies and describes the location of a medical device, and in what units or vocabulary?", "kind": "definition", "answer_data": [ "identifiers", "types and classes", "values with units", "explicit unknowns" ] }, { "id": "position-and-frame-q02", "text": "Who or what asserted this about the location of a medical device, by which method, and when was it true?", "kind": "provenance", "answer_data": [ "authority", "method", "evidence", "event time", "knowledge time" ] }, { "id": "position-and-frame-q03", "text": "What may an agent decide or do once the location of a medical device is known, and what must it refuse?", "kind": "action", "answer_data": [ "permitted actions", "preconditions", "refusals", "escalation" ] } ] } ] }, { "id": "movement-and-transfer", "name": "Movement and transfer", "description": "How a medical device is carried, installed or relocated.", "findings": [ { "id": "movement-events", "name": "Movement events and constraints", "description": "What counts as a movement, what records it and what limits it.", "questions": [ { "id": "movement-events-q01", "text": "What identifies and describes the movement of a medical device, and in what units or vocabulary?", "kind": "definition", "answer_data": [ "identifiers", "types and classes", "values with units", "explicit unknowns" ] }, { "id": "movement-events-q02", "text": "Who or what asserted this about the movement of a medical device, by which method, and when was it true?", "kind": "provenance", "answer_data": [ "authority", "method", "evidence", "event time", "knowledge time" ] }, { "id": "movement-events-q03", "text": "What may an agent decide or do once the movement of a medical device is known, and what must it refuse?", "kind": "action", "answer_data": [ "permitted actions", "preconditions", "refusals", "escalation" ] } ] } ] } ] }, { "id": "state-and-lifecycle", "name": "State and lifecycle", "description": "The states a medical device passes through and the events that move it between them.", "rationale": "Most decisions about a thing depend on what state it is in now, which is a claim with a time on it, not a property.", "layers": [ { "id": "lifecycle-stages", "name": "Lifecycle stages", "description": "From coming into existence to ceasing to be one of these.", "findings": [ { "id": "stages-and-transitions", "name": "Stages and transitions", "description": "The stages worth naming and what moves a medical device between them.", "questions": [ { "id": "stages-and-transitions-q01", "text": "What identifies and describes the lifecycle of a medical device, and in what units or vocabulary?", "kind": "definition", "answer_data": [ "identifiers", "types and classes", "values with units", "explicit unknowns" ] }, { "id": "stages-and-transitions-q02", "text": "Who or what asserted this about the lifecycle of a medical device, by which method, and when was it true?", "kind": "provenance", "answer_data": [ "authority", "method", "evidence", "event time", "knowledge time" ] }, { "id": "stages-and-transitions-q03", "text": "What may an agent decide or do once the lifecycle of a medical device is known, and what must it refuse?", "kind": "action", "answer_data": [ "permitted actions", "preconditions", "refusals", "escalation" ] } ] } ] }, { "id": "observations-and-status", "name": "Observations and current status", "description": "What is observed about a medical device, how often and by whom.", "findings": [ { "id": "observation-record", "name": "Observation record", "description": "How an observation of a medical device is recorded so that it can be superseded rather than overwritten.", "questions": [ { "id": "observation-record-q01", "text": "What identifies and describes an observation of a medical device, and in what units or vocabulary?", "kind": "definition", "answer_data": [ "identifiers", "types and classes", "values with units", "explicit unknowns" ] }, { "id": "observation-record-q02", "text": "Who or what asserted this about an observation of a medical device, by which method, and when was it true?", "kind": "provenance", "answer_data": [ "authority", "method", "evidence", "event time", "knowledge time" ] }, { "id": "observation-record-q03", "text": "What may an agent decide or do once an observation of a medical device is known, and what must it refuse?", "kind": "action", "answer_data": [ "permitted actions", "preconditions", "refusals", "escalation" ] } ] } ] } ] }, { "id": "function-and-principle", "name": "Function and operating principle", "description": "What medical device is for and how it achieves it.", "rationale": "Two devices with the same name can work on different principles, and the principle is what predicts failure and constrains use.", "layers": [ { "id": "intended-function", "name": "Intended function", "description": "The job it does, and the jobs it is used for anyway.", "findings": [ { "id": "function-record", "name": "Function, principle and variants", "description": "What it does, how, and which variants do it differently.", "questions": [ { "id": "function-record-q01", "text": "What function does medical device perform, on what operating principle, and which variants differ in that principle?", "kind": "definition" }, { "id": "function-record-q02", "text": "What use falls outside the intended function but happens in practice?", "kind": "boundary" } ] } ] }, { "id": "capacity-and-rating", "name": "Capacity and rating", "description": "The numbers that say what it can do and where it stops.", "findings": [ { "id": "ratings", "name": "Ratings and their conditions", "description": "Rated capacity, power, throughput and the conditions each assumes.", "questions": [ { "id": "ratings-q01", "text": "What ratings characterise medical device, in what units, and under what stated conditions?", "kind": "measurement" }, { "id": "ratings-q02", "text": "What happens beyond the rating - degradation, refusal, damage - and how is that detected?", "kind": "action" } ] } ] } ] }, { "id": "operation-and-state", "name": "Operation, controls and state", "description": "How medical device is operated and what state it is in right now.", "rationale": "An agent acting on a device needs its current state and the controls that change it, not just its specification.", "layers": [ { "id": "controls-and-modes", "name": "Controls and modes", "description": "What can be set, what that changes, and what is interlocked.", "findings": [ { "id": "control-surface", "name": "Control surface and interlocks", "description": "The settings available and the conditions that block them.", "questions": [ { "id": "control-surface-q01", "text": "What controls and modes does medical device have, and what does each change?", "kind": "definition" }, { "id": "control-surface-q02", "text": "Which actions are interlocked or forbidden in which state, and what must be true before acting?", "kind": "action" } ] } ] }, { "id": "condition-and-maintenance", "name": "Condition and maintenance", "description": "Wear, service intervals, consumables and the line between working and broken.", "findings": [ { "id": "service-record", "name": "Condition, service and consumables", "description": "What is consumed, what is serviced, and how condition is judged.", "questions": [ { "id": "service-record-q01", "text": "What consumables and service does medical device need, at what interval, and on whose authority?", "kind": "measurement" }, { "id": "service-record-q02", "text": "What evidence separates a unit that is working from one that is out of service?", "kind": "boundary" } ] } ] } ] }, { "id": "kind-model-unit", "name": "Kind, model and unit", "description": "Whether a claim about medical device is about the kind, a product line, or one physical unit.", "rationale": "This is the boundary most often got wrong for made things, and getting it wrong mixes a catalogue entry with the machine in the yard.", "layers": [ { "id": "level-of-reference", "name": "Level of reference", "description": "The three levels and what belongs at each.", "findings": [ { "id": "level-rules", "name": "What belongs to kind, model and unit", "description": "Which properties are shared by all of them and which are not.", "questions": [ { "id": "level-rules-q01", "text": "Which facts about medical device hold for every one of them, which for a model, and which only for one unit?", "kind": "boundary" }, { "id": "level-rules-q02", "text": "What identifies an individual unit, and what should an agent do when it has only the kind?", "kind": "action" } ] } ] }, { "id": "standards-and-conformity", "name": "Standards and conformity", "description": "The standards a working example must meet and who attests it.", "findings": [ { "id": "conformity", "name": "Standards, marks and attestation", "description": "Which standard applies, who certifies, and what the mark means.", "questions": [ { "id": "conformity-q01", "text": "Which standards govern medical device, issued by whom, and what does conformity actually assert?", "kind": "provenance" }, { "id": "conformity-q02", "text": "What may an agent conclude from a certification mark, and what may it not?", "kind": "boundary" } ] } ] } ] }, { "id": "provenance-and-evidence", "name": "Provenance, evidence and time", "description": "Where every claim about a medical device came from and when it held.", "rationale": "A claim without a source and a time cannot be superseded, only overwritten, and an agent that overwrites loses the ability to explain itself.", "layers": [ { "id": "source-and-authority", "name": "Source and authority", "description": "Who said it, on what evidence, and how strongly.", "findings": [ { "id": "claim-provenance", "name": "Claim provenance and confidence", "description": "The authority behind each claim about a medical device and how confident it is.", "questions": [ { "id": "claim-provenance-q01", "text": "What identifies and describes a claim about a medical device, and in what units or vocabulary?", "kind": "definition", "answer_data": [ "identifiers", "types and classes", "values with units", "explicit unknowns" ] }, { "id": "claim-provenance-q02", "text": "Who or what asserted this about a claim about a medical device, by which method, and when was it true?", "kind": "provenance", "answer_data": [ "authority", "method", "evidence", "event time", "knowledge time" ] }, { "id": "claim-provenance-q03", "text": "What may an agent decide or do once a claim about a medical device is known, and what must it refuse?", "kind": "action", "answer_data": [ "permitted actions", "preconditions", "refusals", "escalation" ] } ] } ] }, { "id": "time-and-versions", "name": "Time, versions and supersession", "description": "When a claim was true, when it was learnt, and what replaced it.", "findings": [ { "id": "validity-and-supersession", "name": "Validity period and supersession", "description": "How an old claim about a medical device is retired without being erased.", "questions": [ { "id": "validity-and-supersession-q01", "text": "What identifies and describes the validity of a claim about a medical device, and in what units or vocabulary?", "kind": "definition", "answer_data": [ "identifiers", "types and classes", "values with units", "explicit unknowns" ] }, { "id": "validity-and-supersession-q02", "text": "Who or what asserted this about the validity of a claim about a medical device, by which method, and when was it true?", "kind": "provenance", "answer_data": [ "authority", "method", "evidence", "event time", "knowledge time" ] }, { "id": "validity-and-supersession-q03", "text": "What may an agent decide or do once the validity of a claim about a medical device is known, and what must it refuse?", "kind": "action", "answer_data": [ "permitted actions", "preconditions", "refusals", "escalation" ] } ] } ] } ] } ] }, "statistics": { "bundles": 8, "layers": 17, "findings": 19, "questions": 51 } } } }