{ "vercy": "1.0-draft", "publication": { "status": "research-draft", "adjudicationStatus": "unreviewed", "publishableCanonical": false, "generatedAt": "2026-09-12T11:13:04Z", "providers": [ "Codex" ], "breadth": "recalled by Codex without web access - no source was read", "missingProviders": [], "pass": 2, "cost": { "grok": { "seconds": 23.5, "error": "Reading additional input from stdin...\nOpenAI Codex v0.153.4\n--------\nworkdir: R:\\02_PROJECTS\\02_Meta_Models_Platforms\\Ver.cy\\current\\thing-registry-backlog\nmodel: gpt-6-astra\nprovider: openai\napproval: never\nsandbox: read-only\nreasoning effort: none\nreasoning summaries: none\nsession id: 01a09550-e262-74a2-90ad-cb8b165d95ab\n--------\nuser\nDescribe what is already known about one registered thing. Answer as JSON only, no prose around it.\n\nThing: medical equipment\nSense to describe: (none recorded)\nDomain code: PHY.OBJ\nAlso known as: (none)\n\n\nContext for this batch of 1001 things:\n# Batch 044: 10", "usd": 0.0, "recall": true }, "codex": { "seconds": 83.5, "error": "Reading additional input from stdin...\nOpenAI Codex v0.153.4\n--------\nworkdir: R:\\02_PROJECTS\\02_Meta_Models_Platforms\\Ver.cy\\current\\thing-registry-backlog\nmodel: gpt-6-astra\nprovider: openai\napproval: never\nsandbox: read-only\nreasoning effort: none\nreasoning summaries: none\nsession id: 01a09550-e256-7a22-b200-1deddaf6ac40\n--------\nuser\nYou are drafting a Vercy meta-model for one registered thing. Answer as JSON only, no prose around it.\n\nThing: medical equipment\nRegistry id: vr.tr.medical-equipment\nPlane / domain: PHY / PHY.OBJ\nRegistry definition: (none recorded)\nNames folded into this entr" } }, "enrichment": { "pass": 3, "engine": "claude", "producedAt": "2026-10-06T12:00:00Z", "ingestedAt": "2026-10-06T08:02:28+00:00", "fields": [ "agent_conduct", "ethics", "failure_modes_and_hazards", "owners", "standards_and_regulation", "visual_identification" ] }, "gate": { "passed": true, "version": "1.0", "at": "2026-10-07T10:10:32+00:00", "evidence": [ "completeness 1.00", "sense: Wikidata description", "2 live sources", "review by codex: pass" ] } }, "metaModel": { "id": "THING-Q6657015", "registryId": "vr.tr.medical-equipment", "name": "medical equipment", "version": "0.1.0-research.1", "entryKind": "thing", "family": "Thing Registry", "domain": [ "PHY.OBJ" ], "status": "research-draft" }, "canonicalUrl": "https://ver.cy/models/thing/q6657015/", "model": { "registry_id": "vr.tr.medical-equipment", "name": "medical equipment", "purpose": "Enable an AI agent to recognise medical equipment, assess evidence of its clinical readiness, and identify permitted use, maintenance or withdrawal actions.", "definition": "Medical equipment is the reusable apparatus and machinery used for medical purposes such as diagnosis, monitoring, treatment or rehabilitation, generally requiring calibration, maintenance, repair, user training or eventual decommissioning.", "scope_statement": "This model owns the category of physical equipment intended for medical purposes and the evidence needed to assess its capabilities, configuration, condition and use constraints; product-specific and unit-specific records instantiate or specialise this category.", "in_scope": [ "Medical intended purpose, patient population, care setting and equipment classification", "Diagnostic, monitoring, therapeutic, life-support or rehabilitation capabilities and their limits", "Patient-contact components, accessories, consumables and configuration dependencies", "Clinical readiness, performance verification, maintenance and reprocessing status", "Equipment-specific hazards, protective functions and responses to loss of essential function", "Identification, applicable conformity evidence, recalls and restrictions on use" ], "out_of_scope": [ "Clinical diagnosis, prescribing and patient treatment decisions", "Medicines, biological products and their therapeutic properties, except as equipment interfaces", "Standalone medical software, except its relationship to physical equipment", "Hospital buildings, utility infrastructure and general furniture without a medical intended purpose", "Detailed models of individual equipment subtypes, product lines or serial-numbered assets", "Healthcare staffing, procurement contracts and service-provider organisations" ], "distinguishing_features": [ "Look for a documented medical intended purpose; presence in a hospital or use by a clinician alone does not establish category membership.", "Distinguish the physical equipment from a medicine it administers, a specimen it analyses or a patient condition it measures.", "Distinguish equipment from supplies consumed during its operation; record disposable equipment and combination products as boundary cases requiring an explicit inclusion rule.", "Separate equipment capability from clinical suitability: a functioning unit may still be unsuitable for a particular patient, procedure or care environment.", "Treat this entry as an umbrella category; an infusion pump, imaging system or ventilator requires subtype-specific detail rather than assumptions shared by every medical device." ], "characteristics": [ { "name": "Intended medical purpose", "kind": "category", "unit_or_values": "Documented purpose; diagnosis, monitoring, therapy, life support, rehabilitation or another evidenced medical function", "why_it_matters": "Establishes category membership and the limits within which suitability can be assessed." }, { "name": "Equipment subtype", "kind": "relation", "unit_or_values": "Link to the applicable narrower equipment model", "why_it_matters": "Locates operating principles and constraints that cannot be meaningfully specified for all medical equipment." }, { "name": "Intended population and setting", "kind": "category", "unit_or_values": "Documented patient groups, anatomical applications and professional, home, transport or other settings", "why_it_matters": "Prevents an agent from treating capability in one context as evidence of suitability in another." }, { "name": "Clinical performance envelope", "kind": "measurement", "unit_or_values": "Subtype-specific ranges, accuracy, resolution, capacity and duty limits with units and test conditions", "why_it_matters": "Allows requirements to be compared against verified capability without inventing universal equipment limits." }, { "name": "Patient interface", "kind": "category", "unit_or_values": "No direct contact, external contact, invasive contact or another documented interface; include contact site and duration where relevant", "why_it_matters": "Identifies patient-contact risks and evidence needed for compatible accessories and reprocessing." }, { "name": "Operating and release status", "kind": "state", "unit_or_values": "Unknown, awaiting inspection, ready, in use, degraded, awaiting reprocessing, under maintenance, quarantined or retired", "why_it_matters": "Distinguishes physical operation from authorisation for clinical use." }, { "name": "Protective-function status", "kind": "state", "unit_or_values": "Verified, failed, disabled, untested or not applicable for each alarm, interlock or protective function", "why_it_matters": "Makes unavailable safeguards visible before equipment is assigned to care." }, { "name": "Configuration and compatibility", "kind": "relation", "unit_or_values": "Links to supported accessories, consumables, software versions and connected systems", "why_it_matters": "A compatible configuration is part of the evidence for safe and effective operation." }, { "name": "Power and service dependencies", "kind": "category", "unit_or_values": "Documented electrical, battery, gas, water, suction, network or other dependencies; not applicable where appropriate", "why_it_matters": "Exposes conditions that may prevent operation or interrupt a clinically important function." }, { "name": "Maintenance and verification evidence", "kind": "relation", "unit_or_values": "Applicable service instructions, inspection results, calibration records and next-due criteria", "why_it_matters": "Supports a readiness judgement based on evidence rather than appearance or power-on status." }, { "name": "Reprocessing status", "kind": "state", "unit_or_values": "Unknown, contaminated, cleaned, disinfected, sterilised, released or not applicable, as required by the equipment instructions", "why_it_matters": "Prevents reuse when the required infection-control process is incomplete or unsupported." }, { "name": "Regulatory and restriction evidence", "kind": "relation", "unit_or_values": "Jurisdiction-specific classification, conformity records, applicable standards and editions, notices and use restrictions", "why_it_matters": "Connects use decisions to evidence applicable to the equipment and location." } ], "affordances": [ "Classify equipment by documented medical purpose and link it to a narrower equipment model.", "Compare documented capabilities and configuration with a specified clinical-use requirement, flagging gaps for qualified review.", "Assess readiness from inspection, performance, maintenance, reprocessing and protective-function evidence.", "Identify compatible patient interfaces, accessories, consumables and supporting services.", "Route faults, contamination, overdue checks or applicable safety notices into inspection, servicing or quarantine workflows.", "Present documented operating constraints and escalation requirements without independently selecting patient treatment settings." ], "agent_conduct": { "may": [ "Track inventory, location, calibration and maintenance dates of medical equipment.", "Report faults, alarms and overdue checks to the responsible clinical engineering team.", "Operate equipment only within the functions it is authorized and trained for." ], "must_not": [ "Use or release equipment that has failed safety checks or is past its calibration date.", "Silence or disable alarms on equipment connected to a patient.", "Change settings on equipment in use on a patient without a clinician's instruction.", "Reuse single-use parts or skip decontamination between patients." ], "requires_human": [ "Any change to equipment settings that affects a patient's treatment.", "Withdrawing equipment from service during care." ] }, "ethics": { "considerations": [ "Equipment failures can injure or kill patients.", "Fair access to equipment affects who gets diagnosis and treatment." ], "affected_parties": [ "Patients", "Clinicians and technicians", "Hospitals and clinics" ] }, "owners": { "steward": "The healthcare organization that owns it; regulators keep device registers and recall records.", "master_systems": [ "National medical device registers and recall databases" ] }, "visual_identification": [ "Apparatus bearing device labels, serial numbers and asset tags.", "Found in clinical settings, often on carts or mounted near patient beds." ], "failure_modes_and_hazards": [ "Malfunction, miscalibration or wrong settings that harm patients.", "Infection from poorly decontaminated equipment.", "Electrical and radiation hazards to patients and staff." ], "standards_and_regulation": [ "IEC 60601, medical electrical equipment, International Electrotechnical Commission.", "ISO 13485, quality management for medical devices, International Organization for Standardization." ], "what_it_is_for": [ "Medical equipment is used in hospitals, clinics, laboratories, ambulances and home-care settings.", "It supports diagnosis, monitoring, treatment and rehabilitation through functions such as imaging, physiological measurement and therapeutic support.", "Equipment management includes assessing readiness for its intended clinical use and arranging maintenance, calibration and eventual replacement." ] }, "sources": [ { "id": "wikidata", "title": "Wikidata item Q6657015: medical equipment", "url": "https://www.wikidata.org/wiki/Q6657015", "url_status": "live", "what_it_supports": "identity and sense of the item", "checked_by": "wikidata-api" }, { "id": "wikipedia-en", "title": "Wikipedia: Medical equipment", "url": "https://en.wikipedia.org/wiki/Medical_equipment", "url_status": "live", "what_it_supports": "general description of the item", "checked_by": "wikidata-api sitelink" } ], "structure": { "bundles": [ { "id": "medical-purpose-and-boundaries", "name": "Medical purpose and boundaries", "description": "Establishes why equipment belongs in this category and where its intended medical use ends.", "rationale": "Medical equipment spans many functions, so membership and suitability must rest on intended purpose rather than location or appearance.", "layers": [ { "id": "intended-medical-function", "name": "Intended medical function", "description": "Captures the evidenced medical role and its relationship to narrower equipment types.", "findings": [ { "id": "purpose-evidence", "name": "Purpose evidence", "description": "Record the intended medical purpose with its documentary basis and identify the subtype that supplies further detail.", "questions": [ { "text": "What medical purpose is stated in the equipment's authoritative documentation?", "kind": "definition", "id": "purpose-evidence-q01" }, { "text": "Which narrower equipment model covers its principal function, and what remains owned by this umbrella model?", "kind": "boundary", "id": "purpose-evidence-q02" } ] } ] }, { "id": "patient-and-care-context", "name": "Patient and care context", "description": "Describes the people, procedures and environments for which suitability is documented.", "findings": [ { "id": "intended-use-limits", "name": "Intended-use limits", "description": "Record supported patient groups, applications, care settings and explicit exclusions without inferring clinical appropriateness.", "questions": [ { "text": "Which patient populations, anatomical applications and care settings are included or excluded?", "kind": "boundary", "id": "intended-use-limits-q01" }, { "text": "What evidence or qualified review is required before assigning this equipment to the proposed use?", "kind": "action", "id": "intended-use-limits-q02" } ] } ] } ] }, { "id": "clinical-function-and-performance", "name": "Clinical function and performance", "description": "Connects the equipment's operating principle to its measurable medical capabilities.", "rationale": "Readiness depends on whether the equipment performs its particular medical function within the required limits.", "layers": [ { "id": "medical-inputs-and-outputs", "name": "Medical inputs and outputs", "description": "Identifies what the equipment senses, processes, delivers or physically supports.", "findings": [ { "id": "operating-principle-and-envelope", "name": "Operating principle and envelope", "description": "Record the operating principle and subtype-specific output or measurement limits with units and relevant conditions.", "questions": [ { "text": "What physical principle enables the equipment to measure, image, deliver treatment or support a patient?", "kind": "definition", "id": "operating-principle-and-envelope-q01" }, { "text": "What ranges, accuracy, resolution, capacity and duty limits describe its medical function, and under which conditions?", "kind": "measurement", "id": "operating-principle-and-envelope-q02" } ] } ] }, { "id": "performance-verification", "name": "Performance verification", "description": "Captures evidence that the required medical function remains within accepted limits.", "findings": [ { "id": "verified-clinical-capability", "name": "Verified clinical capability", "description": "Distinguish successful startup from documented verification of the measurements or outputs relevant to clinical use.", "questions": [ { "text": "Which checks verify clinically relevant performance, and what acceptance limits and reference equipment do they use?", "kind": "measurement", "id": "verified-clinical-capability-q01" }, { "text": "Where are the latest results recorded, and what changes or events invalidate their applicability?", "kind": "provenance", "id": "verified-clinical-capability-q02" } ] } ] } ] }, { "id": "patient-interface-and-reprocessing", "name": "Patient interface and reprocessing", "description": "Covers contact with patients and biological material, including the conditions for safe reuse.", "rationale": "A functioning instrument may remain unusable because its patient interface is incompatible, contaminated or beyond its permitted reuse life.", "layers": [ { "id": "contact-and-accessories", "name": "Contact and accessories", "description": "Identifies patient-contact pathways and the accessories through which medical functions are performed.", "findings": [ { "id": "patient-pathway-compatibility", "name": "Patient pathway compatibility", "description": "Record contact sites, contact duration and supported accessories or consumables for the intended application.", "questions": [ { "text": "Which components contact the patient, sterile tissue, bodily fluids or specimens, and for how long?", "kind": "boundary", "id": "patient-pathway-compatibility-q01" }, { "text": "Which patient interfaces and consumables are documented as compatible with this configuration and application?", "kind": "provenance", "id": "patient-pathway-compatibility-q02" } ] } ] }, { "id": "reuse-and-contamination-control", "name": "Reuse and contamination control", "description": "Records the required contamination-control process and evidence supporting release after processing.", "findings": [ { "id": "reprocessing-and-reuse-limits", "name": "Reprocessing and reuse limits", "description": "Identify single-use restrictions or documented reusable pathways, including process compatibility and release evidence.", "questions": [ { "text": "Which components are single-use, and which have documented cleaning, disinfection or sterilisation instructions and reuse limits?", "kind": "provenance", "id": "reprocessing-and-reuse-limits-q01" }, { "text": "What evidence is required to release equipment after use, contamination or reprocessing?", "kind": "action", "id": "reprocessing-and-reuse-limits-q02" } ] } ] } ] }, { "id": "safe-operation-and-continuity", "name": "Safe operation and continuity", "description": "Describes operating states, protective functions and dependencies that affect patient safety.", "rationale": "Equipment failure and interruption have different consequences depending on the medical function and available safeguards.", "layers": [ { "id": "controls-alarms-and-protection", "name": "Controls, alarms and protection", "description": "Captures how operating modes and protective functions constrain equipment use.", "findings": [ { "id": "protective-function-readiness", "name": "Protective-function readiness", "description": "Record applicable alarms, interlocks, output limits and their verified status without assuming every equipment type has them.", "questions": [ { "text": "Which operating modes, controls, alarms and interlocks govern this equipment's clinically relevant functions?", "kind": "definition", "id": "protective-function-readiness-q01" }, { "text": "What documented response applies when a required protective function fails, is disabled or has not been checked?", "kind": "action", "id": "protective-function-readiness-q02" } ] } ] }, { "id": "dependencies-and-interruption", "name": "Dependencies and interruption", "description": "Identifies resources and environmental conditions needed to sustain the medical function.", "findings": [ { "id": "loss-of-function-response", "name": "Loss-of-function response", "description": "Record supply requirements, applicable backup capability and documented escalation when medical function is interrupted.", "questions": [ { "text": "What power, battery endurance, gas, suction, network and environmental limits apply, with units and operating conditions where relevant?", "kind": "measurement", "id": "loss-of-function-response-q01" }, { "text": "What documented equipment response and operator escalation apply when a required dependency is lost?", "kind": "action", "id": "loss-of-function-response-q02" } ] } ] } ] }, { "id": "configuration-maintenance-and-release", "name": "Configuration, maintenance and release", "description": "Connects equipment configuration and service history to evidence of clinical readiness.", "rationale": "A repair, software change or accessory substitution can alter the applicability of previous performance and safety checks.", "layers": [ { "id": "supported-configuration", "name": "Supported configuration", "description": "Records the combination of hardware, software and interfaces used to perform a medical function.", "findings": [ { "id": "configuration-dependent-suitability", "name": "Configuration-dependent suitability", "description": "Identify supported component combinations and clinically significant dependencies on software or connected systems.", "questions": [ { "text": "Which hardware, software, accessories and connected systems define the configuration being assessed?", "kind": "provenance", "id": "configuration-dependent-suitability-q01" }, { "text": "Which configuration changes require compatibility review or renewed verification before clinical use?", "kind": "action", "id": "configuration-dependent-suitability-q02" } ] } ] }, { "id": "service-and-clinical-release", "name": "Service and clinical release", "description": "Distinguishes service completion from evidence supporting return to clinical use.", "findings": [ { "id": "maintenance-status-and-release-evidence", "name": "Maintenance status and release evidence", "description": "Record required inspections, calibration where applicable, wear limits and unresolved faults alongside release authority.", "questions": [ { "text": "What maintenance, inspection, calibration or replacement criteria apply, and which are currently satisfied or overdue?", "kind": "provenance", "id": "maintenance-status-and-release-evidence-q01" }, { "text": "Who may release the equipment after servicing or a fault, and what evidence must support that decision?", "kind": "action", "id": "maintenance-status-and-release-evidence-q02" } ] } ] } ] }, { "id": "regulatory-evidence-and-traceability", "name": "Regulatory evidence and traceability", "description": "Connects equipment identity to applicable market requirements and subsequent safety restrictions.", "rationale": "Classification, conformity evidence and safety notices must match the equipment, configuration and jurisdiction being assessed.", "layers": [ { "id": "classification-and-conformity", "name": "Classification and conformity", "description": "Records jurisdiction-specific requirements without treating one jurisdiction's rules as universal.", "findings": [ { "id": "applicable-requirement-evidence", "name": "Applicable requirement evidence", "description": "Identify the regulatory category, relevant standards and conformity records, including their scope and applicability.", "questions": [ { "text": "How is this equipment classified in the intended jurisdiction, and which authoritative source establishes that classification?", "kind": "provenance", "id": "applicable-requirement-evidence-q01" }, { "text": "Which standards, issuing bodies, editions, conformity records or marks apply to this subtype and configuration?", "kind": "provenance", "id": "applicable-requirement-evidence-q02" } ] } ] }, { "id": "identity-and-safety-notices", "name": "Identity and safety notices", "description": "Supports matching equipment to recalls, corrective actions and restrictions on use.", "findings": [ { "id": "notice-applicability-and-disposition", "name": "Notice applicability and disposition", "description": "Specify identity evidence needed to determine whether a safety notice applies and whether its required action is complete.", "questions": [ { "text": "Which manufacturer, model, serial or lot identifiers, device identifiers where applicable, and software versions determine notice applicability?", "kind": "provenance", "id": "notice-applicability-and-disposition-q01" }, { "text": "What use restriction, corrective action or withdrawal is required by an applicable notice, and how is completion evidenced?", "kind": "action", "id": "notice-applicability-and-disposition-q02" } ] } ] } ] }, { "id": "evidence-and-external-alignment", "name": "Evidence and external alignment", "description": "What the world already says about this thing, gathered so the model can be checked against it.", "rationale": "A model that cannot be lined up against existing standards, identifiers and practice cannot be adopted by anyone who already uses them.", "layers": [ { "id": "reported-evidence", "name": "Reported evidence", "description": "Findings from the breadth pass, kept separate from the structural claims.", "findings": [ { "id": "evidence-confidence-notes", "name": "Check these first", "description": "Recalled without web access and unsourced; every item is a lead to verify.", "evidence": [ "Medical equipment has no single universally applied boundary; confirm whether the registry includes reusable instruments, assistive products and laboratory analyzers.", "The listed standards exist, but applicability, editions and jurisdictional recognition require checking for each equipment type.", "No category-wide operating principle, power requirement, capacity or dimensional range is meaningful; these require a narrower equipment class." ], "questions": [ { "id": "evidence-confidence-notes-q01", "text": "Which of these check these first hold for the sense of medical equipment this model covers, and on what evidence?", "kind": "provenance" } ] }, { "id": "evidence-kinds", "name": "Kinds and varieties", "description": "Recalled without web access and unsourced; every item is a lead to verify.", "evidence": [ "Diagnostic imaging equipment", "Physiological monitoring equipment", "Laboratory diagnostic equipment", "Therapeutic and life-support equipment", "Surgical equipment", "Rehabilitation and mobility equipment" ], "questions": [ { "id": "evidence-kinds-q01", "text": "Which of these kinds and varieties hold for the sense of medical equipment this model covers, and on what evidence?", "kind": "provenance" } ] }, { "id": "evidence-identifiers", "name": "Identifiers and schemes", "description": "Recalled without web access and unsourced; every item is a lead to verify.", "evidence": [ { "scheme": "Unique Device Identification (UDI)", "value_or_pattern": "Device identifier plus applicable production identifiers", "note": "Identifies devices under applicable regulatory systems; production identifiers can include lot, serial number and manufacturing or expiration dates." }, { "scheme": "Global Medical Device Nomenclature (GMDN)", "value_or_pattern": "Five-digit numerical code", "note": "Identifies a generic device type, rather than an individual equipment unit." } ], "questions": [ { "id": "evidence-identifiers-q01", "text": "Which of these identifiers and schemes hold for the sense of medical equipment this model covers, and on what evidence?", "kind": "provenance" } ] }, { "id": "evidence-standards-and-regulation", "name": "Standards and regulation", "description": "Recalled without web access and unsourced; every item is a lead to verify.", "evidence": [ "IEC 60601-1 - International Electrotechnical Commission: basic safety and essential performance of medical electrical equipment.", "IEC 62353 - International Electrotechnical Commission: recurrent testing and testing after repair of medical electrical equipment.", "ISO 14971 - International Organization for Standardization: application of risk management to medical devices.", "ISO 13485 - International Organization for Standardization: quality management systems for medical device organizations.", "IEC 62366-1 - International Electrotechnical Commission: application of usability engineering to medical devices." ], "questions": [ { "id": "evidence-standards-and-regulation-q01", "text": "Which of these standards and regulation hold for the sense of medical equipment this model covers, and on what evidence?", "kind": "provenance" } ] }, { "id": "evidence-real-world-use", "name": "Real-world use", "description": "Recalled without web access and unsourced; every item is a lead to verify.", "evidence": [ "Producing diagnostic images with ultrasound, radiography or magnetic resonance equipment.", "Monitoring physiological variables such as heart rhythm and blood oxygen saturation.", "Delivering treatment through infusion pumps, ventilators or dialysis machines.", "Measuring properties of patient specimens using laboratory analyzers.", "Supporting mobility and rehabilitation using wheelchairs and therapeutic exercise equipment." ], "questions": [ { "id": "evidence-real-world-use-q01", "text": "Which of these real-world use hold for the sense of medical equipment this model covers, and on what evidence?", "kind": "provenance" } ] }, { "id": "evidence-failure-modes-and-hazards", "name": "Failure modes and hazards", "description": "Recalled without web access and unsourced; every item is a lead to verify.", "evidence": [ "Sensor drift or loss of calibration causing inaccurate measurements.", "Power failure or depleted batteries interrupting monitoring or treatment.", "Electrical insulation failure causing shock, burns or fire.", "Inadequate cleaning or reprocessing allowing cross-infection.", "Software faults, incorrect configuration or confusing controls causing unsafe operation." ], "questions": [ { "id": "evidence-failure-modes-and-hazards-q01", "text": "Which of these failure modes and hazards hold for the sense of medical equipment this model covers, and on what evidence?", "kind": "provenance" } ] }, { "id": "evidence-regional-variation", "name": "Regional variation", "description": "Recalled without web access and unsourced; every item is a lead to verify.", "evidence": [ "Regulatory definitions, risk classifications and market authorization requirements vary by jurisdiction.", "Electrical supply, plug types and compatibility with local medical gas systems affect installation requirements.", "Availability of trained maintenance staff, replacement parts and consumables affects which equipment can be sustainably operated." ], "questions": [ { "id": "evidence-regional-variation-q01", "text": "Which of these regional variation hold for the sense of medical equipment this model covers, and on what evidence?", "kind": "provenance" } ] }, { "id": "evidence-neighbours", "name": "Neighbouring kinds and how to tell them apart", "description": "Recalled without web access and unsourced; every item is a lead to verify.", "evidence": [ { "name": "medical device", "difference": "Medical device is the broader category and can include implants, disposable articles and software; medical equipment usually denotes reusable physical apparatus." }, { "name": "medical consumable", "difference": "A consumable is depleted or routinely discarded during use, whereas equipment normally remains in service across repeated uses." }, { "name": "laboratory equipment", "difference": "Laboratory equipment also serves nonmedical research and industrial testing; its intended medical purpose determines the overlap." }, { "name": "medical equipment model", "difference": "A model specifies a particular product design; medical equipment names the general category." }, { "name": "individual medical equipment unit", "difference": "A unit is a physical asset with its own serial number, condition and service history." } ], "questions": [ { "id": "evidence-neighbours-q01", "text": "Which of these neighbouring kinds and how to tell them apart hold for the sense of medical equipment this model covers, and on what evidence?", "kind": "provenance" } ] } ] } ] } ] }, "openQuestions": [ "Does the registry intend medical equipment to include single-use instruments, implants, in vitro diagnostic instruments and assistive devices, or are some owned by neighbouring entries?", "Does an existing Vercy world model already own this concept, requiring this registry entry to link to it rather than produce a second publication?", "Which authoritative definitions and subtype taxonomy should establish the umbrella category when the registry has no recorded definition?", "Which jurisdictions and equipment subtypes should be researched first to establish applicable classifications, standards, issuing bodies and conformity evidence?", "Which subtype sources establish typical capacities, dimensions, failure modes and release criteria without falsely generalising them across all medical equipment?" ], "statistics": { "bundles": 7, "layers": 13, "findings": 20, "questions": 32 } }