TianGong PCR产品类别规则

Ultra-violet or infra-red ray apparatus, used in medical, surgical, dental or veterinary sciences

Ultra-violet or infra-red ray apparatus, used in medical, surgical, dental or veterinary sciences: This PCR applies to complete apparatus whose declared intended…

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Status, classification and source details

Readiness

  • Warnings methodology_not_reviewed Authored methodology is candidate guidance and still requires methodology review.

Classification mapping

CPC 3.0:48122 · exact

Source

1. Scope and Applicability

This PCR applies to complete apparatus whose declared intended medical, surgical, dental, or veterinary function is delivered by ultraviolet or infrared optical radiation. It covers non-laser ultraviolet or infrared treatment, diagnostic, monitoring, or procedure-support apparatus supplied as a complete market-ready product, including the installed source, controls, housing, optical parts, power connection, and supplied accessories needed for the declared function.

The product definition is determined by intended purpose and radiation function, not merely by the presence of a lamp or heater. General-purpose lighting, space heating, tanning, industrial curing, material testing, germicidal fixtures without the assigned medical, surgical, dental, or veterinary intended purpose, laser equipment, ionizing-radiation equipment, electro-diagnostic apparatus whose diagnostic function is not delivered by ultraviolet or infrared radiation, and separately marketed consumables or replacement lamps are outside this boundary. Product variants using ultraviolet, infrared, or both are represented by conditional atomic rows; they are not multiplied across every lifecycle stage.

The base foreground package covers component receipt, apparatus assembly, final test, and packaging through the factory gate. Distribution, use and maintenance, and end of life are conditional modules that become mandatory whenever the study claims those lifecycle stages or a cradle-to-grave result. Applicable legal or conformity obligations remain jurisdiction- and intended-use-specific; this PCR does not certify medical-device safety or regulatory compliance.

2. Product Category Identity

FieldValue
canonical_pcr_idpcr.metal-products-machinery-and-equipment.medical-appliances-precision-and-optical-instruments-watches-and-clocks.ultra-violet-or-infra-red-ray-apparatus-used-in-medical-surgical-dental-or-veterinary-sciences
classification_refsCPC 3.0: 48122, exact classification context; the classification remains unmapped until separately accepted
covered_productsComplete ultraviolet or infrared apparatus specifically intended for medical, surgical, dental, or veterinary treatment, diagnosis, monitoring, or procedure support; non-laser light-source equipment within IEC 60601-2-57 is a representative technical subset
excluded_productsGeneral-purpose lamps and luminaires; tanning and domestic heating appliances; industrial curing and testing equipment; general germicidal fixtures without the assigned intended purpose; laser equipment; X-ray, alpha, beta, or gamma apparatus; electro-diagnostic apparatus outside this radiation-function boundary; separately sold replacement sources and consumables
representative_productReusable electrically powered ultraviolet phototherapy or infrared therapeutic apparatus with source module, control electronics, enclosure, optical components, power cable, instructions, and sales packaging
production_routeReceipt of specified components and materials; mechanical and electrical assembly; software or control configuration where present; optical/radiometric and electrical final test; cleaning where applicable; packaging and release
market_stateComplete, factory-tested, calibrated where required, labelled, and packaged apparatus ready for professional or declared lay use; sterile state applies only when explicitly declared

3. Reference Flow

FieldValue
WhatProvision of the declared medical, surgical, dental, or veterinary function by ultraviolet or infrared radiation from one defined apparatus configuration
How muchOperation of one complete apparatus under the declared utilization profile
How wellAt the declared wavelength band, radiant output or irradiance, treatment or diagnostic performance, exposure-control configuration, and applicable safety classification
How long or cycleThe declared reference service life, stated in years and operating hours or treatment cycles, including the declared maintenance and source-replacement regime
reference_flow_linkOne market-ready apparatus, with lifecycle exchanges normalized to that apparatus and its declared reference service life
FieldValue
Reference amount1 Item(s)
Reference product flowMarket-ready ultra-violet or infra-red medical apparatus (Tiangong UUID unresolved)
Reference flow propertyNumber of items 01846770-4cfe-4a25-8ad9-919d8d378345
Reference unit groupUnits of items 5beb6eed-33a9-47b8-9ede-1dfe8f679159
Reference unitItem(s)
Required qualifiersultraviolet, infrared, or combined source; intended medical/surgical/dental/veterinary purpose; wavelength band; source technology; rated radiant output or irradiance; exposure-control mode; mains or battery supply; apparatus model and configuration; installed source count; net and packaged mass; production geography and year; declared service life; utilization profile; cleaning/disinfection state; sterile state if any; supplied accessories; packaging configuration; end-of-life geography when included

When constructing a foreground data package, the items listed in Required qualifiers must be declared in dataset metadata, process notes, reference flow comment, product description, or an equivalent data package field. Missing required qualifiers make the reference flow definition incomplete for that data package.

4. Measurement and Unit Rules

rule_idApplies toRequired propertyRequired unitRule
reference_item_countreference productNumber of items 01846770-4cfe-4a25-8ad9-919d8d378345Item(s)Count only complete released apparatus conforming to the declared configuration. Report net apparatus mass and packaged mass separately in kg per item; do not substitute lamp count for apparatus count.
component_mass_basiscomponent and packaging product inputsMass 93a60a56-a3c8-11da-a746-0800200b9a66kgRecord the mass crossing the foreground boundary after incoming inspection, excluding returnable supplier transport packaging unless it is consumed by the product system.
energy_conversionelectricity inputsNet calorific value 93a60a56-a3c8-11da-a746-0800200c9a66MJPreserve the metered kWh record and convert to MJ using the exact identity 1 kWh = 3.6 MJ. Do not combine electricity with heat or fuel.
transport_mass_distancefreight service inputsmass*distance 118f2a40-50ec-457c-aa60-9bc6b6af9931kg*kmCalculate each mode separately as shipped mass multiplied by route distance; disclose vehicle or vessel class, load factor convention, and whether empty returns are included.
optical_performance_disclosurereference apparatus and use scenariodeclared wavelength and radiant-performance metricmanufacturer-declared unitPreserve the manufacturer's wavelength band and the applicable radiant output, irradiance, radiant exposure, or treatment-control metric. Do not convert unlike optical performance metrics into one generic energy value.

5. System Boundary

Boundary Abstraction

FieldValue
declared_starting_conditionComponents and materials accepted at the apparatus assembly site, with supplier identities, product states, masses, origins, and upstream dataset links declared
starting_condition_roleForeground entry point for apparatus manufacturing; upstream component and material production remains represented by linked secondary or background datasets
product_classification_scopeThe semantic ultraviolet/infrared medical-apparatus boundary described in sections 1 and 2; CPC 48122 is classification context rather than canonical identity authority
recursive_input_ruleA same-category apparatus or subassembly purchased for integration is recorded once as an incoming product flow with its upstream dataset; it is not recursively decomposed again inside the receiving process
upstream_dataset_requirementEvery purchased component, material, packaging item, electricity supply, water supply, and transport service must link to a geographically and technologically representative upstream dataset or carry a documented unresolved-data gap
disclosureDeclare assembly and packaging sites, included lifecycle modules, cut-offs, shared-facility treatment, product configuration, software/control content, sterilization or cleaning steps, supplier data coverage, electricity geography, distribution routes, use profile, maintenance, and end-of-life scenario
rule_idapplies_torulesource_ids
boundary_base_gatemanufacturing foregroundInclude accepted components and materials, assembly, configuration, final electrical and optical/radiometric testing, process utilities, cleaning where performed, packaging, rejects actually generated, and release to the factory gate.eu-pef-2021-2279; eu-mdr-2017-745
boundary_lifecycle_moduleslifecycle claimsA cradle-to-grave or downstream claim must add distribution, installation if material, use electricity, cleaning or disinfection when prescribed, maintenance and source replacement, and end-of-life collection and treatment. A factory-gate dataset must state that these modules are excluded.eu-pef-2021-2279; eu-mdr-2017-745
boundary_configurationproduct variantsModel one declared apparatus configuration. Include ultraviolet and infrared source rows only when present; do not average incompatible source technologies, intended purposes, service lives, or sterile/reusable states without disclosed weighting.iec-60601-2-57-2023; eu-mdr-2017-745
boundary_upstream_linkspurchased inputsRepresent purchased inputs by specific product flows and representative upstream datasets. Do not replace a missing component identity with an umbrella material or utility flow.eu-pef-2021-2279
boundary_end_of_lifediscarded equipmentWhen end of life is included, keep the discarded apparatus and spent ultraviolet or infrared lamps as separate waste flows and apply jurisdiction-specific collection, contamination, dismantling, recovery, recycling, or disposal scenarios.eu-weee-2012-19; eu-mdr-2017-745

6. Process Inventory Structure

Process Map

process_idprocess_nameinclusioninclusion_conditionrolequantitative_reference
apparatus_assemblyApparatus assembly, configuration, and final testrequiredAlways included for a manufactured complete apparatusForeground manufacturingPer accepted assembled apparatus
packaging_releasePackaging and market releaserequiredAlways included for a market-ready apparatusForeground packagingPer released packaged apparatus
distributionDistribution to the first userconditionalInclude when distribution or any downstream lifecycle stage is claimedDownstream transportkg*km by transport mode per reference apparatus
use_maintenanceUse, cleaning, maintenance, and source replacementconditionalInclude when use stage or cradle-to-grave performance is claimedUse-stage foreground scenarioPer reference service life and utilization profile
end_of_lifeCollection and end-of-life transferconditionalInclude when end of life or cradle-to-grave performance is claimedEnd-of-life scenarioPer discarded reference apparatus

Process: Apparatus assembly, configuration, and final test (apparatus_assembly)

Inputs

Product flows
Ultraviolet light-source module (uv_emitter_module)

Record one ultraviolet emitter module when it is installed in the declared apparatus; omit this row only for an infrared-only configuration.

  • Selected flow: Ultraviolet light-source module (Tiangong UUID unresolved)
  • Flow property / unit: Mass / kg
  • Amount rule: Measured accepted mass of ultraviolet emitter modules installed in accepted apparatus
  • Value mode: Foreground record (foreground_record)
  • Specificity: Product-specific (product_specific)
  • Normalization basis: per accepted assembled apparatus
  • Basis kind: Process output (process_output)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_assembly_bom
  • Sources: iec-60601-2-57-2023
Infrared light-source module (infrared_emitter_module)

Record one infrared emitter module when it is installed in the declared apparatus; omit this row only for an ultraviolet-only configuration.

  • Selected flow: Infrared light-source module (Tiangong UUID unresolved)
  • Flow property / unit: Mass / kg
  • Amount rule: Measured accepted mass of infrared emitter modules installed in accepted apparatus
  • Value mode: Foreground record (foreground_record)
  • Specificity: Product-specific (product_specific)
  • Normalization basis: per accepted assembled apparatus
  • Basis kind: Process output (process_output)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_assembly_bom
  • Sources: iec-60601-2-57-2023
Printed wire board (printed_wire_board)

Record this input only when an unpopulated printed wire board crosses the assembly boundary; a purchased populated control assembly requires its own future exact flow identity.

  • Selected flow: Printed Wire Board a8bd954c-59b3-4317-b4de-02a17d6da5ca
  • Flow property / unit: Mass 93a60a56-a3c8-11da-a746-0800200b9a66 / kg; unit group Units of mass 93a60a57-a4c8-11da-a746-0800200c9a66
  • Amount rule: Measured accepted mass of printed wire boards installed in accepted apparatus
  • Value mode: Foreground record (foreground_record)
  • Specificity: Product-specific (product_specific)
  • Normalization basis: per accepted assembled apparatus
  • Basis kind: Process output (process_output)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_assembly_bom
  • Sources:
Aluminium-alloy housing (aluminium_alloy_housing)

Record the finished aluminium-alloy housing when it crosses the boundary as one purchased apparatus component.

  • Selected flow: Aluminium-alloy apparatus housing (Tiangong UUID unresolved)
  • Flow property / unit: Mass / kg
  • Amount rule: Measured accepted housing mass installed in accepted apparatus
  • Value mode: Foreground record (foreground_record)
  • Specificity: Product-specific (product_specific)
  • Normalization basis: per accepted assembled apparatus
  • Basis kind: Process output (process_output)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_assembly_bom
  • Sources:
Stainless-steel housing (stainless_steel_housing)

Record the finished stainless-steel housing when it crosses the boundary as one purchased apparatus component.

  • Selected flow: Stainless-steel apparatus housing (Tiangong UUID unresolved)
  • Flow property / unit: Mass / kg
  • Amount rule: Measured accepted housing mass installed in accepted apparatus
  • Value mode: Foreground record (foreground_record)
  • Specificity: Product-specific (product_specific)
  • Normalization basis: per accepted assembled apparatus
  • Basis kind: Process output (process_output)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_assembly_bom
  • Sources:
Optical glass pressing blank (optical_glass_pressing_blank)

Record this input only when an optical glass pressing blank is processed at the assembly site; purchased finished optics require their own product identity.

  • Selected flow: Optical Glass Pressing Blank a68c2948-174f-4e17-a3ee-f2b289d50d18
  • Flow property / unit: Mass 93a60a56-a3c8-11da-a746-0800200b9a66 / kg; unit group Units of mass 93a60a57-a4c8-11da-a746-0800200c9a66
  • Amount rule: Measured accepted mass of optical glass pressing blanks consumed in accepted apparatus
  • Value mode: Foreground record (foreground_record)
  • Specificity: Product-specific (product_specific)
  • Normalization basis: per accepted assembled apparatus
  • Basis kind: Process output (process_output)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_assembly_bom
  • Sources:
Power cable (power_cable)

Record the supplied mains power cable or internal power-cable assembly as one product input when present.

  • Selected flow: Medical apparatus power cable (Tiangong UUID unresolved)
  • Flow property / unit: Mass / kg
  • Amount rule: Measured accepted mass of power cables installed in or supplied with accepted apparatus
  • Value mode: Foreground record (foreground_record)
  • Specificity: Product-specific (product_specific)
  • Normalization basis: per accepted assembled apparatus
  • Basis kind: Process output (process_output)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_assembly_bom
  • Sources:
Assembly and final-test electricity (assembly_electricity)

Record metered electricity used for mechanical and electrical assembly, control configuration, burn-in, and final electrical and optical/radiometric testing.

  • Selected flow: Electricity 67b723a9-6f63-4802-adca-b52ce7967d47
  • Flow property / unit: Net calorific value 93a60a56-a3c8-11da-a746-0800200c9a66 / MJ; unit group Units of energy 93a60a57-a3c8-11da-a746-0800200c9a66
  • Amount rule: Metered or facility-submetered electricity attributable to accepted apparatus
  • Value mode: Calculated value (calculated_value)
  • Specificity: Site-specific (site_specific)
  • Normalization basis: per accepted assembled apparatus
  • Basis kind: Process output (process_output)
  • Evidence kind: Calculated from collection (calculated_from_collection)
  • Collection protocol: cp_assembly_utilities
  • Sources:
Assembly process water (assembly_process_water)

Record process water used for component or apparatus cleaning at the assembly site when it crosses the process boundary.

  • Selected flow: Process Water 94a04f7e-2d5c-41f0-b182-d54a3b373a02
  • Flow property / unit: Mass 93a60a56-a3c8-11da-a746-0800200b9a66 / kg; unit group Units of mass 93a60a57-a4c8-11da-a746-0800200c9a66
  • Amount rule: Metered or batch-record process-water mass attributable to accepted apparatus
  • Value mode: Calculated value (calculated_value)
  • Specificity: Site-specific (site_specific)
  • Normalization basis: per accepted assembled apparatus
  • Basis kind: Process output (process_output)
  • Evidence kind: Calculated from collection (calculated_from_collection)
  • Collection protocol: cp_assembly_utilities
  • Sources:
Waste flows
Elementary flows

Outputs

Product flows
Accepted assembled apparatus (assembled_apparatus)

Record complete apparatus that passed the declared electrical, optical/radiometric, software/control, and release tests before sales packaging.

  • Selected flow: Assembled ultra-violet or infra-red medical apparatus (Tiangong UUID unresolved)
  • Flow property / unit: Number of items / item
  • Amount rule: Count of accepted assembled apparatus
  • Value mode: Foreground record (foreground_record)
  • Specificity: Product-specific (product_specific)
  • Normalization basis: per apparatus assembly campaign
  • Basis kind: Process output (process_output)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_output_units
  • Sources: un-cpc-3-0-structure-2025; iec-60601-2-57-2023
Waste flows
Elementary flows

Process: Packaging and market release (packaging_release)

Inputs

Product flows
Corrugated-board boxes (corrugated_board_boxes)

Record corrugated-board sales and transit boxes consumed for the reference apparatus.

  • Selected flow: corrugated board boxes 4f197bec-7b3b-11dd-ad8b-0800200c9a66
  • Flow property / unit: Mass 93a60a56-a3c8-11da-a746-0800200b9a66 / kg; unit group Units of mass 93a60a57-a4c8-11da-a746-0800200c9a66
  • Amount rule: Measured box mass consumed for released packaged apparatus
  • Value mode: Foreground record (foreground_record)
  • Specificity: Product-specific (product_specific)
  • Normalization basis: per released packaged apparatus
  • Basis kind: Process output (process_output)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_packaging_bom
  • Sources:
Polyethylene packaging film (polyethylene_packaging_film)

Record non-cellular polyethylene film consumed as bag, wrap, or protective film; retain film grade and thickness as foreground qualifiers.

  • Selected flow: Polyethylene 1ff32f1d-77ac-4a6f-b91c-67b08b13e55a
  • Flow property / unit: Mass 93a60a56-a3c8-11da-a746-0800200b9a66 / kg; unit group Units of mass 93a60a57-a4c8-11da-a746-0800200c9a66
  • Amount rule: Measured polyethylene film mass consumed for released packaged apparatus
  • Value mode: Foreground record (foreground_record)
  • Specificity: Product-specific (product_specific)
  • Normalization basis: per released packaged apparatus
  • Basis kind: Process output (process_output)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_packaging_bom
  • Sources:
Packaging electricity (packaging_electricity)

Record electricity used by packaging equipment and final release operations when separately metered or allocated by a physical driver.

  • Selected flow: Electricity 67b723a9-6f63-4802-adca-b52ce7967d47
  • Flow property / unit: Net calorific value 93a60a56-a3c8-11da-a746-0800200c9a66 / MJ; unit group Units of energy 93a60a57-a3c8-11da-a746-0800200c9a66
  • Amount rule: Metered packaging electricity attributable to released apparatus
  • Value mode: Calculated value (calculated_value)
  • Specificity: Site-specific (site_specific)
  • Normalization basis: per released packaged apparatus
  • Basis kind: Process output (process_output)
  • Evidence kind: Calculated from collection (calculated_from_collection)
  • Collection protocol: cp_assembly_utilities
  • Sources:
Waste flows
Elementary flows

Outputs

Product flows
Market-ready packaged apparatus (packaged_apparatus)

Record the released reference product with all included accessories, instructions, and sales packaging.

  • Selected flow: Market-ready ultra-violet or infra-red medical apparatus (Tiangong UUID unresolved)
  • Flow property / unit: Number of items / item
  • Amount rule: Count of released packaged apparatus
  • Value mode: Foreground record (foreground_record)
  • Specificity: Product-specific (product_specific)
  • Normalization basis: per packaging campaign
  • Basis kind: Process output (process_output)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_output_units
  • Sources: un-cpc-3-0-structure-2025
Waste flows
Elementary flows

Process: Distribution to the first user (distribution)

Inputs

Product flows
Road freight transport (road_freight)

Record each road leg for the packaged apparatus using actual shipped mass and route distance.

  • Selected flow: Road freight transport service 482c5e1a-bd9d-53d0-afeb-f2d3b56e8179
  • Flow property / unit: massdistance 118f2a40-50ec-457c-aa60-9bc6b6af9931 / kgkm; unit group Unit of kg*km 3620148f-c5db-48ce-9065-a10092089aca
  • Amount rule: Shipped mass multiplied by road-route distance for each leg
  • Value mode: Calculated value (calculated_value)
  • Specificity: Route-specific (route_specific)
  • Normalization basis: per delivered reference apparatus
  • Basis kind: Transport service (transport_service)
  • Evidence kind: Calculated from collection (calculated_from_collection)
  • Collection protocol: cp_distribution_routes
  • Sources: eu-pef-2021-2279
Container-ship sea freight (sea_freight_container_ship)

Record container-ship sea transport only when it occurs in the declared distribution route.

  • Selected flow: Freight transport by sea, container ship eb46993a-20d8-400e-81eb-66732ff4900b
  • Flow property / unit: massdistance 118f2a40-50ec-457c-aa60-9bc6b6af9931 / kgkm; unit group Unit of kg*km 3620148f-c5db-48ce-9065-a10092089aca
  • Amount rule: Shipped mass multiplied by sea-route distance for each container-ship leg
  • Value mode: Calculated value (calculated_value)
  • Specificity: Route-specific (route_specific)
  • Normalization basis: per delivered reference apparatus
  • Basis kind: Transport service (transport_service)
  • Evidence kind: Calculated from collection (calculated_from_collection)
  • Collection protocol: cp_distribution_routes
  • Sources: eu-pef-2021-2279
Waste flows
Elementary flows

Outputs

Product flows
Waste flows
Elementary flows

Process: Use, cleaning, maintenance, and source replacement (use_maintenance)

Inputs

Product flows
Use-stage electricity (use_electricity)

Record apparatus electricity over the declared utilization profile, including standby and prescribed warm-up or cooling modes.

  • Selected flow: Electricity 67b723a9-6f63-4802-adca-b52ce7967d47
  • Flow property / unit: Net calorific value 93a60a56-a3c8-11da-a746-0800200c9a66 / MJ; unit group Units of energy 93a60a57-a3c8-11da-a746-0800200c9a66
  • Amount rule: Sum of metered electricity by operating mode over the reference service life
  • Value mode: Calculated value (calculated_value)
  • Specificity: Scenario-specific (scenario_specific)
  • Normalization basis: per reference apparatus service life
  • Basis kind: Reference flow (reference_flow)
  • Evidence kind: Calculated from collection (calculated_from_collection)
  • Collection protocol: cp_use_logs
  • Sources: eu-mdr-2017-745; eu-pef-2021-2279
Cleaning process water (cleaning_process_water)

Record process water only when the validated instructions prescribe water-based cleaning or disinfection during the declared use scenario.

  • Selected flow: Process Water 94a04f7e-2d5c-41f0-b182-d54a3b373a02
  • Flow property / unit: Mass 93a60a56-a3c8-11da-a746-0800200b9a66 / kg; unit group Units of mass 93a60a57-a4c8-11da-a746-0800200c9a66
  • Amount rule: Measured water per cleaning event multiplied by recorded event count over the reference service life
  • Value mode: Calculated value (calculated_value)
  • Specificity: Scenario-specific (scenario_specific)
  • Normalization basis: per reference apparatus service life
  • Basis kind: Reference flow (reference_flow)
  • Evidence kind: Calculated from collection (calculated_from_collection)
  • Collection protocol: cp_use_logs
  • Sources: eu-mdr-2017-745
Replacement ultraviolet emitter (replacement_uv_emitter)

Record one ultraviolet replacement-emitter product flow when the service log shows replacement within the reference service life.

  • Selected flow: Replacement ultraviolet emitter module (Tiangong UUID unresolved)
  • Flow property / unit: Mass / kg
  • Amount rule: Measured mass of replacement ultraviolet emitter modules installed over the reference service life
  • Value mode: Calculated value (calculated_value)
  • Specificity: Product-specific (product_specific)
  • Normalization basis: per reference apparatus service life
  • Basis kind: Reference flow (reference_flow)
  • Evidence kind: Calculated from collection (calculated_from_collection)
  • Collection protocol: cp_maintenance_logs
  • Sources: eu-mdr-2017-745; iec-60601-2-57-2023
Replacement infrared emitter (replacement_ir_emitter)

Record one infrared replacement-emitter product flow when the service log shows replacement within the reference service life.

  • Selected flow: Replacement infrared emitter module (Tiangong UUID unresolved)
  • Flow property / unit: Mass / kg
  • Amount rule: Measured mass of replacement infrared emitter modules installed over the reference service life
  • Value mode: Calculated value (calculated_value)
  • Specificity: Product-specific (product_specific)
  • Normalization basis: per reference apparatus service life
  • Basis kind: Reference flow (reference_flow)
  • Evidence kind: Calculated from collection (calculated_from_collection)
  • Collection protocol: cp_maintenance_logs
  • Sources: eu-mdr-2017-745; iec-60601-2-57-2023
Waste flows
Elementary flows

Outputs

Product flows
Waste flows
Spent ultraviolet lamp (spent_uv_lamp)

Record spent ultraviolet lamps separately from the apparatus and from infrared lamps; retain mercury or other hazardous-substance status in the waste description when applicable.

  • Selected flow: Spent ultraviolet lamp (Tiangong UUID unresolved)
  • Flow property / unit: Mass / kg
  • Amount rule: Measured mass of ultraviolet lamps removed over the reference service life
  • Value mode: Calculated value (calculated_value)
  • Specificity: Product-specific (product_specific)
  • Normalization basis: per reference apparatus service life
  • Basis kind: Reference flow (reference_flow)
  • Evidence kind: Calculated from collection (calculated_from_collection)
  • Collection protocol: cp_maintenance_logs
  • Sources: eu-weee-2012-19; eu-mdr-2017-745
Spent infrared lamp (spent_ir_lamp)

Record spent infrared lamps separately from the apparatus and from ultraviolet lamps.

  • Selected flow: Spent infrared lamp (Tiangong UUID unresolved)
  • Flow property / unit: Mass / kg
  • Amount rule: Measured mass of infrared lamps removed over the reference service life
  • Value mode: Calculated value (calculated_value)
  • Specificity: Product-specific (product_specific)
  • Normalization basis: per reference apparatus service life
  • Basis kind: Reference flow (reference_flow)
  • Evidence kind: Calculated from collection (calculated_from_collection)
  • Collection protocol: cp_maintenance_logs
  • Sources: eu-weee-2012-19; eu-mdr-2017-745
Elementary flows

Process: Collection and end-of-life transfer (end_of_life)

Inputs

Product flows
Waste flows
Discarded ultraviolet or infrared medical apparatus (discarded_apparatus)

Record the complete discarded apparatus entering the declared collection or treatment route. Do not use an unspecified waste flow, and disclose whether contamination changes the legally available route.

  • Selected flow: Discarded ultra-violet or infra-red medical apparatus (Tiangong UUID unresolved)
  • Flow property / unit: Mass / kg
  • Amount rule: Measured net mass of the discarded apparatus entering the declared end-of-life route
  • Value mode: Foreground record (foreground_record)
  • Specificity: Scenario-specific (scenario_specific)
  • Normalization basis: per discarded reference apparatus
  • Basis kind: Reference flow (reference_flow)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_end_of_life_records
  • Sources: eu-weee-2012-19; eu-mdr-2017-745
Elementary flows

Outputs

Product flows
Waste flows
Elementary flows

7. Allocation and Co-product Handling

rule_idapplies_torulesource_ids
allocation_subdivide_firstmulti-product and shared processesAvoid allocation by subdividing assembly, test, packaging, and utility records to the declared apparatus family whenever separate measurements or production records are available.eu-pef-2021-2279
allocation_physical_driverresidual shared burdensWhen subdivision is not possible, allocate shared electricity, water, cleaning, and packaging operations using a documented causal physical driver such as machine time, test time, metered energy, processed mass, or accepted unit count. Economic allocation requires a documented reason that no causal physical relation is practicable.eu-pef-2021-2279
allocation_rejectsrejected apparatus and componentsAttribute burdens through the point of rejection using measured process participation; do not distribute post-rejection rework or treatment to accepted output unless the chosen physical driver causally requires it.eu-pef-2021-2279
allocation_recyclingend-of-life recoveryState the recycled-content and end-of-life attribution convention, use it consistently for incoming and recovered materials, and prevent double credit between the apparatus system and downstream material systems.eu-pef-2021-2279; eu-weee-2012-19

8. Foreground Data Collection, Calculation, and Quality Rules

Data Collection Protocols

protocol_idprocess_idflow_rolerecord_typeraw_fieldscollection_methodunitfrequencytemporal_coveragesite_scopeaggregation_rulequality_evidence
cp_assembly_bomapparatus_assemblyinstalled component inputapproved BOM, goods receipt, and production issuemodel; revision; component identity; supplier; batch; accepted mass; issued mass; return mass; accepted apparatus countReconcile approved BOM to warehouse issues and accepted build recordskg and itemeach batch or campaignrepresentative continuous 12-month period or all production if shorterevery assembly site in scopeNet accepted component mass divided by accepted assembled apparatus; keep configuration-specific records separateapproved BOM revision, supplier specification, calibrated scale record, and reconciliation sign-off
cp_assembly_utilitiesapparatus_assembly; packaging_releaseelectricity and process waterutility meter, submeter, and production logmeter start/end; kWh; water mass or volume; density assumption if converted; operating hours; apparatus count; allocation driverRead dedicated meters where available; otherwise allocate a reconciled facility meter using a causal physical driverkWh, MJ, kg, and hmonthly and each representative campaignrepresentative continuous 12-month period or all production if shortereach assembly and packaging siteSubtract documented non-production loads, allocate by the declared driver, and divide by accepted outputmeter calibration, invoice reconciliation, downtime log, and allocation worksheet
cp_output_unitsapparatus_assembly; packaging_releaseaccepted outputrelease and test recordserial or lot; model; configuration; accepted count; rejected count; net mass; packaged mass; test statusCount only units passing the declared release tests and measure representative net and gross massesitem and kgeach batchentire reporting periodevery release siteSum accepted units by configuration; do not net rejects into accepted outputsigned release record, test result, and scale calibration
cp_packaging_bompackaging_releasepackaging inputpackaging specification and issue recordpackaging component identity; material; grade; unit mass; issued count; return or scrap count; released apparatus countReconcile packaging BOM to issued quantities and released unitskg and itemeach packaging configuration and revisionreporting periodevery packaging siteNet packaging mass divided by released apparatus; separate reusable transport packagingapproved packaging specification, supplier declaration, and issue reconciliation
cp_distribution_routesdistributionfreight serviceshipment and route recordorigin; destination; mode; vehicle or vessel class; shipped gross mass; distance; load factor convention; empty return; delivered unitsMatch carrier documents to geospatial or carrier distance recordskg, km, and kg*kmeach shipment or representative route stratumreporting periodall included distribution routesCalculate each mode and leg separately, then divide by delivered reference apparatusbill of lading, carrier invoice, route record, and mass reconciliation
cp_use_logsuse_maintenanceuse electricity and cleaning watermeter, treatment log, and validated instructionsmodel; operating mode; power; duration; treatments; standby time; cleaning events; water per event; service-life basisMeter representative apparatus or use validated mode-specific power data with recorded utilizationkWh, MJ, h, cycle, and kg waterper test campaign with annual utilization updatedeclared reference service life scenariodeclared user geography and settingSum mode energy and event water over the declared utilization profile; keep user settings separatecalibrated meter, protocol, instructions for use, and scenario approval
cp_maintenance_logsuse_maintenancereplacement emitter and spent lampservice and parts recordserial; date; emitter type; part number; installed mass; removed mass; failure mode; operating hours; treatment routeReconcile service tickets, parts issues, and removed-component recordsitem, kg, and heach maintenance eventdeclared reference service lifeincluded installed base or representative service sampleSum installed and removed mass by source technology per reference apparatusservice ticket, part specification, scale record, and waste consignment note
cp_end_of_life_recordsend_of_lifediscarded apparatuscollection and treatment recordmodel; net mass; contamination status; collection route; treatment facility; downstream dataset; geographyMatch asset retirement to collection and treatment documentationitem and kgeach disposal event or representative scenario updatedeclared end-of-life scenario yeardeclared end-of-life geographyKeep collected, reused, treated, recovered, recycled, and disposed routes separate; normalize to one discarded apparatusasset retirement record, waste transfer note, facility evidence, and scenario approval

Calculation Rules

rule_idApplies toFormula or ruleInputsOutputsource_ids
calc_component_per_itemassembly and packaging material rows(issued mass - returned unused mass) / accepted output countcomponent or packaging issue mass; return mass; accepted apparatus countkg per apparatus
calc_electricity_mjassembly, packaging, and use electricitymetered kWh × 3.6 MJ/kWhmetered kWh by process and modeMJ per apparatus or service life
calc_transport_serviceroad and sea freightshipped gross mass in kg × route distance in km / delivered apparatus countshipped mass; leg distance; delivered countkg*km per delivered apparatuseu-pef-2021-2279
calc_lifetime_useuse electricity and cleaning waterSum mode- or event-specific amount × event count over the declared reference service lifeoperating-mode power and hours; standby power and hours; cleaning water and event countMJ electricity and kg process water per reference service lifeeu-mdr-2017-745; eu-pef-2021-2279
calc_replacement_balancereplacement emitter and spent lamp rowsSum installed replacement mass and removed spent-lamp mass separately by ultraviolet and infrared technologyservice records; installed part mass; removed part masskg replacement product and kg spent lamp per reference service lifeeu-mdr-2017-745

Data Quality Requirements

requirement_idApplies toRequirementEvidence
dq_identityreference apparatusPreserve model, configuration revision, intended purpose, radiation type, wavelength band, source technology, installed source count, and market state; do not combine incompatible variants without weights.product specification, technical documentation, release record, and un-cpc-3-0-structure-2025; iec-60601-2-57-2023; eu-mdr-2017-745
dq_completenessmanufacturing foregroundReconcile BOM, accepted output, component issues, packaging, electricity, water, rejects, and any additional site-specific product, waste, or elementary flows. Explain every exclusion.BOM reconciliation, utility reconciliation, release report, and eu-pef-2021-2279
dq_temporalforeground recordsUse a representative continuous 12-month period or all production when the product has been manufactured for less than 12 months; disclose exceptional campaigns, shutdowns, and substitutions.reporting-period statement and production calendar
dq_measurementmeasured and calculated rowsRetain meter and scale calibration, raw units, conversions, allocation drivers, and calculation workbooks so each normalized value is reproducible.calibration certificates, raw records, and calculation review
dq_use_scenariouse and maintenanceAlign operating modes, utilization, cleaning, maintenance, replacement, service life, and electricity geography to one internally consistent intended-use scenario.instructions for use, measured test protocol, service plan, and scenario approval
dq_end_of_lifewaste scenarioState jurisdiction, collection route, contamination status, lamp hazardous-substance status, downstream treatment datasets, and allocation convention.waste records and eu-weee-2012-19; eu-mdr-2017-745

9. Validation Rules

rule_idapplies_torulesource_ids
validate_identityreference flowFail validation when intended purpose, ultraviolet/infrared configuration, wavelength band, source technology, model, service-life basis, or market state is missing.un-cpc-3-0-structure-2025; iec-60601-2-57-2023; eu-mdr-2017-745
validate_reference_countnormalizationRequire exactly one released apparatus as the reference amount and require net mass plus packaged mass as separate metadata; lamp count cannot replace apparatus count.
validate_atomic_rowsinventoryReject combined utilities, combined ultraviolet/infrared emitter rows, unspecified packaging, unspecified waste, or any row that cannot resolve to one concrete exchange.
validate_variant_conditionsinventory applicabilityRequire ultraviolet rows only for ultraviolet-containing configurations and infrared rows only for infrared-containing configurations; require an explicit zero or not-applicable record for demonstrably absent conditional flows.iec-60601-2-57-2023
validate_energyelectricityRequire kWh source records, the exact 3.6 MJ/kWh conversion, electricity geography, and separate manufacturing, packaging, and use-stage values.
validate_transportdistributionRequire mass, distance, mode, vehicle or vessel class, and route for each included transport leg; do not merge road and sea services.eu-pef-2021-2279
validate_lifecycle_claimsystem boundaryReject a cradle-to-grave claim unless distribution, use/maintenance, replacement, and end-of-life modules are complete or each exclusion is justified as not applicable to the declared configuration.eu-pef-2021-2279; eu-mdr-2017-745; eu-weee-2012-19
validate_uuid_gapsunresolved flow identityKeep every unresolved UUID explicit and prevent substitution of rejected broad, mismatched, or unspecified candidates.
validate_no_external_rangesquantitative evidenceTreat all amounts as foreground collection or calculation requirements until at least two independent, original-text-verified, boundary-compatible sources or reviewed foreground datasets justify a range.

10. Published Dataset Profile

FieldValue
dataset_roleProduct-specific foreground data package for one declared ultraviolet or infrared medical, surgical, dental, or veterinary apparatus configuration
downstream_usesecondary_dataset for a reviewed product study; background_dataset only after representativeness, review, and aggregation are documented
allowed_useConfiguration-specific manufacturing comparison at a common factory-gate boundary; lifecycle modelling when all claimed conditional modules use a consistent utilization and geography; hotspot and improvement assessment with disclosed unresolved identities
excluded_useSafety or regulatory certification; comparison of unlike intended purposes or optical performance without functional equivalence; use of a factory-gate package as cradle-to-grave; substitution of rejected UUID candidates; generic claims across ultraviolet and infrared technologies without weighting
required_metadataPCR id and version; product model and revision; intended purpose; radiation type; wavelength and radiant-performance metric; source technology; production sites and period; net and packaged mass; supplied accessories; packaging; included lifecycle modules; electricity geography; distribution route; utilization; cleaning; maintenance; replacement; service life; end-of-life geography; upstream dataset versions; allocation and cut-off decisions
required_quality_disclosureForeground coverage; BOM and output reconciliation; meter and scale calibration; supplier-data coverage; temporal, geographical, and technological representativeness; allocation drivers; assumptions; unresolved UUIDs; unresolved range evidence; scenario sensitivity; reviewer and review date
update_triggerChange in intended purpose, radiation type, source technology, optical performance, product configuration or BOM, assembly or packaging site, firmware/control behavior affecting energy, cleaning or sterilization instructions, service life, replacement regime, distribution route, electricity mix, end-of-life route, or a material change in foreground data

11. Data Sources

Source idTypeReferenceUsed for
un-cpc-3-0-structure-2025official_guidanceUnited Nations Statistics Division, CPC Version 3.0 Structure, 30 June 2025, code 48122, https://unstats.un.org/unsd/classifications/Econ/Download/In%20Text/CPC_Ver_3.0_Structure_30Jun2025.csv (retrieved 2026-09-06)Official classification title, hierarchy, and assigned product identity context
iec-60601-2-57-2023standardIEC 60601-2-57:2023, Medical electrical equipment — Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use, https://webstore.iec.ch/en/publication/73147 (retrieved 2026-09-06)Non-laser optical-radiation scope, intended-use distinction, wavelength and performance qualifiers, and ultraviolet/infrared configuration rules
iec-62471-6-2022standardIEC 62471-6:2022, Photobiological safety of lamps and lamp systems — Part 6: Ultraviolet lamp products, https://webstore.iec.ch/en/publication/59543 (retrieved 2026-09-06)Ultraviolet lamp-product identity, source-technology breadth, risk-group and user-information context; no inventory range derived
eu-mdr-2017-745official_guidanceRegulation (EU) 2017/745 on medical devices, Annexes I and II, https://op.europa.eu/o/opportal-service/download-handler?identifier=83bdc18f-315d-11e7-9412-01aa75ed71a1&format=xhtml&language=en&productionSystem=cellar&part= (retrieved 2026-09-07)Intended-purpose and configuration records; installation, calibration, maintenance, cleaning/disinfection, consumable replacement, emitted-radiation, and safe-disposal disclosures
eu-pef-2021-2279official_guidanceEuropean Commission Recommendation (EU) 2021/2279, Annex I Product Environmental Footprint Method, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32021H2279 (retrieved 2026-09-06)Functional-unit structure, lifecycle stages, foreground data, transport calculation, allocation hierarchy, completeness, data quality, reporting, and validation
eu-weee-2012-19official_guidanceDirective 2012/19/EU on waste electrical and electronic equipment, consolidated 8 April 2024, https://eur-lex.europa.eu/eli/dir/2012/19/2024-04-08/eng (retrieved 2026-09-06)Conditional electrical-equipment end-of-life boundary, separate collection, contamination exception, treatment, and recovery/recycling records

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System boundary rules · 5
Rule IDApplies toRuleSource IDs
boundary_base_gatemanufacturing foregroundInclude accepted components and materials, assembly, configuration, final electrical and optical/radiometric testing, process utilities, cleaning where performed, packaging, rejects actually generated, and release to the factory gate.eu-pef-2021-2279, eu-mdr-2017-745
boundary_lifecycle_moduleslifecycle claimsA cradle-to-grave or downstream claim must add distribution, installation if material, use electricity, cleaning or disinfection when prescribed, maintenance and source replacement, and end-of-life collection and treatment. A factory-gate dataset must state that these modules are excluded.eu-pef-2021-2279, eu-mdr-2017-745
boundary_configurationproduct variantsModel one declared apparatus configuration. Include ultraviolet and infrared source rows only when present; do not average incompatible source technologies, intended purposes, service lives, or sterile/reusable states without disclosed weighting.iec-60601-2-57-2023, eu-mdr-2017-745
boundary_upstream_linkspurchased inputsRepresent purchased inputs by specific product flows and representative upstream datasets. Do not replace a missing component identity with an umbrella material or utility flow.eu-pef-2021-2279
boundary_end_of_lifediscarded equipmentWhen end of life is included, keep the discarded apparatus and spent ultraviolet or infrared lamps as separate waste flows and apply jurisdiction-specific collection, contamination, dismantling, recovery, recycling, or disposal scenarios.eu-weee-2012-19, eu-mdr-2017-745
Allocation rules · 4
Rule IDApplies toRuleSource IDs
allocation_subdivide_firstmulti-product and shared processesAvoid allocation by subdividing assembly, test, packaging, and utility records to the declared apparatus family whenever separate measurements or production records are available.eu-pef-2021-2279
allocation_physical_driverresidual shared burdensWhen subdivision is not possible, allocate shared electricity, water, cleaning, and packaging operations using a documented causal physical driver such as machine time, test time, metered energy, processed mass, or accepted unit count. Economic allocation requires a documented reason that no causal physical relation is practicable.eu-pef-2021-2279
allocation_rejectsrejected apparatus and componentsAttribute burdens through the point of rejection using measured process participation; do not distribute post-rejection rework or treatment to accepted output unless the chosen physical driver causally requires it.eu-pef-2021-2279
allocation_recyclingend-of-life recoveryState the recycled-content and end-of-life attribution convention, use it consistently for incoming and recovered materials, and prevent double credit between the apparatus system and downstream material systems.eu-pef-2021-2279, eu-weee-2012-19
Validation rules · 9
Rule IDApplies toRuleSource IDs
validate_identityreference flowFail validation when intended purpose, ultraviolet/infrared configuration, wavelength band, source technology, model, service-life basis, or market state is missing.un-cpc-3-0-structure-2025, iec-60601-2-57-2023, eu-mdr-2017-745
validate_reference_countnormalizationRequire exactly one released apparatus as the reference amount and require net mass plus packaged mass as separate metadata; lamp count cannot replace apparatus count.
validate_atomic_rowsinventoryReject combined utilities, combined ultraviolet/infrared emitter rows, unspecified packaging, unspecified waste, or any row that cannot resolve to one concrete exchange.
validate_variant_conditionsinventory applicabilityRequire ultraviolet rows only for ultraviolet-containing configurations and infrared rows only for infrared-containing configurations; require an explicit zero or not-applicable record for demonstrably absent conditional flows.iec-60601-2-57-2023
validate_energyelectricityRequire kWh source records, the exact 3.6 MJ/kWh conversion, electricity geography, and separate manufacturing, packaging, and use-stage values.
validate_transportdistributionRequire mass, distance, mode, vehicle or vessel class, and route for each included transport leg; do not merge road and sea services.eu-pef-2021-2279
validate_lifecycle_claimsystem boundaryReject a cradle-to-grave claim unless distribution, use/maintenance, replacement, and end-of-life modules are complete or each exclusion is justified as not applicable to the declared configuration.eu-pef-2021-2279, eu-mdr-2017-745, eu-weee-2012-19
validate_uuid_gapsunresolved flow identityKeep every unresolved UUID explicit and prevent substitution of rejected broad, mismatched, or unspecified candidates.
validate_no_external_rangesquantitative evidenceTreat all amounts as foreground collection or calculation requirements until at least two independent, original-text-verified, boundary-compatible sources or reviewed foreground datasets justify a range.
Processes and inputs/outputs · 5
Process IDProcess nameInput flowsOutput flows
apparatus_assemblyApparatus assembly, configuration, and final test91
packaging_releasePackaging and market release31
distributionDistribution to the first user20
use_maintenanceUse, cleaning, maintenance, and source replacement42
end_of_lifeCollection and end-of-life transfer10

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1. Scope and Applicability2. Product Category Identity3. Reference Flow4. Measurement and Unit Rules5. System BoundaryBoundary Abstraction6. Process Inventory StructureProcess MapProcess: Apparatus assembly, configuration, and final test (apparatus_assembly)InputsProduct flowsUltraviolet light-source module (uv_emitter_module)Infrared light-source module (infrared_emitter_module)Printed wire board (printed_wire_board)Aluminium-alloy housing (aluminium_alloy_housing)Stainless-steel housing (stainless_steel_housing)Optical glass pressing blank (optical_glass_pressing_blank)Power cable (power_cable)Assembly and final-test electricity (assembly_electricity)Assembly process water (assembly_process_water)Waste flowsElementary flowsOutputsProduct flowsAccepted assembled apparatus (assembled_apparatus)Waste flowsElementary flowsProcess: Packaging and market release (packaging_release)InputsProduct flowsCorrugated-board boxes (corrugated_board_boxes)Polyethylene packaging film (polyethylene_packaging_film)Packaging electricity (packaging_electricity)Waste flowsElementary flowsOutputsProduct flowsMarket-ready packaged apparatus (packaged_apparatus)Waste flowsElementary flowsProcess: Distribution to the first user (distribution)InputsProduct flowsRoad freight transport (road_freight)Container-ship sea freight (sea_freight_container_ship)Waste flowsElementary flowsOutputsProduct flowsWaste flowsElementary flowsProcess: Use, cleaning, maintenance, and source replacement (use_maintenance)InputsProduct flowsUse-stage electricity (use_electricity)Cleaning process water (cleaning_process_water)Replacement ultraviolet emitter (replacement_uv_emitter)Replacement infrared emitter (replacement_ir_emitter)Waste flowsElementary flowsOutputsProduct flowsWaste flowsSpent ultraviolet lamp (spent_uv_lamp)Spent infrared lamp (spent_ir_lamp)Elementary flowsProcess: Collection and end-of-life transfer (end_of_life)InputsProduct flowsWaste flowsDiscarded ultraviolet or infrared medical apparatus (discarded_apparatus)Elementary flowsOutputsProduct flowsWaste flowsElementary flows7. Allocation and Co-product Handling8. Foreground Data Collection, Calculation, and Quality RulesData Collection ProtocolsCalculation RulesData Quality Requirements9. Validation Rules10. Published Dataset Profile11. Data Sources