TianGong PCR产品类别规则

Medical, surgical or laboratory sterilizers

Medical, surgical or laboratory sterilizers: This PCR covers cradle-to-gate production of finished sterilizers designed for medical, surgical or laboratory loads…

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Methodology and translation states come from the source record; publishing this website does not change their review status.

Content languages

zh-CN · Aligned
Status, classification and source details

Readiness

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

Classification mapping

CPC 3.0:48140 · exact

Source

1. Scope and Applicability

This PCR covers cradle-to-gate production of finished sterilizers designed for medical, surgical or laboratory loads, including steam, dry-heat and low-temperature sterilizers. It includes upstream production of bill-of-material inputs and purchased components, foreground fabrication and assembly, factory testing and cleaning, and shipping packaging up to the manufacturer factory gate.

The representative route is a configurable laboratory steam sterilizer with a stainless-steel pressure chamber, electronic controls and optional integral steam generation. For another sterilization technology, declare the technology and instantiate its technology-specific BOM, process inputs, wastes and test requirements as separate atomic exchanges without duplicating the common rules.

Use-phase cycles, customer installation, distribution after the factory gate, maintenance, replacement consumables and end-of-life are excluded. Washer-disinfectors without a sterilization function, household appliances, and industrial food or pharmaceutical treatment equipment outside the medical, surgical or laboratory boundary are excluded. Detachable accessories and loading equipment are included only when shipped with the declared product.

2. Product Category Identity

FieldValue
canonical_pcr_idpcr.metal-products-machinery-and-equipment.medical-appliances-precision-and-optical-instruments-watches-and-clocks.medical-surgical-or-laboratory-sterilizers
classification_refsCPC 3.0: 48140, exact contextual reference
covered_productsFinished medical, surgical and laboratory sterilizers using steam, dry heat or low-temperature sterilizing agents
excluded_productsWasher-disinfectors without sterilization; household sterilizers; sterilization services; separately sold use consumables; non-medical industrial thermal-treatment equipment
representative_productConfigurable laboratory steam sterilizer with stainless-steel chamber, electronic controls and optional integral steam generator
production_routeBOM-based component supply, on-site metal fabrication where applicable, assembly, factory functional and safety testing, cleaning, and shipping packaging
market_stateFinished, tested and packaged capital equipment at the manufacturer factory gate

3. Reference Flow

FieldValue
WhatProduction of a finished medical, surgical or laboratory sterilizer ready to leave the manufacturer factory gate
How much1 kg net finished sterilizer, excluding detachable shipping packaging
How wellConforming to the declared intended use, sterilization technology, validated factory test plan and applicable market requirements
How long or cycleOne factory-gate product delivery; design life and rated cycle capability are metadata and are not amortized into this reference flow
reference_flow_linkReference product output row finished_sterilizer
FieldValue
Reference amount1 kg net finished sterilizer
Reference product flowMedical, surgical or laboratory sterilizer (Tiangong UUID unresolved)
Reference flow propertyMass 93a60a56-a3c8-11da-a746-0800200b9a66
Reference unit groupUnits of mass 93a60a57-a4c8-11da-a746-0800200c9a66
Reference unitkg
Required qualifierssterilization technology and agent; intended application and validated loads; model and usable chamber volume; pressure-vessel and principal materials; integrated or external utility generation; installed options and shipped accessories; net mass; factory geography and year; packaging inclusion and reuse basis

When constructing a foreground data package, all Required qualifiers must be declared in dataset metadata, process notes, reference flow comment, product description, or an equivalent field.

4. Measurement and Unit Rules

rule_idApplies toRequired propertyRequired unitRule
net_product_massreference product and BOM normalizationMass 93a60a56-a3c8-11da-a746-0800200b9a66kgWeigh or reconcile the net finished sterilizer without detachable shipping packaging; normalize amounts to 1 kg net finished product.
packaging_separationshipping packagingMass 93a60a56-a3c8-11da-a746-0800200b9a66kgRecord each packaging exchange separately and exclude it from net product mass; reused pallets use net consumption per shipment after documented turns.
electricity_conversionpurchased electricityNet calorific value 93a60a56-a3c8-11da-a746-0800200c9a66MJPreserve meter records in kWh and convert using 1 kWh = 3.6 MJ; do not mix factory and customer-use electricity.
water_mass_conversionprocess water and cleaning wastewaterMass 93a60a56-a3c8-11da-a746-0800200b9a66kgPrefer direct mass records; when only volume is available, use measured or supplier-declared density and retain the conversion record.

5. System Boundary

The cradle-to-gate system includes raw-material extraction and component production through upstream datasets, inbound component supply, manufacturer-controlled fabrication, assembly, factory testing, cleaning and final packaging. The verified Getinge PEP uses a BOM-based material model and separates supplier production from factory and final packaging; the FDA record supports stainless pressure-vessel construction for the representative steam route.

Distribution after the factory gate, operation, on-site utilities consumed by customers, service, maintenance and end-of-life are outside this PCR. Factory test cycles remain inside the boundary.

Boundary Abstraction

FieldValue
declared_starting_conditionPurchased raw materials, components and packaging received at the reporting factory gate, with linked upstream cradle-to-supplier datasets
starting_condition_roleForeground entry condition for fabrication, assembly, testing, cleaning and packaging
product_classification_scopeFinished equipment that performs sterilization for medical, surgical or laboratory loads
recursive_input_ruleIf an input is a complete or near-complete sterilizer, stop recursion at that transfer and link a separately documented upstream sterilizer dataset.
upstream_dataset_requirementPrefer supplier-specific datasets for metals, electronics, cables, plastics and packaging; otherwise use representative background datasets and disclose substitutions.
disclosureDeclare factory geography/year, model, net mass, technology, included fabrication, supplier-data coverage, test boundary, packaging, recycled content and allocation.
rule_idapplies_torulesource_ids
boundary_cradle_to_gateproduct_systemInclude upstream BOM/component production, manufacturer operations, factory tests and final packaging through the factory gate; exclude downstream distribution, use, service and end-of-life.getinge-lancer-lss-pep-2025
boundary_route_disclosuretechnology_routeDeclare technology, intended load, chamber capacity, integrated utilities and included fabrication because configuration changes BOM and factory requirements.getinge-lancer-lss-pep-2025; fda-getinge-k122071-2013
boundary_test_utilitiesfactory_testingInclude utilities consumed by factory acceptance, safety and leak tests; exclude customer sterilization cycles.fda-getinge-k122071-2013

6. Process Inventory Structure

Process Map

process_idprocess_nameinclusioninclusion_conditionrolequantitative_reference
sterilizer_manufacturingSterilizer fabrication, assembly, factory testing and packagingrequiredAlways included; conditional exchanges apply only when the stated operation occurs inside the foreground boundary.foreground production1 kg net finished sterilizer

Process: Sterilizer fabrication, assembly, factory testing and packaging (sterilizer_manufacturing)

Inputs

Product flows
Stainless-steel sheet for chamber and casing (stainless_steel_sheet)

Record stainless sheet entering manufacturer-controlled forming or assembly. Use the actual alloy and thickness; the representative vessel uses a 316-family grade.

  • Selected flow: Stainless-steel sheet (Tiangong UUID unresolved)
  • Flow property / unit: Mass / kg
  • Amount rule: purchased mass issued to the product, including measured fabrication scrap
  • Value mode: Foreground record (foreground_record)
  • Specificity: Product-specific (product_specific)
  • Normalization basis: per 1 kg net finished sterilizer
  • Basis kind: Reference flow (reference_flow)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_bom_mass
  • Sources: getinge-lancer-lss-pep-2025; fda-getinge-k122071-2013
Aluminium sheet (aluminium_sheet)

Record aluminium sheet entering product-specific fabrication or assembly, retaining the alloy, temper and thickness in foreground records.

  • Selected flow: aluminium sheet 4f197be4-7b3b-11dd-ad8b-0800200c9a66
  • Flow property / unit: Mass / kg
  • Amount rule: purchased mass issued to the product, including measured aluminium scrap
  • Value mode: Foreground record (foreground_record)
  • Specificity: Product-specific (product_specific)
  • Normalization basis: per 1 kg net finished sterilizer
  • Basis kind: Reference flow (reference_flow)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_bom_mass
  • Sources: getinge-lancer-lss-pep-2025
ABS granulate for in-house moulding (abs_granulate)

Include only when ABS parts are moulded in the foreground factory; purchased parts of another resin are separate instantiated product rows.

  • Selected flow: Acrylonitrile butadiene styrene (ABS) granulate b895c3a1-076e-4a42-a2c0-6088890c0bd9
  • Flow property / unit: Mass / kg
  • Amount rule: purchased ABS issued to in-house moulding
  • Value mode: Foreground record (foreground_record)
  • Specificity: Technology-specific (technology_specific)
  • Normalization basis: per 1 kg net finished sterilizer; zero with documented non-applicability when absent
  • Basis kind: Reference flow (reference_flow)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_bom_mass
  • Sources: getinge-lancer-lss-pep-2025
Printed wire board (printed_wire_board)

Record the installed printed wire boards for the declared control-system configuration by measured or BOM mass.

  • Selected flow: Printed Wire Board a8bd954c-59b3-4317-b4de-02a17d6da5ca
  • Flow property / unit: Mass / kg
  • Amount rule: BOM mass installed in the declared control configuration
  • Value mode: Foreground record (foreground_record)
  • Specificity: Product-specific (product_specific)
  • Normalization basis: per 1 kg net finished sterilizer
  • Basis kind: Reference flow (reference_flow)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_bom_mass
  • Sources: getinge-lancer-lss-pep-2025
Low-voltage cable (low_voltage_cable)

Record installed low-voltage cable length from the approved cut list, preserving conductor and insulation specifications.

  • Selected flow: Low-voltage cable 49101b44-20cc-46a0-adfb-af07e4cc8908
  • Flow property / unit: Length / m
  • Amount rule: installed cut-list or BOM length; retain conductor and insulation specification
  • Value mode: Foreground record (foreground_record)
  • Specificity: Product-specific (product_specific)
  • Normalization basis: per 1 kg net finished sterilizer
  • Basis kind: Reference flow (reference_flow)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_cable_length
  • Sources: getinge-lancer-lss-pep-2025
Purchased electricity (electricity)

Record purchased electrical energy attributable to included fabrication, assembly, factory testing and packaging operations.

  • Selected flow: Electricity 890a70b7-b677-4e2a-8a1b-7d017e0a10ae
  • Flow property / unit: Net calorific value / MJ
  • Amount rule: metered or causally allocated factory electricity converted from kWh
  • Value mode: Foreground record (foreground_record)
  • Specificity: Site-specific (site_specific)
  • Normalization basis: per 1 kg net finished sterilizer
  • Basis kind: Reference flow (reference_flow)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_factory_electricity
  • Sources: getinge-lancer-lss-pep-2025
Process water (process_water)

Record process water consumed in included fabrication, cleaning and factory testing, with source, quality and conversion basis retained.

  • Selected flow: Process Water 94a04f7e-2d5c-41f0-b182-d54a3b373a02
  • Flow property / unit: Mass / kg
  • Amount rule: metered water for included fabrication, cleaning and factory testing
  • Value mode: Foreground record (foreground_record)
  • Specificity: Site-specific (site_specific)
  • Normalization basis: per 1 kg net finished sterilizer
  • Basis kind: Reference flow (reference_flow)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_factory_water
  • Sources: getinge-lancer-lss-pep-2025
Industrial oxygen for on-site fabrication (industrial_oxygen)

Include industrial oxygen only when cutting, brazing or another oxygen-consuming fabrication operation occurs inside the foreground boundary.

  • Selected flow: Industrial oxygen bd4b0f96-2090-4806-a648-335ab20ff401
  • Flow property / unit: Volume / m3
  • Amount rule: purchased or metered oxygen used by an included cutting or brazing operation
  • Value mode: Foreground record (foreground_record)
  • Specificity: Technology-specific (technology_specific)
  • Normalization basis: per 1 kg net finished sterilizer; zero with documented non-applicability when absent
  • Basis kind: Reference flow (reference_flow)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_process_gases
  • Sources:
Carbon dioxide shielding gas for on-site welding (carbon_dioxide_shielding_gas)

Include carbon dioxide only when it is consumed as shielding gas by welding inside the foreground boundary.

  • Selected flow: Carbon dioxide 27f41c1c-535e-4d2a-bce9-2c7f4de11549
  • Flow property / unit: Mass / kg
  • Amount rule: purchased cylinder or bulk mass consumed as welding shielding gas
  • Value mode: Foreground record (foreground_record)
  • Specificity: Technology-specific (technology_specific)
  • Normalization basis: per 1 kg net finished sterilizer; zero with documented non-applicability when absent
  • Basis kind: Reference flow (reference_flow)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_process_gases
  • Sources:
Wooden shipping pallet (wooden_pallet)

Record wooden pallet mass shipped with the product and account explicitly for documented reuse and losses.

  • Selected flow: Wooden pallet (EURO) 96b2b9ac-cfb6-46bf-8ad1-c056e338950a
  • Flow property / unit: Mass / kg
  • Amount rule: pallet dry mass divided by documented reuse turns, adjusted for losses
  • Value mode: Calculated value (calculated_value)
  • Specificity: Product-specific (product_specific)
  • Normalization basis: per 1 kg net finished sterilizer
  • Basis kind: Reference flow (reference_flow)
  • Evidence kind: Calculated from collection (calculated_from_collection)
  • Collection protocol: cp_packaging_mass
  • Sources: getinge-lancer-lss-pep-2025
Corrugated board shipping boxes (corrugated_board_boxes)

Record the mass of corrugated board boxes shipped with the finished sterilizer under the declared packaging configuration.

  • Selected flow: corrugated board boxes 4f197bec-7b3b-11dd-ad8b-0800200c9a66
  • Flow property / unit: Mass / kg
  • Amount rule: measured or specification-derived box mass shipped with the product
  • Value mode: Foreground record (foreground_record)
  • Specificity: Product-specific (product_specific)
  • Normalization basis: per 1 kg net finished sterilizer
  • Basis kind: Reference flow (reference_flow)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_packaging_mass
  • Sources: getinge-lancer-lss-pep-2025
Waste flows
Elementary flows

Outputs

Product flows
Finished sterilizer at factory gate (finished_sterilizer)

The reference product is the net mass of a complete sterilizer released at the factory gate, excluding removable transport packaging.

  • Selected flow: Medical, surgical or laboratory sterilizer (Tiangong UUID unresolved)
  • Flow property / unit: Mass / kg
  • Amount rule: 1 kg net finished sterilizer by reference-flow definition
  • Value mode: Fixed value (fixed_value)
  • Specificity: Generic (generic)
  • Normalization basis: 1 kg net finished sterilizer
  • Basis kind: Reference flow (reference_flow)
  • Evidence kind: Source rule (source_rule)
  • Collection protocol:
  • Sources: un-cpc-3-0-structure-2025; getinge-lancer-lss-pep-2025; fda-getinge-k122071-2013
Waste flows
316-family stainless-steel fabrication scrap (stainless_steel_scrap)

Record segregated 316-family stainless-steel scrap leaving included foreground fabrication, without an avoided-primary-metal credit unless the background model requires it.

  • Selected flow: stainless steel scrap (316, from external supply) f20af980-11c6-4a6b-8dbc-4aa7683bfd98
  • Flow property / unit: Mass / kg
  • Amount rule: weighed segregated scrap dispatched for recovery
  • Value mode: Foreground record (foreground_record)
  • Specificity: Technology-specific (technology_specific)
  • Normalization basis: per 1 kg net finished sterilizer; zero with documented non-applicability when fabrication is off-site
  • Basis kind: Reference flow (reference_flow)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_factory_waste
  • Sources: fda-getinge-k122071-2013
Aluminium fabrication scrap (aluminium_scrap)

Record segregated aluminium scrap leaving included foreground fabrication and retain its measured destination.

  • Selected flow: Aluminium Scrap 96c5f842-ea53-419b-b1cd-c02c479efb45
  • Flow property / unit: Mass / kg
  • Amount rule: weighed segregated aluminium scrap dispatched from the factory
  • Value mode: Foreground record (foreground_record)
  • Specificity: Technology-specific (technology_specific)
  • Normalization basis: per 1 kg net finished sterilizer; zero with documented non-applicability when fabrication is off-site
  • Basis kind: Reference flow (reference_flow)
  • Evidence kind: Collected record (collected_record)
  • Collection protocol: cp_factory_waste
  • Sources: getinge-lancer-lss-pep-2025
Wastewater from equipment cleaning (cleaning_wastewater)

Record wastewater discharged from included equipment-cleaning operations, reconciled to process-water input and separately measured losses.

  • Selected flow: Wastewater from cleaning f0402393-e82c-47e8-9cd8-a486c97f3e89
  • Flow property / unit: Mass / kg
  • Amount rule: metered discharge or water-balance result for included cleaning
  • Value mode: Calculated value (calculated_value)
  • Specificity: Site-specific (site_specific)
  • Normalization basis: per 1 kg net finished sterilizer; zero with documented non-applicability when no wet cleaning discharge occurs
  • Basis kind: Reference flow (reference_flow)
  • Evidence kind: Calculated from collection (calculated_from_collection)
  • Collection protocol: cp_cleaning_wastewater
  • Sources: getinge-lancer-lss-pep-2025
Elementary flows

7. Allocation and Co-product Handling

rule_idapplies_torulesource_ids
allocation_subdivide_firstshared_factory_processesSubdivide product-specific fabrication, assembly and tests before allocating shared burdens.
allocation_shared_utilitiesshared_electricity_water_and_gasesUse dedicated records first; otherwise allocate by a causal driver such as machine time, test-cycle duration or line throughput. Use mass only when no better driver exists and disclose it.
allocation_scrapmetal_scrap_and_recoveryReport scrap mass and route at the factory boundary. Do not credit avoided primary metal unless the chosen background model explicitly applies and discloses that convention.
allocation_reusable_packagingwooden_palletDivide pallet mass by documented expected turns adjusted for losses; if turns are unknown, assign the full pallet to the shipment.getinge-lancer-lss-pep-2025

8. Foreground Data Collection, Calculation, and Quality Rules

Data Collection Protocols

protocol_idprocess_idflow_rolerecord_typeraw_fieldscollection_methodunitfrequencytemporal_coveragesite_scopeaggregation_rulequality_evidence
cp_bom_masssterilizer_manufacturingmass-based BOM inputs and finished productapproved BOM and issue recordmodel; revision; material; purchased, issued and installed mass; net product mass; unitsreconcile BOM, purchasing, issue records and product weighingkgeach revision and batchrepresentative yearfactory and declared suppliersatomic mass divided by total net finished massapproved BOM, invoices, weigh tickets, calibration
cp_cable_lengthsterilizer_manufacturinglow-voltage cablecable cut list and BOMspecification; conductor; insulation; voltage; installed length; unitsreconcile cut list and installed lengthmeach revision and batchrepresentative yearfactoryinstalled length divided by net finished massapproved cut list and issue record
cp_factory_electricitysterilizer_manufacturingelectricitymeter and production recordmeter readings; kWh; area; test cycles; units; net massdedicated meter or reconciled site meter with causal allocationkWhmonthlyone complete representative production yearincluded factory operationssubtract excluded loads, allocate, convert to MJ and normalizecalibration, invoices, allocation reconciliation
cp_factory_watersterilizer_manufacturingprocess watermeter, batch and test recordvolume or mass; source; quality; operation; density; net massmeter or reconcile invoices and batch recordskg or m3monthly and test campaignone complete representative production yearincluded factory operationsallocate included water, convert to mass and normalizecalibration, invoices, batch logs, density evidence
cp_process_gasessterilizer_manufacturingoxygen and shielding carbon dioxidecylinder/bulk and job recordgas; purity; delivery; inventory change; job; reference conditionsreconcile supply and inventory change to jobskg or m3each delivery and batchrepresentative yearon-site fabricationattributable consumption divided by net product masscertificates, invoices, cylinder logs
cp_packaging_masssterilizer_manufacturingpallet and corrugated boxesspecification and dispatch recordidentity; dry mass; model; units; turns; lossweigh or verified packaging specificationkgeach design revision and samplerepresentative yearfinal packagingnet consumed mass divided by net product massdrawing, calibration, dispatch and reuse evidence
cp_factory_wastesterilizer_manufacturingmetal scrapsegregated dispatch recordalloy; gross/tare mass; destination; batch; net massweighbridge or container weights reconciled to transfer documentskgeach dispatchone complete representative production yearfactoryincluded atomic waste divided by net product massweigh tickets, transfer records, segregation
cp_cleaning_wastewatersterilizer_manufacturingcleaning wastewaterdischarge and cleaning recordwater input; discharge; retained water; losses; chemistry; route; net massmeter or calculated water balancekg or m3each campaign, monthly aggregateone complete representative production yearcleaning operationsreconcile wastewater to water input and normalizecalibration, balance, analysis, treatment receipt

Calculation Rules

rule_idApplies toFormula or ruleInputsOutputsource_ids
calc_mass_normalizationmass-based rowsnormalized amount = included row mass / total net finished sterilizer massrow mass; net product masskg/kg net productgetinge-lancer-lss-pep-2025
calc_cable_normalizationlow_voltage_cableinstalled cable length / total net finished sterilizer masscable length; net massm/kg net productgetinge-lancer-lss-pep-2025
calc_electricityelectricityincluded kWh × 3.6 / total net finished sterilizer masskWh; net massMJ/kg net productgetinge-lancer-lss-pep-2025
calc_reusable_palletwooden_palletdry mass × (1 + loss allowance) / expected turns / net product masspallet mass; turns; loss; net masskg/kg net productgetinge-lancer-lss-pep-2025
calc_cleaning_wastewatercleaning_wastewaterwater input − retained water − separately measured losseswater records; net masskg/kg net productgetinge-lancer-lss-pep-2025

Data Quality Requirements

requirement_idApplies toRequirementEvidence
dq_product_identityreference productIdentify model, technology, intended loads, chamber volume, utilities, options and conformity basis.technical file, conformity declaration, model BOM
dq_bom_completenessmaterial and component rowsReconcile all materially significant net product mass to atomic BOM inputs; explain every excluded or unquantified remainder with named rows, never an umbrella flow.BOM reconciliation and completeness review
dq_temporalutilities and wastesUse one complete representative production year or justify a shorter campaign that captures production and test variability.dated meters, production and dispatch records
dq_supplier_coverageupstream datasetsReport supplier-specific mass coverage and every generic background substitution.supplier data register and dataset mapping
dq_mass_balancematerials, product and wastesReconcile issued material to installed product, scrap, returned stock and losses without counting supplier scrap twice.batch material balance

9. Validation Rules

rule_idapplies_torulesource_ids
validation_reference_flowreference_productConfirm output is exactly 1 kg net finished sterilizer and detachable shipping packaging is excluded.getinge-lancer-lss-pep-2025
validation_required_qualifiersdataset_metadataReject a package missing technology, intended load, model, chamber volume, utility configuration, net mass, factory geography/year or packaging basis.getinge-lancer-lss-pep-2025; fda-getinge-k122071-2013
validation_atomic_inventoryprocess_inventoryConfirm each row is one physical, chemical, waste or energy exchange; reject umbrellas and route selectors.
validation_uuid_and_unittiangong_referencesVerify public state 100, flow type, baseName, property and unit group for UUID rows; register every blank UUID in manifest unresolved metadata.
validation_boundaryproduct_systemConfirm upstream BOM production and factory tests are included and customer operation, downstream distribution, service and end-of-life are excluded.getinge-lancer-lss-pep-2025
validation_balancemass_and_water_balanceReconcile net product, issued materials, segregated scrap, packaging separation and cleaning-water balance; investigate gaps.

10. Published Dataset Profile

FieldValue
dataset_rolesecondary_dataset or background_dataset after review and publication
downstream_useCradle-to-gate inventories for procurement, product LCAs and lifecycle models that add downstream stages separately
allowed_useDeclared configurations whose technology, model, chamber volume, BOM coverage, factory geography/year and packaging basis match or are transparently adapted
excluded_useComparing sterilization-cycle performance, claiming use-phase impacts, representing washer-disinfectors, or applying to an undisclosed materially different technology
required_metadataPCR/version; model; technology/agent; intended loads; chamber volume; utilities; options/accessories; net mass; factory geography/year; supplier coverage; packaging; allocation
required_quality_disclosureBOM coverage; temporal coverage; metering/allocation; unresolved UUIDs; background substitutions; recycled content; scrap routes; water balance; verification
update_triggerModel or technology change; BOM/chamber redesign; factory or supplier change; utility change; packaging redesign; new exact reference UUID; stale foreground period

11. Data Sources

Source idTypeReferenceUsed for
un-cpc-3-0-structure-2025official_guidanceUnited Nations Statistics Division, CPC Version 3.0 Structure, 30 June 2025, https://unstats.un.org/unsd/classifications/Econ/Download/In%20Text/CPC_Ver_3.0_Structure_30Jun2025.csv (hash-verified original; retrieved 2026-09-06)Official CPC 48140 identity
getinge-lancer-lss-pep-2025literatureGetinge, Product Environmental Profile: Getinge Lancer LSS Laboratory Steam Sterilizer, DMS-0011032, 2025, https://www.getinge.com/dam/life-science/documents/english/getinge-lancer-lss-pep-107396-en.pdf (original PDF verified; retrieved 2026-09-06)Representative product, BOM-based cradle-to-gate model, material/component families, packaging, factory energy and water
fda-getinge-k122071-2013official_guidanceU.S. FDA, 510(k) Summary K122071, Getinge 400HC-E/500HC-E Series Steam Sterilizer, 2013, https://www.accessdata.fda.gov/cdrh_docs/pdf12/k122071.pdf (original PDF verified; retrieved 2026-09-06)Intended use, steam principle, stainless pressure vessel and factory test context
samr-sterilizer-terminologyofficial_guidanceState Administration for Market Regulation, national-standard record for safety requirements for sterilizers and washer-disinfectors used to treat medical materials, https://std.samr.gov.cn/gb/search/gbDetailed?id=bThFnEWwh9Q%3D&mode=p (official page verified; retrieved 2026-09-06)Professional Chinese term 灭菌器 and washer-disinfector distinction

Raw downloads

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Structured rule index

This index comes from verified structured.yaml and retains the canonical English rule text.

System boundary rules · 5
Rule IDApplies toRuleSource IDs
system_boundary_rule_1foreground_system_boundaryThe cradle-to-gate system includes raw-material extraction and component production through upstream datasets, inbound component supply, manufacturer-controlled fabrication, assembly, factory testing, cleaning and final packaging. The verified Getinge PEP uses a BOM-based material model and separates supplier production from factory and final packaging; the FDA record supports stainless pressure-vessel construction for the representative steam route.
system_boundary_rule_2foreground_system_boundaryDistribution after the factory gate, operation, on-site utilities consumed by customers, service, maintenance and end-of-life are outside this PCR. Factory test cycles remain inside the boundary.
boundary_cradle_to_gateproduct_systemInclude upstream BOM/component production, manufacturer operations, factory tests and final packaging through the factory gate; exclude downstream distribution, use, service and end-of-life.getinge-lancer-lss-pep-2025
boundary_route_disclosuretechnology_routeDeclare technology, intended load, chamber capacity, integrated utilities and included fabrication because configuration changes BOM and factory requirements.getinge-lancer-lss-pep-2025, fda-getinge-k122071-2013
boundary_test_utilitiesfactory_testingInclude utilities consumed by factory acceptance, safety and leak tests; exclude customer sterilization cycles.fda-getinge-k122071-2013
Allocation rules · 4
Rule IDApplies toRuleSource IDs
allocation_subdivide_firstshared_factory_processesSubdivide product-specific fabrication, assembly and tests before allocating shared burdens.
allocation_shared_utilitiesshared_electricity_water_and_gasesUse dedicated records first; otherwise allocate by a causal driver such as machine time, test-cycle duration or line throughput. Use mass only when no better driver exists and disclose it.
allocation_scrapmetal_scrap_and_recoveryReport scrap mass and route at the factory boundary. Do not credit avoided primary metal unless the chosen background model explicitly applies and discloses that convention.
allocation_reusable_packagingwooden_palletDivide pallet mass by documented expected turns adjusted for losses; if turns are unknown, assign the full pallet to the shipment.getinge-lancer-lss-pep-2025
Validation rules · 6
Rule IDApplies toRuleSource IDs
validation_reference_flowreference_productConfirm output is exactly 1 kg net finished sterilizer and detachable shipping packaging is excluded.getinge-lancer-lss-pep-2025
validation_required_qualifiersdataset_metadataReject a package missing technology, intended load, model, chamber volume, utility configuration, net mass, factory geography/year or packaging basis.getinge-lancer-lss-pep-2025, fda-getinge-k122071-2013
validation_atomic_inventoryprocess_inventoryConfirm each row is one physical, chemical, waste or energy exchange; reject umbrellas and route selectors.
validation_uuid_and_unittiangong_referencesVerify public state 100, flow type, baseName, property and unit group for UUID rows; register every blank UUID in manifest unresolved metadata.
validation_boundaryproduct_systemConfirm upstream BOM production and factory tests are included and customer operation, downstream distribution, service and end-of-life are excluded.getinge-lancer-lss-pep-2025
validation_balancemass_and_water_balanceReconcile net product, issued materials, segregated scrap, packaging separation and cleaning-water balance; investigate gaps.
Processes and inputs/outputs · 1
Process IDProcess nameInput flowsOutput flows
sterilizer_manufacturingSterilizer fabrication, assembly, factory testing and packaging114

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