Orthopaedic appliances; splints and other fracture appliances; artificial parts of the body

1. Scope and Applicability

This PCR covers gate-to-gate manufacture of finished orthopaedic appliances, splints and other fracture appliances, and artificial parts of the body. Covered products include external orthoses and fracture supports, prosthetic limbs and components, artificial joints, and other implantable or non-implantable artificial body parts, including standard-sized and patient-matched devices. The foreground boundary begins with qualified purchased materials, components and packaging at the manufacturing-site gate and ends with the quality-released packaged product at the factory gate.

Hearing aids and separately classified compensating devices, biological tissues or cells, medicines, generic raw-material production, clinical fitting and surgery, use, maintenance and end-of-life are excluded. A data package shall identify the exact device family and include only route modules and atomic exchanges that actually apply. Mass normalization does not establish clinical equivalence between unlike devices.

2. Product Category Identity

Field	Value
canonical_pcr_id	pcr.metal-products-machinery-and-equipment.medical-appliances-precision-and-optical-instruments-watches-and-clocks.orthopaedic-appliances-splints-and-other-fracture-appliances-artificial-parts-of-the-body
classification_refs	CPC 3.0: 48171 — Orthopaedic appliances; splints and other fracture appliances; artificial parts of the body
covered_products	External orthoses and splints; fracture-fixation appliances; prosthetic limbs and components; artificial joints; implantable and non-implantable artificial body parts; standard-sized and patient-matched devices
excluded_products	Hearing aids and separately classified compensating devices; biological tissues and cells; medicines; raw materials sold as such; clinical fitting and surgery; use, maintenance and end-of-life services
representative_product	One quality-released finished orthopaedic appliance, fracture appliance or artificial body part belonging to a declared device family
production_route	Conventional forming or machining, additive manufacturing, polymer molding or lay-up, cleaning, assembly, optional thermal processing, optional validated sterilization, final inspection and packaging, as applicable
market_state	Finished, quality-released and packaged; sterile or non-sterile state declared; standard-sized or patient-matched state declared

3. Reference Flow

Field	Value
What	Provide the declared orthopaedic support, fracture stabilization, anatomical replacement or prosthetic function of one specified device family
How much	1 kg net mass of quality-released finished product, excluding transport packaging but including components that remain in the device
How well	Meets declared design, material, dimensional, mechanical, biocompatibility, cleanliness and, when applicable, validated sterile-state specifications for intended use
How long or cycle	Declared design life, implantation period, reuse cycles or single-use status; duration is a required qualifier and is not silently normalized
reference_flow_link	finished_appliance

Field	Value
Reference amount	1 kg
Reference product flow	Orthopaedic appliances, splints and other fracture appliances, artificial parts of the body 5ce1d551-f011-4400-8717-bdde251252f7
Reference flow property	Mass 93a60a56-a3c8-11da-a746-0800200b9a66
Reference unit group	Units of mass 93a60a57-a4c8-11da-a746-0800200c9a66
Reference unit	kg
Required qualifiers	device family and intended function; model or patient-matched identifier; implantable or external state; standard-sized or patient-matched state; complete material composition and net product mass; manufacturing technology and included route modules; sterile state and sterilization method; reusable or single-use status; design life or use cycles; packaging configuration; site, geography and reference year

Every required qualifier shall be declared in dataset metadata, process notes, the reference-flow comment, product description or an equivalent data-package field. Missing qualifiers make the reference flow incomplete.

4. Measurement and Unit Rules

rule_id	Applies to	Required property	Required unit	Rule
reference_mass	reference product and normalization	Mass 93a60a56-a3c8-11da-a746-0800200b9a66	kg	Report net finished-product mass after quality release and before transport packaging; normalize foreground exchanges to exactly 1 kg accepted product.
electricity_energy	purchased electricity	Net calorific value 93a60a56-a3c8-11da-a746-0800200c9a66	MJ	Preserve metered electricity by process; convert kWh with 1 kWh = 3.6 MJ and disclose voltage, grid geography and loss boundary.
gas_volume	gaseous natural gas and industrial oxygen	Volume 93a60a56-a3c8-22da-a746-0800200c9a66	m3	Record supplier or meter volume and disclose pressure, temperature or billing reference conditions; do not mix standard and actual volumes.
chemical_mass	sodium hydroxide and ethylene oxide	Mass 93a60a56-a3c8-11da-a746-0800200b9a66	kg	Report pure-substance mass; for solutions multiply delivered solution mass by measured or certified mass fraction and retain raw fields.
waste_mass	solid scrap and cleaning wastewater	Mass 93a60a56-a3c8-11da-a746-0800200b9a66	kg	Report wet wastewater mass and as-dispatched mass for each chemically distinct scrap stream; disclose moisture or entrained liquid when material.

5. System Boundary

Boundary Abstraction

Field	Value
declared_starting_condition	Qualified purchased materials, components, chemicals, energy carriers and packaging have crossed the site gate with supplier identity and incoming quantity records available
starting_condition_role	foreground_gate_input
product_classification_scope	Finished orthopaedic appliances, fracture appliances and artificial body parts within the reviewed semantic boundary; classification does not replace the declared device family
recursive_input_rule	A purchased item meeting this same product-category boundary is recorded once as a product input with an upstream dataset and is not recursively decomposed inside the receiving process
upstream_dataset_requirement	Link upstream datasets for every purchased material, component, chemical, energy input and outsourced in-boundary process; disclose supplier, geography, technology and recycled content where relevant
disclosure	Declare site and year; device family and model; included modules; material and packaging composition; net mass; reject and scrap treatment; sterile state and sterilization location; allocation; cut-offs; outsourced operations

rule_id	Applies to	Rule	source_ids
boundary_gate_to_gate	foreground manufacturing system	Include transformation, post-processing, cleaning, assembly, inspection and packaging under declared manufacturing responsibility; exclude raw-material production, clinical use and end-of-life while linking required upstream datasets.	fda-am-medical-devices-2017; fda-qmsr-2026
boundary_route_condition	conditional modules	Include additive manufacturing, thermal processing and sterilization only when performed for the declared product; identify each step, parameter set and output specification.	fda-am-medical-devices-2017
boundary_sterile_state	sterile and non-sterile products	If supplied sterile, include controlled packaging and validated sterilization whether on-site or represented by an upstream contracted-process dataset; otherwise declare non-sterile state and packaging cleanliness controls.	eu-mdr-2017-745
boundary_no_silent_cutoff	material, waste and emission completeness	Do not omit a small-mass exchange when it can affect biocompatibility, cleanliness, sterile-state assurance, hazardous emissions or regulated waste classification.	eu-mdr-2017-745; fda-am-medical-devices-2017

6. Process Inventory Structure

Process Map

process_id	process_name	inclusion	inclusion_condition	role	quantitative_reference
material_transformation	Material preparation and transformation	conditional	Include when cutting, machining, molding, lay-up or additive fabrication occurs within the foreground boundary.	Convert qualified feedstock to device components.	Accepted component mass entering cleaning and assembly
cleaning_assembly	Post-processing, cleaning and assembly	required	Always include; record zero chemical use only when documented.	Remove residues, finish surfaces and assemble the device.	Accepted assembled-device mass
thermal_processing	Thermal processing	conditional	Include when furnaces, ovens, annealing, curing or hot isostatic pressing are controlled within the boundary.	Achieve specified material properties.	Accepted processed component mass
sterilization	Sterilization	conditional	Include for products supplied sterile when ethylene-oxide sterilization is in the foreground boundary; other technologies need their own atomic exchanges.	Establish validated sterile state.	Released sterilization-load mass
packaging_release	Final inspection, packaging and quality release	required	Always include.	Verify, package and release conforming product.	1 kg net accepted finished product

Process: Material preparation and transformation (material_transformation)

Inputs

Product flows

Titanium plate feedstock (titanium_plate)

Record only when titanium plate is transformed for the device; retain alloy and medical grade.

• Selected flow: Titanium Plate f32fc628-252f-40fe-8f8d-fd0efb955e92
• Flow property / unit: Mass / kg
• Amount rule: measured accepted plate mass issued to production, net of returned unopened stock
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg net accepted finished product
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_material_receipts
• Sources:

Stainless-steel feedstock (stainless_steel)

Record only when stainless steel enters the device bill of materials; retain grade and form.

• Selected flow: Stainless steel 84c2403f-5062-5d68-8276-838384d32b89
• Flow property / unit: Mass / kg
• Amount rule: measured accepted stainless-steel mass issued to production, net of returned stock
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg net accepted finished product
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_material_receipts
• Sources:

UHMWPE molding or machining stock (uhmwpe_molding_stock)

Record medical-grade ultra-high-molecular-weight polyethylene stock only when retained in a component; UUID unresolved.

• Selected flow: Ultra-high-molecular-weight polyethylene molding stock
• Flow property / unit: Mass / kg
• Amount rule: measured accepted UHMWPE stock mass issued to production
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg net accepted finished product
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_material_receipts
• Sources:

Medical-grade silicone rubber (medical_grade_silicone_rubber)

Record only when silicone becomes a retained liner, interface or prosthetic component; UUID unresolved.

• Selected flow: Medical-grade silicone rubber
• Flow property / unit: Mass / kg
• Amount rule: measured accepted silicone-rubber mass issued to production
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg net accepted finished product
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_material_receipts
• Sources:

Electricity for material transformation (material_transformation_electricity)

Record energy for cutting, machining, molding, additive fabrication and local extraction.

• Selected flow: Electricity 890a70b7-b677-4e2a-8a1b-7d017e0a10ae
• Flow property / unit: Net calorific value / MJ
• Amount rule: submetered electricity or verified equipment demand integrated over allocated operating time
• Value mode: Foreground record (foreground_record)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg net accepted finished product
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_energy_meters
• Sources:

Industrial oxygen for cutting (industrial_oxygen)

Record only for oxygen-assisted cutting when supplied oxygen crosses the site boundary.

• Selected flow: Industrial oxygen bd4b0f96-2090-4806-a648-335ab20ff401
• Flow property / unit: Volume / m3
• Amount rule: supplier or process-meter volume allocated to accepted production
• Value mode: Foreground record (foreground_record)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg net accepted finished product
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_material_receipts
• Sources:

Waste flows

Elementary flows

Outputs

Product flows

Waste flows

Titanium machining scrap (titanium_machining_scrap)

Record segregated titanium chips and offcuts; UUID unresolved.

• Selected flow: Titanium machining scrap
• Flow property / unit: Mass / kg
• Amount rule: weighed as-dispatched scrap corrected for documented coolant carryover
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg net accepted finished product
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_waste_records
• Sources:

Stainless-steel machining scrap (stainless_steel_machining_scrap)

Record segregated stainless-steel chips and offcuts; UUID unresolved.

• Selected flow: Stainless-steel machining scrap
• Flow property / unit: Mass / kg
• Amount rule: weighed as-dispatched scrap corrected for documented coolant carryover
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg net accepted finished product
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_waste_records
• Sources:

UHMWPE scrap (uhmwpe_scrap)

Record segregated UHMWPE sprues, chips and offcuts; UUID unresolved.

• Selected flow: Ultra-high-molecular-weight polyethylene scrap
• Flow property / unit: Mass / kg
• Amount rule: weighed as-dispatched UHMWPE scrap
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg net accepted finished product
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_waste_records
• Sources:

Silicone-rubber scrap (silicone_rubber_scrap)

Record segregated cured or uncured silicone trimmings; UUID unresolved.

• Selected flow: Silicone rubber scrap
• Flow property / unit: Mass / kg
• Amount rule: weighed as-dispatched silicone-rubber scrap
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg net accepted finished product
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_waste_records
• Sources:

Elementary flows

Process: Post-processing, cleaning and assembly (cleaning_assembly)

Inputs

Product flows

Process water for cleaning (process_water)

Record process water for rinsing or cleaning accepted parts and assemblies.

• Selected flow: Process Water 94a04f7e-2d5c-41f0-b182-d54a3b373a02
• Flow property / unit: Mass / kg
• Amount rule: measured water mass; volume conversion requires documented measured density
• Value mode: Foreground record (foreground_record)
• Specificity: Site-specific (site_specific)
• Normalization basis: per 1 kg net accepted finished product
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_cleaning_records
• Sources:

Sodium hydroxide cleaning chemical (sodium_hydroxide)

Record pure sodium-hydroxide mass only when used by the declared cleaning route.

• Selected flow: Sodium hydroxide e0abcced-0611-4c24-9290-5a2c5a0c4169
• Flow property / unit: Mass / kg
• Amount rule: net solution mass multiplied by recorded NaOH mass fraction
• Value mode: Calculated value (calculated_value)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg net accepted finished product
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_cleaning_records
• Sources:

Electricity for cleaning and assembly (cleaning_assembly_electricity)

Record energy for finishing, cleaning, drying and assembly equipment.

• Selected flow: Electricity 890a70b7-b677-4e2a-8a1b-7d017e0a10ae
• Flow property / unit: Net calorific value / MJ
• Amount rule: submetered electricity or verified equipment demand integrated over allocated operating time
• Value mode: Foreground record (foreground_record)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg net accepted finished product
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_energy_meters
• Sources:

Waste flows

Elementary flows

Outputs

Product flows

Waste flows

Cleaning wastewater (cleaning_wastewater)

Record aqueous cleaning waste crossing to treatment; retain composition, hazard status and destination.

• Selected flow: Wastewater from cleaning f0402393-e82c-47e8-9cd8-a486c97f3e89
• Flow property / unit: Mass / kg
• Amount rule: measured wet mass or documented water-and-chemical mass balance
• Value mode: Foreground record (foreground_record)
• Specificity: Site-specific (site_specific)
• Normalization basis: per 1 kg net accepted finished product
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_waste_records
• Sources:

Elementary flows

Process: Thermal processing (thermal_processing)

Inputs

Product flows

Gaseous natural gas (natural_gas)

Record only when directly combusted in foreground furnaces, ovens or thermal oxidizers.

• Selected flow: natural gas in the gaseous state 4f19ca0e-7b3b-11dd-ad8b-0800200c9a66
• Flow property / unit: Volume / m3
• Amount rule: metered or invoiced volume allocated to accepted production at declared conditions
• Value mode: Foreground record (foreground_record)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg net accepted finished product
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_energy_meters
• Sources:

Electricity for thermal processing (thermal_processing_electricity)

Record electricity for thermal equipment and dedicated controls.

• Selected flow: Electricity 890a70b7-b677-4e2a-8a1b-7d017e0a10ae
• Flow property / unit: Net calorific value / MJ
• Amount rule: submetered electricity or verified equipment demand integrated over allocated time
• Value mode: Foreground record (foreground_record)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg net accepted finished product
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_energy_meters
• Sources:

Waste flows

Elementary flows

Outputs

Product flows

Waste flows

Elementary flows

Direct fossil carbon dioxide (fossil_carbon_dioxide)

Record only direct fossil CO2 from foreground natural-gas combustion, not upstream electricity emissions.

• Selected flow: carbon dioxide (fossil) 08a91e70-3ddc-11dd-923d-0050c2490048
• Flow property / unit: Mass / kg
• Amount rule: measured stack emission or gas use multiplied by a documented applicable fossil-carbon factor
• Value mode: Calculated value (calculated_value)
• Specificity: Site-specific (site_specific)
• Normalization basis: per 1 kg net accepted finished product
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_combustion_emissions
• Sources:

Process: Sterilization (sterilization)

Inputs

Product flows

Ethylene oxide sterilant (ethylene_oxide)

Record only for validated ethylene-oxide sterilization; retain concentration and load.

• Selected flow: Ethylene Oxide a460460e-055f-4b74-9c6f-c1a0b315f31a
• Flow property / unit: Mass / kg
• Amount rule: batch dosing mass allocated to released sterilization-load product
• Value mode: Foreground record (foreground_record)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg released sterilization-load product
• Basis kind: Process output (process_output)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_sterilization_records
• Sources: eu-mdr-2017-745

Electricity for sterilization (sterilization_electricity)

Record energy for chamber, aeration and dedicated abatement equipment.

• Selected flow: Electricity 890a70b7-b677-4e2a-8a1b-7d017e0a10ae
• Flow property / unit: Net calorific value / MJ
• Amount rule: submetered electricity allocated by released load mass
• Value mode: Foreground record (foreground_record)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg released sterilization-load product
• Basis kind: Process output (process_output)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_energy_meters
• Sources: eu-mdr-2017-745

Waste flows

Elementary flows

Outputs

Product flows

Waste flows

Elementary flows

Ethylene oxide emitted to air (ethylene_oxide_to_air)

Record residual ethylene oxide released to unspecified air after controls.

• Selected flow: ethylene oxide fe0acd60-3ddc-11dd-a488-0050c2490048
• Flow property / unit: Mass / kg
• Amount rule: monitored emission or validated batch mass balance after abatement
• Value mode: Foreground record (foreground_record)
• Specificity: Site-specific (site_specific)
• Normalization basis: per 1 kg released sterilization-load product
• Basis kind: Process output (process_output)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_sterilization_records
• Sources: eu-mdr-2017-745

Process: Final inspection, packaging and quality release (packaging_release)

Inputs

Product flows

Low-density polyethylene film (ldpe_film)

Record PE-LD film remaining in declared unit or sterile-barrier packaging.

• Selected flow: Low-density polyethylene foil (PE-LD) 2cecd3a7-d90e-44b4-aec5-1d9dfb907477
• Flow property / unit: Mass / kg
• Amount rule: packaging BOM mass verified by counts or receipt reconciliation
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg net accepted finished product
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_packaging_records
• Sources: eu-mdr-2017-745

Corrugated board box (corrugated_box)

Record the corrugated box in the declared sales or distribution packaging.

• Selected flow: corrugated board boxes 4f197bec-7b3b-11dd-ad8b-0800200c9a66
• Flow property / unit: Mass / kg
• Amount rule: packaging BOM mass verified by box counts and measured unit mass
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg net accepted finished product
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_packaging_records
• Sources: eu-mdr-2017-745

Electricity for packaging and release (packaging_release_electricity)

Record energy for inspection, packaging, labeling and dedicated controlled environment.

• Selected flow: Electricity 890a70b7-b677-4e2a-8a1b-7d017e0a10ae
• Flow property / unit: Net calorific value / MJ
• Amount rule: submetered electricity or verified equipment demand integrated over allocated time
• Value mode: Foreground record (foreground_record)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg net accepted finished product
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_energy_meters
• Sources:

Waste flows

Elementary flows

Outputs

Product flows

Quality-released finished appliance (finished_appliance)

This is the quantitative reference; packaging mass is reported separately.

• Selected flow: Orthopaedic appliances, splints and other fracture appliances, artificial parts of the body 5ce1d551-f011-4400-8717-bdde251252f7
• Flow property / unit: Mass / kg
• Amount rule: exactly 1 kg net quality-released finished product after normalization
• Value mode: Fixed value (fixed_value)
• Specificity: Generic (generic)
• Normalization basis: reference flow of 1 kg net accepted finished product
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_packaging_records
• Sources:

Waste flows

Elementary flows

7. Allocation and Co-product Handling

rule_id	Applies to	Rule	source_ids
allocation_subdivide	shared equipment and lines	Prefer subdivision, batch records and submetering so burdens are assigned to the device family causing them.
allocation_batch_driver	shared batch processes	Allocate first by a causal driver such as occupied chamber capacity or validated machine time; use released mass only when no better measured driver exists.
allocation_recycling	segregated scrap	Report each scrap flow and destination without an avoided-virgin credit inside the foreground process unless a consistently declared background recycling model supplies it.
allocation_disclosure	residual allocation	Disclose process, products, driver, numerator, denominator, factor and sensitivity; factors sharing a burden shall sum to one.

8. Foreground Data Collection, Calculation, and Quality Rules

Data Collection Protocols

protocol_id	process_id	flow_role	record_type	raw_fields	collection_method	unit	frequency	temporal_coverage	site_scope	aggregation_rule	quality_evidence
cp_material_receipts	material_transformation	material and gas inputs	receipt, issue and inventory record	identity; grade; form; supplier; lot; stock; receipt; issue; return; mass or volume; reference conditions	Reconcile qualified warehouse and production issues to declared lots.	kg or m3	each receipt and issue	continuous 12 months or complete shorter campaign	all production sites in scope	sum net issued amount and allocate by lot or causal driver	certificate; lot traceability; calibrated scale or meter; reconciliation
cp_energy_meters	all included processes	electricity and natural gas	meter, invoice and run log	meter id; readings; unit; conditions; equipment; run time; lot; accepted output	Prefer submeters; otherwise integrate verified demand over logged time and reconcile to invoices.	MJ, kWh or m3	batch or month	continuous 12 months or complete shorter campaign	all in-scope locations	difference readings, convert, causally allocate and normalize	calibration; invoice; run log; allocation worksheet
cp_cleaning_records	cleaning_assembly	water and NaOH	meter, recipe and issue record	water; density; solution mass; NaOH fraction; return; batch; output	Meter water and reconcile chemicals to controlled recipes.	kg, m3 and mass fraction	cleaning batch	same production period	all cleaning lines	calculate pure NaOH, aggregate accepted batches and normalize	calibration; concentration certificate; recipe; batch record
cp_waste_records	material_transformation; cleaning_assembly	scrap and wastewater	scale ticket, manifest and effluent meter	identity; composition; wet mass; carryover; destination; treatment; batch; wastewater	Weigh segregated dispatches and meter wastewater; reconcile stocks.	kg or m3	dispatch or discharge period	same production period	all generation points	opening stock plus generation minus closing stock and returns	calibration; manifest; treatment receipt; composition record
cp_combustion_emissions	thermal_processing	fossil CO2	stack monitor or fuel-carbon record	fuel; conditions; carbon factor; oxidation; measured CO2; period	Prefer calibrated monitoring; otherwise calculate from metered fuel and documented applicable factor.	kg CO2	monitored period or fuel batch	same thermal period	all combustion units	aggregate and causally allocate by furnace load	calibration; fuel certificate; factor record; balance check
cp_sterilization_records	sterilization	ethylene oxide and emission	chamber, dose, aeration and abatement record	dose; concentration; released load; chamber; cycle; destroyed mass; emission; status	Reconcile dosing to released loads and measured or validated emissions.	kg	cycle	all cycles in period	each in-scope chamber and control	released loads only; allocate by validated load driver	validated cycle; calibration; release; monitor or mass balance
cp_packaging_records	packaging_release	packaging and finished product	BOM, count, unit-mass and release record	material; unit mass; count; model; net product mass; reject; sterile state; status	Verify BOM by counts and unit masses; weigh product separately.	kg and count	lot	continuous 12 months or complete shorter campaign	all packaging sites	sum released product and associated packaging, normalize to 1 kg	BOM; calibration; count reconciliation; release record

Calculation Rules

rule_id	Applies to	Formula or rule	Inputs	Output	source_ids
calc_reference_normalization	every row	normalized amount = amount assigned to accepted product / net accepted product mass in kg	assigned amount; accepted mass	amount per 1 kg product
calc_electricity_mj	electricity	MJ = metered kWh × 3.6	kWh	MJ
calc_naoh_pure_mass	sodium_hydroxide	pure NaOH = net solution mass × NaOH mass fraction	solution mass; fraction; return	kg NaOH
calc_waste_stock_balance	solid scrap	generated waste = dispatches + closing stock − opening stock − externally received waste, adjusted for returns	dispatch, stock and return	kg generated scrap
calc_combustion_co2	fossil_carbon_dioxide	use calibrated measurement; otherwise multiply metered gas by documented applicable fossil-carbon factor and oxidation treatment	gas; factor; oxidation	kg direct fossil CO2
calc_allocation_check	shared processes	sum of allocation factors sharing a burden = 1	factors and total	reconciliation

Data Quality Requirements

requirement_id	Applies to	Requirement	Evidence
dq_product_identity	reference product	Preserve family, model, function, sterile state, composition, net mass and release status.	specification, BOM and release record
dq_process_traceability	all processes	Link lots from qualified input through parameters, rejects, sterilization when applicable and release.	traveller, batch record, equipment log and QMS record
dq_measurement	meters and scales	Use calibrated equipment; document conversions, reference conditions, gaps and estimates.	calibration, meter log and worksheet
dq_temporal	annual or campaign inventory	Use continuous 12 months or a complete shorter campaign and explain shutdowns, validation builds and atypical rejects.	calendar, coverage and review
dq_mass_balance	materials, product and wastes	Reconcile major inputs to accepted product, rejects, wastes and stock changes by material family.	signed balance and stock reconciliation
dq_sterile_packaging	sterile products	Link sterilization and packaging records to released sterile state and configuration.	validated cycle, package-integrity and release evidence

9. Validation Rules

rule_id	Applies to	Rule	source_ids
validate_identity	identity and reference flow	Fail if family, function, model or patient match, net mass, sterile state, life or cycles, route, site or year is missing.	un-cpc-3-0-2025; fda-am-medical-devices-2017
validate_reference_mass	reference product	Confirm finished_appliance is exactly 1 kg net accepted product and packaging is excluded from net mass.
validate_route_inventory	process map and inventory	Confirm each declared module has atomic material, energy, waste and direct-emission exchanges; reject combined labels.	fda-am-medical-devices-2017
validate_mass_balance	transformation and packaging	Reconcile major inputs, accepted product, rejects, wastes and stocks; investigate residuals.	fda-qmsr-2026
validate_no_double_count	energy and emissions	Confirm direct combustion and sterilization emissions are not counted again upstream.
validate_sterility	sterile products	Confirm validated sterilization, controlled packaging and release evidence cover product and period.	eu-mdr-2017-745; fda-qmsr-2026
validate_allocation	shared processes	Confirm driver and worksheet are disclosed and factors sharing a burden sum to one.
validate_unresolved	UUID and range evidence	Keep unresolved identities and unsupported ranges explicit; do not substitute proxies or invented ranges.

10. Published Dataset Profile

Field	Value
dataset_role	foreground manufacturing dataset eligible as secondary_dataset or background_dataset after review
downstream_use	product carbon footprints, compatible within-family LCA, hotspot analysis, process datasets and lifecyclemodel projections
allowed_use	Use when identity, performance, life, composition, sterile state, packaging, modules, geography, year and allocation are compatible.
excluded_use	Do not compare unlike functions on mass alone or represent clinical fitting, surgery, patient outcomes, use, maintenance or end-of-life without added processes.
required_metadata	PCR id and version; family and model; function; standard or patient-matched state; implantable or external state; net mass; composition; modules; sterile state and sterilization; packaging; site; geography; year; technology; allocation; upstream datasets; cut-offs
required_quality_disclosure	source shares; meter coverage; temporal coverage; supplier specificity; allocation; mass-balance residual; reject treatment; missing data; unresolved UUIDs; range gaps; sterilization and packaging validation
update_trigger	Update after material design, technology, sterilization, packaging, sterile state, site, supplier or allocation changes; data-age failure; or resolution of identity and range gaps.

11. Data Sources

Source id	Type	Reference	Used for
un-cpc-3-0-2025	Official guidance (official_guidance)	United 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	CPC 48171 identity and wording
china-mof-tariff-concordance-2021-2022	Official guidance (official_guidance)	Ministry of Finance of the People's Republic of China, 2021–2022 tariff conversion table, Part I, p. 114. https://m.mof.gov.cn/zcfb/202112/P020211231585098397303.pdf	Professional Chinese terminology for orthopaedic appliances, fracture appliances and artificial body parts
fda-am-medical-devices-2017	Official guidance (official_guidance)	U.S. FDA, Technical Considerations for Additive Manufactured Medical Devices, December 2017, docket FDA-2016-D-1210. https://www.fda.gov/media/97633/download	Route, material control, post-processing, cleaning, sterilization, packaging, testing and quality data
eu-mdr-2017-745	Standard (standard)	Regulation (EU) 2017/745 on medical devices, Annex I. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745	Contamination, sterilization, packaging and sterile-state rules
fda-qmsr-2026	Official guidance (official_guidance)	U.S. FDA, Quality Management System Regulation, updated 2 February 2026. https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr	Current finished-device QMS, records and traceability context