Other instruments and appliances used in medical, surgical or veterinary sciences

1. Scope and Applicability

This PCR covers cradle-to-factory-gate production of finished medical, surgical, ophthalmic, or veterinary instruments and appliances in the CPC 48150 boundary, including syringes, needles, catheters, cannulae, and electro-medical apparatus not elsewhere classified. It applies to sterile and non-sterile products, disposable and reusable products, and passive and powered products only when the foreground data package declares the concrete device type, bill of materials, manufacturing route, sterile state, intended use, packaging configuration, and factory-gate product state.

It excludes electro-diagnostic apparatus, ultraviolet or infrared medical apparatus, dental instruments other than syringes and needles, medical or laboratory sterilizers as products, mechano-therapy and respiratory appliances, orthopaedic and prosthetic appliances, medical furniture, standalone parts and accessories, pharmaceuticals, and health-care services. Use and maintenance, clinical consumables, distribution beyond the factory gate, and end-of-life are outside the default boundary. A study may extend the boundary only by disclosing the additional processes separately.

The category is heterogeneous. The shared rules below do not authorize a generic average device. Each dataset shall represent one declared product specification and include only the applicable material, cleaning, sterilization, and packaging routes.

2. Product Category Identity

Field	Value
canonical_pcr_id	pcr.metal-products-machinery-and-equipment.medical-appliances-precision-and-optical-instruments-watches-and-clocks.other-instruments-and-appliances-used-in-medical-surgical-or-veterinary-sciences-includ-cacd41f4
classification_refs	CPC 3.0:48150 (exact)
covered_products	Finished syringes, needles, catheters, cannulae, ophthalmic instruments and appliances n.e.c., and other medical, surgical, veterinary, or electro-medical instruments and appliances n.e.c.
excluded_products	Electro-diagnostic apparatus; ultraviolet or infrared medical apparatus; dental instruments other than syringes and needles; sterilizers sold as products; mechano-therapy and respiratory appliances; orthopaedic or prosthetic appliances; medical furniture; standalone parts and accessories; pharmaceuticals; services
representative_product	One declared finished device model or homogeneous device family within the covered boundary
production_route	Declared bill-of-material route with applicable component fabrication, assembly and cleaning, sterilization, and packaging processes
market_state	Finished device at the manufacturer factory gate, with sterile state, reusable/disposable status, packaging configuration, and release specification declared

3. Reference Flow

Field	Value
What	Provide a finished medical, surgical, ophthalmic, or veterinary instrument or appliance that performs its declared intended function
How much	1 kg net mass of conforming finished device at the factory gate
How well	Meets the declared model, intended-use, performance, cleanliness, sterile-state, and release specifications
How long or cycle	One factory-gate delivery; use-stage lifetime or procedure count is declared for interpretation but is not included in this cradle-to-gate reference amount
reference_flow_link	The reference product output finished_medical_instrument equals the 1 kg reference amount

Field	Value
Reference amount	1 kg net mass of conforming finished device
Reference product flow	Other instruments and appliances used in medical, surgical or veterinary sciences (including syringes, needles, catheters, cannulae, ophthalmic instruments and appliances n.e.c. and electro-medical apparatus n.e.c.) 01d838ad-6413-41ad-ba7a-a159be4b8a20
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 generic name and model or homogeneous family; intended medical, surgical, ophthalmic, or veterinary function; disposable or reusable state; passive or powered state; net device mass excluding packaging; principal materials and grades; manufacturing technologies; sterile or non-sterile state; sterilization method and site when applicable; sterile-barrier and sales-pack configuration; production geography and reference year; factory-gate boundary; accepted and rejected product mass; co-product and scrap-credit treatment

When constructing a foreground data package, every required qualifier shall be declared in metadata, process notes, the reference-flow comment, the product description, or an equivalent data-package field. A missing qualifier makes the reference-flow definition incomplete.

4. Measurement and Unit Rules

rule_id	Applies to	Required property	Required unit	Rule
reference_net_mass	Reference product and normalization denominator	Mass 93a60a56-a3c8-11da-a746-0800200b9a66	kg	Weigh conforming finished devices without transport packaging; include integral components and non-removable accessories supplied as part of the declared device. Normalize all inventory amounts to 1 kg accepted output.
packaging_mass_separation	Sterile barrier, protective packaging, labels, and sales cartons	Mass 93a60a56-a3c8-11da-a746-0800200b9a66	kg	Record each packaging material separately from net device mass; convert item counts using measured average mass from the same packaging specification.
energy_conversion	Purchased electricity and process energy	Net calorific value 93a60a56-a3c8-11da-a746-0800200c9a66 or the directly audited energy property	MJ	Preserve the source meter unit and convert electricity only with 1 kWh = 3.6 MJ; do not mix delivered steam mass with heat energy.
water_mass_conversion	Process water and wastewater recorded volumetrically	Mass 93a60a56-a3c8-11da-a746-0800200b9a66	kg	Retain measured volume, temperature, and an applicable measured or documented density; report the converted mass and do not assume wastewater density when composition materially differs from water.
sterilization_service_basis	Contract irradiation sterilization	Mass 93a60a56-a3c8-11da-a746-0800200b9a66	kg treated device	Normalize the invoiced or treatment-record service quantity to the accepted device mass in the same sterilization load and disclose dose, load allocation, and return yield.

5. System Boundary

Boundary Abstraction

Field	Value
declared_starting_condition	Purchased raw materials, purchased components, packaging items, utilities, and contracted sterilization services at their receiving boundary; supplier processes are represented by upstream datasets
starting_condition_role	Cradle-to-gate foreground manufacturing starting condition
product_classification_scope	Finished CPC 48150 instruments and appliances only; adjacent device categories, standalone components, pharmaceuticals, and services are excluded
recursive_input_rule	A purchased CPC 48150 device used as a component or subassembly is recorded as an upstream product input with its own dataset and is not recursively decomposed inside this foreground system
upstream_dataset_requirement	Use geography-, technology-, grade-, and product-state-compatible upstream datasets for every purchased material, component, utility, packaging item, and contract service
disclosure	Declare manufacturing sites, outsourced operations, bill-of-material coverage, sterile state, sterilization route, packaging configuration, rejected-product treatment, allocation basis, and any boundary extension

rule_id	Applies to	Rule	source_ids
boundary_factory_gate	All foreground datasets	Include receipt and preparation of inputs, in-house component fabrication, assembly, cleaning, testing, applicable sterilization, packaging, release, and all wastes and direct emissions through the finished-device factory gate.	un-isic-rev4-3250; us-fda-qmsr-2026
boundary_outsourced_operations	Contract manufacturing and sterilization	Include outsourced operations as upstream services or linked foreground processes and prevent double counting of returned device mass.	us-fda-qmsr-2026; us-fda-sterilization-process-controls
boundary_sterile_route	Products placed on the market sterile	Include the validated sterilization cycle, preconditioning, conditioning, aeration or cooling, monitoring, rejected loads, and sterile-pack integrity controls applicable to the declared method.	eu-mdr-2017-745; us-fda-sterilization-process-controls
boundary_direct_emissions	Site-controlled releases	Record measured direct releases at the elementary-flow boundary, including controlled and fugitive ethylene oxide when that route applies; do not duplicate upstream electricity or fuel emissions.	us-epa-ethylene-oxide-neshap
boundary_excluded_lifecycle	Default cradle-to-gate study	Exclude distribution after the factory gate, clinical use, reprocessing during use, maintenance, and end-of-life unless the declared study extends and reports those stages separately.

6. Process Inventory Structure

Process Map

process_id	process_name	inclusion	inclusion_condition	role	quantitative_reference
component_fabrication	Component and material preparation	required	Always; record only materials and fabrication operations used by the declared bill of materials	Foreground component fabrication and preparation	kg accepted components transferred to assembly
assembly_cleaning_testing	Assembly, cleaning, and release testing	required	Always; cleaning chemicals and water apply only when used	Foreground assembly and product release	kg conforming device before sterilization or packaging
ethylene_oxide_sterilization	Ethylene oxide sterilization	conditional	Include only when the declared product is sterilized with ethylene oxide	Foreground or contracted terminal sterilization	kg accepted device released from the EtO cycle
steam_sterilization	Steam sterilization	conditional	Include only when the declared product is steam sterilized	Foreground or contracted terminal sterilization	kg accepted device released from the steam cycle
irradiation_sterilization	Irradiation sterilization	conditional	Include only when the declared product is sterilized by gamma, electron-beam, or X-ray irradiation	Contract or foreground terminal sterilization	kg accepted irradiated device
packaging_release	Packaging, labelling, and factory-gate release	required	Always; each packaging row applies only when present in the declared configuration	Foreground packaging and final release	1 kg net conforming finished device at factory gate

Process: Component and material preparation (component_fabrication)

Inputs

Product flows

Polypropylene granulate for moulded components (polypropylene_granulate)

Record virgin polypropylene granulate only when polypropylene components are moulded within the foreground boundary. The Tiangong UUID remains unresolved.

• Selected flow: Polypropylene granulate
• Flow property / unit: Mass / kg
• Amount rule: measured issued mass less unopened material returned to controlled inventory
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg accepted finished device
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_component_materials
• Sources:

Stainless steel for metal components (stainless_steel)

Record stainless steel only for declared metal-component routes and disclose alloy grade and supplied form.

• Selected flow: Stainless steel 84c2403f-5062-5d68-8276-838384d32b89
• Flow property / unit: Mass / kg
• Amount rule: measured stainless-steel issue less unchanged material returned to inventory
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg accepted finished device
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_component_materials
• Sources:

Electricity for component fabrication (fabrication_electricity)

Record metered electricity for moulding, machining, forming, welding, and directly attributable fabrication auxiliaries.

• Selected flow: Electricity 890a70b7-b677-4e2a-8a1b-7d017e0a10ae
• Flow property / unit: Net calorific value / MJ
• Amount rule: metered electricity allocated to accepted components using machine time or validated submetering
• Value mode: Calculated value (calculated_value)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg accepted finished device
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_component_utilities
• Sources:

Process water for component washing (fabrication_process_water)

Record process water only when component washing or rinsing occurs within this process.

• Selected flow: Process Water 94a04f7e-2d5c-41f0-b182-d54a3b373a02
• Flow property / unit: Mass / kg
• Amount rule: measured water supplied to component washing after documented recirculation is netted once
• Value mode: Calculated value (calculated_value)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg accepted finished device
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_component_utilities
• Sources:

Carbon dioxide shielding gas (carbon_dioxide_shielding_gas)

Record carbon dioxide only when it is purchased and consumed as welding shielding gas for declared components.

• Selected flow: Carbon dioxide 27f41c1c-535e-4d2a-bce9-2c7f4de11549
• Flow property / unit: Mass / kg
• Amount rule: cylinder or bulk-tank mass balance attributable to the declared welding route
• Value mode: Calculated value (calculated_value)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg accepted finished device
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_component_utilities
• Sources:

Waste flows

Elementary flows

Outputs

Product flows

Waste flows

Polypropylene fabrication waste (polypropylene_waste)

Record segregated polypropylene runners, sprues, rejects, and trimmings leaving this process; internal regrind reused in the same system is not a boundary output.

• Selected flow: Polypropylene Wastes 88215d1b-e6b6-4ec7-af7f-83375e80637b
• Flow property / unit: Mass / kg
• Amount rule: measured outgoing polypropylene waste by destination
• Value mode: Foreground record (foreground_record)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg accepted finished device
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_component_scrap
• Sources:

Stainless-steel fabrication scrap (stainless_steel_scrap)

Record site-generated stainless-steel offcuts, swarf, and rejected pieces leaving this process. The Tiangong UUID remains unresolved because audited candidates did not match this site-generated alloy state.

• Selected flow: Site-generated stainless-steel scrap
• Flow property / unit: Mass / kg
• Amount rule: measured outgoing stainless-steel scrap by alloy grade and destination
• Value mode: Foreground record (foreground_record)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg accepted finished device
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_component_scrap
• Sources:

Elementary flows

Process: Assembly, cleaning, and release testing (assembly_cleaning_testing)

Inputs

Product flows

Isopropanol for product cleaning (assembly_isopropanol)

Record isopropanol only when consumed in cleaning or surface preparation and disclose purity and recovery.

• Selected flow: Isopropanol a4a75541-e156-4e30-947c-ba067a682afd
• Flow property / unit: Mass / kg
• Amount rule: purchase-and-inventory mass balance less recovered isopropanol returned to use
• Value mode: Calculated value (calculated_value)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg accepted finished device
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_assembly_inputs
• Sources:

Sodium hydroxide cleaning agent (assembly_sodium_hydroxide)

Record sodium hydroxide only when used in an aqueous cleaning formulation; report pure sodium-hydroxide mass and solution concentration.

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

Process water for final cleaning (assembly_process_water)

Record process water supplied to final cleaning and rinsing, netting recirculated water once.

• Selected flow: Process Water 94a04f7e-2d5c-41f0-b182-d54a3b373a02
• Flow property / unit: Mass / kg
• Amount rule: measured water supplied to the declared cleaning train
• Value mode: Calculated value (calculated_value)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg accepted finished device
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_assembly_utilities
• Sources:

Electricity for assembly and testing (assembly_electricity)

Record metered electricity for assembly equipment, clean-area equipment allocated to the product, leak testing, functional testing, and release inspection.

• Selected flow: Electricity 890a70b7-b677-4e2a-8a1b-7d017e0a10ae
• Flow property / unit: Net calorific value / MJ
• Amount rule: metered electricity allocated by validated equipment time, clean-area occupancy, or submetering
• Value mode: Calculated value (calculated_value)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg accepted finished device
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_assembly_utilities
• Sources: us-fda-qmsr-2026

Waste flows

Elementary flows

Outputs

Product flows

Waste flows

Cleaning wastewater (cleaning_wastewater)

Record wastewater leaving cleaning and rinsing before external treatment; disclose composition, on-site treatment, and destination.

• Selected flow: Wastewater d2d44ce1-c0f4-461d-9413-f4b33e0d200f
• Flow property / unit: Mass / kg
• Amount rule: measured discharged wastewater mass after internal recirculation and before external treatment
• Value mode: Calculated value (calculated_value)
• Specificity: Site-specific (site_specific)
• Normalization basis: per 1 kg accepted finished device
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_cleaning_wastewater
• Sources:

Elementary flows

Process: Ethylene oxide sterilization (ethylene_oxide_sterilization)

Inputs

Product flows

Ethylene oxide sterilant (ethylene_oxide_sterilant)

Record purchased ethylene oxide entering the validated cycle, including preconditioning, chamber injection, and any carrier formulation allocation.

• Selected flow: Ethylene Oxide a460460e-055f-4b74-9c6f-c1a0b315f31a
• Flow property / unit: Mass / kg
• Amount rule: measured injected ethylene-oxide mass allocated to the accepted product mass in the load
• Value mode: Calculated value (calculated_value)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg accepted sterilized device
• Basis kind: Process output (process_output)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_eto_cycle
• Sources: us-fda-sterilization-process-controls

Electricity for EtO sterilization (eto_sterilization_electricity)

Record electricity for preconditioning, chamber operation, abatement, aeration, and directly attributable auxiliaries.

• Selected flow: Electricity 890a70b7-b677-4e2a-8a1b-7d017e0a10ae
• Flow property / unit: Net calorific value / MJ
• Amount rule: metered electricity allocated to the accepted product mass in the sterilization load
• Value mode: Calculated value (calculated_value)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg accepted sterilized device
• Basis kind: Process output (process_output)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_eto_cycle
• Sources: us-fda-sterilization-process-controls

Waste flows

Elementary flows

Outputs

Product flows

Waste flows

Elementary flows

Ethylene oxide emitted to air (ethylene_oxide_to_air)

Record measured controlled-stack and fugitive ethylene-oxide releases without subtracting regulatory allowances; keep emission points traceable.

• Selected flow: ethylene oxide fe0acd60-3ddc-11dd-a488-0050c2490048
• Flow property / unit: Mass / kg
• Amount rule: sum of measured or validated mass-balance releases to air for the allocated sterilization load
• Value mode: Calculated value (calculated_value)
• Specificity: Site-specific (site_specific)
• Normalization basis: per 1 kg accepted sterilized device
• Basis kind: Process output (process_output)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_eto_emissions
• Sources: us-epa-ethylene-oxide-neshap

Process: Steam sterilization (steam_sterilization)

Inputs

Product flows

Process steam supplied to the sterilizer (process_steam)

Record delivered process steam for the validated steam cycle, net of separately measured condensate returned across the boundary.

• Selected flow: Process steam 41a70607-cc98-4ae8-8556-e33cdf13157e
• Flow property / unit: Mass / kg
• Amount rule: measured delivered steam mass less measured condensate returned to the supplier system
• Value mode: Calculated value (calculated_value)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg accepted sterilized device
• Basis kind: Process output (process_output)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_steam_cycle
• Sources: us-fda-sterilization-process-controls

Electricity for steam sterilization (steam_sterilization_electricity)

Record electricity for the sterilizer, controls, vacuum, drying, cooling, and directly attributable auxiliaries.

• Selected flow: Electricity 890a70b7-b677-4e2a-8a1b-7d017e0a10ae
• Flow property / unit: Net calorific value / MJ
• Amount rule: metered electricity allocated to the accepted product mass in the sterilization load
• Value mode: Calculated value (calculated_value)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg accepted sterilized device
• Basis kind: Process output (process_output)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_steam_cycle
• Sources: us-fda-sterilization-process-controls

Waste flows

Elementary flows

Outputs

Product flows

Waste flows

Elementary flows

Process: Irradiation sterilization (irradiation_sterilization)

Inputs

Product flows

Medical-device irradiation sterilization service (irradiation_sterilization_service)

Record the contracted gamma, electron-beam, or X-ray sterilization service as one declared service route. The Tiangong UUID remains unresolved.

• Selected flow: Medical-device irradiation sterilization service
• Flow property / unit: Mass / kg treated device
• Amount rule: invoiced or treatment-record mass allocated to accepted devices in the declared load
• Value mode: Calculated value (calculated_value)
• Specificity: Route-specific (route_specific)
• Normalization basis: per 1 kg accepted sterilized device
• Basis kind: Process output (process_output)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_irradiation_service
• Sources: us-fda-sterilization-process-controls

Waste flows

Elementary flows

Outputs

Product flows

Waste flows

Elementary flows

Process: Packaging, labelling, and factory-gate release (packaging_release)

Inputs

Product flows

Paper box (paper_box)

Record paper or paperboard boxes present in the declared sales or transport-pack configuration.

• Selected flow: Paper box 12d5d744-7725-4dbc-b102-43c80547f777
• Flow property / unit: Mass / kg
• Amount rule: item count multiplied by measured average mass for the current box specification
• Value mode: Calculated value (calculated_value)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg accepted finished device
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_packaging_materials
• Sources: eu-mdr-2017-745

Polyethylene packaging film (polyethylene_packaging_film)

Record polyethylene film only when it forms a pouch, wrap, or other declared packaging layer. The Tiangong UUID remains unresolved.

• Selected flow: Polyethylene packaging film
• Flow property / unit: Mass / kg
• Amount rule: item count multiplied by measured average film mass for the current packaging specification
• Value mode: Calculated value (calculated_value)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg accepted finished device
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_packaging_materials
• Sources: eu-mdr-2017-745

Electricity for packaging and release (packaging_electricity)

Record electricity for forming, sealing, labelling, inspection, and release operations attributable to the declared product.

• Selected flow: Electricity 890a70b7-b677-4e2a-8a1b-7d017e0a10ae
• Flow property / unit: Net calorific value / MJ
• Amount rule: metered electricity allocated by packaging-line time or output count
• Value mode: Calculated value (calculated_value)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg accepted finished device
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_packaging_utilities
• Sources: us-fda-qmsr-2026

Waste flows

Elementary flows

Outputs

Product flows

Conforming finished medical instrument or appliance (finished_medical_instrument)

This is the released factory-gate reference product after applicable sterilization and packaging; packaging mass is excluded from the reference amount.

• Selected flow: Other instruments and appliances used in medical, surgical or veterinary sciences (including syringes, needles, catheters, cannulae, ophthalmic instruments and appliances n.e.c. and electro-medical apparatus n.e.c.) 01d838ad-6413-41ad-ba7a-a159be4b8a20
• Flow property / unit: Mass / kg
• Amount rule: 1 kg net mass of conforming finished device
• Value mode: Fixed value (fixed_value)
• Specificity: Generic (generic)
• Normalization basis: PCR reference flow
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Identity reference (identity_reference)
• Sources: un-cpc-3-0-structure-2025

Waste flows

Elementary flows

7. Allocation and Co-product Handling

rule_id	Applies to	Rule	source_ids
allocation_subdivide_first	Shared manufacturing, clean-area, sterilization, and packaging operations	Avoid allocation by submetering or subdividing processes by device family, line, cycle, or load whenever technically feasible.
allocation_physical_driver	Residual shared utilities and services	Allocate by the physical driver that causes consumption, such as machine time, occupied clean-area time, treated mass, chamber volume-time, packaging-line time, or tested units; document the selected driver and sensitivity.
allocation_rejects	Rejected products and failed sterilization loads	Assign burdens through the point of rejection to total production and normalize to accepted output; disclose rework and resterilization separately.	us-fda-sterilization-process-controls
allocation_recycling	Scrap and recovered materials	Use the study's declared recycling approach consistently; report gross scrap mass and destination and do not subtract an avoided-production credit directly from foreground material input.
allocation_no_economic_default	Multi-product sites	Do not use economic allocation unless physical subdivision or a causal physical driver is demonstrably unavailable; justify and sensitivity-test any economic allocation.

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_component_materials	component_fabrication	polypropylene granulate; stainless steel	ERP issue/return records and verified bill of materials	material identity; grade; lot; issued mass; returned mass; accepted component mass	Reconcile issued and returned material by product order	kg	Each batch or production order	A production-representative reporting period; justify shorter or discontinuous coverage	Every fabrication site in scope	Sum net issued mass by material and normalize to accepted finished-device mass	Purchase specification, lot traceability, calibrated scales, ERP reconciliation
cp_component_utilities	component_fabrication	electricity; process water; carbon dioxide	Submeters, machine logs, cylinder or tank records	meter start/end; machine time; water recirculation; gas stock and deliveries; accepted output	Direct metering or documented mass balance with causal allocation	kWh; kg	Each batch, shift, or meter period	Same period as production denominator	Every fabrication site in scope	Sum net use, allocate with recorded driver, then normalize	Meter calibration, utility invoices, machine logs, inventory reconciliation
cp_component_scrap	component_fabrication	polypropylene waste; stainless-steel scrap	Waste tickets, bins, weighbridge records	material; alloy or polymer; mass; contamination; destination; internal regrind	Weigh each segregated outgoing stream	kg	Each shipment or batch	Same period as material input	Every fabrication site in scope	Sum external boundary outputs by material and destination	Calibrated scale, waste transfer record, recycler receipt
cp_assembly_inputs	assembly_cleaning_testing	isopropanol; sodium hydroxide	Chemical issue, concentration, recovery, and inventory records	chemical identity; purity; solution mass; concentration; opening/closing stock; recovery	Chemical mass balance by cleaning campaign	kg	Each batch or campaign	Same period as accepted output	Every assembly/cleaning site	Calculate pure chemical consumption and normalize	Supplier certificate, formulation record, calibrated dosing record
cp_assembly_utilities	assembly_cleaning_testing	process water; electricity	Water and electricity submeters plus equipment logs	meter start/end; recirculation; line time; clean-area occupancy; accepted output	Direct meter or causal allocation	kg; kWh	Each batch, shift, or meter period	Same period as accepted output	Every assembly and test site	Sum net use and normalize after conversion	Meter calibration, invoices, line records
cp_cleaning_wastewater	assembly_cleaning_testing	wastewater	Discharge meter and treatment records	volume or mass; temperature; density; composition; internal treatment; destination	Measure each discharge or balanced treatment-system total	kg	Each batch or daily	Same period as cleaning inputs	Every discharge point in scope	Sum net boundary discharge and normalize	Flow-meter calibration, sampling results, treatment log
cp_eto_cycle	ethylene_oxide_sterilization	ethylene oxide; electricity	Validated cycle and utility records	product load mass; injected EtO; formulation; time; temperature; pressure; humidity; aeration; electricity; accepted and rejected mass	Capture each sterilization-cycle record and allocate only to accepted load output	kg; kWh	Each cycle	All cycles in the reporting period	Each in-house or contracted EtO facility	Sum allocated inputs and normalize to accepted sterilized mass	Approved validation, cycle chart, calibrated sensors, load-release record
cp_eto_emissions	ethylene_oxide_sterilization	ethylene oxide to air	Continuous monitoring, stack tests, leak surveys, or validated mass balance	vent identity; measured concentration; flow; duration; capture efficiency; fugitive release; load id	Quantify each release point with the permitted validated method	kg	Each cycle or regulatory monitoring period	Same period as EtO input	All controlled and fugitive release points	Sum direct air releases and allocate to accepted loads	Monitoring QA/QC, calibration, regulatory report
cp_steam_cycle	steam_sterilization	process steam; electricity	Validated cycle, steam meter, condensate meter, and electricity meter	load mass; steam in; condensate returned; cycle parameters; electricity; accepted and rejected mass	Capture each cycle and meter balance	kg; kWh	Each cycle	All cycles in the reporting period	Each steam-sterilization facility	Sum net steam and allocated electricity; normalize to accepted sterilized mass	Approved validation, calibrated meters, cycle and release records
cp_irradiation_service	irradiation_sterilization	irradiation sterilization service	Contract treatment and invoice records	technology; facility; load id; treated mass; dose; load allocation; accepted and rejected mass	Reconcile service records with returned released product	kg treated device	Each load	All loads in the reporting period	Every contracted or in-house irradiation facility	Sum treated mass allocated to accepted output	Dose record, service certificate, receipt and release reconciliation
cp_packaging_materials	packaging_release	paper box; polyethylene film	Packaging specification, issue record, and sample weighing	material identity; specification; item count; sample masses; scrap; packaged units	Weigh representative current-specification samples and reconcile issued counts	kg	Each specification change and monthly reconciliation	Same period as packaged output	Every packaging site	Average verified item mass times used count, normalized to net device mass	Approved packaging specification, calibrated scale, line reconciliation
cp_packaging_utilities	packaging_release	electricity	Submeter and packaging-line records	meter start/end; line time; packaged units; accepted output	Direct meter or line-time allocation	kWh	Each shift or meter period	Same period as packaged output	Every packaging site	Sum allocated electricity and normalize	Meter calibration, line log, invoice reconciliation

Calculation Rules

rule_id	Applies to	Formula or rule	Inputs	Output	source_ids
calc_reference_normalization	Every non-reference inventory row	normalized amount = attributable period amount / net accepted finished-device mass in the same period	attributable flow amount; accepted net device mass	flow amount per 1 kg reference product
calc_electricity_mj	Electricity rows	MJ = measured kWh × 3.6	measured kWh	electricity in MJ
calc_solution_active_mass	Sodium hydroxide	pure sodium-hydroxide mass = solution mass × measured or supplier-certified mass fraction	solution mass; sodium-hydroxide mass fraction	kg sodium hydroxide
calc_water_mass	Process water and wastewater	mass = measured volume × applicable documented density; retain both source volume and density	volume; temperature; density	kg water or wastewater
calc_load_allocation	Sterilization inputs, services, and emissions	allocated amount = cycle total × declared causal share of accepted product in the load	cycle total; load composition; accepted mass; causal allocation driver	amount attributable to the declared product	us-fda-sterilization-process-controls
calc_packaging_mass	Paper box and polyethylene film	packaging mass = verified average item mass × items used for accepted product	sample masses; used item count; accepted device mass	kg packaging per 1 kg reference product	eu-mdr-2017-745

Data Quality Requirements

requirement_id	Applies to	Requirement	Evidence
dq_product_identity	Reference product	Product model or homogeneous family, intended use, net mass, sterile state, reuse state, and packaging configuration shall be traceable to released production records.	Approved specification, device history or batch record, release record
dq_material_completeness	Bill of materials	Reconcile the complete net product mass by identified atomic materials; explain and conservatively model any unreconciled remainder without an umbrella inventory row.	Mass-reconciled bill of materials and supplier specifications
dq_temporal_alignment	All foreground rows	Numerators and accepted-output denominators shall cover the same period; disclose shutdowns, start-up, abnormal batches, and excluded periods.	Timestamped meters, production records, reconciliation worksheet
dq_site_coverage	Multi-site and outsourced production	Include every site and contracted operation that materially contributes to the declared factory-gate product or quantify and justify exclusions.	Site list, contracts, transfer records, coverage calculation
dq_sterilization_traceability	Sterile routes	Link each accepted load to validated cycle parameters, packaging integrity controls, monitoring, rejects, and release evidence.	Validation approval, cycle record, monitoring results, packaging integrity and release records
dq_uuid_disclosure	Unresolved flow identities	Keep the four declared UUID gaps explicit and do not substitute a proxy UUID; update only after a new direct state-100 audit.	Manifest unresolved register and task-bound search receipts
dq_range_disclosure	Important flows without external ranges	Treat the amount as foreground-required and disclose that no cross-product default or QA range is authorized until two independent compatible sources or reviewed foreground evidence exist.	Manifest range-evidence register and foreground collection records

9. Validation Rules

rule_id	Applies to	Rule	source_ids
validate_reference_mass	Reference flow	Confirm that the output is exactly 1 kg net conforming device mass and that all inventory rows use the same accepted-output denominator.
validate_identity_and_route	Dataset metadata and process map	Confirm one concrete device specification, material route, sterile state, sterilization method, packaging configuration, geography, and reporting period; reject a generic category average lacking these qualifiers.	un-cpc-3-0-structure-2025; us-fda-qmsr-2026
validate_process_applicability	Conditional processes and rows	Confirm each conditional material, cleaning chemical, sterilization route, and packaging item is either supported by records or explicitly not applicable; do not populate mutually exclusive sterilization routes simultaneously without documented split production.	us-fda-sterilization-process-controls
validate_mass_reconciliation	Materials, product, and wastes	Reconcile issued materials, returned inventory, accepted product, rejects, scrap, recovered material, and stock change; investigate unexplained imbalance.
validate_eto_emissions	EtO sterilization	Confirm direct EtO air releases cover controlled and fugitive points and remain separate from upstream energy emissions.	us-epa-ethylene-oxide-neshap
validate_packaging_separation	Reference product and packaging	Confirm packaging mass is excluded from net reference-product mass and each present packaging material is recorded separately.	eu-mdr-2017-745
validate_no_proxy_uuid	All UUID-bearing rows	Confirm every stored UUID matches the selected state-100 identity, flow type, property, and unit support; unresolved rows shall remain UUID-empty.
validate_source_ranges	Quantitative ranges	Reject any externally inferred range unless at least two mutually independent original sources have compatible system boundary, functional unit, and product state; no external ranges are authorized in this candidate PCR.

10. Published Dataset Profile

Field	Value
dataset_role	secondary_dataset; may be used as background_dataset only for a matching declared device specification and route
downstream_use	Foreground-data-package publication and downstream process or lifecyclemodel construction for cradle-to-factory-gate assessment
allowed_use	Comparison or modelling of the same device model or homogeneous family with compatible material, sterile-state, sterilization, packaging, geography, technology, allocation, and reference-year qualifiers
excluded_use	Generic substitution for all CPC 48150 products; clinical-procedure comparison without use-stage function and lifetime modelling; proxy for excluded medical-device categories; use of unresolved UUID rows as database matches
required_metadata	Canonical PCR id and version; product model or family; intended use; net mass; bill of materials; disposable/reusable and passive/powered states; sterile state and route; packaging configuration; sites and geography; reporting period; accepted output; allocation; data coverage; unresolved identities
required_quality_disclosure	Primary-data share; mass reconciliation; metering and allocation methods; site and supplier coverage; sterilization validation and monitoring basis; rejects and rework; packaging mass separation; unresolved UUIDs; absence of externally authorized ranges
update_trigger	Material or supplier change; product redesign; new manufacturing site or technology; sterilization or packaging change; allocation change; updated foreground year; new exact Tiangong UUID; two-source range synthesis; boundary or regulation change

11. Data Sources

Source id	Type	Reference	Used for
un-cpc-3-0-structure-2025	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 (retrieved 2026-09-06)	Official English CPC 48150 classification identity and scope
un-cpc-1-1-zh-2002	official_guidance	United Nations Statistics Division, 产品总分类版本1.1, Series M No. 77, Ver.1.1, https://unstats.un.org/unsd/publication/SeriesM/M_77ver1_1c.pdf (retrieved 2026-09-06)	Verified professional Chinese wording for the unchanged CPC 48150 label
un-isic-rev4-3250	official_guidance	United Nations Statistics Division, ISIC Rev.4 class 3250 detail, https://unstats.un.org/unsd/classifications/Econ/Structure/Detail/EN/27/3250 (retrieved 2026-09-06)	Manufacturing-scope examples, including syringes, needles, catheters, cannulae, and ophthalmic goods
eu-mdr-2017-745	standard	Regulation (EU) 2017/745 on medical devices, consolidated original text, https://eur-lex.europa.eu/eli/reg/2017/745/2017-05-05/eng (retrieved 2026-09-06)	Device/material qualifiers, sterile-state and sterile-packaging boundary, packaging integrity and disclosure
us-fda-qmsr-2026	official_guidance	U.S. Food and Drug Administration, Quality Management System Regulation (QMSR), https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr (retrieved 2026-09-06)	Finished-device market state and production-record boundary
us-fda-sterilization-process-controls	official_guidance	U.S. Food and Drug Administration, Sterilization Process Controls, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/sterilization-process-controls (retrieved 2026-09-06)	Conditional sterilization process map, cycle parameters, monitoring, rejects, and packaging-integrity controls
us-epa-ethylene-oxide-neshap	official_guidance	U.S. Environmental Protection Agency, Ethylene Oxide Emissions Standards for Sterilization Facilities: NESHAP, https://www.epa.gov/stationary-sources-air-pollution/ethylene-oxide-emissions-standards-sterilization-facilities-0 (retrieved 2026-09-06)	Direct ethylene-oxide air-emission boundary and control-system disclosure