Mechano-therapy, massage, aptitude-testing, therapeutic respiration and breathing apparatus, and gas masks

1. Scope and Applicability

This PCR applies to the manufacture of finished mechano-therapy appliances, massage apparatus, psychological aptitude-testing apparatus, ozone-therapy, oxygen-therapy and aerosol-therapy apparatus, artificial-respiration and other therapeutic-respiration apparatus, other breathing appliances, and gas masks. It covers mechanically complete apparatus and the integral accessories supplied in the declared product configuration. The foreground data package is model- and route-specific because this category contains materially different electrical, pneumatic, mechanical, reusable, single-use, sterile, non-sterile, filtered-air and externally supplied-air products.

The PCR excludes protective masks having neither mechanical parts nor replaceable filters, stand-alone medicinal or industrial gases, stand-alone gas cylinders, separately marketed replacement filters or generic components, and medical, surgical or diagnostic equipment outside the stated product boundary. A component or replacement item delivered with the reference apparatus remains an input or included accessory of that apparatus and must not be reported as a second reference product.

The default dataset boundary is cradle-to-factory-gate: purchased materials and components enter with linked upstream datasets; actual foreground manufacture, assembly, treatment, testing and packaging are recorded through the point at which a conforming product is ready to leave the manufacturing site. Distribution, installation, use, maintenance and end-of-life are excluded from this foreground dataset and must be added explicitly by a downstream study when relevant.

2. Product Category Identity

Field	Value
canonical_pcr_id	pcr.metal-products-machinery-and-equipment.medical-appliances-precision-and-optical-instruments-watches-and-clocks.mechano-therapy-appliances-massage-apparatus-psychological-aptitude-testing-apparatus-o-0c93c769
classification_refs	CPC 3.0: 48160 — Mechano-therapy appliances; massage apparatus; psychological aptitude-testing apparatus; ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; other breathing appliances and gas masks (excluding protective masks having neither mechanical parts nor replaceable filters)
covered_products	finished mechanical-therapy and massage apparatus; psychological aptitude-testing apparatus; finished ozone-, oxygen- and aerosol-therapy apparatus; artificial-respiration and other therapeutic-respiration apparatus; breathing appliances; gas masks with mechanical parts and/or replaceable filters
excluded_products	simple protective masks with neither mechanical parts nor replaceable filters; stand-alone gases and cylinders; replacement filters and generic components sold separately; unrelated medical, surgical, veterinary or diagnostic equipment
representative_product	the declared, model-specific finished apparatus configuration; no category-average apparatus is presumed because function, construction, mass, energy source, treatment status and service life vary materially
production_route	purchased materials and components and/or in-house component preparation → assembly and integration → conditional cleaning, disinfection or sterilisation → final testing, calibration and packaging
market_state	new, conforming finished apparatus in its declared sales configuration, production mix at plant; net product mass is distinguished from packaging mass

3. Reference Flow

Field	Value
What	provision at the factory gate of a finished apparatus performing the declared mechanical-therapy, massage, aptitude-testing, therapeutic-respiration, breathing-protection or gas-mask function
How much	1 kg net mass of conforming finished apparatus, including integral parts and accessories in the declared configuration and excluding transport and sales packaging
How well	the declared model meets its documented intended function, performance specification and final acceptance criteria; applicable sterile state, respiratory protection or gas-delivery characteristics are preserved
How long or cycle	one completed production batch normalised to 1 kg of conforming output; declared service life, number of uses or treatment cycles is a required qualifier rather than a conversion of the mass reference
reference_flow_link	net conforming product mass after final testing and any required cleaning or sterilisation, immediately before dispatch beyond the manufacturing gate

Field	Value
Reference amount	1 kg
Reference product flow	Mechano-therapy appliances, massage apparatus, psychological aptitude-testing apparatus, ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus, other breathing appliances and gas masks (excluding protective masks having neither mechanical parts nor replaceable filters) de3969a1-8fd2-433a-979d-176043362c2e
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 and configuration; electrical, pneumatic or mechanical operating principle; reusable or single-use status; declared service life or treatment-cycle basis; net product mass; included accessories and consumables; sterile or non-sterile state; cleaning or disinfection state; filtration, supplied-air or supplied-gas mode where applicable; filter class or declared protection type where applicable; gas-contact materials where applicable; battery and electronics configuration; packaging configuration and packaging mass; production route; manufacturing site and geography; production period

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

4. Measurement and Unit Rules

rule_id	Applies to	Required property	Required unit	Rule
reference_mass	reference product	Mass 93a60a56-a3c8-11da-a746-0800200b9a66	kg	Use measured net mass of conforming finished apparatus. Exclude transport and sales packaging from the reference amount and report packaging as separate inventory inputs.
batch_normalisation	all foreground inventory rows	row-specific property	row-specific SI unit	Divide each batch total by the conforming net product mass from the same batch or reconciled production period to express the row per 1 kg reference product.
item_to_mass_conversion	components, accessories and packaging recorded by count	Mass	kg	Convert counts to mass only with model- and lot-specific measured unit mass; retain count, sample size and scale evidence.
energy_carrier_separation	electricity, fuels, steam, compressed air and supplied gases	carrier-specific energy, mass or volume property	carrier-specific SI unit	Preserve each energy or gas carrier as a separate flow. Do not combine carriers into one energy total unless the conversion basis and original quantities remain available.
gas_volume_conditions	process or test gases measured by volume	Volume	m3	Record reference temperature and pressure and the meter basis; do not treat an unqualified normal or standard cubic metre as interchangeable with an actual cubic metre.
packaging_separation	primary, secondary and transport packaging	Mass	kg	Record packaging by material and level. Packaging mass must not be included in the net apparatus reference mass.

5. System Boundary

Boundary Abstraction

Field	Value
declared_starting_condition	materials, purchased components, subassemblies, accessories and packaging received at the declared manufacturing site with identity, quantity and upstream dataset links
starting_condition_role	cradle-to-gate upstream product inputs entering the foreground manufacturing system
product_classification_scope	the finished apparatus boundary stated in Section 2, independent of whether a particular model is medical electrical equipment, non-electrical therapy apparatus or respiratory PPE
recursive_input_rule	an input already belonging to this same finished-apparatus category must remain a visible product input with its own upstream dataset and must not be recursively re-expanded inside this foreground package
upstream_dataset_requirement	every purchased material, component, subassembly, accessory, energy carrier, treatment medium and packaging input requires a geographically, technologically and temporally representative upstream dataset or an explicitly documented data gap
disclosure	declare the actual manufacturing sites, route steps, outsourced operations, sterile or non-sterile status, respiratory protection or gas-supply mode, included accessories, packaging boundary, excluded downstream stages and any unmodelled route step

rule_id	Applies to	Rule	source_ids
sb_foreground_gate	cradle-to-factory-gate foreground package	Include all actual on-site and directly controlled processes from received inputs through conforming tested and packaged apparatus; link purchased inputs to upstream datasets and justify every exclusion.	eu-pef-2021; ghg-protocol-product-standard
sb_route_specificity	model and production route	Include only route steps that actually occur, but do not omit a material process because it is outsourced; outsourced preparation, treatment or testing remains represented through a purchased service or upstream dataset.	eu-mdr-2017; eu-pef-2021
sb_treatment_controls	cleaning, disinfection, sterilisation and gas-contact processing	Include treatment media, energy, water, cycle losses, residual handling and validation-related rejects whenever the declared product route uses the treatment.	eu-mdr-2017
sb_respiratory_configuration	gas masks and other breathing appliances	Distinguish filtered polluted air from externally supplied breathable air, and disclose replaceable filter, supplied-air, supplied-gas and oxygen-deficient-atmosphere applicability; never use one configuration as an undeclared proxy for another.	eu-ppe-2016-425-consolidated-2026
sb_downstream_separation	distribution, installation, use, maintenance and end-of-life	Exclude downstream stages from this foreground production package while clearly disclosing the exclusion; a full product study must add the applicable stages and scenarios separately.	iec-60601-1-9-2007; eu-pef-2021

6. Process Inventory Structure

Process Map

process_id	process_name	inclusion	inclusion_condition	role	quantitative_reference
component_preparation	In-house component and part preparation	conditional	include when the foreground site forms, machines, moulds, coats, joins, cleans or otherwise transforms raw materials or semi-finished parts	foreground component manufacture	kg accepted prepared components or parts transferred to assembly
assembly_integration	Apparatus assembly and integration	required	always include for a mechanically complete finished apparatus	foreground production and integration	kg assembled apparatus transferred to treatment or final testing
cleaning_sterilisation	Cleaning, disinfection or sterilisation	conditional	include when the declared route includes cleaning, disinfection, microbial-state control or sterilisation	foreground conditioning and validated treatment	kg treated apparatus released from the treatment step
final_testing_packaging	Final testing, calibration, acceptance and packaging	required	always include final acceptance and the declared packaging operation; calibration and test media are included when applicable	foreground quality release and factory-gate completion	kg conforming net finished apparatus

Process: In-house component and part preparation (component_preparation)

Inputs

Product flows

Raw materials and semi-finished parts (preparation_material_inputs)

Record each metal, polymer, elastomer, textile, adsorbent, electronic substrate, coating material or other material that is transformed at the foreground site as a separate product input.

• Selected flow: exact material- or part-specific Tiangong product flow; do not use the finished-apparatus reference flow as a proxy
• Flow property / unit: Mass / kg
• Amount rule: measured issued quantity minus documented return to stock, by material and batch
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg conforming net finished apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_bom_material_records
• Sources:

Preparation electricity and energy carriers (preparation_energy)

Record metered electricity, fuel, steam, compressed air or other energy carriers used by in-house part preparation as separate carrier-specific inputs.

• Selected flow: exact carrier-specific Tiangong product flow
• Flow property / unit: carrier-specific energy, mass or volume property / corresponding SI unit
• Amount rule: measured process-line use or allocated shared-meter use according to calc_shared_utility_allocation
• Value mode: Foreground record (foreground_record)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg conforming net finished apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_preparation_utility_records
• Sources:

Process water and preparation auxiliaries (preparation_water_auxiliaries)

Record water, lubricants, coolants, mould-release agents, coatings, adhesives, cleaning agents and other preparation auxiliaries as separate flows when they cross the foreground boundary.

• Selected flow: exact water- or auxiliary-specific Tiangong product flow
• Flow property / unit: Mass / kg or volume / m3 as measured
• Amount rule: measured withdrawal, issue or purchase quantity attributable to the declared preparation route
• Value mode: Foreground record (foreground_record)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg conforming net finished apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_preparation_consumable_records
• Sources:

Waste flows

Elementary flows

Outputs

Product flows

Accepted prepared components (prepared_components)

Record the mass of accepted in-house prepared components transferred to apparatus assembly, separated by component family when this is needed for mass balance or upstream linkage.

• Selected flow: component- or part-specific product flow resolved for the data package
• Flow property / unit: Mass / kg
• Amount rule: measured or calculated accepted component mass released to assembly
• Value mode: Calculated value (calculated_value)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg conforming net finished apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_preparation_output_records
• Sources:

Waste flows

Preparation scrap and rejects (preparation_scrap)

Record metal, polymer, composite, textile, electronic and mixed scrap or rejected parts separately by waste identity and destination.

• Selected flow: exact waste-specific Tiangong flow
• Flow property / unit: Mass / kg
• Amount rule: measured waste or reject mass leaving the preparation process, net of documented return to process
• Value mode: Foreground record (foreground_record)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg conforming net finished apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_preparation_waste_records
• Sources:

Elementary flows

Direct preparation emissions (preparation_direct_emissions)

Record only measured or calculation-supported releases to air, water or soil from the declared preparation operations, such as particulate, solvent or process-water releases; do not create a generic default emission.

• Selected flow: exact elementary flow for each released substance and compartment
• Flow property / unit: Mass / kg
• Amount rule: monitored release or calculation from collected activity data and a cited substance-specific factor
• Value mode: Calculated value (calculated_value)
• Specificity: Site-specific (site_specific)
• Normalization basis: per 1 kg conforming net finished apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_direct_emission_records
• Sources:

Process: Apparatus assembly and integration (assembly_integration)

Inputs

Product flows

Purchased and prepared components (assembly_components)

Record the model-specific bill of materials for frames, housings, actuators, pumps, valves, hoses, masks, filters supplied with the apparatus, electronics, sensors, controls, displays, batteries, wiring, fasteners and other included components.

• Selected flow: exact component-specific Tiangong product flow; prepared internal components remain visible intermediate inputs
• Flow property / unit: Mass / kg
• Amount rule: component quantity multiplied by verified unit mass, reconciled to issue and return records
• Value mode: Calculated value (calculated_value)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg conforming net finished apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_bom_material_records
• Sources:

Assembly auxiliaries and consumables (assembly_auxiliaries)

Record adhesives, solders, joining consumables, lubricants, cleaning wipes, protective films and other materials consumed during assembly as separate product flows.

• Selected flow: exact auxiliary-specific Tiangong product flow
• Flow property / unit: Mass / kg
• Amount rule: measured issue or purchase quantity minus documented unused return
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg conforming net finished apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_assembly_consumable_records
• Sources:

Assembly electricity and utilities (assembly_energy)

Record carrier-specific electricity, compressed air, process gas, heat or other utilities used for assembly and integration.

• Selected flow: exact carrier-specific Tiangong product flow
• Flow property / unit: carrier-specific energy, mass or volume property / corresponding SI unit
• Amount rule: metered process use or allocated shared-meter use according to calc_shared_utility_allocation
• Value mode: Foreground record (foreground_record)
• Specificity: Site-specific (site_specific)
• Normalization basis: per 1 kg conforming net finished apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_assembly_utility_records
• Sources:

Waste flows

Elementary flows

Outputs

Product flows

Assembled apparatus transferred to the next route step (assembled_apparatus)

Record the net mass and number of assembled units transferred either to treatment or directly to final testing.

• Selected flow: model-specific intermediate apparatus product flow resolved for the data package
• Flow property / unit: Mass / kg
• Amount rule: measured transfer mass reconciled with unit count and model-specific net mass
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg conforming net finished apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_assembly_output_records
• Sources:

Waste flows

Assembly waste and rejected components (assembly_waste)

Record rejected components, offcuts, joining residues, protective films and mixed assembly wastes separately by waste identity and destination.

• Selected flow: exact waste-specific Tiangong flow
• Flow property / unit: Mass / kg
• Amount rule: measured waste mass, net of documented rework and return to stock
• Value mode: Foreground record (foreground_record)
• Specificity: Site-specific (site_specific)
• Normalization basis: per 1 kg conforming net finished apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_assembly_waste_records
• Sources:

Elementary flows

Direct assembly emissions (assembly_direct_emissions)

Record only measured or calculation-supported substance-specific releases from soldering, bonding, welding or other assembly operations.

• Selected flow: exact elementary flow for each released substance and compartment
• Flow property / unit: Mass / kg
• Amount rule: monitored release or calculation from collected activity data and a cited substance-specific factor
• Value mode: Calculated value (calculated_value)
• Specificity: Site-specific (site_specific)
• Normalization basis: per 1 kg conforming net finished apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_direct_emission_records
• Sources:

Process: Cleaning, disinfection or sterilisation (cleaning_sterilisation)

Inputs

Product flows

Apparatus entering treatment (treatment_apparatus_input)

Record the mass and number of assembled apparatus units entering each declared cleaning, disinfection or sterilisation route.

• Selected flow: model-specific intermediate apparatus product flow resolved for the data package
• Flow property / unit: Mass / kg
• Amount rule: measured batch load mass reconciled with unit count
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg treated apparatus output
• Basis kind: Process output (process_output)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_treatment_batch_records
• Sources:

Treatment water, media and consumables (treatment_media)

Record water, detergents, disinfectants, sterilants, process gases, wraps, indicators and other route-specific treatment inputs separately.

• Selected flow: exact medium- or consumable-specific Tiangong product flow
• Flow property / unit: Mass / kg or volume / m3 as measured
• Amount rule: measured cycle consumption allocated only across the accepted load treated in that cycle
• Value mode: Foreground record (foreground_record)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg treated apparatus output
• Basis kind: Process output (process_output)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_treatment_consumable_records
• Sources:

Treatment electricity, heat and utilities (treatment_energy)

Record electricity, steam, heat, compressed air or other utilities for each treatment cycle as separate carrier-specific flows.

• Selected flow: exact carrier-specific Tiangong product flow
• Flow property / unit: carrier-specific energy, mass or volume property / corresponding SI unit
• Amount rule: metered cycle use or validated equipment-cycle record allocated across accepted treated output
• Value mode: Foreground record (foreground_record)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg treated apparatus output
• Basis kind: Process output (process_output)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_treatment_utility_records
• Sources:

Waste flows

Elementary flows

Outputs

Product flows

Treated apparatus released to final testing (treated_apparatus)

Record accepted treated apparatus mass and the achieved declared microbial, cleaning or sterilisation state.

• Selected flow: model-specific treated apparatus product flow resolved for the data package
• Flow property / unit: Mass / kg
• Amount rule: measured accepted output mass after treatment and treatment-release checks
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg treated apparatus output
• Basis kind: Process output (process_output)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_treatment_output_records
• Sources:

Waste flows

Treatment wastewater, spent media and rejected loads (treatment_waste)

Record wastewater, spent treatment chemicals or media, used indicators and rejected apparatus or packaging by waste identity and destination.

• Selected flow: exact waste-specific Tiangong flow
• Flow property / unit: Mass / kg or volume / m3 as measured
• Amount rule: measured discharge or waste mass from the treatment cycle
• Value mode: Foreground record (foreground_record)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg treated apparatus output
• Basis kind: Process output (process_output)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_treatment_waste_records
• Sources:

Elementary flows

Direct treatment emissions (treatment_direct_emissions)

Record only monitored or calculation-supported releases of treatment substances to air, water or soil, with the actual substance and compartment identified.

• Selected flow: exact elementary flow for each released substance and compartment
• Flow property / unit: Mass / kg
• Amount rule: monitored release or calculation from collected treatment consumption, capture records and a cited substance-specific factor
• Value mode: Calculated value (calculated_value)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg treated apparatus output
• Basis kind: Process output (process_output)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_direct_emission_records
• Sources:

Process: Final testing, calibration, acceptance and packaging (final_testing_packaging)

Inputs

Product flows

Apparatus entering final acceptance (final_test_apparatus_input)

Record assembled or treated apparatus units entering model-specific final testing and acceptance.

• Selected flow: model-specific intermediate apparatus product flow resolved for the data package
• Flow property / unit: Mass / kg
• Amount rule: measured input mass reconciled with serial, lot or batch count
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg conforming net finished apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_final_acceptance_records
• Sources:

Test media, gases and consumables (test_media)

Record test gases, filters consumed in testing, calibration media, test loads, labels and other consumables that cross the final-test boundary.

• Selected flow: exact medium- or consumable-specific Tiangong product flow
• Flow property / unit: carrier-specific mass or volume property / corresponding SI unit
• Amount rule: measured issue or metered use attributable to accepted and rejected units in the declared production period
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg conforming net finished apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_final_test_consumable_records
• Sources:

Final-test electricity and utilities (final_test_energy)

Record electricity, compressed air, vacuum service, supplied gases or other utilities used for calibration, leak testing, burn-in and final acceptance as separate flows.

• Selected flow: exact carrier-specific Tiangong product flow
• Flow property / unit: carrier-specific energy, mass or volume property / corresponding SI unit
• Amount rule: metered test-cell use or allocated shared-meter use according to calc_shared_utility_allocation
• Value mode: Foreground record (foreground_record)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg conforming net finished apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_final_test_utility_records
• Sources:

Packaging materials (packaging_materials)

Record primary, secondary and transport packaging by material and packaging level, including instructions and included protective inserts.

• Selected flow: exact packaging-material-specific Tiangong product flow
• Flow property / unit: Mass / kg
• Amount rule: packaging count multiplied by verified unit mass or directly measured packaging material issue
• Value mode: Calculated value (calculated_value)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg conforming net finished apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_packaging_records
• Sources:

Waste flows

Elementary flows

Outputs

Product flows

Conforming finished apparatus (finished_apparatus)

This is the quantitative reference output. Record only conforming net apparatus mass released after final acceptance; packaging mass remains separate.

• Selected flow: Mechano-therapy appliances, massage apparatus, psychological aptitude-testing apparatus, ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus, other breathing appliances and gas masks (excluding protective masks having neither mechanical parts nor replaceable filters) de3969a1-8fd2-433a-979d-176043362c2e
• Flow property / unit: Mass 93a60a56-a3c8-11da-a746-0800200b9a66 / kg
• Amount rule: exactly 1 kg after normalisation from measured conforming net batch output
• Value mode: Fixed value (fixed_value)
• Specificity: Product-specific (product_specific)
• Normalization basis: PCR reference flow
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_finished_output_records
• Sources:

Waste flows

Final-test rejects and packaging waste (final_rejects_packaging_waste)

Record failed units, replaced parts, spent test items and packaging offcuts or rejects separately by waste identity and destination; reworked units are not waste unless they leave the process as waste.

• Selected flow: exact waste-specific Tiangong flow
• Flow property / unit: Mass / kg
• Amount rule: measured waste or reject mass from final testing and packaging, net of documented rework returned to process
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per 1 kg conforming net finished apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_final_waste_records
• Sources:

Elementary flows

Direct final-test emissions (final_test_direct_emissions)

Record only measured or calculation-supported releases from gas, aerosol, leakage, burn-in or other final-test operations, identified by substance and compartment.

• Selected flow: exact elementary flow for each released substance and compartment
• Flow property / unit: Mass / kg
• Amount rule: monitored release or calculation from collected test consumption, recovery records and a cited substance-specific factor
• Value mode: Calculated value (calculated_value)
• Specificity: Technology-specific (technology_specific)
• Normalization basis: per 1 kg conforming net finished apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_direct_emission_records
• Sources:

7. Allocation and Co-product Handling

rule_id	Applies to	Rule	source_ids
allocation_avoid	separable products, lines, batches and route steps	Avoid allocation by process subdivision, separate meters, separate batch records or a redefined process boundary whenever the studied apparatus can be isolated.	ghg-protocol-product-standard
allocation_physical_causal	unavoidable shared utilities, treatment loads and common processes	Allocate by a documented physical relationship that reflects causation, such as metered use, machine time, treatment-cycle occupancy, test time or another engineering driver; mass allocation is acceptable only when mass drives the shared burden.	ghg-protocol-product-standard
allocation_economic_fallback	common process without a defensible physical relationship	Use economic or another justified relationship only when subdivision and physical allocation are not feasible; disclose the factor, data period and sensitivity.	ghg-protocol-product-standard
allocation_waste_recycling	scrap, rejects, spent media and recovered materials	Keep waste outputs and treatment burdens visible. Do not apply an undeclared recycling or avoided-product credit in the foreground package; any downstream recycling allocation must be stated separately and consistently.	ghg-protocol-product-standard; eu-pef-2021

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_bom_material_records	component_preparation; assembly_integration	raw materials, parts and components	controlled bill of materials, issue and return records	model; revision; part id; material identity; supplier; quantity; unit mass; issued mass; returned mass; lot; date	reconcile controlled BOM with warehouse issues, returns and sampled or complete weighing	item; kg	each BOM revision and production batch	full declared production period	all sites supplying the reference output	sum net issued mass by exact flow and normalise by conforming net output mass	BOM approval, scale calibration, supplier specification, issue and return trace
cp_preparation_utility_records	component_preparation	preparation energy	meter and equipment log	meter id; carrier; opening and closing reading; machine time; batch; allocation driver	direct submeter preferred; otherwise reconciled shared meter and causal driver	kWh; MJ; kg; m3	each batch or meter interval	full declared production period	all in-house preparation lines	sum carrier-specific use and allocate only under Section 7	meter calibration, utility invoice and machine log
cp_preparation_consumable_records	component_preparation	water and auxiliaries	meter, purchase, issue and return records	flow id; material name; batch; opening stock; receipts; issues; returns; closing stock	meter or mass-balance reconciliation by exact material	kg; m3	each batch and inventory period	full declared production period	all in-house preparation lines	calculate net consumption by material and reconcile stock change	meter calibration, inventory reconciliation and lot trace
cp_preparation_output_records	component_preparation	accepted prepared components	production transfer record	component id; accepted count; unit mass; accepted mass; rejects; destination; batch	weigh or calculate from verified unit mass and accepted count	item; kg	each transfer batch	full declared production period	all in-house preparation lines	sum accepted mass by component family	transfer record, scale check and acceptance record
cp_preparation_waste_records	component_preparation	preparation scrap and rejects	waste log and transfer note	waste identity; source batch; gross; tare; net mass; return to process; destination	calibrated weighing and destination reconciliation	kg	each waste transfer	full declared production period	all in-house preparation lines	sum net waste by identity and destination	scale calibration, waste ticket and contractor receipt
cp_assembly_consumable_records	assembly_integration	assembly auxiliaries	issue, return and stock records	auxiliary id; lot; opening stock; issue; return; closing stock; batch	material balance by exact auxiliary	kg	each batch and inventory period	full declared production period	all assembly sites	calculate net use and normalise by conforming output	inventory reconciliation and lot trace
cp_assembly_utility_records	assembly_integration	assembly utilities	meter and production log	carrier; meter id; readings; batch; line time; allocation driver	direct submeter preferred; otherwise reconciled shared meter	kWh; MJ; kg; m3	each batch or meter interval	full declared production period	all assembly lines	sum carrier-specific use and allocate only under Section 7	meter calibration, invoice and line log
cp_assembly_output_records	assembly_integration	assembled apparatus	serial, lot and transfer record	model; serial or lot; unit count; unit net mass; transfer mass; date; next route step	calibrated weighing plus serial or lot reconciliation	item; kg	each transfer batch	full declared production period	all assembly sites	sum accepted transfer mass by model and route	scale calibration, release signature and serial or lot trace
cp_assembly_waste_records	assembly_integration	assembly waste	waste and rework log	waste identity; rejected component; batch; mass; rework return; destination	calibrated weighing and rework reconciliation	kg	each batch and waste transfer	full declared production period	all assembly sites	sum net waste excluding documented rework returned to process	waste ticket, rework closure and scale calibration
cp_treatment_batch_records	cleaning_sterilisation	apparatus entering treatment	treatment load record	treatment route; equipment id; load id; model; count; load mass; start and end time	controlled load record reconciled to apparatus transfer	item; kg	each treatment load	full declared production period	each treatment site, including outsourced site	sum input load by route and reconcile accepted and rejected outputs	validated load record and transfer trace
cp_treatment_consumable_records	cleaning_sterilisation	treatment media and consumables	cycle consumption and issue record	load id; medium id; water; chemical or gas quantity; wraps; indicators; recovered quantity	metering, dosing record or reconciled material issue	kg; m3; item	each treatment load	full declared production period	each treatment route and site	sum exact inputs per load and divide by accepted treated output	dosing calibration, batch certificate and cycle record
cp_treatment_utility_records	cleaning_sterilisation	treatment utilities	equipment-cycle and meter record	load id; electricity; steam; heat; compressed air; cycle duration; accepted load	dedicated meter or validated equipment-cycle record	kWh; MJ; kg; m3	each treatment load	full declared production period	each treatment route and site	sum utility by cycle and allocate across accepted load only	meter calibration, equipment validation and cycle log
cp_treatment_output_records	cleaning_sterilisation	treated apparatus	treatment release record	load id; model; count; accepted mass; rejected mass; achieved state; release decision	weigh accepted output and reconcile with release record	item; kg	each treatment load	full declared production period	each treatment route and site	sum accepted treated mass by declared state	release signature, validation result and load reconciliation
cp_treatment_waste_records	cleaning_sterilisation	treatment wastes	discharge, waste and rejected-load record	load id; wastewater volume; spent medium; waste identity; rejected mass; destination	meter, calibrated weighing and waste-transfer reconciliation	kg; m3	each load or discharge event	full declared production period	each treatment route and site	sum by waste identity and destination	discharge meter, waste ticket and load record
cp_final_acceptance_records	final_testing_packaging	apparatus entering and passing final acceptance	serial, lot, calibration and final-test record	model; serial or lot; input count and mass; test route; result; rework; rejection; release	controlled final-test record reconciled to production output	item; kg	each tested unit or batch	full declared production period	all final-test sites	reconcile input, pass, rework and reject status by model	test-system calibration, approval and traceable test result
cp_final_test_consumable_records	final_testing_packaging	test media and consumables	test-cell meter and material issue record	test id; gas or medium; opening and closing reading; issue; recovery; returned quantity	direct meter or material balance by test route	kg; m3; item	each test or batch	full declared production period	all final-test sites	sum net use by exact flow over accepted and rejected tests	meter calibration, cylinder or material reconciliation and test log
cp_final_test_utility_records	final_testing_packaging	final-test utilities	meter and equipment log	meter id; carrier; reading; test duration; unit or batch; allocation driver	direct submeter preferred; otherwise reconciled shared meter	kWh; MJ; kg; m3	each test batch or meter interval	full declared production period	all final-test sites	sum by carrier and allocate only under Section 7	meter calibration, equipment log and utility reconciliation
cp_packaging_records	final_testing_packaging	packaging materials	packaging specification, issue and weighing record	packaging level; material id; package count; unit mass; issued mass; unused return	verified unit mass times count or direct issue weighing	item; kg	each packaging configuration and batch	full declared production period	all packaging sites	sum net packaging mass by material and level	approved specification, scale calibration and issue record
cp_finished_output_records	final_testing_packaging	conforming finished apparatus	production release and weighing record	model; configuration; serial or lot; conforming count; gross packed mass; packaging mass; net apparatus mass; release date	calibrated net weighing or gross-minus-verified-packaging calculation	item; kg	each released batch	full declared production period	all sites releasing reference output	sum conforming net mass; this is the normalisation denominator	scale calibration, release approval, packaging reconciliation and serial or lot trace
cp_final_waste_records	final_testing_packaging	rejects and packaging waste	reject, rework and waste-transfer record	model; part or waste identity; mass; rework status; disposition; destination	calibrated weighing and closure of rework records	kg	each batch and waste transfer	full declared production period	all final-test and packaging sites	sum net waste excluding closed rework returned to production	reject disposition, waste ticket and scale calibration
cp_direct_emission_records	component_preparation; assembly_integration; cleaning_sterilisation; final_testing_packaging	direct releases	monitoring result or calculation worksheet	process; substance; compartment; sample or meter result; activity data; factor; factor source; capture or recovery; period	direct monitoring preferred; otherwise calculation from collected activity and a cited substance-specific factor	kg; m3; concentration unit	each monitoring event or calculation period	full declared production period	every site with a direct release	calculate substance-specific released mass and normalise by corresponding conforming output	laboratory report, instrument calibration, factor citation and calculation review

Calculation Rules

rule_id	Applies to	Formula or rule	Inputs	Output	source_ids
calc_reference_normalisation	every foreground amount	normalised amount = reconciled period or batch amount / conforming net finished apparatus mass from the same scope	applicable collection protocol; cp_finished_output_records	row-specific quantity per 1 kg finished apparatus
calc_component_mass	components and accessories recorded by count	component mass = accepted count × verified model- and lot-specific unit mass; reconcile with net issued mass	cp_bom_material_records	kg component per reference flow
calc_packaging_mass	packaging recorded by count	packaging mass = package count × verified unit mass, separated by material and packaging level	cp_packaging_records	kg packaging material per reference flow
calc_shared_utility_allocation	shared meters and common equipment	allocated quantity = reconciled shared quantity × documented causal-driver share; prefer direct metering, machine time, cycle occupancy or test time and use mass only when mass drives consumption	utility protocols; production or equipment logs	carrier-specific allocated quantity per reference flow	ghg-protocol-product-standard
calc_direct_release	calculated direct emissions	released mass = collected activity × cited substance-specific factor × (1 − measured capture or recovery fraction); preserve factor source and all input units	cp_direct_emission_records	kg substance to the declared compartment per reference flow
calc_mass_reconciliation	each process and full foreground package	reconcile input mass = product outputs + waste outputs + measured elementary releases + documented stock change; investigate and disclose unresolved difference rather than forcing balance	material, output, waste and direct-emission protocols	mass-balance check and unexplained difference

Data Quality Requirements

requirement_id	Applies to	Requirement	Evidence
dq_product_identity	reference product and all batches	Records must identify model, configuration, intended function, route, included accessories, sterile or non-sterile state, respiratory configuration when applicable, manufacturing site and production period.	controlled product specification, BOM revision, route record and release record; eu-mdr-2017; eu-ppe-2016-425-consolidated-2026
dq_temporal_coverage	foreground records	Cover a representative continuous production period or all batches in the declared campaign; disclose start, end, shutdowns, abnormal batches and seasonal or campaign limitations.	dated meter, production, inventory and waste records
dq_completeness	all included processes and flows	Reconcile BOM, utility, treatment, testing, output and waste records; document missing flows, excluded sites and unresolved mass-balance differences.	completeness checklist, mass reconciliation and exclusion log
dq_measurement	mass, energy, gas, water and release measurements	Use calibrated or verified instruments with the resolution and range suitable for the recorded quantity; retain the meter basis and any temperature or pressure condition for gas volume.	calibration certificate, meter id and measurement record
dq_supplier_upstream	purchased materials, components and outsourced services	Use upstream datasets matching actual material or component identity, supplier technology, geography and period where available; disclose proxy use and its limitation.	supplier specification, purchase record, dataset metadata and eu-pef-2021 data-quality assessment
dq_factor_traceability	calculated releases or utility conversions	Every non-physical factor must have a named source, applicable technology and period, original unit and calculation trail; unsupported default factors are not permitted.	factor source and reviewed calculation worksheet
dq_allocation	shared processes and utilities	Retain the unallocated total, allocation driver, factor, period, affected outputs and sensitivity or justification for any non-physical basis.	meter total, production driver record and allocation worksheet; ghg-protocol-product-standard
dq_representativeness	complete dataset	Assess and disclose technological, geographical and time-related representativeness, completeness and precision for significant processes.	data-quality assessment and improvement log; eu-pef-2021; ghg-protocol-product-standard

9. Validation Rules

rule_id	Applies to	Rule	source_ids
validate_identity	product category and reference flow	The declared product must fall within Section 2, must not be a simple protective mask excluded by CPC 48160, and must use exact flow de3969a1-8fd2-433a-979d-176043362c2e with Mass property 93a60a56-a3c8-11da-a746-0800200b9a66, unit group 93a60a57-a4c8-11da-a746-0800200c9a66 and unit kg.
validate_qualifiers	reference product metadata	All Required qualifiers applicable to the model and route must be present; non-applicability must be explicit rather than blank.	eu-mdr-2017; eu-ppe-2016-425-consolidated-2026
validate_reference_mass	quantitative reference	Conforming finished apparatus output must equal exactly 1 kg after normalisation, and packaging mass must remain outside the net reference amount.
validate_process_coverage	foreground system boundary	assembly_integration and final_testing_packaging must be present; each actual component-preparation or cleaning, disinfection or sterilisation route must be included or represented by an upstream purchased service with documented site and dataset.	eu-mdr-2017; eu-pef-2021
validate_inventory_production	all non-reference inventory rows	Each amount must derive from a named collection protocol or a transparent calculation from collected records; category-level default quantities and uncited emission factors are rejected.	ghg-protocol-product-standard
validate_respiratory_route	breathing appliances and gas masks	The dataset must distinguish filtration of polluted air from external breathable-air or gas supply and must identify replaceable filter and oxygen-deficient-atmosphere applicability.	eu-ppe-2016-425-consolidated-2026
validate_treatment_route	sterile, disinfected or cleaned apparatus	The treatment route, validated method, load basis, treatment media, accepted output and treatment wastes or releases must be present when the product claims the corresponding state.	eu-mdr-2017
validate_allocation	shared process burdens	Allocation must follow Section 7 and disclose total, driver, factor and affected products; unsupported economic allocation or undisclosed recycling credit fails validation.	ghg-protocol-product-standard; eu-pef-2021
validate_data_quality	complete foreground package	Temporal coverage, completeness, measurement evidence, upstream representativeness, factor traceability and unresolved gaps must be disclosed; an unreported data gap makes validation inconclusive.	eu-pef-2021; ghg-protocol-product-standard

10. Published Dataset Profile

Field	Value
dataset_role	unit_process
downstream_use	secondary_dataset; background_dataset
allowed_use	cradle-to-gate modelling of a matching apparatus model, configuration, production route, treatment state, respiratory mode, geography, period and factory-gate condition
excluded_use	category-average environmental claims; comparisons of different therapeutic or protective functions; simple protective masks excluded by CPC 48160; use-phase, maintenance or end-of-life claims without separately modelled scenarios; substitution for a different sterile, filter, gas-supply, electrical or reusable configuration
required_metadata	PCR id; reference flow UUID; model and configuration; intended function; net product mass; included accessories; reusable or single-use status; service life or cycle basis; sterile and cleaning state; filtration or supplied-air or gas mode; packaging configuration; route and outsourced steps; manufacturing sites and geography; production period; allocation methods; upstream dataset identities
required_quality_disclosure	collection-protocol coverage; meter and scale quality; BOM and output reconciliation; mass-balance difference; data gaps and proxies; allocation basis; technological, geographical and temporal representativeness; completeness and precision; treatment and final-test evidence where applicable
update_trigger	change in model or configuration, intended function, material or BOM, operating principle, filter or gas-supply mode, sterile state or treatment method, manufacturing or supplier route, site or geography, packaging, allocation basis, upstream dataset, production period, service-life assumption or material data-quality finding

11. Data Sources

Source id	Type	Reference	Used for
eu-pef-2021	official_guidance	European Commission, Commission Recommendation (EU) 2021/2279, Annex I Product Environmental Footprint method, https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021H2279 (retrieved 2026-08-10)	functional-unit fields; supply-chain system-boundary logic; company-specific data; process and data-quality requirements; disclosure of exclusions and downstream stages
ghg-protocol-product-standard	standard	World Resources Institute and World Business Council for Sustainable Development, Product Life Cycle Accounting and Reporting Standard, https://ghgprotocol.org/sites/default/files/standards/Product-Life-Cycle-Accounting-Reporting-Standard-EReader_041613_0.pdf (retrieved 2026-08-10)	process mapping; primary foreground data; data quality; allocation hierarchy and disclosure
eu-mdr-2017	official_guidance	Regulation (EU) 2017/745 on medical devices, Annexes I and II, https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745 (retrieved 2026-08-10)	route-specific manufacturing and validation records; material and process effects; sterile-state processing and packaging; final testing, sites and safe-disposal disclosure for medical-device variants
eu-ppe-2016-425-consolidated-2026	official_guidance	Regulation (EU) 2016/425 on personal protective equipment, consolidated version 29 May 2026, Annex II section 3.10.1, https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02016R0425-20260529 (retrieved 2026-08-10)	respiratory-protection configuration; filtered-air versus external breathable-air supply; required gas-mask and breathing-appliance qualifiers
iec-60601-1-9-2007	standard	IEC 60601-1-9:2007+AMD1:2013+AMD2:2020 CSV, Medical electrical equipment — environmentally conscious design, https://webstore.iec.ch/en/publication/2601 (retrieved 2026-08-10)	life-cycle-stage disclosure and route applicability for medical electrical equipment; separation of production package from downstream life-cycle stages