Electro-diagnostic apparatus, used in medical, surgical, dental or veterinary sciences

1. Scope and Applicability

This PCR covers complete electro-diagnostic apparatus whose intended purpose is to acquire, process, display, store, or transmit physiological or diagnostic information in medical, surgical, dental, or veterinary practice. It covers multiparameter and dedicated patient-monitoring equipment, diagnostic electrocardiographs, diagnostic ultrasound systems, and other non-therapeutic electro-diagnostic systems with a complete apparatus-level function.

Every foreground data package shall declare the following configuration dimensions before data are aggregated. Results for different rows shall not be combined unless component, use, and cleaning differences are retained.

Configuration dimension	Required declaration
diagnostic_modality	patient_monitoring, electrocardiography, diagnostic_ultrasound, or other_electrodiagnostic; for other_electrodiagnostic, state the measured physiological phenomenon and intended diagnostic output
installation	portable, mobile_cart, or fixed; state the installed mass and any separate cart, dock, wall mount, or room-side unit included
product_configuration	host_only, host_with_declared_reusable_probes_and_accessories, or integrated_system; list every included host, probe, transducer, patient cable, cuff, sensor module, dock, and accessory
display_computing_power	State whether display, local computing, data storage, printer, external power supply, charger, and central or remote computing are integrated, separately included, or excluded
battery_boundary	State no_battery, installed_battery_only, or installed_and_replacement_batteries; report chemistry, rated capacity, installed mass, and replacement schedule when applicable
consumables_boundary	State whether electrodes, conductive gel, recording media, probe covers, sample lines, wipes, cleaning agents, and other single-use items are excluded from the product, included in delivered packaging, or modelled per use scenario
use_and_reprocessing	State annual examinations or monitoring hours, active/idle/off hours, service life, utilization, power mode, patient-contact class, cleaning/disinfection method, cycle frequency, and reusable accessory lifetime

The reference product is a category configuration, not a single commercial model. Manufacturer-specific models may instantiate this PCR only after their configuration and mass have been declared.

Excluded products are therapeutic electrical or ultrasonic equipment, defibrillators and electrosurgical treatment units, ultraviolet or infrared treatment apparatus, stand-alone sensors or probes sold without a complete apparatus-level diagnostic function, generic computers or displays not dedicated to the declared system, in-vitro diagnostic analyzers, and apparatus based primarily on X-rays or alpha, beta, or gamma radiation. Diagnostic ultrasound is included; ultrasonic therapeutic equipment is excluded. Magnetic-resonance, scintigraphic, nuclear-medicine, or other materially distinct high-infrastructure systems require a dedicated PCR or documented manual methodology review rather than automatic use of this generic rule.

2. Product Category Identity

Field	Value
canonical_pcr_id	pcr.metal-products-machinery-and-equipment.medical-appliances-precision-and-optical-instruments-watches-and-clocks.electro-diagnostic-apparatus-used-in-medical-surgical-dental-or-veterinary-sciences
classification_refs	CPC 3.0: 48121 — Electro-diagnostic apparatus, used in medical, surgical, dental or veterinary sciences
covered_products	Complete patient monitors, diagnostic ECG apparatus, diagnostic ultrasound systems with declared transducers, and other complete non-therapeutic electro-diagnostic apparatus for human or veterinary use
excluded_products	Therapeutic equipment; stand-alone sensors, probes, accessories, batteries, or consumables; ionizing-radiation apparatus; generic IT equipment; in-vitro diagnostic analyzers; a single proprietary model represented as the category
representative_product	Mass-normalized finished electro-diagnostic apparatus at the manufacturer gate, configured by modality, portability, host/accessory boundary, display/computing/power architecture, battery boundary, and consumables boundary
production_route	Supplier production of electronic, electromechanical, display, power, and modality-specific subassemblies; enclosure and mechanical fabrication; final assembly; software loading; calibration and quality testing; packaging
market_state	Finished, calibrated, packaged apparatus at the manufacturer gate; use, disinfection, replacement, and end-of-life stages are separate declared scenarios

3. Reference Flow

Field	Value
What	Finished electro-diagnostic apparatus with the declared configuration at the manufacturer gate
How much	1 kg net mass of accepted apparatus, excluding tertiary transport packaging and excluding any accessory or consumable not explicitly listed in the configuration
How well	Complete, calibrated, quality-released, and capable of its declared diagnostic or monitoring function; supplied host, probes, accessories, display/computing, power hardware, battery, and packaged consumables are identified separately
How long or cycle	One delivered product mass reference; no service duration or examination count is implied unless a use scenario is declared
reference_flow_link	Reference product output of final_assembly_calibration_and_packaging; use-service results shall additionally report examinations or monitoring hours over the declared service life

Field	Value
Reference amount	1 kg
Reference product flow	Electro-diagnostic apparatus, used in medical, surgical, dental or veterinary sciences 81ec0b79-a1f0-4fb0-bc88-e6ac81427ebe
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	diagnostic modality; measured physiological phenomenon or imaging mode; human or veterinary use; portable/mobile-cart/fixed installation; host-only/host-with-accessories/integrated-system boundary; included probes, transducers, cables, cuffs, sensor modules, docks, displays, computers, storage and printers; power-supply architecture; battery chemistry, capacity and replacement boundary; consumables boundary; net apparatus mass; production geography and year; use intensity and service life when use is included; patient-contact class and cleaning/disinfection scenario

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	accepted finished apparatus and every included reusable accessory	Mass 93a60a56-a3c8-11da-a746-0800200b9a66	kg	Normalize manufacturing inventory to 1 kg net accepted apparatus. Record gross delivered mass, packaging mass, and net apparatus mass separately; do not infer mass from a catalogue family or nominal shipping weight.
configuration_mass_reconciliation	host, probes/accessories, display/computing, power hardware, installed battery, and included consumables	Mass 93a60a56-a3c8-11da-a746-0800200b9a66	kg	The sum of declared configuration masses shall reconcile with net apparatus mass. Consumables and packaging shall remain separate even when supplied in the same shipment.
manufacturing_activity_units	electricity, fuels, water, compressed air, and process chemicals	Activity-specific property	Native metered unit	Preserve native meter or invoice units and document every conversion before normalization to 1 kg accepted apparatus. Do not substitute rated equipment power for measured manufacturing electricity without disclosure.
use_intensity_basis	active, idle, standby, charging, and off modes	Energy or power with time	kWh, W, h, examination, or monitoring-hour	Report measured power by mode, mode hours, examinations or monitoring hours, annual utilization, service life, and geography. A product-mass result shall not silently include an unspecified use profile.
battery_accounting	installed and replacement batteries	Mass and rated energy	kg and Wh	Record battery chemistry, rated capacity, installed mass, number of replacements, charging losses when measured, and end-of-life route separately from the host apparatus.
cleaning_and_consumables_accounting	disinfectants, water, wipes, probe covers, gel, electrodes, recording media, sample lines, and similar items	Mass, volume, or count	kg, L, or item	Record per-cycle quantity, cycle count, reusable-item lifetime, product concentration, and waste route. Do not embed use consumables in host mass.

5. System Boundary

Boundary Abstraction

Field	Value
declared_starting_condition	A verified bill of materials and supplier list for the declared apparatus configuration, with component or material supply datasets identified at the point they enter foreground assembly
starting_condition_role	Foreground assembly starts from disclosed electronic, electromechanical, display, computing, storage, power, enclosure, probe/accessory, battery, and packaging inputs; upstream production is represented by traceable background datasets
product_classification_scope	Complete electro-diagnostic apparatus corresponding to CPC 3.0 48121 and the scope restrictions in this PCR; accessories are included only when declared as part of the supplied configuration
recursive_input_rule	A purchased complete electro-diagnostic apparatus of the same category shall be recorded as a technosphere input with supplier PCR-compliant upstream data and shall not be recursively decomposed again in the same foreground package
upstream_dataset_requirement	Use geographically and temporally representative datasets for materials, printed circuit assemblies, displays, semiconductors, batteries, power supplies, cables, probes, packaging, energy, transport, and waste treatment; disclose proxies and data gaps
disclosure	Declare modality, installation, configuration boundary, component masses, supplier coverage, manufacturing sites, accepted and rejected output, packaging, use scope, service life, use intensity, cleaning/disinfection, consumables, battery replacements, and end-of-life assumptions

rule_id	Applies to	Rule	source_ids
boundary_configuration_separation	all datasets	Keep host apparatus, reusable probes/accessories, display/computing/storage, power hardware, installed battery, delivered consumables, use consumables, and packaging as separately identifiable inventory blocks before aggregation.	who-oxygen-therapy-monitoring-2020; who-radiotherapy-equipment-ultrasound-2021; eu-mdr-2017-745
boundary_lifecycle_stages	cradle-to-gate and life-cycle datasets	Include product specification-relevant component production, manufacturing, assembly, testing, and packaging in cradle-to-gate results. Add distribution, installation, use, maintenance, cleaning/disinfection, consumables, battery replacement, data infrastructure, and end of life only when those stages are explicitly claimed and parameterized.	iec-60601-1-9-2007; jacr-ultrasound-lca-2026
boundary_diagnostic_only	category eligibility	Include diagnostic ultrasound and electro-diagnostic monitoring or recording systems; exclude therapeutic ultrasound and other equipment whose primary function is treatment. Route ionizing-radiation apparatus and materially distinct high-infrastructure imaging systems to a dedicated PCR or manual review.	iec-60601-2-37-2024
boundary_reprocessing	reusable patient-contact parts	Model cleaning, disinfection, or sterilization according to manufacturer instructions and patient-contact class. Keep console surfaces, reusable cables/cuffs, external probes, endocavitary probes, surgical probes, and single-use covers as distinct scenarios.	cdc-disinfection-healthcare-equipment-2008; eu-mdr-2017-745
boundary_end_of_life	end-of-life scenarios	Separate non-infective electrical/electronic equipment, batteries, infectious items, and ordinary packaging. Do not apply a generic WEEE route to equipment expected to be infective before end of life.	eu-weee-directive-2012-19; eu-batteries-regulation-2023-1542

6. Process Inventory Structure

Process Map

process_id	process_name	inclusion	inclusion_condition	role	quantitative_reference
electronics_display_and_power_subassembly	Electronics, display, computing, storage, and power subassembly	required	Always include; record absent blocks as zero only with configuration evidence	Foreground and supplier-linked subassembly production	Per kg accepted subassembly delivered to final assembly
enclosure_and_mechanical_subassembly	Enclosure, chassis, cart, dock, and mechanical subassembly	required	Always include the mechanical configuration delivered with the apparatus	Foreground and supplier-linked mechanical production	Per kg accepted mechanical subassembly delivered to final assembly
modality_probe_and_accessory_subassembly	Modality-specific acquisition modules, probes, transducers, cables, cuffs, and accessories	required	Include only items within the declared supplied configuration; identify host-only exclusions	Foreground and supplier-linked diagnostic-function production	Per kg accepted modality subassembly and included reusable accessories
final_assembly_calibration_and_packaging	Final assembly, software loading, calibration, quality testing, and packaging	required	Always include	Reference-product manufacturing	Per 1 kg net accepted apparatus at manufacturer gate
use_maintenance_and_reprocessing	Use, maintenance, cleaning/disinfection, consumables, and battery replacement	conditional	Include when a life-cycle or use-service result is claimed	Use-stage scenario	Per declared service life and per examination or monitoring-hour, additionally reported per kg apparatus
end_of_life_management	De-installation, sorting, battery removal, decontamination, recycling, treatment, and disposal	conditional	Include when an end-of-life or full life-cycle result is claimed	End-of-life scenario	Per kg apparatus and separately per kg battery, consumable, packaging, and infectious fraction

Process: Electronics, display, computing, storage, and power subassembly (electronics_display_and_power_subassembly)

Inputs

Product flows

Electronic components and printed circuit assemblies (electronic_components_pcba)

Record populated and bare printed circuit boards, semiconductors, connectors, memories, communication modules, and other electronic components entering the declared host or acquisition architecture.

• Selected flow: Foreground-resolved electronic components and printed circuit assemblies
• Flow property / unit: Mass / kg
• Amount rule: Supplier mass records or verified bill-of-material mass by component family
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per kg accepted electronics, display, computing, storage, and power subassembly
• Basis kind: Process output (process_output)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_bom_and_supplier_mass
• Sources: kokare-cardiac-monitoring-lca-2021

Display, computing, storage, and communication hardware (display_computing_storage)

Record integrated displays, processors, local storage, printers, network modules, and dedicated remote computing hardware only when included in the product configuration.

• Selected flow: Foreground-resolved display, computing, storage, and communication hardware
• Flow property / unit: Mass / kg
• Amount rule: Measured or supplier-declared mass for each included block
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per kg accepted electronics, display, computing, storage, and power subassembly
• Basis kind: Process output (process_output)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_bom_and_supplier_mass
• Sources: who-oxygen-therapy-monitoring-2020; who-radiotherapy-equipment-ultrasound-2021

Power supply and installed battery components (power_and_installed_battery)

Record internal and external power supplies, chargers, power cables, and installed batteries separately by mass and battery chemistry.

• Selected flow: Foreground-resolved power supply, charger, cable, and battery inputs
• Flow property / unit: Mass / kg
• Amount rule: Measured installed mass by power block and battery chemistry
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per kg accepted electronics, display, computing, storage, and power subassembly
• Basis kind: Process output (process_output)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_bom_and_supplier_mass
• Sources: who-oxygen-therapy-monitoring-2020; eu-batteries-regulation-2023-1542

Subassembly electricity and utilities (electronics_subassembly_utilities)

Record metered electricity, compressed air, process heat, water, and directly used production chemicals for board assembly, soldering, cleaning, inspection, and subassembly testing.

• Selected flow: Foreground-resolved manufacturing utilities
• Flow property / unit: Energy, volume, or mass / native metered unit
• Amount rule: Metered activity allocated to accepted subassembly output using the allocation rules in section 7
• Value mode: Foreground record (foreground_record)
• Specificity: Site-specific (site_specific)
• Normalization basis: per kg accepted electronics, display, computing, storage, and power subassembly
• Basis kind: Process output (process_output)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_manufacturing_activity
• Sources: kokare-cardiac-monitoring-lca-2021

Waste flows

Elementary flows

Outputs

Product flows

Accepted electronics and power subassembly (accepted_electronics_subassembly)

Record the mass of accepted electronics, display, computing, storage, and power subassembly transferred to final assembly.

• Selected flow: Foreground-specific accepted electronics and power subassembly
• Flow property / unit: Mass / kg
• Amount rule: Measured accepted output mass
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per electronics subassembly production batch
• Basis kind: Process output (process_output)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_output_scrap_and_rework
• Sources: kokare-cardiac-monitoring-lca-2021

Waste flows

Electronics scrap, rejects, and spent process materials (electronics_scrap_and_rejects)

Record printed-board scrap, component rejects, soldering residues, spent cleaning materials, and rework losses by treatment route; do not net them against accepted output.

• Selected flow: Foreground-resolved electronics manufacturing waste by treatment route
• Flow property / unit: Mass / kg
• Amount rule: Weighed or inventory-reconciled waste and reject mass
• Value mode: Foreground record (foreground_record)
• Specificity: Site-specific (site_specific)
• Normalization basis: per kg accepted electronics, display, computing, storage, and power subassembly
• Basis kind: Process output (process_output)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_output_scrap_and_rework
• Sources: kokare-cardiac-monitoring-lca-2021

Elementary flows

Process: Enclosure, chassis, cart, dock, and mechanical subassembly (enclosure_and_mechanical_subassembly)

Inputs

Product flows

Enclosure and mechanical materials (enclosure_mechanical_materials)

Record polymers, metals, glass, elastomers, fasteners, cables, wheels, carts, docks, wall mounts, and protective parts included in the declared apparatus configuration.

• Selected flow: Foreground-resolved enclosure and mechanical materials
• Flow property / unit: Mass / kg
• Amount rule: Verified bill-of-material or supplier mass by material family
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per kg accepted enclosure and mechanical subassembly
• Basis kind: Process output (process_output)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_bom_and_supplier_mass
• Sources: kokare-cardiac-monitoring-lca-2021

Mechanical fabrication utilities (mechanical_fabrication_utilities)

Record electricity, fuels, water, coatings, adhesives, machining fluids, and other direct activities used for moulding, forming, machining, coating, and mechanical assembly.

• Selected flow: Foreground-resolved mechanical fabrication utilities
• Flow property / unit: Energy, volume, or mass / native metered unit
• Amount rule: Metered activity allocated to accepted mechanical output
• Value mode: Foreground record (foreground_record)
• Specificity: Site-specific (site_specific)
• Normalization basis: per kg accepted enclosure and mechanical subassembly
• Basis kind: Process output (process_output)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_manufacturing_activity
• Sources: kokare-cardiac-monitoring-lca-2021

Waste flows

Elementary flows

Outputs

Product flows

Accepted enclosure and mechanical subassembly (accepted_mechanical_subassembly)

Record the accepted housing, chassis, cart, dock, mount, and other mechanical configuration transferred to final assembly.

• Selected flow: Foreground-specific accepted enclosure and mechanical subassembly
• Flow property / unit: Mass / kg
• Amount rule: Measured accepted output mass
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per mechanical subassembly production batch
• Basis kind: Process output (process_output)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_output_scrap_and_rework
• Sources: kokare-cardiac-monitoring-lca-2021

Waste flows

Mechanical scrap and rejected parts (mechanical_scrap_and_rejects)

Record polymer, metal, glass, cable, coating, and mixed rejects by material and treatment route.

• Selected flow: Foreground-resolved mechanical manufacturing waste by treatment route
• Flow property / unit: Mass / kg
• Amount rule: Weighed or inventory-reconciled waste and reject mass
• Value mode: Foreground record (foreground_record)
• Specificity: Site-specific (site_specific)
• Normalization basis: per kg accepted enclosure and mechanical subassembly
• Basis kind: Process output (process_output)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_output_scrap_and_rework
• Sources: kokare-cardiac-monitoring-lca-2021

Elementary flows

Process: Modality-specific acquisition modules, probes, transducers, cables, cuffs, and accessories (modality_probe_and_accessory_subassembly)

Inputs

Product flows

Modality-specific modules and reusable patient interfaces (modality_modules_and_interfaces)

Record the acquisition and signal-conditioning module and all reusable patient interfaces included in the supplied configuration. Distinguish monitoring sensor modules, ECG lead systems, ultrasound transducers, and other electro-diagnostic electrodes or interfaces.

• Selected flow: Foreground-resolved modality modules, probes, transducers, patient cables, cuffs, and reusable accessories
• Flow property / unit: Mass / kg
• Amount rule: Measured or supplier-declared mass by separately replaceable module or accessory
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per kg accepted modality subassembly and included reusable accessories
• Basis kind: Process output (process_output)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_accessory_configuration
• Sources: who-oxygen-therapy-monitoring-2020; who-radiotherapy-equipment-ultrasound-2021; eu-mdr-2017-745

Modality subassembly utilities (modality_subassembly_utilities)

Record electricity, water, compressed air, adhesives, encapsulants, coupling materials, and test consumables used for acquisition-module and probe/accessory production.

• Selected flow: Foreground-resolved modality-subassembly manufacturing utilities
• Flow property / unit: Energy, volume, or mass / native metered unit
• Amount rule: Metered activity allocated to accepted modality subassembly and accessories
• Value mode: Foreground record (foreground_record)
• Specificity: Site-specific (site_specific)
• Normalization basis: per kg accepted modality subassembly and included reusable accessories
• Basis kind: Process output (process_output)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_manufacturing_activity
• Sources: iec-60601-2-37-2024

Waste flows

Elementary flows

Outputs

Product flows

Accepted modality subassembly and declared accessories (accepted_modality_subassembly)

Record accepted acquisition modules and included reusable probes/accessories by modality and replaceable-item identity.

• Selected flow: Foreground-specific accepted modality subassembly and reusable accessories
• Flow property / unit: Mass / kg
• Amount rule: Measured accepted output mass by module and accessory
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per modality-subassembly production batch
• Basis kind: Process output (process_output)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_output_scrap_and_rework
• Sources: who-oxygen-therapy-monitoring-2020; who-radiotherapy-equipment-ultrasound-2021

Waste flows

Probe, accessory, and module rejects (modality_rejects)

Record rejected electronics, cables, probes, transducers, cuffs, sensors, encapsulants, and test items by treatment route.

• Selected flow: Foreground-resolved modality-subassembly waste by treatment route
• Flow property / unit: Mass / kg
• Amount rule: Weighed or inventory-reconciled reject mass
• Value mode: Foreground record (foreground_record)
• Specificity: Site-specific (site_specific)
• Normalization basis: per kg accepted modality subassembly and included reusable accessories
• Basis kind: Process output (process_output)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_output_scrap_and_rework
• Sources: who-radiotherapy-equipment-ultrasound-2021

Elementary flows

Process: Final assembly, software loading, calibration, quality testing, and packaging (final_assembly_calibration_and_packaging)

Inputs

Product flows

Accepted subassemblies and supplied accessories (final_assembly_subassemblies)

Record accepted electronics/power, mechanical, modality, probe/accessory, and separately supplied dedicated display/computing blocks entering final assembly without double counting their upstream burdens.

• Selected flow: Foreground-specific accepted subassemblies and supplied accessories
• Flow property / unit: Mass / kg
• Amount rule: Measured transfer mass reconciled to the configuration bill of materials
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per kg net accepted finished apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_final_assembly_mass_balance
• Sources: who-oxygen-therapy-monitoring-2020; who-radiotherapy-equipment-ultrasound-2021

Final assembly, calibration, and test utilities (final_assembly_utilities)

Record metered electricity and direct materials for assembly, software loading, calibration, burn-in, functional testing, quality control, and rework.

• Selected flow: Foreground-resolved final-assembly and test utilities
• Flow property / unit: Energy, volume, or mass / native metered unit
• Amount rule: Metered batch or line activity allocated to accepted finished apparatus
• Value mode: Foreground record (foreground_record)
• Specificity: Site-specific (site_specific)
• Normalization basis: per kg net accepted finished apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_manufacturing_activity
• Sources: iec-60601-1-9-2007

Primary and secondary packaging (product_packaging)

Record packaging supplied with the apparatus by material and mass. Tertiary distribution packaging shall be reported separately when included.

• Selected flow: Foreground-resolved packaging materials
• Flow property / unit: Mass / kg
• Amount rule: Measured packaging mass by material and packaging level
• Value mode: Foreground record (foreground_record)
• Specificity: Product-specific (product_specific)
• Normalization basis: per kg net accepted finished apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_packaging_records
• Sources: iec-60601-1-9-2007

Waste flows

Elementary flows

Outputs

Product flows

Finished electro-diagnostic apparatus (finished_electrodiagnostic_apparatus)

Record only quality-released product matching the declared modality and configuration. Host, reusable accessories, installed battery, included delivered consumables, and packaging masses remain traceable below the aggregate.

• Selected flow: Electro-diagnostic apparatus, used in medical, surgical, dental or veterinary sciences 81ec0b79-a1f0-4fb0-bc88-e6ac81427ebe
• Flow property / unit: Mass 93a60a56-a3c8-11da-a746-0800200b9a66 / kg
• Amount rule: 1 kg net accepted apparatus
• 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:

Waste flows

Final assembly rejects and packaging waste (final_assembly_waste)

Record rejected assemblies, replaced test parts, calibration consumables, and packaging waste by material and treatment route.

• Selected flow: Foreground-resolved final-assembly and packaging waste by treatment route
• Flow property / unit: Mass / kg
• Amount rule: Weighed or inventory-reconciled waste and reject mass
• Value mode: Foreground record (foreground_record)
• Specificity: Site-specific (site_specific)
• Normalization basis: per kg net accepted finished apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_final_assembly_mass_balance
• Sources: iec-60601-1-9-2007

Elementary flows

Process: Use, maintenance, cleaning/disinfection, consumables, and battery replacement (use_maintenance_and_reprocessing)

Inputs

Product flows

Electricity by operating mode (use_electricity)

Record measured active, idle, standby, charging, and off-mode electricity over the declared annual use and service life. State examinations, monitoring hours, occupancy, power-management settings, and electricity geography.

• Selected flow: Geography-specific electricity supply
• Flow property / unit: Energy / kWh
• Amount rule: Sum of measured mode power multiplied by mode hours, plus separately measured charging losses when applicable
• Value mode: Calculated value (calculated_value)
• Specificity: Scenario-specific (scenario_specific)
• Normalization basis: per declared service life and per examination or monitoring-hour; additionally per kg apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_use_intensity_and_power
• Sources: iec-60601-1-9-2007; jacr-ultrasound-lca-2026

Replacement parts and batteries (maintenance_and_replacement_parts)

Record replaced probes, cables, cuffs, modules, power supplies, displays, batteries, and other parts over the service life without counting the original installed item twice.

• Selected flow: Foreground-resolved replacement parts and batteries
• Flow property / unit: Mass and count / kg and item
• Amount rule: Service records multiplied by measured replacement-item mass; batteries remain separated by chemistry
• Value mode: Calculated value (calculated_value)
• Specificity: Scenario-specific (scenario_specific)
• Normalization basis: per declared service life and per examination or monitoring-hour; additionally per kg apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_maintenance_and_battery_records
• Sources: who-oxygen-therapy-monitoring-2020; eu-batteries-regulation-2023-1542

Diagnostic consumables (diagnostic_consumables)

Record modality-specific single-use electrodes, gel, recording media, probe covers, sample lines, wipes, and similar items actually consumed. Keep reusable accessories outside this row.

• Selected flow: Foreground-resolved diagnostic consumables by material or product type
• Flow property / unit: Mass, volume, or count / kg, L, or item
• Amount rule: Purchasing, issue, or procedure records reconciled to declared examinations or monitoring hours
• Value mode: Foreground record (foreground_record)
• Specificity: Scenario-specific (scenario_specific)
• Normalization basis: per examination or monitoring-hour over the declared service life; additionally per kg apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_consumables_and_reprocessing
• Sources: who-oxygen-therapy-monitoring-2020; who-radiotherapy-equipment-ultrasound-2021; jacr-ultrasound-lca-2026

Cleaning and disinfection inputs (cleaning_and_disinfection_inputs)

Record cleaning agents, disinfectants, water, wipes, probe covers, energy, and any sterilization service according to patient-contact class and manufacturer instructions. Distinguish console surfaces, external probes, endocavitary probes, and surgical probes.

• Selected flow: Foreground-resolved cleaning, disinfection, and sterilization inputs
• Flow property / unit: Mass, volume, energy, or count / kg, L, kWh, or item
• Amount rule: Per-cycle measured or purchasing-reconciled quantity multiplied by documented cycle count
• Value mode: Calculated value (calculated_value)
• Specificity: Scenario-specific (scenario_specific)
• Normalization basis: per examination or monitoring-hour over the declared service life; additionally per kg apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Calculated from collection (calculated_from_collection)
• Collection protocol: cp_consumables_and_reprocessing
• Sources: cdc-disinfection-healthcare-equipment-2008; eu-mdr-2017-745

Waste flows

Elementary flows

Outputs

Product flows

Delivered diagnostic or monitoring service (diagnostic_service_output)

Report examination count and/or monitoring hours as a complementary service denominator. Do not replace the mass reference flow with a service count.

• Selected flow: Foreground-specific diagnostic examination or monitoring service
• Flow property / unit: Count or duration / examination or h
• Amount rule: Completed examinations or verified monitoring hours over the declared period
• Value mode: Foreground record (foreground_record)
• Specificity: Scenario-specific (scenario_specific)
• Normalization basis: per declared service life and additionally per kg apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_use_intensity_and_power
• Sources: jacr-ultrasound-lca-2026

Waste flows

Used consumables, replaced parts, and reprocessing waste (use_stage_waste)

Record infectious and non-infectious fractions, used gel and wipes, probe covers, electrodes, sample lines, recording media, replaced parts, and spent batteries by treatment route.

• Selected flow: Foreground-resolved use-stage waste by infection status, material, and treatment route
• Flow property / unit: Mass and count / kg and item
• Amount rule: Weighed waste, purchase-to-waste reconciliation, and service records
• Value mode: Foreground record (foreground_record)
• Specificity: Scenario-specific (scenario_specific)
• Normalization basis: per examination or monitoring-hour over the declared service life; additionally per kg apparatus
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_consumables_and_reprocessing
• Sources: cdc-disinfection-healthcare-equipment-2008; eu-weee-directive-2012-19; eu-batteries-regulation-2023-1542

Elementary flows

Process: De-installation, sorting, battery removal, decontamination, recycling, treatment, and disposal (end_of_life_management)

Inputs

Product flows

Waste flows

Retired apparatus and separately collected batteries (retired_apparatus_input)

Record retired host, reusable accessories, batteries, remaining consumables, and packaging as separate waste inputs. State infection status and any required decontamination before ordinary electrical/electronic treatment.

• Selected flow: Foreground-resolved retired apparatus and battery waste
• Flow property / unit: Mass / kg
• Amount rule: Measured retired mass by host, accessory, battery chemistry, packaging, and infectious status
• Value mode: Foreground record (foreground_record)
• Specificity: Scenario-specific (scenario_specific)
• Normalization basis: per kg apparatus entering end-of-life management
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_end_of_life_records
• Sources: eu-weee-directive-2012-19; eu-batteries-regulation-2023-1542; cdc-disinfection-healthcare-equipment-2008

Elementary flows

Outputs

Product flows

Recovered material and reusable parts (recovered_materials_and_parts)

Record measured recovered metals, polymers, glass, circuit-board fractions, reusable parts, and batteries leaving sorting or treatment; apply section 7 consistently to recycling credits.

• Selected flow: Foreground-resolved recovered material or reusable part
• Flow property / unit: Mass / kg
• Amount rule: Weighed recovered output by material and destination
• Value mode: Foreground record (foreground_record)
• Specificity: Scenario-specific (scenario_specific)
• Normalization basis: per kg apparatus entering end-of-life management
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_end_of_life_records
• Sources: eu-weee-directive-2012-19; eu-batteries-regulation-2023-1542

Waste flows

Residual treatment and disposal outputs (end_of_life_residuals)

Record hazardous, infectious, mixed, incinerated, and landfilled residuals without subtracting recovered outputs.

• Selected flow: Foreground-resolved treatment residual by route
• Flow property / unit: Mass / kg
• Amount rule: Weighed residual output by treatment destination
• Value mode: Foreground record (foreground_record)
• Specificity: Scenario-specific (scenario_specific)
• Normalization basis: per kg apparatus entering end-of-life management
• Basis kind: Reference flow (reference_flow)
• Evidence kind: Collected record (collected_record)
• Collection protocol: cp_end_of_life_records
• Sources: eu-weee-directive-2012-19; cdc-disinfection-healthcare-equipment-2008

Elementary flows

7. Allocation and Co-product Handling

rule_id	Applies to	Rule	source_ids
allocation_subdivision_first	shared manufacturing lines and facilities	Subdivide and meter modality, subassembly, assembly, calibration, test, and packaging activities directly whenever technically feasible.	iec-60601-1-9-2007
allocation_shared_manufacturing	residual shared utilities and overhead	When direct metering is not feasible, allocate electricity and utilities using a documented causal driver such as machine time, line time, test duration, or batch occupancy. Use mass only when no more causal driver is available, and disclose sensitivity.	iec-60601-1-9-2007
allocation_rework_and_rejects	rework, scrap, and rejected apparatus	Assign rework and reject burdens to the production batch that caused them; do not dilute them across unrelated product families.	kokare-cardiac-monitoring-lca-2021
allocation_shared_use_infrastructure	central stations, remote displays, servers, storage, printers, and shared chargers	Allocate shared use-stage equipment by measured device-hours, monitoring-hours, examinations, stored data, or another documented causal service driver; report excluded shared infrastructure.	jacr-ultrasound-lca-2026
allocation_recycling	recovered materials and reusable parts	Report gross treatment burdens and recovered outputs. Apply cut-off, substitution, or another recycling approach only as required by the governing study method; state the approach and do not combine approaches within one result.	eu-weee-directive-2012-19; eu-batteries-regulation-2023-1542

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_and_supplier_mass	electronics_display_and_power_subassembly; enclosure_and_mechanical_subassembly	component and material inputs	bill of materials, supplier specification, receiving record, measured mass	part id; supplier; material or component family; quantity; unit mass; included configuration block; battery chemistry and capacity when applicable	Reconcile engineering BOM, procurement records, and measured sample mass for the exact configuration	kg, item, Wh	each design revision and production period	current design and reporting year	all manufacturing sites and material suppliers in scope	Sum quantity multiplied by verified unit mass; retain supplier-specific datasets before normalization	revision-controlled BOM, scale calibration, supplier declaration, sampling record
cp_manufacturing_activity	all_manufacturing_processes	electricity, fuels, water, compressed air, chemicals, test and calibration activity	meters, invoices, equipment logs, batch travellers	activity type; meter start/end; native unit; batch; accepted output; machine time; test time; allocation driver	Prefer submetering; otherwise reconcile invoices to line logs and documented allocation drivers	native meter unit, h	each batch or at least monthly	representative continuous 12-month period where available	each foreground and material supplier manufacturing site	Allocate by direct measurement, machine time, line time, test duration, or disclosed fallback driver	meter identification, calibration, invoice reconciliation, production log
cp_output_scrap_and_rework	all_subassembly_processes	accepted output, rejects, scrap, and rework	production and waste records	accepted mass; rejected mass; reworked mass; material; waste code; destination	Weigh outputs and reconcile to batch input and stock change	kg	each batch	same period as manufacturing activity	each manufacturing site	Sum by product, material, and destination; keep rework separate	calibrated scales, waste transfer record, mass-balance sign-off
cp_accessory_configuration	modality_probe_and_accessory_subassembly	host, probe, transducer, cable, cuff, sensor module, dock, and accessory boundary	configuration BOM and product documentation	modality; installation; host id; accessory id; included/excluded status; unit mass; reusable/single-use status; patient-contact class	Verify supplied configuration against BOM, packing list, and instructions for use	kg, item	each configuration revision	current configuration	all configurations represented by the dataset	Sum included reusable items separately from host; never average across undeclared configurations	signed configuration record, packing list, instructions for use
cp_final_assembly_mass_balance	final_assembly_calibration_and_packaging	transferred subassemblies, finished product, rejects, and calibration materials	batch traveller, quality-release record, scale record	input masses; net accepted mass; rejected mass; rework; serial or lot; calibration status	Reconcile every released batch to configuration BOM and weighed output	kg	each batch	reporting period	each final assembly site	Divide net accepted batch inventory by net accepted output mass	calibrated scale, quality-release signature, reconciliation report
cp_packaging_records	final_assembly_calibration_and_packaging	primary, secondary, and tertiary packaging	packaging BOM, supplier record, sample weighing	material; packaging level; unit mass; quantity; recycled content if documented	Measure representative packaging sets and reconcile to purchased quantity	kg	each packaging revision	current packaging design	each packaging configuration	Sum by material and packaging level per net kg apparatus	scale calibration, packaging specification, sample record
cp_use_intensity_and_power	use_maintenance_and_reprocessing	examination or monitoring service and electricity by mode	plug meter, onboard log, facility meter, scheduling record	active/idle/standby/charging/off power; mode hours; examinations; monitoring hours; annual utilization; service life; geography	Measure representative operation and reconcile mode hours to scheduling or monitoring logs	W, h, kWh, examination	representative measurement campaign plus annual reconciliation	declared use year and service life	each use setting represented	Sum mode power multiplied by mode time and separately report service denominator	meter calibration, log completeness, sampling plan, scenario approval
cp_maintenance_and_battery_records	use_maintenance_and_reprocessing	replacement parts, batteries, and maintenance	service work orders, parts issue, battery test and purchasing records	part id; mass; quantity; date; reason; battery chemistry; capacity; charging data; disposal route	Reconcile service records to installed population and service life	kg, item, Wh	each maintenance event	full declared service life or justified projection	each use setting represented	Sum original and replacement parts separately; normalize to service and mass denominators	work order, part receipt, battery test, traceable projection method
cp_consumables_and_reprocessing	use_maintenance_and_reprocessing	consumables, cleaning, disinfection, sterilization, and resulting waste	purchase/issue records, procedure logs, reprocessing logs, waste records	item or chemical; concentration; quantity; cycle; patient-contact class; probe/accessory id; water; energy; waste route	Reconcile issued quantities and documented cycles to examinations or monitoring hours; follow manufacturer instructions	kg, L, kWh, item, cycle	each procedure or representative campaign with annual reconciliation	declared use year and service life	each clinical or veterinary setting represented	Sum by modality, contact class, and cycle; multiply per-cycle records only by verified cycle count	instructions for use, infection-control protocol, lot record, waste manifest
cp_end_of_life_records	end_of_life_management	retired equipment, decontamination, batteries, recovery, and residuals	asset retirement, decontamination certificate, treatment and weighing records	host/accessory/battery mass; infection status; decontamination; treatment route; recovered output; residual	Trace representative retired units through authorized treatment	kg, item	each retirement batch	declared retirement period	all end-of-life routes represented	Mass-balance input to recovered and residual outputs; retain route-specific results	asset register, decontamination certificate, scale ticket, treatment certificate

Calculation Rules

rule_id	Applies to	Formula or rule	Inputs	Output	source_ids
calc_manufacturing_per_kg	manufacturing inventory rows	Normalized amount = batch amount divided by net accepted apparatus or subassembly mass; exclude rework output from the denominator until accepted	batch activity; accepted output mass	amount per kg accepted output	kokare-cardiac-monitoring-lca-2021
calc_configuration_mass_balance	final apparatus configuration	Net apparatus mass = host + included reusable probes/accessories + integrated/separately included display/computing/storage + power hardware + installed battery; delivered consumables and packaging are separate checks	configuration masses	reconciled net apparatus mass	who-oxygen-therapy-monitoring-2020; who-radiotherapy-equipment-ultrasound-2021
calc_use_electricity	use electricity	Lifetime electricity = sum over modes of measured power multiplied by mode hours, divided by 1000 for W-to-kWh conversion, plus separately measured charging losses	mode power; mode time; service life; charging loss	kWh per service life, examination or monitoring-hour, and kg apparatus	iec-60601-1-9-2007; jacr-ultrasound-lca-2026
calc_consumables_and_disinfection	consumables and reprocessing	Lifetime quantity = measured or purchase-reconciled quantity per cycle multiplied by verified cycle count; do not apply one modality's cycle to another	per-cycle quantity; examinations or monitoring events; contact class; reuse count	kg, L, kWh, or items per service denominator and kg apparatus	cdc-disinfection-healthcare-equipment-2008; eu-mdr-2017-745
calc_replacement_parts	maintenance and batteries	Lifetime replacement inventory = sum of actual replacement events; projections shall use documented survival or service assumptions and be labelled as projections	service records; part mass; battery chemistry; service life	replacement mass and count per service life and kg apparatus	eu-batteries-regulation-2023-1542
calc_end_of_life_mass_balance	end-of-life treatment	Retired input mass = recovered product output + residual waste output + measured direct releases, within documented stock change and moisture corrections	retired mass; recovered mass; residual mass; direct releases	route-specific mass balance	eu-weee-directive-2012-19; eu-batteries-regulation-2023-1542

Data Quality Requirements

requirement_id	Applies to	Requirement	Evidence
dq_identity_and_configuration	all datasets	Identify modality, installation, host/accessory boundary, display/computing/power architecture, battery boundary, consumables boundary, product mass, and intended human or veterinary use; do not represent a model-family average without sales-weighted configuration evidence	configuration BOM, instructions for use, packing list, product label, weighting method
dq_mass_completeness	manufacturing and end of life	Reconcile material and component inputs, accepted output, rejects, stock change, packaging, batteries, recovered outputs, and residuals; disclose unresolved mass	signed mass balance and calibrated scale records
dq_temporal_and_geographic	all foreground and background data	Use data representative of the declared production and use geography and year; identify supplier, grid, treatment, or use proxies	dataset metadata, supplier coverage table, proxy log
dq_use_profile	use-stage results	Report measured power modes, hours, examinations or monitoring hours, utilization, service life, maintenance, data infrastructure, and electricity geography; provide sensitivity for materially uncertain drivers	meter logs, scheduling records, service records, scenario analysis
dq_reprocessing	cleaning and disinfection	Match patient-contact class and manufacturer instructions; distinguish console, external probe, endocavitary probe, surgical probe, reusable accessory, and single-use cover scenarios	instructions for use, infection-control approval, reprocessing logs
dq_quantitative_evidence	all inventory amounts	Use foreground records or explicit calculations from collected records. No category-wide default amount from this PCR may replace missing foreground data	collection protocol linkage, raw record retention, calculation audit

9. Validation Rules

rule_id	Applies to	Rule	source_ids
validate_reference_identity	reference flow	Confirm the product flow UUID, Mass property UUID, Units of mass UUID, kg reference unit, and 1 kg amount; reject a stand-alone probe, sensor, accessory, therapeutic unit, ionizing-radiation apparatus, or single model as the category reference.
validate_configuration_declaration	product identity	Require every configuration dimension in section 1 and every qualifier in section 3; fail validation when host/accessory, display/computing/power, battery, consumables, or installation boundaries are ambiguous.	who-oxygen-therapy-monitoring-2020; who-radiotherapy-equipment-ultrasound-2021; eu-mdr-2017-745
validate_modality_separation	aggregation and comparison	Do not aggregate monitoring, ECG, ultrasound, or other electro-diagnostic apparatus without retaining modality-specific configuration, manufacturing, use, consumable, and disinfection records.	iec-60601-2-37-2024; who-oxygen-therapy-monitoring-2020
validate_mass_balance	manufacturing and end of life	Check net apparatus mass against host, accessories, display/computing, power, battery, consumables, packaging, rejects, and treatment outputs; report any unreconciled mass.	kokare-cardiac-monitoring-lca-2021
validate_use_intensity	use-stage claims	Require annual examinations or monitoring hours, mode power and time, service life, utilization, maintenance, charging, data infrastructure, and electricity geography; a generic “in use” scenario is inconclusive.	iec-60601-1-9-2007; jacr-ultrasound-lca-2026
validate_disinfection	reprocessing claims	Require patient-contact class, manufacturer method, agent and concentration, quantity, cycle count, reusable-item lifetime, and waste route; probe covers shall not silently eliminate required disinfection.	cdc-disinfection-healthcare-equipment-2008; eu-mdr-2017-745
validate_battery_and_consumables	product and use boundary	Separate original installed batteries, replacements, charging losses, diagnostic consumables, cleaning materials, and delivered starter supplies; reject double counting between product mass and use inventory.	who-oxygen-therapy-monitoring-2020; eu-batteries-regulation-2023-1542
validate_source_and_protocol_links	all constraining rows and rules	Every external-source or source-rule claim shall cite a listed source; every collected or calculated foreground row shall link to a defined collection protocol.

10. Published Dataset Profile

Field	Value
dataset_role	Foreground product-category dataset for a declared electro-diagnostic apparatus configuration; may be published as a secondary_dataset or background_dataset after review
downstream_use	Product manufacturing, procurement comparison, equipment-fleet modelling, and downstream process or lifecyclemodel projections with explicit modality and scenario qualifiers
allowed_use	Cradle-to-gate comparison of functionally and configurationally comparable apparatus; life-cycle or use-service modelling when service life, use intensity, reprocessing, consumables, battery, data infrastructure, and end-of-life scenarios are complete
excluded_use	Clinical safety or efficacy claims; comparison across undeclared modalities or configurations; treatment equipment; stand-alone sensors/probes; ionizing-radiation systems; extrapolation from a single model to the whole category without weighting evidence
required_metadata	PCR id and version; CPC ref; modality; intended diagnostic output; human/veterinary use; installation; host/accessory/display/computing/power/battery/consumables boundaries; net and gross mass; manufacturing geography/year; supplier coverage; use scenario and service denominator when included; cleaning/disinfection; end-of-life route; allocation method; source and protocol ids
required_quality_disclosure	BOM and supplier coverage; mass-balance result; foreground measurement coverage; proxy list; temporal and geographic representativeness; uncertainty and sensitivity for use intensity, service life, replacements, reprocessing, and end of life; unresolved data gaps
update_trigger	Material change in modality scope, product architecture, reference UUIDs, manufacturing route, configuration mass, software or computing boundary, battery chemistry, supplied accessories, use profile, reprocessing instructions, consumables, regulation, evidence, or end-of-life route

11. Data Sources

Source id	Type	Reference	Used for
who-oxygen-therapy-monitoring-2020	official_guidance	World Health Organization, COVID-19 technical specifications for procurement of oxygen therapy and monitoring devices, WHO/2020-nCoV/MedDev/TS/O2T.V1, https://cdn.who.int/media/docs/default-source/medical-devices/tech-specs-o2-therapy-monitoring-final-draft.pdf?sfvrsn=d684989_2 (retrieved 2026-08-09)	Patient-monitor and ECG functional blocks, display, power, rechargeable battery, accessories, reusable probes, consumables, maintenance, and configuration disclosure
who-radiotherapy-equipment-ultrasound-2021	official_guidance	World Health Organization and International Atomic Energy Agency, Technical specifications of radiotherapy equipment for cancer treatment, ISBN 978-92-4-001998-0, section 4.4 and Annex 10, https://iris.who.int/bitstream/handle/10665/339912/9789240019980-eng.pdf (retrieved 2026-08-09)	Diagnostic ultrasound console, transducer, display, computing, storage, connectivity, gel, and quality-assurance configuration
iec-60601-1-9-2007	standard	IEC 60601-1-9:2007+AMD1:2013+AMD2:2020 CSV, Medical electrical equipment — Requirements for environmentally conscious design, https://webstore.iec.ch/en/publication/2601 (retrieved 2026-08-09)	Life-cycle stage coverage from specification and manufacturing through use and end of life
iec-60601-2-37-2024	standard	IEC 60601-2-37:2024, Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, https://webstore.iec.ch/en/publication/78093 (retrieved 2026-08-09)	Diagnostic ultrasound scope and explicit exclusion of ultrasonic therapeutic equipment
eu-mdr-2017-745	official_guidance	Regulation (EU) 2017/745 on medical devices, ELI http://data.europa.eu/eli/reg/2017/745/oj (retrieved 2026-08-09)	Intended purpose, accessory and generic-device-group distinctions, separate accessory classification, reusable-device cleaning/disinfection instructions, and configuration boundary
cdc-disinfection-healthcare-equipment-2008	official_guidance	US Centers for Disease Control and Prevention, Guideline for Disinfection and Sterilization in Healthcare Facilities (2008): Recommendations, https://www.cdc.gov/infection-control/hcp/disinfection-sterilization/summary-recommendations.html (retrieved 2026-08-09)	Risk-based cleaning, disinfection and sterilization; distinct external, endocavitary and surgical probe scenarios; probe-cover limitation
eu-weee-directive-2012-19	official_guidance	Directive 2012/19/EU on waste electrical and electronic equipment, ELI http://data.europa.eu/eli/dir/2012/19/oj (retrieved 2026-08-09)	Electrical/electronic end-of-life boundary and separate treatment of equipment expected to be infective
eu-batteries-regulation-2023-1542	official_guidance	Regulation (EU) 2023/1542 concerning batteries and waste batteries, ELI http://data.europa.eu/eli/reg/2023/1542/oj (retrieved 2026-08-09)	Installed and replacement battery identity, mass, spare/replacement boundary, separate collection, and end-of-life accounting
kokare-cardiac-monitoring-lca-2021	literature	Kokare, S. et al., “A comparative life cycle assessment of stretchable and rigid electronics: a case study of cardiac monitoring devices,” International Journal of Environmental Science and Technology 19, 3087–3102, https://doi.org/10.1007/s13762-021-03388-x	Cardiac-monitor materials and manufacturing decomposition: enclosure, printed circuit boards, semiconductors, wires, assembly, battery, scrap, and end-of-life separation
jacr-ultrasound-lca-2026	literature	Thiel, C. et al., “Harmonizing Diagnostic Ultrasound Practice with Environmental Sustainability: A Life Cycle Assessment of Diagnostic Ultrasound in a Single Adult University Hospital,” Journal of the American College of Radiology 23(4), 522–531, https://doi.org/10.1016/j.jacr.2025.09.031	Use-stage boundary for ultrasound equipment, electricity, production/disposal, examination supplies, data storage, and interpretation equipment