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Home/Sectors/Electromedical

electromedical sector

Clinical trolleys, healthcare furniture and instruments: the mechanical part of products that go into hospitals, from concept to catalogue product for the international market.

Clinical trolleysHealthcare furnitureInstrumentsMechanical hazardsStabilityEN 60601-1EN ISO 14971Regulation (EU) 2017/745

The work in this sector

In an electromedical device the mechanics are part of safety: a trolley that tips over, an arm that fails or a sharp edge are risks that the standard requires to be demonstrably under control, with tests and calculations.

The studio has handled the design and technical communication of electromedical instruments and healthcare furniture for the international market. Today we look after the mechanical part of the product and of its evidence, alongside the manufacturer and its regulatory consultants.

What we design

Trolleys and mobile basesFrames, castors and brakes, with verification of stability when stationary and when moving, and of obstacle crossing.
Healthcare furnitureStructures, adjustments and mechanisms for hospital furniture, with attention to cleaning and disinfection.
Arms and supportsSupports for monitors and instruments, with the loads, the safety factors and the fixing points.
Enclosures and plastic partsCovers and housings designed for moulding, with controlled edges, openings and accessibility.
Mechanical hazardsAnalysis of moving parts, crushing points and mechanical strength for the product file.
Technical communicationManuals, exploded views, spare parts catalogues and technical illustrations, also in several languages.

Reference standards

Before designing, the regulatory scope is defined: which standards apply, in which version and with which customer requirements.

Regulation (EU) 2017/745Medical devices: general safety and performance requirements and the manufacturer's technical documentation.
EN 60601-1General safety of medical electrical equipment: the section on mechanical hazards covers stability, strength, moving parts and suspension systems.
EN 60601-1-2Electromagnetic compatibility, for the interfaces between the mechanical and the electrical parts.
EN ISO 14971Risk management for medical devices: mechanical risks go into the risk management file.
EN 62366-1Usability engineering: handles, controls, forces and postures of the user.
EN ISO 13485Quality system of the medical device manufacturer, which the design work complies with.
Particular standardsStandards of the 60601-2 series for the individual families of equipment, where applicable.
Versions in force

Standards are revised fairly often: the first activity in every project is to check which edition applies at the date of the design.

How we work

  1. Intended useUsers, environment, loads, cleaning and service life of the product.
  2. ConceptMechanical architecture, materials and processes, with the mechanical risks already identified.
  3. Design and verifications3D model, strength and stability calculations, selection of components.
  4. EvidenceCalculation reports, test specifications and contributions to the risk management file.
  5. IndustrialisationDrawings for the suppliers, bill of materials, manuals and product documentation.

What you receive

3D model of the productManufacturing drawingsBill of materialsStability verificationStrength calculationsTest specificationsContribution to the risk analysisManuals and spare parts catalogues

Images

Powered healthcare furniture
Powered healthcare furniture
3D design
3D design
Extruded aluminium profiles
Extruded aluminium profiles
Prototyping
Prototyping

FAQ

Can you carry out the tests according to EN 60601-1?

The tests are carried out in accredited laboratories. We prepare the calculations and the test specifications for the mechanical part and interpret the results for the file.

Do you handle the CE marking of the device?

The regulatory part stays with the manufacturer and its consultants. We provide the mechanical evidence: design, calculations, contributions to the risk analysis and documentation.

Do you also design for plastic moulding?

Yes: wall thicknesses, draft angles, ribs and fits are designed together with the mould supplier.

Let's talk about your project

Describe the product or the plant, where you are now and what you need. We reply with the scope of work, the timing and a quotation.

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electromedical sector

The mechanical part of your device, with the evidence the file needs

Tell us about the project: we reply within 24 working hours with the method, the timing and a written quotation.

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