Certifications

As a company operating in the emergency medicine field supplying high-tech devices, Spencer must create a structure and business organization with the highest levels of efficiency and quality. The roots of the company are based on two strategic factors:

 

• The certication of our Quality Assurance system (since 1998) in conformity with the EN ISO 9001:2015 (certificate n° 50 100 6189 issued by TÜV ITALIA ), together with the conformity to the specialist standards relative to medical devices EN ISO 13485:2016 (certificate n° Q5_033230_0033 issued by TÜV SÜV Product Service GmbH)
• Research and development for the design of highly advanced technological devices.

All medical devices manufactured by Spencer are in compliance with the essential requirements of the Regulation 2017/745 and to the applicable regulations and common specifications (For class II medical devices Art. 12o of the above regulation applies).

For years now Spencer has constantly worked to develop new, safe and reliable products which set the standards of quality on the market. Following the specifications for emergency vehicles and their equipment and medical device described by the UNI EN 1789 and UNI EN 1865-1 Spencer today offers a wide range of products tested and certified 10G.

Find below the norms and standards we apply for manufacturing ambulance self-loading stretchers, transport chairs, spine boards, vacuum mattresses and evacuation transport sheets:

 

• EU Regulation 2017/745: Medical Devices
• UNI EN 1865-1: Patient handling equipment used in road ambulances. Part 1: General stretcher systems and patient handling equipment
• UNI EN 1865-4: Patient handling equipment used in road ambulances. Part 4: Foldable patient transfer chair
• UNI EN 1789: Medical vehicles and their equipment. Road ambulances

Find below the norms and standards we apply for manufacturing ambulance stretcher support systems:

• Dir. 2006/42/CE: Machinery Directive, Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006
• Regulation 10: Uniform provisions concerning the approval of vehicles with regard to electromagnetic compatibility
• UNI EN 1789: Medical vehicles and their equipment. Road ambulances
• UNI EN 1865-5: Patient handling equipment used in road ambulances. Part 5: Stretcher support

 

Find below the norms and standards we apply for manufacturing oxygen delivery systems for emergency vehicles:

• 93/42/EEC Directive: Medical Devices – Art. 120 EU Regulation 2017/745
• UNI EN 1789: Medical vehicles and their equipment. Road ambulances
• UNI EN ISO 18562 (part 1, 2, 3): Biocompatibility evaluation of breathing gas pathways in healthcare applications
• UNI EN ISO 9170-1: Terminal units for medical gas pipeline systems. Part 1: Terminal units for use with compressed medical gases and vacuum
• UNI EN ISO 5359: Anaesthetic and respiratory equipment – low-pressure hose assemblies for use with medical gases
• UNI EN ISO 15001: Anaesthetic and respiratory equipment — Compatibility with oxygen

Find below the norms and standards we apply for manufacturing electronic ventilators:

• 93/42/EEC Directive: Medical Devices – Art. 120 EU Regulation 2017/745
• UNI EN 1789: Medical vehicles and their equipment. Road ambulances
• EN 794-3: Particular requirements for emergency and transport ventilators
• CEI EN 60601-1 + A1 + A2: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
• EN 60601-1-2 + A1: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
• CEI EN 60601-1-6/A1: Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
• Regulation 10: Uniform provisions concerning the approval of vehicles with regard to electromagnetic compatibility
• EN 60601-1-8: Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
• UNI EN ISO 15001: Anaesthetic and respiratory equipment — Compatibility with oxygen.

Find below the norms and standards we apply for manufacturing pneumatic ventilators:

• 93/42/EEC Directive: Medical Devices – Art. 120 EU Regulation 2017/745
• UNI EN 1789: Medical vehicles and their equipment. Road ambulances
• EN 794-3: Particular requirements for emergency and transport ventilators
• UNI EN ISO 15001: Anaesthetic and respiratory equipment — Compatibility with oxygen.

Find below the norms and standards we apply for manufacturing electrical suction units:

• 93/42/EEC Directive: Medical Devices – Art. 120 EU Regulation 2017/745
• UNI EN 1789: Medical vehicles and their equipment. Road ambulances
• ISO 10079-1: Medical suction equipment — Part 1: Electrically powered suction equipment
• CEI EN 60601-1 + A1 + A2: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
• EN 60601-1-2 + A1: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests
• RTCA/DO-160E: Section 21.0: Category M

As requested by D.Lgs 81/08 which regulates the Health and Safety procedures in work places, Spencer guarantees that all our production centers operate following the correct procedures in order to offer the highest standards of health and safety to personnel, environment and company assets.