From design and selection of materials and components to cybersecurity associated with digital products, medical devices must undergo rigorous testing and evaluation to prove they are safe, perform as intended and meet the standards and regulatory requirements of the target market.
Medical device testing
Our industry experts will devise a tailormade testing program of services focusing on your needs.
Which standards can SGS test to?
As market leader, delivering a global service, we test and certify materials, components and products to a broad choice of standards, including:
- Biocompatibility – ISO 10933 series, ISO 18562
- Electro-medical devices – IEC 60601 series, IEC 61010 series
- Implantable medical devices – ISO 10933 series, EN 45502 series
- Medical PPE – EN 455-1 & -2, ASTM F2407, ASTM F1670, ASTM F2100, EN 14683, EN 13795-1
- Packaging – ISO 11607, ASTM F1980, ASTM F1140, ASTM F1929, ASTM F1608, ASTM F88, ASTM F2096, ASTM F1980, ASTM D4169, ISO 11607-1, ISTA 3A
- Sterilization – ISO 11137, ISO 11135, ISO 17665, ISO 11737, USP 85
- Syringes, medical tubing, needles – ISO 7886-1, ISO 594-1
- Wheelchairs and walking aids – ASTM D4169, EN 12183, EN 1986
Our dedicated medical device teams have experience in testing:
- Biocompatibility
- Chemicals and materials – for compatibility and suitability
- Cybersecurity
- Eco-environment (hazardous substance analysis, life cycle analysis)
- Electrical safety
- Electromagnetic compatibility (EMC)
- Electromagnetic fields (EMF)
- Failure analysis
- Flammability testing
- Functional safety
- Mechanical and climatic
- Packaging
- Performance and reliability
- Sterilization
- Wireless connectivity
201 Route 17 North,
7th Floor,
Rutherford, New Jersey, 7070,
United States