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Medical Device Testing Standards

MET has expertise in testing to a wide range of standards, here are just a few of them

Devices

  • ASTM F2394 Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
  • ASTM F2081 Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
  • ASTM F2477 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents1
  • ASTM F2743 - 11 Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
  • EN 1283 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
  • EN 1617 Sterile drainage catheters and accessory devices for single use
  • EN 13726 Test methods for primary wound dressings, all sections
  • EN 13795-2 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment. Part 2. Test methods
  • EN 13868 Catheters: test methods for kinking of single lumen catheters and medical tubing
  • EN 14079 Non-active medical devices: performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
  • EN ISO 14607 Non-active surgical implants -- Mammary implants – all particular requirements
  • ISO 15747 Plastic containers for intravenous injections – all sections
  • ISO 5833 Implants for surgery - Acrylic resin cements
  • ISO 7198 Cardiovascular implants - Tubular vascular prostheses
  • ISO 7864 Sterile hypodermic needles for single use
  • ISO 8536 Infusion equipment for medical use, various parts
  • ISO 8669 Urine clecting bags - Requirements and test methods
  • ISO 10993 Biological evaluation of medical devices - various parts
  • ISO 10993-18 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
  • ISO 11608 Pen-injectors for medical use - Parts 1-4: Pen-injectors - Requirements and test methods
  • ISO 11948 Urine absorbing aids - Whole product testing
  • ISO 14708 Implants for surgery - Active implantable medical devices - various parts
  • ISO 15137 Self-adhesive hanging devices for infusion bottles and injection vials - Requirements and test methods
  • ISO 15747 Plastics containers for intravenous injection
  • ISO 18671 Intravenous infusion needles for single use
  • ISO 20072 Aerosol drug delivery device design verification - Requirements and test methods
  • ISO 21649 Needle-free injectors for medical use - Requirements and test methods
  • ISO 22413 Transfer sets for pharmaceutical preparations - Requirements and test methods
  • ISO 25539 Cardiovascular implants - various parts
  • ISO 28620 Medical devices - Non-electrically driven portable infusion devices
  • Orthopaedics Test facilities for a wide variety of ASTM and ISO standards
  • Ph Eur Monograph 2.9.27. UNIFORMITY OF MASS OF DELIVERED DOSES FROM MULTIDOSE CONTAINERS

Materials

Primary Packaging

Shipping

Stability

Medical Device Testing Standards