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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
- EN 1283 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
- 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 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 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.
Materials
- ASTM D882 Standard Test Method for Tensile Properties of Thin Plastic Sheeting
- ASTM D1003 Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics
- ASTM D1079 Standard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method
- ISO 180 Plastics determination of Izod impact strength
- ISO 527 Plastics determination of tensile properties
Primary Packaging
- ISO 11607 Packaging for terminally sterilized medical devices, parts 1 and 2
- ASTM D3078 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
- ASTM D4991 Standard Test Method for Leakage Testing of Empty Rigid Containers by Vacuum Method
- ASTM D6653 Standard Test Method for Determining the Affects of High Altitude on Packaging Systems by Vacuum Method
- ASTM F88/F88M Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F1140 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
- ASTM F1585 Standard Guide for Integrity Testing of Porous Barrier Medical Packages1
- ASTM F1886 Standard Test method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
- ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM F2054 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization within Restraining Plates
- ASTM F2096 Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
- ASTM F2338 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
Shipping
- ASTM D880 Standard Test Method for Impact Testing for Shipping Containers and Systems
- ASTM D999 Standard Test Method for Vibration Testing of Shipping Containers
- ASTM D3103 Standard Test Method for Thermal Insulation Performance of Distribution Packages
- ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM D4332 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
- ASTM D4728 Standard Test Method for Random Vibration Testing of Shipping Containers
- ASTM D6344 Standard Test Method for Concentrated Impacts to Transport Packages
- ISTA Procedures International Safe Transit Association
