Standards for the medical/pharmaceutical industry
Here you will find an overview of the most important test standards in the medical/pharmaceutical industries. Learn more from our industry experts about the test objectives and respective requirements for testing systems to ensure standard compliant performance.
Spinal implants Hip implants Osteosynthesis Knee implants Dental implants Implant materials Transtibial prostheses Packaging Rubber & silicone Therapy systems Catheters & stents Cleanrooms
Spinal implants
| Content | Standard |
|---|---|
| Static and dynamic component testing on spinal implants | ISO 12189 |
| Tests on spinal implants (vertebrectomy model) | ASTM F1717 |
| Static and dynamic component testing on spinal implants | ASTM F1798 |
| Tests on metallic bone plates and fixation devices | ASTM F2193 |
| Component testing on spinal implants | ASTM F2706 |
| Tests on intervertebral body fusion devices | ASTM F2077 |
| Tests on intervertebral body fusion devices | ASTM F2267 |
| Static and fatigue tests on intervertebral body fusion devices | ASTM F2346 |
| Tests on extra-discal motion-preserving spinal implants | ASTM F2624 |
Hip implants
| Content | Standard |
|---|---|
| Implants for surgery – Partial and total hip joint prostheses – Part 4: Determination of endurance properties and performance of stemmed femoral components | |
| Implants for surgery – Partial and total hip joint prostheses – Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components | ISO 7206-06 |
| Implants for surgery – Partial and total hip joint prostheses – Part 10: Determination of resistance to static load of modular femoral heads | ISO 7206-10 |
| Implants for surgery – Partial and total hip joint prostheses – Part 12: Deformation test method for acetabular shells | ISO 7206-12 |
| Implants for surgery – Partial and total hip joint prostheses – Part 13: Determination of resistance to torque of head fixation of stemmed femoral components | ISO 7206-13 |
| Insert push-out test on hip endoprostheses | |
| Tensile tests on tapered connections on prostheses | ASTM F2009 |
| Static strength and fatigue strength of ceramic femoral heads | ASTM F2345 |
| Fatigue test on endoprostheses | ASTM F2580 |
| Tests on endoprostheses | ASTM F2068 |
| Non-active surgical implants - joint replacement implants - special requirements for hip replacement implants | ISO 21535 |
Osteosynthesis
| Content | Standard |
|---|---|
| Tests on metallic bone plates and fixation devices | |
| Implants for surgery - Metal intramedullary nailing systems - Part 1: Intramedullary nails | ISO 15142-1 |
| Implants for surgery - Metal intramedullary nailing systems - Part 2: Locking components | ISO 15142-2 |
| Implants for surgery - Metal intramedullary nailing systems - Part 3: Connection devices and reamer diameter measurements | ISO 15142-3 |
| Tests on metallic bone plates and fixation devices | ASTM F382 |
| Tests on intramedullary rods | ASTM F383 |
| Tests on metallic angled osteosynthetic fracture fixation devices | ASTM F384 |
| Testing of Bone Screws | ASTM F543 |
| Testing of Bone Screws | ISO 6475 |
| Tests on metallic bone staples | ASTM F564 |
| Tests on intramedullary fixation devices | ASTM F1264 |
| Tests on external skeletal fixation devices | ASTM F1541 |
| Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices | ASTM F1831 |
| Tests on implantable strands and cables | ASTM F2180 |
| Tests on absorbable plates and screws for internal fixation implants | ASTM F2502 |
| Implants for surgery — Skeletal pins and wires; Part 3: Kirschner skeletal wires | ISO 5838-3 |
Knee implants
| Content | Standard |
|---|---|
| Fatigue Tests on the Tibial Plateau of Artificial Knee Joints | |
| Determination of endurance properties of knee tibial trays | ISO 14879 |
Dental implants
| Content | Standard |
|---|---|
| Dynamic loading test for endosseous dental implants | |
| Ceramic materials for dentistry | DIN EN ISO 6872 |
| Dentistry - Refractory investment and die material | ISO 15912 |
| Dentistry - Torsion test of implant body/connecting part joints of endosseous dental implant systems | ISO 13498 |
| Dentistry - Screw loosening test using cyclic torsional loading for implant body/implant abutment connection of endosseous dental implants | ISO /TR 18130 |
Implant materials
| Content | Standard |
|---|---|
| Coatings | |
| Shear test on coatings | ASTM F1044 |
| Shear and bending fatigue test on medical coatings | ASTM F1160 |
| Tension testing of coatings | ASTM F1147 |
| Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength | ISO 13779-4 |
| Plastics | |
| Standard Test Method for Tensile Properties of Plastics | ASTM D638 |
| Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants | ASTM F2183 |
| Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants | ASTM F648 |
| Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopedic Devices and Instruments | ASTM F1839 |
| Standard Test Method for Tensile Properties of Thin Plastic Sheeting | ASTM D882 |
| Bone cement | |
| Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials | ASTM F2118 |
| Flexural fatigue testing of acrylic resin cements used in orthopedics | ISO 16402 |
| Standard Specification for Acrylic Bone Cement | ASTM F451 |
| Implants for surgery - Acrylic resin cements | ISO 5833 |
| Metals | |
| Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Applications | ASTM F136 |
| Tension Testing of Nickel-Titanium Superelastic Materials (Nitinol) | ASTM F2516 |
| Testing of metallic materials - Compression test of metallic cellular materials | DIN 50134 |
| Metallic materials - Tensile testing Part 1: Method of test at room temperature | ISO 6892-1 |
| Ceramics | |
| Advanced technical ceramics - Mechanical properties of monolithic ceramics at room temperature - Part 4: Vickers, Knoop and Rockwell superficial hardness | EN 843-4 |
| Fine ceramics (advanced ceramics, advanced technical ceramics) — Test method for hardness of monolithic ceramics at room temperature | ISO 14705 |
| Advanced technical ceramics - Mechanical properties of monolithic ceramics at room temperature - Part 2: Determination of Young's modulus, shear modulus and Poisson's ratio | EN 843-2 |
| Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) | ISO 13356 |
| Implants for surgery — Ceramic materials - Part 1: Ceramic materials based on high purity alumina | ISO 6474-1 |
| Implants for surgery — Ceramic materials - Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement | ISO 6474-2 |
Medical and pharmaceutical packaging
| Content | Standard |
|---|---|
| Testing of paper and board - Determination of the bending stiffness by the beam method | DIN 53121 |
| Determining the sealed-seam strength of sealings made of flexible packaging material | DIN 55529 |
| Determining the sealed-seam strength for terminally sterilized medical devices | DIN EN 868 |
| Determining the sealed-seam strength for terminally sterilized medical devices | DIN EN ISO 11607 |
| Paper and board - Determination of bending resistance | ISO 2493-1 |
| Paper and board - Determination of bending stiffness | ISO 5628 |
Rubber and silicone
| Content | Standard |
|---|---|
| Testing of Disposable Medical Gloves | ISO 11193-1 -2 |
Therapy systems
| Content | Standard |
|---|---|
| Bend Testing of Needles Used in Surgical Sutures | ASTM F1874 |
| Testing of hypodermic needles | DIN 13097-4 |
| Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment | DIN EN 1707 |
| Needle-based injection systems for medical use | DIN EN ISO 11608-1/-2/-3 |
| Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling | DIN EN ISO 23908 |
| Sterile hypodermic needles for single use | DIN EN ISO 7864 |
| Sterile hypodermic syringes for single use | DIN EN ISO 7886-1 |
| Small-bore connectors for liquids and gases in healthcare applications | DIN EN ISO 80369 |
| Sterile single-use syringes, with or without needle, for insulin | DIN EN ISO 8537 |
| Stainless steel needle tubing for manufacture of medical devices | DIN EN ISO 9626 |
| Prefilled syringes | ISO 11040 |
| Small-bore connectors for liquids and gases in healthcare applications | DIN EN ISO 80369 |
Catheters and Stents
| Content | Standard |
| Standard Specification for Ureteral Stents | ASTM F1828 |
| Characterization and Presentation of the Dimensional Attributes of Vascular Stents | ASTM F2081 |
| Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems | ASTM F2606 |
| Intravascular catheters - Sterile and single-use catheters | DIN EN ISO 10555 |
| Cardiovascular implants - Endovascular devices | DIN EN ISO 25539 |
| Cardiovascular implants - Endovascular devices - Part 2: Vascular stents | DIN EN ISO 25539-2 |
| Small-bore connectors for liquids and gases in healthcare applications | DIN EN ISO 80369 |
Cleanrooms
| Content | Standard |
|---|---|
| Cleanrooms and associated controlled environments | DIN EN ISO 14644 |