D412-16(2021) | Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension |
MIL STD 177A | Rubber Products, Terms for Visible Defects |
F86-21 | Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants |
F2042-18 | Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II´Crosslinking and Fabrication |
F2038-18 | Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I´Formulations and Uncured Materials |
F983-86(2018) | Standard Practice for Permanent Marking of Orthopaedic Implant Components |
F981-23 | Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices |
F748-16 | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
F601-23 | Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants |
F67-13(2017) | Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700) |
D624-00(2020) | Standard Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers |
D813-07(2019) | Standard Test Method for Rubber Deterioration´Crack Growth |
ISO 10993-1 | Biological Evaluations of Medical Devices -- Part 1: Evaluation and testing within a risk management process |
D2240-15(2021) | Standard Test Method for Rubber Property—Durometer Hardness |
D1052-09(2019) | Standard Test Method for Measuring Rubber Deterioration´Cut Growth Using Ross Flexing Apparatus |
21 CFR 820 | Good Manufacturing Practices for Medical Devices |