ASTM F1781-03(2009)

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