ASTM F2042-00e1

F1906-98

Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte, Proliferation, and Cell Migration

D624-00(2020)

Standard Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers

D430-06(2018)

Standard Test Methods for Rubber Deterioration´Dynamic Fatigue

D412-16(2021)

Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension

D395-18

Standard Test Methods for Rubber Property´Compression Set

F1905-98

Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity

F981-23

Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices

AAMI TIR8–251

Microbiological Methods for Gamma Irradiation Sterilization of Medical Devices

HIMA Memorandum

Guidance for Manufacturers of Silicone Devices Affected by Withdrawal of Dow Corning Silastic Materials, 7/14/93 Available from Advanced Medical Technology Association, 1200 G St. N.W. Suite 400 Washington, D.C. 20005-3814, http://www.advamed.org.

Biological Performance of Materials:

J. Black, Marcel Dekker, NY 1992

21 CFR 211

Current Good Manufacturing Practice for Finished Pharmaceuticals (current revision)

F813-20

Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices

F748-16

Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

F720-17

Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test

F719-20e1

Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation (Includes all amendments and changes 11/2/2020).

F1984-99(2018)

Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials

F2038-18

Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I´Formulations and Uncured Materials

D792-20

Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement

D813-07(2019)

Standard Test Method for Rubber Deterioration´Crack Growth

D814-95(2020)

Standard Test Method for Rubber Property´Vapor Transmission of Volatile Liquids

D926-17(2022)

Standard Test Method for Rubber Property—Plasticity and Recovery (Parallel Plate Method)

D955-21

Standard Test Method of Measuring Shrinkage from Mold Dimensions of Thermoplastics

D1349-14(2019)

Standard Practice for Rubber´Standard Conditions for Testing

D1566-21a

Standard Terminology Relating to Rubber (Includes all amendments and changes 11/10/2021).

D2240-15(2021)

Standard Test Method for Rubber Property—Durometer Hardness

F619-20

Standard Practice for Extraction of Materials Used in Medical Devices