ASTM F 1251 : 1989 : R1995
|
Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices |
ASTM F 2051 : 2000 : R2014
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Standard Specification for Implantable Saline Filled Breast Prosthesis |
ASTM D 1349 : 2014 : R2019
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Standard Practice for Rubber—Standard Conditions for Testing |
ISO 11135:2014
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Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices |
ASTM F 703 : 2018
|
Standard Specification for Implantable Breast Prostheses |
ASTM F 2042 : 2000 : EDT 1
|
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication |
CFR 21(PTS800-1299) : 0
|
FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
ASTM D 412 : 2016 : EDT 1
|
Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension |
ASTM D 1349 : 2014 : REDLINE
|
Standard Practice for Rubber—Standard Conditions for Testing |
ASTM F 2042 : 2000 : R2005
|
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication |
ASTM D 412 : 2016
|
Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension |
ASTM D 1349 : 1999
|
Standard Practice for Rubber-Standard Temperatures For Testing |
ASTM D 1349 : 2009
|
Standard Practice for Rubber-Standard Temperatures for Testing |
ASTM D 1349 : 2014
|
Standard Practice for Rubber—Standard Conditions for Testing |
ASTM F 748 : 2016 : REDLINE
|
Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
ISO 10993-1:2009
|
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
ASTM F 2038 : 2000 : R2005
|
Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials |
ISO 11134:1994
|
Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization |
ASTM F 2051 : 2000
|
Standard Specification for Implantable Saline Filled Breast Prosthesis |
ASTM D 412 : 2016 : R2021
|
Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension |
ASTM D 1349 : 2007
|
Standard Practice for Rubber-Standard Temperatures for Testing |
ASTM F 2038 : 2018
|
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials |
ASTM F 2038 : 2000
|
Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials |
ASTM F 2038 : 2000 : R2011
|
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials |
ASTM F 1251 : 1989 : R2003
|
Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012) |
ASTM F 2042 : 2018
|
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication |
ASTM F 2042 : 2000
|
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication |
ASTM F 2042 : 2000 : R2011
|
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication |
ASTM F 2051 : 2000 : R2006
|
Standard Specification for Implantable Saline Filled Breast Prosthesis |
ASTM F 2038 : 2000 : EDT 1
|
Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials |