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