ASTM D 2857 : 2016
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Standard Practice for Dilute Solution Viscosity of Polymers |
ASTM F 2791 : 2015 : REDLINE
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Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions |
ASTM D 3418 : 2015 : REDLINE
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Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry |
ASTM F 2312 : 2011 : REDLINE
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Standard Terminology Relating to Tissue Engineered Medical Products |
ASTM D 4001 : 2013 : REDLINE
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Standard Test Method for Determination of Weight-Average Molecular Weight of Polymers By Light Scattering |
ASTM E 177 : 2014 : REDLINE
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Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods |
ASQ Q9000:2005
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Quality Management Systems - Fundamentals And Vocabulary |
ASTM F 1983 : 2014 : REDLINE
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Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications |
ISO 80000-9:2009
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Quantities and units Part 9: Physical chemistry and molecular physics |
ISO 10993-13:2010
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Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
ASTM F 2900 : 2011
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Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020) |
ISO 1133-1:2011
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Plastics Determination of the melt mass-flow rate (MFR) and melt volume-flow rate (MVR) of thermoplastics Part 1: Standard method |
ASTM F 2212 : 2011 : REDLINE
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Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs) |
AAMI STBK9 3 : 2001
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STERILIZATION - PART 3: INDUSTRIAL PROCESS CONTROL |
ASTM E 1078 : 2014 : REDLINE
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Standard Guide for Specimen Preparation and Mounting in Surface Analysis |
BS EN 12442-3:2000
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Animal tissues and their derivatives utilized in the manufacture of medical devices Validation of the elimination and/or inactivation of viruses and transmissible agents |
BS EN 12442-2:2000
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Animal tissues and their derivatives utilized in the manufacture of medical devices Controls on sourcing, collection and handling |
ASTM D 1623 : 2017 : REDLINE
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Standard Test Method for Tensile and Tensile Adhesion Properties of Rigid Cellular Plastics |
ASTM F 2809 : 2010
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Standard Terminology Relating to Medical and Surgical Materials and Devices (Withdrawn 2019) |
ASTM D 1238 : 2013 : REDLINE
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Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer |
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 5226 : 2016 : REDLINE
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Standard Practice for Dissolving Polymer Materials |
ASTM D 792 : 2013 : REDLINE
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Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement |
ASTM D 5296 : 2011 : REDLINE
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Standard Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography |
AAMI STBK9 1 : 2001
|
STERILIZATION - PART 1: STERILIZATION IN HEALTH CARE FACILITIES |
ASTM F 1635 : 2016 : REDLINE
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Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants |
ASTM F 2027 : 2016 : REDLINE
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Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
ISO 10993-14:2001
|
Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics |
ISO 11357-2:2013
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Plastics Differential scanning calorimetry (DSC) Part 2: Determination of glass transition temperature and glass transition step height |
ASTM E 1142 : 2015 : REDLINE
|
Standard Terminology Relating to Thermophysical Properties |
ASTM D 6474 : 2012 : REDLINE
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Standard Test Method for Determining Molecular Weight Distribution and Molecular Weight Averages of Polyolefins by High Temperature Gel Permeation Chromatography |
ASTM E 1829 : 2014 : REDLINE
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Standard Guide for Handling Specimens Prior to Surface Analysis |
ASTM D 790 : 2017 : REDLINE
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Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials |
ASTM F 748 : 2016 : REDLINE
|
Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
CFR 21(PTS1-99) : 0
|
FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99 |
ANSI/ISO/ASQ Q9001:2008
|
Quality Management Systems - Requirements |
ASTM D 648 : 2016
|
Standard Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position |
ISO 10993-9:2009
|
Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
AAMI STBK9 2 : 2001
|
STERILIZATION - PART 2: STERILIZATION EQUIPMENT |
ASTM D 3039/D3039M : 2017 : REDLINE
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Standard Test Method for Tensile Properties of Polymer Matrix Composite Materials |
BS EN 12442-1:2000
|
Animal tissues and their derivatives utilized in the manufacture of medical devices Analysis and management of risk |
ASTM F 1980 : 2016 : REDLINE
|
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
ASTM D 1621 : 2016 : REDLINE
|
Standard Test Method for Compressive Properties of Rigid Cellular Plastics |
ASTM E 473 : 2016-05
|
TERMINOLOGY RELATING TO THERMAL ANALYSIS AND RHEOLOGY |
ASTM D 695 : 2015 : REDLINE
|
Standard Test Method for Compressive Properties of Rigid Plastics |
ASTM D 6539 : 2013 : REDLINE
|
Standard Test Method for Measurement of the Permeability of Unsaturated Porous Materials by Flowing Air |
ASTM D 570 : 1998 : R2018
|
Standard Test Method for Water Absorption of Plastics |
ISO 11357-1:2016
|
Plastics — Differential scanning calorimetry (DSC) — Part 1: General principles |
ASTM D 2990 : 2017 : REDLINE
|
Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics |
ASTM D 638 : 2014 : REDLINE
|
Standard Test Method for Tensile Properties of Plastics |
ASTM E 128 : 1999
|
Standard Test Method for Maximum Pore Diameter and Permeability of Rigid Porous Filters for Laboratory Use |
ASTM F 1249 : 2013 : REDLINE
|
Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor |
ASTM F 2883 : 2011
|
Standard Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications (Withdrawn 2020) |
ASTM G 120 : 2015 : REDLINE
|
Standard Practice for Determination of Soluble Residual Contamination by Soxhlet Extraction |