Jordi Labs

Regulatory Testing Services

Image of blood bag for analysis on a single use bioprocess system.

See Jordi Labs' example analysis on a single use bioprocess system and use this case study to demonstrate an LC/MS and GC/MS software workflow for analysis of E&L’s.

Jordi Labs’ team of Ph.D. analytical chemists excels at helping companies worldwide comply with regulatory testing. Jordi Labs has become well known in the industry for its innovation in the area of extractables and leachables (E&L). Along with its E&L services, Jordi Labs has been providing risk assessments and toxicological evaluations to its customers for their pharmaceutical packaging, medical devices, food contact applications and consumer goods.  Our toxicologists work with our chemists to understand risk profiles, design protocols, set analytical evaluation thresholds, and identify compounds and their toxicity. This team works closely with our customers to satisfy their regulatory needs and respond to the specific requests of the regulatory agencies. We can also provide more routine analyses when testing to a specific standard is required. In all cases, we have the expertise and understanding of the regulatory landscape to provide the testing and consulting required to help get your product to market.

Find more details about how we can assist with your regulatory needs:

Here is a short list of some of the regulations we regularly work with:

We have specific experience with testing for European Union (EU) regulations:

Read case studies from some of our previous regulatory work:

Please contact us to find out more about our range of regulatory testing experience.

Standards we work with:

ASTM 1120ASTMStandard Test Method for Boiling Point of Engine Coolants
ASTM 2214-02ASTMStandard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
ASTM 2605ASTMStandard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection
ASTM 3148ASTMStandard Test Method for Elastic Moduli of Intact Rock Core Specimens in Uniaxial Compression
ASTM 3418ASTMStandard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
ASTM B923ASTMStandard Test Method for Metal Powder Skeletal Density by Helium or Nitrogen Pycnometry
ASTM C1749ASTMStandar Guide for Measurment of the Rheological Properties of Hyraulic Cementious Paste Using a Rotational Rheometer
ASTM C25-31ASTMStandard Test Methods for Chemical Analysis of Limestone, Quicklime, and Hydrated Lime
ASTM C518ASTMStandard Test Method for Steady-State Thermal Transmission Properties by Means of the Heat Flow Meter Apparatus
ASTM D 217-02ASTMStandard Test Methods for Cone Penetration of Lubricating Grease
ASTM D 301ASTMStandard Test Methods for Soluble Cellulose Nitrate
ASTM D1003ASTMStandard Test Method for Haze and Luminous Transmittance of Transparent Plastics
ASTM D1004ASTMStandard Test Method for Tear Resistance (Graves Tear) of Plastic Film and Sheeting
ASTM D1042ASTMStandard Test Method for Linear Dimensional Changes of Plastics Caused by Exposure to Heat and Moisture
ASTM D1078ASTMStandard Test Method for Distillation Range of Volatile Organic Liquids
ASTM D1125ASTMStandard Test Methods for Electrical Conductivity and Resistivity of Water
ASTM D1149ASTMStandard Test Methods for Rubber Deterioration—Cracking in an Ozone Controlled Environment
ASTM D117ASTMStandard Guide for Sampling, Test Methods, and Specifications for Electrical Insulating Liquids
ASTM D1177ASTMStandard Test Method for Freezing Point of Aqueous Engine Coolants
ASTM D1209ASTMStandard Test Method for Color of Clear Liquids
ASTM D1238ASTMStandard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
ASTM D1269ASTMMethod of Test for Lead Antiknock Compounds in Gasoline
ASTM D1287ASTMStandard Test Method for pH of Engine Coolants and Antirusts
ASTM D1298ASTMStandard Test Method for Density, Relative Density, or API Gravity of Crude Petroleum and Liquid Petroleum Products by Hydrometer Method
ASTM D1335ASTMStandard Test Method for Tuft Bind of Pile Yarn Floor Coverings
ASTM D1403ASTMStandard Test Methods for Cone Penetration of Lubricating Grease Using One-Quarter and One-Half Scale Cone Equipment
ASTM D1434ASTMStandard Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting
ASTM D1439ASTMStandard Test Methods for Sodium Carboxymethylcellulose
ASTM D1475ASTMStandard Test Method For Density of Liquid Coatings, Inks, and Related Products
ASTM D149ASTMStandard Test Method for Dielectric Breakdown Voltage and Dielectric Strength of Solid Electrical Insulating Materials at Commercial Power Frequencies
ASTM D150ASTMStandard Test Methods for AC Loss Characteristics and Permittivity (Dielectric Constant) of Solid Electrical Insulation
ASTM D1525ASTMStandard Test Method for Vicat Softening Temperature of Plastics
ASTM D153ASTMStandard Test Methods for Specific Gravity of Pigments
ASTM D1599ASTMStandard Test Method for Resistance to Short-Time Hydraulic Pressure of Plastic Pipe, Tubing, and Fittings
ASTM D1613ASTMStandard Test Method for Acidity in Volatile Solvents and Chemical Intermediates Used in Paint, Varnish, Lacquer, and Related Products
ASTM D1652ASTMStandard Test Method for Epoxy Content of Epoxy Resins
ASTM D1708ASTMStandard Test Method for Tensile Properties of Plastics by Use of Microtensile Specimens
ASTM D1709ASTMStandard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method
ASTM D1722ASTMStandard Test Method for Water Miscibility of Water-Soluble Solvents
ASTM D1762ASTMStandard Test Method for Chemical Analysis of Wood Charcoal
ASTM D1876ASTMStandard Test Method for Peel Resistance of Adhesives (T-Peel Test)
ASTM D1894ASTMStandard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting
ASTM D1907ASTMStandard Test Method for Linear Density of Yarn (Yarn Number) by the Skein Method
ASTM D1922ASTMStandard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method
ASTM D2007ASTMStandard Test Method for Characteristic Groups in Rubber Extender and Processing Oils and Other Petroleum-Derived Oils by the Clay-Gel Absorption Chromatographic Method
ASTM D2116ASTMStandard Specification for FEP Resin Molding and Extrusion Materials
ASTM D2122ASTMStandard Test Method for Determining Dimensions of Thermoplastic Pipe and Fittings
ASTM D2137ASTMStandard Test Methods for Rubber Property—Brittleness Point of Flexible Polymers and Coated Fabrics
ASTM D222ASTMStandards and Specifications for Nonmetallic Minerals and Their Products
ASTM D2222ASTMStandard Test Method for Methanol Extract of Vinyl Chloride Resins
ASTM D2236ASTMStandard Method Of Test For Dynamic Mechanical Properties Of Plastics By Means Of A Torsional Pendulum
ASTM D2240ASTMStandard Test Method for Rubber Property—Durometer Hardness
ASTM D2256ASTMStandard Test Method for Tensile Properties of Yarns by the Single-Strand Method
ASTM D2393ASTMTest Method for Viscosity of Epoxy Resins and Related Components *Withdrawn, No Replacement
ASTM D2425ASTMStandard Test Method for Hydrocarbon Types in Middle Distillates by Mass Spectrometry
ASTM D2515ASTMStandard Specification for Kinematic Glass Viscometers
ASTM D256ASTMStandard Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics
ASTM D257ASTMStandard Test Methods for DC Resistance or Conductance of Insulating Materials
ASTM D2709ASTMStandard Test Method for Water and Sediment in Middle Distillate Fuels by Centrifuge
ASTM D2765ASTMStandard Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics
ASTM D2839ASTMUse of a Melt Index Strand for Determining Density of Polyethylene
ASTM D2857ASTMStandard Practice for Dilute Solution Viscosity of Polymers
ASTM D2887ASTMStandard Test Method for Boiling Range Distribution of Petroleum Fractions by Gas Chromatography
ASTM D2896ASTMStandard Test Method for Base Number of Petroleum Products by Potentiometric Perchloric Acid Titration
ASTM D2902ASTMStandard Specification for Fluoropolymer Resin Heat-Shrinkable Tubing for Electrical Insulation
ASTM D1002ASTMStandard Test Method for Apparent Shear Strength of Single-Lap-Joint Adhesively Bonded Metal Specimens by Tension Loading (Metal-to-Metal)
ASTM D3218-07ASTMStandard Specification for Polyolefin Monofilaments
ASTM D3278ASTMStandard Test Methods for Flash Point of Liquids by Small Scale Closed-Cup Apparatus
ASTM D3418ASTMStandard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
ASTM D3616-95ASTMStandard Test Method for Rubber -- Determination of Gel, Swelling Index, and Dilute Solution Viscosity
ASTM D374-99ASTMStandard Test Methods for Thickness of Solid Electrical Insulation
ASTM D3763ASTMStandard Test Method for High Speed Puncture Properties of Plastics Using Load and Displacement Sensors
ASTM D3828ASTMStandard Test Methods for Flash Point by Small Scale Closed Cup Tester
ASTM D3835ASTMStandard Test Method for Determination of Properties of Polymeric Materials by Means of a Capillary Rheometer
ASTM D3849ASTMStandard Test Method for Carbon Black—Morphological Characterization of Carbon Black Using Electron Microscopy
ASTM D3895ASTMStandard Test Method for Oxidative-Induction Time of Polyolefins by Differential Scanning Calorimetry
ASTM D3985ASTMStandard Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using a Coulometric Sensor
ASTM D4017-02ASTMStandard Test Method for Water in Paints and Paint Materals by Karl Fischer Method
ASTM D4052ASTMStandard Test Method for Density, Relative Density, and API Gravity of Liquids by Digital Density Meter
ASTM D4065ASTMStandard Practice for Plastics: Dynamic Mechanical Properties: Determination and Report of Procedures
ASTM D412ASTMStandard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
ASTM D4176ASTMStandard Test Method for Free Water and Particulate Contamination in Distillate Fuels (Visual Inspection Procedures)
ASTM D422ASTMStandard Guide for Selection of Methods of Particle Size Analysis of Fluvial Sediments (Manual Methods)
ASTM D4274ASTMStandard Test Methods for Testing Polyurethane Raw Materials: Determination of Hydroxyl Numbers of Polyols
ASTM D4441ASTMStandard Specification for Aqueous Dispersions of Polytetrafluoroethylene
ASTM D445ASTMStandard Test Method for Kinematic Viscosity of Transparent and Opaque Liquids (and Calculation of Dynamic Viscosity)
ASTM D4488ASTMStandard Guide for Testing Cleaning Performance of Products Intended for Use on Resilient Flooring and Washable Walls
ASTM D4603ASTMStandard Test Method for Determining Inherent Viscosity of Poly(Ethylene Terephthalate) (PET) by Glass Capillary Viscometer
ASTM D4662ASTMStandard Test Methods for Polyurethane Raw Materials: Determination of Acid and Alkalinity Numbers of Polyols
ASTM D471ASTMStandard Test Method for Rubber Property—Effect of Liquids
ASTM D473-07ASTMStandard Test Method for Sediment in Crude Oils and Fuel Oils by the Extraction Method
ASTM D482ASTMStandard Test Method for Ash from Petroleum Products
ASTM D4883ASTMStandard Test Method for Density of Polyethylene by the Ultrasound Technique
ASTM D4980ASTMStandard Test Methods for Screening of pH in Waste
ASTM D5035ASTMStandard Test Method for Breaking Force and Elongation of Textile Fabrics (Strip Method)
ASTM D5155ASTMStandard Test Methods for Polyurethane Raw Materials: Determination of the Isocyanate Content of Aromatic Isocyanates
ASTM D5225ASTMStandard Test Method for Measuring Solution Viscosity of Polymers with a Differential Viscometer
ASTM D5227ASTMStandard Test Method for Measurement of Hexane Extractable Content of Polyolefins
ASTM D5292ASTMStandard Test Method for Aromatic Carbon Contents of Hydrocarbon Oils by High Resolution Nuclear Magnetic Resonance Spectroscopy
ASTM D5296ASTMStandard Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography
ASTM D5386ASTMStandard Test Method for Color of Liquids Using Tristimulus Colorimetry
ASTM D5470ASTMStandard Test Method for Thermal Transmission Properties of Thermally Conductive Electrical Insulation Materials
ASTM D5492-10ASTMStandard Test Method for Determination of Xylene Solubles in Propylene Plastics
ASTM D5511ASTMStandard Test Method for Determining Anaerobic Biodegradation of Plastic Materials Under High-Solids Anaerobic-Digestion Conditions
ASTM D5527ASTMStandard Test Method for Measurement of Hexane Extractable Content of Polyolefins
ASTM D5594ASTMStandard Test Method for Determination og the Vinyl Acetate Content of Ethylene-Vinyl Acetate (EVA) Copolymers by Fourier Transform Infrared Spectroscopy (FT-IR)
ASTM D56ASTMStandard Test Method for Flash Point by Tag Closed Cup Tester
ASTM D5630ASTMStandard Test Method for Ash Content in Plastics
ASTM D570ASTMStandard Test Method for Water Absorption of Plastics
ASTM D5736ASTMStandard Test Method for Thickness of Highloft Nonwoven Fabrics (Withdrawn 2008)
ASTM D5739ASTMStandard Practice for Oil Spill Source Identification by Gas Chromatography and Positive Ion Electron Impact Low Resolution Mass Spectrometry
ASTM D575ASTMStandard Test Methods for Rubber Properties in Compression
ASTM D5845ASTMStandard Test Method for Determination of MTBE, ETBE, TAME, DIPE, Methanol, Ethanol and tert-Butanol in Gasoline by Infrared Spectroscopy
ASTM D5868ASTMStandard Test Method for Lap Shear Adhesion for Fiber Reinforced Plastic (FRP) Bonding
ASTM D5946ASTMStandard Test Method for Corona-Treated Polymer Films Using Water Contact Angle Measurements
ASTM D6110ASTMStandard Test Method for Determining the Charpy Impact Resistance of Notched Specimens of Plastics
ASTM D6130ASTMStandard Test Method for Determination of Silicon and Other Elements in Engine Coolant by Inductively Coupled Plasma-Atomic Emission Spectroscopy
ASTM D624ASTMStandard Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers
ASTM D6271-04ASTMStandard Test Method for Estimating Contribution of Environmental Tobacco Smoke to Respirable Suspended Particles Based on Solanesol
ASTM D6304ASTMStandard Test Method for Determination of Water in Petroleum Products, Lubricating Oils, and Additives by Coulometric Karl Fischer Titration
ASTM D6370-99ASTMStandard Test Method for Rubber—Compositional Analysis by Thermogravimetry (TGA)
ASTM D638ASTMStandard Test Method for Tensile Properties of Plastics
ASTM D6417ASTMStandard Test Method for Estimation of Engine Oil Volatility by Capillary Gas Chromatography
ASTM D6474-12ASTMStandard Test Method for Determining Molecular Weight Distribution and Molecular Weight Averages of Polyolefins by High Temperature Gel Permeation Chromatography
ASTM D648ASTMStandard Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position
ASTM D6556-10ASTMStandard Test Method for Carbon Black—Total and External Surface Area by Nitrogen Adsorption
ASTM D6730ASTMStandard Test Method for Determination of Individual Components in Spark Ignition Engine Fuels by 100–Metre Capillary (with Precolumn) High-Resolution Gas Chromatography
ASTM D6845 -12ASTMStandard Test Method for Silica, Precipitated, Hydrated—CTAB (Cetyltrimethylammonium Bromide) Surface Area
ASTM D6869ASTMStandard Test Method for Coulometric and Volumetric Determination of Moisture in Plastics Using the Karl Fischer Reaction (the Reaction of Iodine with Water)
ASTM D695ASTMStandard Test Method for Compressive Properties of Rigid Plastics
ASTM D7028ASTMStandard Test Method for Glass Transition Temperature (DMA Tg) of Polymer Matrix Composites by Dynamic Mechanical Analysis (DMA)
ASTM D7169ASTMStandard Test Method for Boiling Point Distribution of Samples with Residues Such as Crude Oils and Atmospheric and Vacuum Residues by High Temperature Gas Chromatography
ASTM D7252ASTMStandard Test Method for Polyurethane Raw Materials: Determination of Monomer and Isomers in Isocyanates
ASTM D7253-06ASTMStandard Test Method for Polyurethane Raw Materials: Determination of Acidity as Acid Number for Polyether Polyols
ASTM D7271-06ASTMStandard Test Method for Viscoelastic Properties of Paste Ink Vehicle Using an Oscillatory Rheometer
ASTM D7334ASTMStandard Practice for Surface Wettability of Coatings, Substrates and Pigments by Advancing Contact Angle Measurement
ASTM D7359ASTMStandard Test Method for Total Fluorine, Chlorine and Sulfur in Aromatic Hydrocarbons and Their Mixtures by Oxidative Pyrohydrolytic Combustion followed by Ion Chromatography Detection (Combustion Ion Chromatography-CIC)
ASTM D7371ASTMStandard Test Method for Determination of Biodiesel (Fatty Acid Methyl Esters) Content in Diesel Fuel Oil Using Mid Infrared Spectroscopy (FTIR-ATR-PLS Method)
ASTM D7394-18ASTMStandard Practice for Rheological Characterization of Architectural Coatings using Three Rotational Bench Viscometers
ASTM D7409ASTMStandard Test Method for Carboxyl End Group Content of Polyethylene Terephthalate (PET) Yarns
ASTM D7419-07ASTMStandard Test Method for Determination of Total Aromatics and Total Saturates in Lube Basestocks by High Performance Liquid Chromatography (HPLC) with Refractive Index Detection
ASTM D746ASTMStandard Test Method for Brittleness Temperature of Plastics and Elastomers by Impact
ASTM D7771ASTMStandard Test Method for Determination of Benzo-α-Pyrene (BaP) Content in Carbon Black
ASTM D7823ASTMStandard Test Method for Determination of Low Level Phthalates in Poly (Vinyl Chloride) Plastics by Thermal Desorption—Gas Chromatography/Mass Spectrometry
ASTM D7836-13ASTMStandard Test Methods for Measurement of Yield Stress of Paints, Inks and Related Liquid Materials
ASTM D789ASTMStandard Test Methods for Determination of Solution Viscosities of Polyamide (PA)
ASTM D790ASTMStandard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
ASTM D792ASTMStandard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
ASTM D86ASTMStandard Test Method for Distillation of Petroleum Products and Liquid Fuels at Atmospheric Pressure
ASTM D865ASTMStandard Test Method for Rubber—Deterioration by Heating in Air (Test Tube Enclosure)
ASTM D882ASTMStandard Test Method for Tensile Properties of Thin Plastic Sheeting
ASTM D903ASTMStandard Test Method for Peel or Stripping Strength of Adhesive Bonds
ASTM D92ASTMStandard Test Method for Flash and Fire Points by Cleveland Open Cup Tester
CEFIC - H2O2 7157EUHydrogen Peroxide for Industrial Use Determination of Hydrogen Peroxide Content Titrimetric Method
CEFIC - H2O2 7161EUHydrogen Peroxide for Industrial Use Stability Test Determination of Percentage Loss of Hydrogen Peroxide after 16h at 96°
CEFIC H2O2 7160EUHydrogen Peroxide for Industrial Use Determination of Apparent pH (pHa) Potentiometric Method
EN 1860-2EUAppliances, Solid Fuels and Firelighters for Barbecueing -- Part 2: Barbecue Charcoal and Barbecue Charcoal Briquettes. Requirements and Test Methods
FDA 176.170FDAComponents of paper and paperboard in contact with aqueous and fatty foods
FDA 177.1810FDAStyrene block polymers
IEC 60250IECRecommended methods for the determination of the permittivity and dielectric dissipation factor of electrical insulating materials at power, audio and radio frequencies including metre wavelengths *Withdrawn; Replaced by IEC 62631-2-1:2018
IEC 62631-2IECDielectric and resistive properties of solid insulating materials - Part 2-1: Relative permittivity and dissipation factor - Technical Frequencies (0,1 Hz - 10 MHz) - AC Methods
ISO 1133ISOPlastics -- Determination of the melt mass-flow rate (MFR) and melt volume-flow rate (MVR) of thermoplastics -- Part 2: Method for materials sensitive to time-temperature history and/or moisture
ISO 11443ISOPlastics -- Determination of the fluidity of plastics using capillary and slit-die rheometers
ISO 178ISOPlastics -- Determination of flexural properties
ISO 180ISOPlastics -- Determination of Izod impact strength
ISO 4892-2ISOPlastics -- Methods of exposure to laboratory light sources -- Part 2: Xenon-arc lamps
ISO 527ISOPlastics -- Determination of tensile properties -- Part 1: General principles
MIL-STD-2041EMILControl of Detrimental Materials
MIL-STD-417MILClassification System and Tests for Solid Elastomeric Materials
UL 1581ULReference Standard for Electrical Wires, Cables, and Flexible Cords
UL 94ULStandard for Tests for Flammability of Plastic Materials for Parts in Devices and Appliances
USP 787USPSubvisible Particulate Matter in Therapeutic Protein Injections
USP 788USPParticulate Matter in Injections
USP 789USPParticulate Matter in Ophathalmic Solutions
ISO 10993ISOBiological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
USP 661USPPlastic Packaging Systems and Their Materials of Construction
USP 232USPElemental Impurities -- Limits
USP 233USPElemental Impurities -- Procedures
USP 467USPResidual Solvents
USP 661.2USPPlastic Packaging Systems for Pharmaceutical Use
USP 661.3USPPlastic Components and Systems Used in Pharmaceutical Manufacturing
USP 671USPContainers—Performance Testing
ASTM D93ASTMStandard Test Methods for Flash Point by Pensky-Martens Closed Cup Tester
ASTM D94ASTMStandard Test Methods for Saponification Number of Petroleum Products
ASTM D974ASTMStandard Test Method for Acid and Base Number by Color-Indicator Titration
ASTM E 1147ASTMStandard Test Method for Partition Coefficient (N-Octanol/Water) Estimation by Liquid Chromatography (Withdrawn 2013) *Withdrawn, No Replacement
ASTM E1064ASTMStandard Test Method for Water in Organic Liquids by Coulometric Karl Fischer Titration
ASTM E1131ASTMStandard Test Method for Compositional Analysis by Thermogravimetry
ASTM E1147ASTMStandard Test Method for Partition Coefficient (N-Octanol/Water) Estimation by Liquid Chromatography (Withdrawn 2013) *Withdrawn, No Replacement
ASTM E1226ASTMStandard Test Method for Explosibility of Dust Clouds
ASTM E1269ASTMStandard Test Method for Determining Specific Heat Capacity by Differential Scanning Calorimetry
ASTM E1530ASTMStandard Test Method for Evaluating the Resistance to Thermal Transmission of Materials by the Guarded Heat Flow Meter Technique
ASTM E1615ASTMStandard Test Method for Iron in Trace Quantities Using the FerroZine Method
ASTM E1868ASTMStandard Test Method for Loss-On-Drying by Thermogravimetry
ASTM E1899ASTMStandard Test Method for Hydroxyl Groups Using Reaction with p-Toluenesulfonyl Isocyanate (TSI) and Potentiometric Titration with Tetrabutylammonium Hydroxide
ASTM E1952ASTMStandard Test Method for Thermal Conductivity and Thermal Diffusivity by Modulated Temperature Differential Scanning Calorimetry
ASTM E202ASTMStandard Test Methods for Analysis of Ethylene Glycols and Propylene Glycols
ASTM E2160ASTMStandard Test Method for Heat of Reaction of Thermally Reactive Materials by Differential Scanning Calorimetry
ASTM E2193ASTMStandard Test Method for Ultraviolet Transmittance of Monoethylene Glycol (using Ultraviolet Spectrophotometry)
ASTM E222ASTMStandard Test Methods for Hydroxyl Groups Using Acetic Anhydride Acetylation
ASTM E2313ASTMStandard Test Method for Aldehydes in Mono-, Di-, and Triethylene Glycol (using Spectrophotometry)
ASTM E2409ASTMStandard Test Method for Glycol Impurities in Mono-, Di-, Tri- and Tetraethylene Glycol and in Mono- and Dipropylene Glycol(Gas Chromatographic Method)
ASTM E2469ASTMStandard Test Method for Chloride in Mono-, Di- and Tri-ethylene Glycol by Ion Chromatography
ASTM E2550 -11ASTMStandard Test Method for Thermal Stability by Thermogravimetry
ASTM E2716ASTMStandard Test Method for Determining Specific Heat Capacity by Sinusoidal Modulated Temperature Differential Scanning Calorimetry
ASTM E308ASTMStandard Practice for Computing the Colors of Objects by Using the CIE System
ASTM E321ASTMStandard Test Method for Atom Percent Fission in Uranium and Plutonium Fuel (Neodymium-148 Method)
ASTM E398ASTMStandard Test Method for Water Vapor Transmission Rate of Sheet Materials Using Dynamic Relative Humidity Measurement
ASTM E659ASTMStandard Test Method for Autoignition Temperature of Chemicals
ASTM E681ASTMStandard Test Method for Concentration Limits of Flammability of Chemicals (Vapors and Gases)
ASTM E711ASTMStandard Test Method for Gross Calorific Value of Refuse-Derived Fuel by the Bomb Calorimeter
ASTM E8ASTMStandard Test Methods forTension Testing of Metallic Materials
ASTM E831ASTMStandard Test Method for Linear Thermal Expansion of Solid Materials by Thermomechanical Analysis
ASTM E84ASTMStandard Test Method for Surface Burning Characteristics of Building Materials
ASTM E86ASTMMethods for Chemical Analysis of Antimony (Withdrawn 1983) *Withdrawn, No Replacement
ASTM E96ASTMStandard Test Methods for Water Vapor Transmission of Materials
ASTM F1249ASTMStandard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor
ASTM F1349-08ASTMStandard Test Method for Nonvolatile Ultraviolet (UV) Absorbing Extractables from Microwave Susceptors
ASTM F1927ASTMStandard Test Method for Determination of Oxygen Gas Transmission Rate, Permeability and Permeance at Controlled Relative Humidity Through Barrier Materials Using a Coulometric Detector
ASTM F1980ASTMStandard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F2024ASTMStandard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
EN 1186-3EUMaterials and Articles in Contact with foodstuffs -- Plastics -- Part 3: Test Methods for overall migration into aqueous food simulants by total immersion
FDA 177.1380FDASubstances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces
ASTM F2214-02ASTMStandard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
ASTM F2602-08ASTMStandard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)
ASTM F2902ASTMStandard Guide for Assessment of Absorbable Polymeric Implants
EPA 8260bEPAVolatile Organic Compounds by Gas Chromatography Mass Spectrometry (GC/MS)
EPA 5021AEPAVolatile Organic Compounds in Various Sample Matrices Using Equilibrium Headspace Analysis
ISO 307ISOPlastics -- Polyamides -- Determination of Viscosity Number
ISO 1628-1ISOPlastics — Determination of the viscosity of polymers in dilute solution using capillary viscometers —
ISO 6427ISOPlastics -- Determination of matter extractable by organic solvents (conventional methods)
ISO 8536-4ISOInfusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
ISO 11357ISOPlastics – Differential scanning calorimetry (DSC) Part 1:General principles (ISO 11357-1 : 1997)
ISO 11979-2ISOOphthalmic implants — Intraocular lenses —Part 2: Optical properties and test methods
ISO 11979-5ISOOphthalmic implants — Intraocular lenses — Part 5: Biocompatibility
ISO 16000-6ISOIndoor air — Part 6: Determination of volatile organic compounds in indoor and test chamber air by active sampling on Tenax TAâ sorbent, thermal desorption and gas chromatography using MS or MS-FID
ISO 16014-4ISOPlastics — Determination of average molecular mass and molecular mass distribution of polymers using size-exclusion chromatography —Part 4: High-temperature method
ISO 18562-3ISOBiocompatibility evaluation of breathing gas pathways in healthcare applications —Part 3: Tests for emissions of volatile organic compounds (VOCs)
ISO 29941ISOCondoms -- Determination of Nitrosamines Migrating from Natural Rubber Latex Condoms
ISO 7864ISOSterile hypodermic needles for single use — Requirements and test methods
ISO 9626ISOStainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
ISO 20795-1ISODentistry — Base polymers —Part 1: Denture base polymers
ISO 1183-3ISOPlastics — Methods for determining thedensity of non-cellular plastics —Part 3:Gas pyknometer method
ISO 10993-9ISOBiological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
ISO 10993-12ISOBiological evaluation of medical devices —Part 12: Sample preparation and reference materials
ISO 10993-13ISOBiological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-17ISOBiological evaluation of medical devices —Part 17: Establishment of allowable limits for leachable substances
ISO 10993-18ISOBiological evaluation of medical devices — Part 18: Chemical characterization of materials
ISO 3960ISORadiometer analytical iodometric titration metod (ISO 3960)
ASTM F312ASTMStandard Test Methods for Microscopical Sizing and Counting Particles from Aerospace Fluids on Membrane Filters
ASTM F88ASTMStandard Test Method for Seal Strength of Flexible Barrier Materials
ISO 11040-5ISOPreilled syringes —Part 5: Plunger stoppers for injectables
USP 40-NF 35USPValidation of Compendial Procedures
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