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:
- Extractables & Leachables
- Medical Devices Testing
- Toxicology Services & Consultation
- Elemental Impurities
- Particulate Analysis
- Surgical Instrument Cleaning Analysis
- Efficacy Studies
- Cleaning Validation
- Compendial Testing
- Ethylene Oxide Residual Analysis
- Storage/Stability Testing
- Accelerated Aging
- Forced Degradation
- Photostability
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:
- EN 13130 – Materials and Articles in Contact With Foodstuffs
- EN 1186 – Migration in Foodstuffs
- EU 10-2011 – Plastic Guidance With Food
Read case studies from some of our previous regulatory work:
- Polymer Deformulation of a Urinary Bag
- Extractables & Leachables
- Identify USP 232 Impurities in Drug Delivery Systems
Please contact us to find out more about our range of regulatory testing experience.
Standards we work with:
| Standard | Category | Description |
|---|---|---|
| ASTM 1120 | ASTM | Standard Test Method for Boiling Point of Engine Coolants |
| ASTM 2214-02 | ASTM | Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE) |
| ASTM 2605 | ASTM | Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection |
| ASTM 3148 | ASTM | Standard Test Method for Elastic Moduli of Intact Rock Core Specimens in Uniaxial Compression |
| ASTM 3418 | ASTM | Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry |
| ASTM B923 | ASTM | Standard Test Method for Metal Powder Skeletal Density by Helium or Nitrogen Pycnometry |
| ASTM C1749 | ASTM | Standar Guide for Measurment of the Rheological Properties of Hyraulic Cementious Paste Using a Rotational Rheometer |
| ASTM C25-31 | ASTM | Standard Test Methods for Chemical Analysis of Limestone, Quicklime, and Hydrated Lime |
| ASTM C518 | ASTM | Standard Test Method for Steady-State Thermal Transmission Properties by Means of the Heat Flow Meter Apparatus |
| ASTM D 217-02 | ASTM | Standard Test Methods for Cone Penetration of Lubricating Grease |
| ASTM D 301 | ASTM | Standard Test Methods for Soluble Cellulose Nitrate |
| ASTM D1003 | ASTM | Standard Test Method for Haze and Luminous Transmittance of Transparent Plastics |
| ASTM D1004 | ASTM | Standard Test Method for Tear Resistance (Graves Tear) of Plastic Film and Sheeting |
| ASTM D1042 | ASTM | Standard Test Method for Linear Dimensional Changes of Plastics Caused by Exposure to Heat and Moisture |
| ASTM D1078 | ASTM | Standard Test Method for Distillation Range of Volatile Organic Liquids |
| ASTM D1125 | ASTM | Standard Test Methods for Electrical Conductivity and Resistivity of Water |
| ASTM D1149 | ASTM | Standard Test Methods for Rubber Deterioration—Cracking in an Ozone Controlled Environment |
| ASTM D117 | ASTM | Standard Guide for Sampling, Test Methods, and Specifications for Electrical Insulating Liquids |
| ASTM D1177 | ASTM | Standard Test Method for Freezing Point of Aqueous Engine Coolants |
| ASTM D1209 | ASTM | Standard Test Method for Color of Clear Liquids |
| ASTM D1238 | ASTM | Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer |
| ASTM D1269 | ASTM | Method of Test for Lead Antiknock Compounds in Gasoline |
| ASTM D1287 | ASTM | Standard Test Method for pH of Engine Coolants and Antirusts |
| ASTM D1298 | ASTM | Standard Test Method for Density, Relative Density, or API Gravity of Crude Petroleum and Liquid Petroleum Products by Hydrometer Method |
| ASTM D1335 | ASTM | Standard Test Method for Tuft Bind of Pile Yarn Floor Coverings |
| ASTM D1403 | ASTM | Standard Test Methods for Cone Penetration of Lubricating Grease Using One-Quarter and One-Half Scale Cone Equipment |
| ASTM D1434 | ASTM | Standard Test Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting |
| ASTM D1439 | ASTM | Standard Test Methods for Sodium Carboxymethylcellulose |
| ASTM D1475 | ASTM | Standard Test Method For Density of Liquid Coatings, Inks, and Related Products |
| ASTM D149 | ASTM | Standard Test Method for Dielectric Breakdown Voltage and Dielectric Strength of Solid Electrical Insulating Materials at Commercial Power Frequencies |
| ASTM D150 | ASTM | Standard Test Methods for AC Loss Characteristics and Permittivity (Dielectric Constant) of Solid Electrical Insulation |
| ASTM D1525 | ASTM | Standard Test Method for Vicat Softening Temperature of Plastics |
| ASTM D153 | ASTM | Standard Test Methods for Specific Gravity of Pigments |
| ASTM D1599 | ASTM | Standard Test Method for Resistance to Short-Time Hydraulic Pressure of Plastic Pipe, Tubing, and Fittings |
| ASTM D1613 | ASTM | Standard Test Method for Acidity in Volatile Solvents and Chemical Intermediates Used in Paint, Varnish, Lacquer, and Related Products |
| ASTM D1652 | ASTM | Standard Test Method for Epoxy Content of Epoxy Resins |
| ASTM D1708 | ASTM | Standard Test Method for Tensile Properties of Plastics by Use of Microtensile Specimens |
| ASTM D1709 | ASTM | Standard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method |
| ASTM D1722 | ASTM | Standard Test Method for Water Miscibility of Water-Soluble Solvents |
| ASTM D1762 | ASTM | Standard Test Method for Chemical Analysis of Wood Charcoal |
| ASTM D1876 | ASTM | Standard Test Method for Peel Resistance of Adhesives (T-Peel Test) |
| ASTM D1894 | ASTM | Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting |
| ASTM D1907 | ASTM | Standard Test Method for Linear Density of Yarn (Yarn Number) by the Skein Method |
| ASTM D1922 | ASTM | Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method |
| ASTM D2007 | ASTM | Standard Test Method for Characteristic Groups in Rubber Extender and Processing Oils and Other Petroleum-Derived Oils by the Clay-Gel Absorption Chromatographic Method |
| ASTM D2116 | ASTM | Standard Specification for FEP Resin Molding and Extrusion Materials |
| ASTM D2122 | ASTM | Standard Test Method for Determining Dimensions of Thermoplastic Pipe and Fittings |
| ASTM D2137 | ASTM | Standard Test Methods for Rubber Property—Brittleness Point of Flexible Polymers and Coated Fabrics |
| ASTM D222 | ASTM | Standards and Specifications for Nonmetallic Minerals and Their Products |
| ASTM D2222 | ASTM | Standard Test Method for Methanol Extract of Vinyl Chloride Resins |
| ASTM D2236 | ASTM | Standard Method Of Test For Dynamic Mechanical Properties Of Plastics By Means Of A Torsional Pendulum |
| ASTM D2240 | ASTM | Standard Test Method for Rubber Property—Durometer Hardness |
| ASTM D2256 | ASTM | Standard Test Method for Tensile Properties of Yarns by the Single-Strand Method |
| ASTM D2393 | ASTM | Test Method for Viscosity of Epoxy Resins and Related Components *Withdrawn, No Replacement |
| ASTM D2425 | ASTM | Standard Test Method for Hydrocarbon Types in Middle Distillates by Mass Spectrometry |
| ASTM D2515 | ASTM | Standard Specification for Kinematic Glass Viscometers |
| ASTM D256 | ASTM | Standard Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics |
| ASTM D257 | ASTM | Standard Test Methods for DC Resistance or Conductance of Insulating Materials |
| ASTM D2709 | ASTM | Standard Test Method for Water and Sediment in Middle Distillate Fuels by Centrifuge |
| ASTM D2765 | ASTM | Standard Test Methods for Determination of Gel Content and Swell Ratio of Crosslinked Ethylene Plastics |
| ASTM D2839 | ASTM | Use of a Melt Index Strand for Determining Density of Polyethylene |
| ASTM D2857 | ASTM | Standard Practice for Dilute Solution Viscosity of Polymers |
| ASTM D2887 | ASTM | Standard Test Method for Boiling Range Distribution of Petroleum Fractions by Gas Chromatography |
| ASTM D2896 | ASTM | Standard Test Method for Base Number of Petroleum Products by Potentiometric Perchloric Acid Titration |
| ASTM D2902 | ASTM | Standard Specification for Fluoropolymer Resin Heat-Shrinkable Tubing for Electrical Insulation |
| ASTM D1002 | ASTM | Standard Test Method for Apparent Shear Strength of Single-Lap-Joint Adhesively Bonded Metal Specimens by Tension Loading (Metal-to-Metal) |
| ASTM D3218-07 | ASTM | Standard Specification for Polyolefin Monofilaments |
| ASTM D3278 | ASTM | Standard Test Methods for Flash Point of Liquids by Small Scale Closed-Cup Apparatus |
| ASTM D3418 | ASTM | Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry |
| ASTM D3616-95 | ASTM | Standard Test Method for Rubber -- Determination of Gel, Swelling Index, and Dilute Solution Viscosity |
| ASTM D374-99 | ASTM | Standard Test Methods for Thickness of Solid Electrical Insulation |
| ASTM D3763 | ASTM | Standard Test Method for High Speed Puncture Properties of Plastics Using Load and Displacement Sensors |
| ASTM D3828 | ASTM | Standard Test Methods for Flash Point by Small Scale Closed Cup Tester |
| ASTM D3835 | ASTM | Standard Test Method for Determination of Properties of Polymeric Materials by Means of a Capillary Rheometer |
| ASTM D3849 | ASTM | Standard Test Method for Carbon Black—Morphological Characterization of Carbon Black Using Electron Microscopy |
| ASTM D3895 | ASTM | Standard Test Method for Oxidative-Induction Time of Polyolefins by Differential Scanning Calorimetry |
| ASTM D3985 | ASTM | Standard Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using a Coulometric Sensor |
| ASTM D4017-02 | ASTM | Standard Test Method for Water in Paints and Paint Materals by Karl Fischer Method |
| ASTM D4052 | ASTM | Standard Test Method for Density, Relative Density, and API Gravity of Liquids by Digital Density Meter |
| ASTM D4065 | ASTM | Standard Practice for Plastics: Dynamic Mechanical Properties: Determination and Report of Procedures |
| ASTM D412 | ASTM | Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension |
| ASTM D4176 | ASTM | Standard Test Method for Free Water and Particulate Contamination in Distillate Fuels (Visual Inspection Procedures) |
| ASTM D422 | ASTM | Standard Guide for Selection of Methods of Particle Size Analysis of Fluvial Sediments (Manual Methods) |
| ASTM D4274 | ASTM | Standard Test Methods for Testing Polyurethane Raw Materials: Determination of Hydroxyl Numbers of Polyols |
| ASTM D4441 | ASTM | Standard Specification for Aqueous Dispersions of Polytetrafluoroethylene |
| ASTM D445 | ASTM | Standard Test Method for Kinematic Viscosity of Transparent and Opaque Liquids (and Calculation of Dynamic Viscosity) |
| ASTM D4488 | ASTM | Standard Guide for Testing Cleaning Performance of Products Intended for Use on Resilient Flooring and Washable Walls |
| ASTM D4603 | ASTM | Standard Test Method for Determining Inherent Viscosity of Poly(Ethylene Terephthalate) (PET) by Glass Capillary Viscometer |
| ASTM D4662 | ASTM | Standard Test Methods for Polyurethane Raw Materials: Determination of Acid and Alkalinity Numbers of Polyols |
| ASTM D471 | ASTM | Standard Test Method for Rubber Property—Effect of Liquids |
| ASTM D473-07 | ASTM | Standard Test Method for Sediment in Crude Oils and Fuel Oils by the Extraction Method |
| ASTM D482 | ASTM | Standard Test Method for Ash from Petroleum Products |
| ASTM D4883 | ASTM | Standard Test Method for Density of Polyethylene by the Ultrasound Technique |
| ASTM D4980 | ASTM | Standard Test Methods for Screening of pH in Waste |
| ASTM D5035 | ASTM | Standard Test Method for Breaking Force and Elongation of Textile Fabrics (Strip Method) |
| ASTM D5155 | ASTM | Standard Test Methods for Polyurethane Raw Materials: Determination of the Isocyanate Content of Aromatic Isocyanates |
| ASTM D5225 | ASTM | Standard Test Method for Measuring Solution Viscosity of Polymers with a Differential Viscometer |
| ASTM D5227 | ASTM | Standard Test Method for Measurement of Hexane Extractable Content of Polyolefins |
| ASTM D5292 | ASTM | Standard Test Method for Aromatic Carbon Contents of Hydrocarbon Oils by High Resolution Nuclear Magnetic Resonance Spectroscopy |
| ASTM D5296 | ASTM | Standard Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography |
| ASTM D5386 | ASTM | Standard Test Method for Color of Liquids Using Tristimulus Colorimetry |
| ASTM D5470 | ASTM | Standard Test Method for Thermal Transmission Properties of Thermally Conductive Electrical Insulation Materials |
| ASTM D5492-10 | ASTM | Standard Test Method for Determination of Xylene Solubles in Propylene Plastics |
| ASTM D5511 | ASTM | Standard Test Method for Determining Anaerobic Biodegradation of Plastic Materials Under High-Solids Anaerobic-Digestion Conditions |
| ASTM D5527 | ASTM | Standard Test Method for Measurement of Hexane Extractable Content of Polyolefins |
| ASTM D5594 | ASTM | Standard Test Method for Determination og the Vinyl Acetate Content of Ethylene-Vinyl Acetate (EVA) Copolymers by Fourier Transform Infrared Spectroscopy (FT-IR) |
| ASTM D56 | ASTM | Standard Test Method for Flash Point by Tag Closed Cup Tester |
| ASTM D5630 | ASTM | Standard Test Method for Ash Content in Plastics |
| ASTM D570 | ASTM | Standard Test Method for Water Absorption of Plastics |
| ASTM D5736 | ASTM | Standard Test Method for Thickness of Highloft Nonwoven Fabrics (Withdrawn 2008) |
| ASTM D5739 | ASTM | Standard Practice for Oil Spill Source Identification by Gas Chromatography and Positive Ion Electron Impact Low Resolution Mass Spectrometry |
| ASTM D575 | ASTM | Standard Test Methods for Rubber Properties in Compression |
| ASTM D5845 | ASTM | Standard Test Method for Determination of MTBE, ETBE, TAME, DIPE, Methanol, Ethanol and tert-Butanol in Gasoline by Infrared Spectroscopy |
| ASTM D5868 | ASTM | Standard Test Method for Lap Shear Adhesion for Fiber Reinforced Plastic (FRP) Bonding |
| ASTM D5946 | ASTM | Standard Test Method for Corona-Treated Polymer Films Using Water Contact Angle Measurements |
| ASTM D6110 | ASTM | Standard Test Method for Determining the Charpy Impact Resistance of Notched Specimens of Plastics |
| ASTM D6130 | ASTM | Standard Test Method for Determination of Silicon and Other Elements in Engine Coolant by Inductively Coupled Plasma-Atomic Emission Spectroscopy |
| ASTM D624 | ASTM | Standard Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers |
| ASTM D6271-04 | ASTM | Standard Test Method for Estimating Contribution of Environmental Tobacco Smoke to Respirable Suspended Particles Based on Solanesol |
| ASTM D6304 | ASTM | Standard Test Method for Determination of Water in Petroleum Products, Lubricating Oils, and Additives by Coulometric Karl Fischer Titration |
| ASTM D6370-99 | ASTM | Standard Test Method for Rubber—Compositional Analysis by Thermogravimetry (TGA) |
| ASTM D638 | ASTM | Standard Test Method for Tensile Properties of Plastics |
| ASTM D6417 | ASTM | Standard Test Method for Estimation of Engine Oil Volatility by Capillary Gas Chromatography |
| ASTM D6474-12 | ASTM | Standard Test Method for Determining Molecular Weight Distribution and Molecular Weight Averages of Polyolefins by High Temperature Gel Permeation Chromatography |
| ASTM D648 | ASTM | Standard Test Method for Deflection Temperature of Plastics Under Flexural Load in the Edgewise Position |
| ASTM D6556-10 | ASTM | Standard Test Method for Carbon Black—Total and External Surface Area by Nitrogen Adsorption |
| ASTM D6730 | ASTM | Standard Test Method for Determination of Individual Components in Spark Ignition Engine Fuels by 100–Metre Capillary (with Precolumn) High-Resolution Gas Chromatography |
| ASTM D6845 -12 | ASTM | Standard Test Method for Silica, Precipitated, Hydrated—CTAB (Cetyltrimethylammonium Bromide) Surface Area |
| ASTM D6869 | ASTM | Standard Test Method for Coulometric and Volumetric Determination of Moisture in Plastics Using the Karl Fischer Reaction (the Reaction of Iodine with Water) |
| ASTM D695 | ASTM | Standard Test Method for Compressive Properties of Rigid Plastics |
| ASTM D7028 | ASTM | Standard Test Method for Glass Transition Temperature (DMA Tg) of Polymer Matrix Composites by Dynamic Mechanical Analysis (DMA) |
| ASTM D7169 | ASTM | Standard 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 D7252 | ASTM | Standard Test Method for Polyurethane Raw Materials: Determination of Monomer and Isomers in Isocyanates |
| ASTM D7253-06 | ASTM | Standard Test Method for Polyurethane Raw Materials: Determination of Acidity as Acid Number for Polyether Polyols |
| ASTM D7271-06 | ASTM | Standard Test Method for Viscoelastic Properties of Paste Ink Vehicle Using an Oscillatory Rheometer |
| ASTM D7334 | ASTM | Standard Practice for Surface Wettability of Coatings, Substrates and Pigments by Advancing Contact Angle Measurement |
| ASTM D7359 | ASTM | Standard 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 D7371 | ASTM | Standard Test Method for Determination of Biodiesel (Fatty Acid Methyl Esters) Content in Diesel Fuel Oil Using Mid Infrared Spectroscopy (FTIR-ATR-PLS Method) |
| ASTM D7394-18 | ASTM | Standard Practice for Rheological Characterization of Architectural Coatings using Three Rotational Bench Viscometers |
| ASTM D7409 | ASTM | Standard Test Method for Carboxyl End Group Content of Polyethylene Terephthalate (PET) Yarns |
| ASTM D7419-07 | ASTM | Standard Test Method for Determination of Total Aromatics and Total Saturates in Lube Basestocks by High Performance Liquid Chromatography (HPLC) with Refractive Index Detection |
| ASTM D746 | ASTM | Standard Test Method for Brittleness Temperature of Plastics and Elastomers by Impact |
| ASTM D7771 | ASTM | Standard Test Method for Determination of Benzo-α-Pyrene (BaP) Content in Carbon Black |
| ASTM D7823 | ASTM | Standard Test Method for Determination of Low Level Phthalates in Poly (Vinyl Chloride) Plastics by Thermal Desorption—Gas Chromatography/Mass Spectrometry |
| ASTM D7836-13 | ASTM | Standard Test Methods for Measurement of Yield Stress of Paints, Inks and Related Liquid Materials |
| ASTM D789 | ASTM | Standard Test Methods for Determination of Solution Viscosities of Polyamide (PA) |
| ASTM D790 | ASTM | Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials |
| ASTM D792 | ASTM | Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement |
| ASTM D86 | ASTM | Standard Test Method for Distillation of Petroleum Products and Liquid Fuels at Atmospheric Pressure |
| ASTM D865 | ASTM | Standard Test Method for Rubber—Deterioration by Heating in Air (Test Tube Enclosure) |
| ASTM D882 | ASTM | Standard Test Method for Tensile Properties of Thin Plastic Sheeting |
| ASTM D903 | ASTM | Standard Test Method for Peel or Stripping Strength of Adhesive Bonds |
| ASTM D92 | ASTM | Standard Test Method for Flash and Fire Points by Cleveland Open Cup Tester |
| CEFIC - H2O2 7157 | EU | Hydrogen Peroxide for Industrial Use Determination of Hydrogen Peroxide Content Titrimetric Method |
| CEFIC - H2O2 7161 | EU | Hydrogen Peroxide for Industrial Use Stability Test Determination of Percentage Loss of Hydrogen Peroxide after 16h at 96° |
| CEFIC H2O2 7160 | EU | Hydrogen Peroxide for Industrial Use Determination of Apparent pH (pHa) Potentiometric Method |
| EN 1860-2 | EU | Appliances, Solid Fuels and Firelighters for Barbecueing -- Part 2: Barbecue Charcoal and Barbecue Charcoal Briquettes. Requirements and Test Methods |
| FDA 176.170 | FDA | Components of paper and paperboard in contact with aqueous and fatty foods |
| FDA 177.1810 | FDA | Styrene block polymers |
| IEC 60250 | IEC | Recommended 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 62631-2 | IEC | Dielectric 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 1133 | ISO | Plastics -- 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 11443 | ISO | Plastics -- Determination of the fluidity of plastics using capillary and slit-die rheometers |
| ISO 178 | ISO | Plastics -- Determination of flexural properties |
| ISO 180 | ISO | Plastics -- Determination of Izod impact strength |
| ISO 4892-2 | ISO | Plastics -- Methods of exposure to laboratory light sources -- Part 2: Xenon-arc lamps |
| ISO 527 | ISO | Plastics -- Determination of tensile properties -- Part 1: General principles |
| MIL-STD-2041E | MIL | Control of Detrimental Materials |
| MIL-STD-417 | MIL | Classification System and Tests for Solid Elastomeric Materials |
| UL 1581 | UL | Reference Standard for Electrical Wires, Cables, and Flexible Cords |
| UL 94 | UL | Standard for Tests for Flammability of Plastic Materials for Parts in Devices and Appliances |
| USP 787 | USP | Subvisible Particulate Matter in Therapeutic Protein Injections |
| USP 788 | USP | Particulate Matter in Injections |
| USP 789 | USP | Particulate Matter in Ophathalmic Solutions |
| ISO 10993 | ISO | Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process |
| USP 661 | USP | Plastic Packaging Systems and Their Materials of Construction |
| USP 232 | USP | Elemental Impurities -- Limits |
| USP 233 | USP | Elemental Impurities -- Procedures |
| USP 467 | USP | Residual Solvents |
| USP 661.2 | USP | Plastic Packaging Systems for Pharmaceutical Use |
| USP 661.3 | USP | Plastic Components and Systems Used in Pharmaceutical Manufacturing |
| USP 671 | USP | Containers—Performance Testing |
| ASTM D93 | ASTM | Standard Test Methods for Flash Point by Pensky-Martens Closed Cup Tester |
| ASTM D94 | ASTM | Standard Test Methods for Saponification Number of Petroleum Products |
| ASTM D974 | ASTM | Standard Test Method for Acid and Base Number by Color-Indicator Titration |
| ASTM E 1147 | ASTM | Standard Test Method for Partition Coefficient (N-Octanol/Water) Estimation by Liquid Chromatography (Withdrawn 2013) *Withdrawn, No Replacement |
| ASTM E1064 | ASTM | Standard Test Method for Water in Organic Liquids by Coulometric Karl Fischer Titration |
| ASTM E1131 | ASTM | Standard Test Method for Compositional Analysis by Thermogravimetry |
| ASTM E1147 | ASTM | Standard Test Method for Partition Coefficient (N-Octanol/Water) Estimation by Liquid Chromatography (Withdrawn 2013) *Withdrawn, No Replacement |
| ASTM E1226 | ASTM | Standard Test Method for Explosibility of Dust Clouds |
| ASTM E1269 | ASTM | Standard Test Method for Determining Specific Heat Capacity by Differential Scanning Calorimetry |
| ASTM E1530 | ASTM | Standard Test Method for Evaluating the Resistance to Thermal Transmission of Materials by the Guarded Heat Flow Meter Technique |
| ASTM E1615 | ASTM | Standard Test Method for Iron in Trace Quantities Using the FerroZine Method |
| ASTM E1868 | ASTM | Standard Test Method for Loss-On-Drying by Thermogravimetry |
| ASTM E1899 | ASTM | Standard Test Method for Hydroxyl Groups Using Reaction with p-Toluenesulfonyl Isocyanate (TSI) and Potentiometric Titration with Tetrabutylammonium Hydroxide |
| ASTM E1952 | ASTM | Standard Test Method for Thermal Conductivity and Thermal Diffusivity by Modulated Temperature Differential Scanning Calorimetry |
| ASTM E202 | ASTM | Standard Test Methods for Analysis of Ethylene Glycols and Propylene Glycols |
| ASTM E2160 | ASTM | Standard Test Method for Heat of Reaction of Thermally Reactive Materials by Differential Scanning Calorimetry |
| ASTM E2193 | ASTM | Standard Test Method for Ultraviolet Transmittance of Monoethylene Glycol (using Ultraviolet Spectrophotometry) |
| ASTM E222 | ASTM | Standard Test Methods for Hydroxyl Groups Using Acetic Anhydride Acetylation |
| ASTM E2313 | ASTM | Standard Test Method for Aldehydes in Mono-, Di-, and Triethylene Glycol (using Spectrophotometry) |
| ASTM E2409 | ASTM | Standard Test Method for Glycol Impurities in Mono-, Di-, Tri- and Tetraethylene Glycol and in Mono- and Dipropylene Glycol(Gas Chromatographic Method) |
| ASTM E2469 | ASTM | Standard Test Method for Chloride in Mono-, Di- and Tri-ethylene Glycol by Ion Chromatography |
| ASTM E2550 -11 | ASTM | Standard Test Method for Thermal Stability by Thermogravimetry |
| ASTM E2716 | ASTM | Standard Test Method for Determining Specific Heat Capacity by Sinusoidal Modulated Temperature Differential Scanning Calorimetry |
| ASTM E308 | ASTM | Standard Practice for Computing the Colors of Objects by Using the CIE System |
| ASTM E321 | ASTM | Standard Test Method for Atom Percent Fission in Uranium and Plutonium Fuel (Neodymium-148 Method) |
| ASTM E398 | ASTM | Standard Test Method for Water Vapor Transmission Rate of Sheet Materials Using Dynamic Relative Humidity Measurement |
| ASTM E659 | ASTM | Standard Test Method for Autoignition Temperature of Chemicals |
| ASTM E681 | ASTM | Standard Test Method for Concentration Limits of Flammability of Chemicals (Vapors and Gases) |
| ASTM E711 | ASTM | Standard Test Method for Gross Calorific Value of Refuse-Derived Fuel by the Bomb Calorimeter |
| ASTM E8 | ASTM | Standard Test Methods forTension Testing of Metallic Materials |
| ASTM E831 | ASTM | Standard Test Method for Linear Thermal Expansion of Solid Materials by Thermomechanical Analysis |
| ASTM E84 | ASTM | Standard Test Method for Surface Burning Characteristics of Building Materials |
| ASTM E86 | ASTM | Methods for Chemical Analysis of Antimony (Withdrawn 1983) *Withdrawn, No Replacement |
| ASTM E96 | ASTM | Standard Test Methods for Water Vapor Transmission of Materials |
| ASTM F1249 | ASTM | Standard Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor |
| ASTM F1349-08 | ASTM | Standard Test Method for Nonvolatile Ultraviolet (UV) Absorbing Extractables from Microwave Susceptors |
| ASTM F1927 | ASTM | Standard Test Method for Determination of Oxygen Gas Transmission Rate, Permeability and Permeance at Controlled Relative Humidity Through Barrier Materials Using a Coulometric Detector |
| ASTM F1980 | ASTM | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices |
| ASTM F2024 | ASTM | Standard Practice for X-ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings |
| EN 1186-3 | EU | Materials and Articles in Contact with foodstuffs -- Plastics -- Part 3: Test Methods for overall migration into aqueous food simulants by total immersion |
| FDA 177.1380 | FDA | Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces |
| ASTM F2214-02 | ASTM | Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE) |
| ASTM F2602-08 | ASTM | Standard 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 F2902 | ASTM | Standard Guide for Assessment of Absorbable Polymeric Implants |
| EPA 8260b | EPA | Volatile Organic Compounds by Gas Chromatography Mass Spectrometry (GC/MS) |
| EPA 5021A | EPA | Volatile Organic Compounds in Various Sample Matrices Using Equilibrium Headspace Analysis |
| ISO 307 | ISO | Plastics -- Polyamides -- Determination of Viscosity Number |
| ISO 1628-1 | ISO | Plastics — Determination of the viscosity of polymers in dilute solution using capillary viscometers — |
| ISO 6427 | ISO | Plastics -- Determination of matter extractable by organic solvents (conventional methods) |
| ISO 8536-4 | ISO | Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed |
| ISO 11357 | ISO | Plastics – Differential scanning calorimetry (DSC) Part 1:General principles (ISO 11357-1 : 1997) |
| ISO 11979-2 | ISO | Ophthalmic implants — Intraocular lenses —Part 2: Optical properties and test methods |
| ISO 11979-5 | ISO | Ophthalmic implants — Intraocular lenses — Part 5: Biocompatibility |
| ISO 16000-6 | ISO | Indoor 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 16014-4 | ISO | Plastics — Determination of average molecular mass and molecular mass distribution of polymers using size-exclusion chromatography —Part 4: High-temperature method |
| ISO 18562-3 | ISO | Biocompatibility evaluation of breathing gas pathways in healthcare applications —Part 3: Tests for emissions of volatile organic compounds (VOCs) |
| ISO 29941 | ISO | Condoms -- Determination of Nitrosamines Migrating from Natural Rubber Latex Condoms |
| ISO 7864 | ISO | Sterile hypodermic needles for single use — Requirements and test methods |
| ISO 9626 | ISO | Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods |
| ISO 20795-1 | ISO | Dentistry — Base polymers —Part 1: Denture base polymers |
| ISO 1183-3 | ISO | Plastics — Methods for determining thedensity of non-cellular plastics —Part 3:Gas pyknometer method |
| ISO 10993-9 | ISO | Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
| ISO 10993-12 | ISO | Biological evaluation of medical devices —Part 12: Sample preparation and reference materials |
| ISO 10993-13 | ISO | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| ISO 10993-17 | ISO | Biological evaluation of medical devices —Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-18 | ISO | Biological evaluation of medical devices — Part 18: Chemical characterization of materials |
| ISO 3960 | ISO | Radiometer analytical iodometric titration metod (ISO 3960) |
| ASTM F312 | ASTM | Standard Test Methods for Microscopical Sizing and Counting Particles from Aerospace Fluids on Membrane Filters |
| ASTM F88 | ASTM | Standard Test Method for Seal Strength of Flexible Barrier Materials |
| ISO 11040-5 | ISO | Preilled syringes —Part 5: Plunger stoppers for injectables |
| USP 40-NF 35 | USP | Validation of Compendial Procedures |