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Medical Device Standards Library - ASTM Collection

Description: Low Voltage Equipment - Medical Subset
The Low Voltage Directive (LVD) contains more than 140 documents and applies to electrical equipment designed for use with a voltage rating of between 50 and 1000 V for alternating current, and between 75 and 1500 V for direct current, and whose primary safety risk is of an electrical nature. Rated voltage refers to the input or output voltage of the equipment and not voltages which are generated internally. The Directive requires manufacturers to offer safety protection against electrical hazards arising from the equipment, and protection against hazards caused by external influences on the equipment. Broadly, the scope of the Directive covers goods designed to operate within those voltage limits, including electrical appliances; lighting equipment; switch gear and control gear; electric wiring; appliance couplers and cord sets; electrical installation equipment; and electrical equipment intended for incorporation into other equipment such as transformers and motors. The LVD lays down eleven “safety objectives”, which represent the essential requirements of this Directive.

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Popular Standards from this Collection.

ASTM A 370

Standard Test Methods and Definitions for Mechanical Testing of Steel Products

ASTM A 967

Standard Specification for Chemical Passivation Treatments for Stainless Steel Parts

ASTM B 117

Standard Practice for Operating Salt Spray (Fog) Apparatus

ASTM B 912

Standard Specification for Passivation of Stainless Steels Using Electropolishing

ASTM D 2240

Standard Test Method for Rubber Property-Durometer Hardness

ASTM D 3078

Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission

ASTM D 3492

Standard Specification for Rubber Contraceptives (Male Condoms)

ASTM D 3574

Standard Test Methods for Flexible Cellular MaterialsSlab, Bonded, and Molded Urethane Foams

ASTM D 3578

Standard Specification for Rubber Examination Gloves

ASTM D 412 REV A

Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers Tension

ASTM D 4169

Standard Practice for Performance Testing of Shipping Containers and Systems

ASTM D 4332

Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing

ASTM D 4356

Standard Practice for Establishing Consistent Test Method Tolerances

ASTM D 4728

Standard Test Method for Random Vibration Testing of Shipping Containers

ASTM D 5250

Standard Specification for Poly(vinyl chloride) Gloves for Medical Application

ASTM D 5276

Standard Test Method for Drop Test of Loaded Containers by Free Fall

ASTM D 543

Standard Practices for Evaluating the Resistance of Plastics to Chemical Reagents

ASTM D 6124

Standard Test Method for Residual Powder on Medical Gloves

ASTM D 638

Standard Test Method for Tensile Properties of Plastics

ASTM D 642

Standard Test Method for Determining Compressive Resistance of Shipping Containers, Components, and Unit Loads

ASTM D 6499

Standard Test Method for The Immunological Measurement of Antigenic Protein in Natural Rubber and its Products

ASTM D 790

Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials

ASTM D 880

Standard Test Method for Impact Testing for Shipping Containers and Systems

ASTM D 882

Standard Test Method for Tensile Properties of Thin Plastic Sheeting

ASTM D 903

Standard Test Method for Peel or Stripping Strength of Adhesive Bonds

ASTM D 999

Standard Test Methods for Vibration Testing of Shipping Containers

ASTM E 1104

Standard Specification for Clinical Thermometer Probe Covers and Sheaths

ASTM E 1112

Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature

ASTM E 122

Standard Practice for Calculating Sample Size to Estimate, with a Specified Tolerable Error, the Average for a Characteristic of a Lot or Process

ASTM E 1262

Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay

ASTM E 1263

Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes

ASTM E 1488

Standard Guide for Statistical Procedures to Use in Developing and Applying Test Methods

ASTM E 1965

Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

ASTM F 1044

Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings

ASTM F 1054

Standard Specification for Conical Fittings

ASTM F 1058

Standard Specification for Wrought 40Cobalt-20Chromium-16Iron- 15Nickel-7Molybdenum Alloy Wire and Strip for Surgical Implant Applications (UNS R30003 and UNS R30008)

ASTM F 1079

Standard Specification for Inserted and Noninserted Surgical Scissors

ASTM F 1088 REV A

Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation

ASTM F 1089

Standard Test Method for Corrosion of Surgical Instruments

ASTM F 1101

Standard Specification for Ventilators Intended for Use During Anesthesia

ASTM F 1108

Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)

ASTM F 1140

Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications

ASTM F 1147

Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings

ASTM F 116

Standard Specification for Medical Screwdriver Bits

ASTM F 1185

Standard Specification for Composition of Hydroxylapatite for Surgical Implants

ASTM F 1205

Standard Specification for Anesthesia Breathing Tubes

ASTM F 1223

Standard Test Method for Determination of Total Knee Replacement Constraint

ASTM F 1266

Standard Performance Specification for Cerebral Stereotactic Instruments

ASTM F 1314

Standard Specification for Wrought Nitrogen Strengthened 22 Chromium - 13 Nickel - 5 Manganese - 2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S20910)

ASTM F 1327

Standard Terminology Relating to Barrier Materials for Medical Packaging

ASTM F 136 REV A

Standard Specification for Wrought Titanium - 6Aluminum - 4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

ASTM F 138

Standard Specification for Wrought 18Chromium-14Nickel- 2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)

ASTM F 1408

Standard Practice for Subcutaneous Screening Test for Implant Materials

ASTM F 1415

Standard Specification for Pulse Oximeters

ASTM F 1440

Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion

ASTM F 1441

Standard Specification for Soft-Tissue Expander Devices

ASTM F 1463

Standard Specification for Alarm Signals in Medical Equipment Used in Anesthesia and Respiratory Care

ASTM F 1464

Standard Specification for Oxygen Concentrators for Domiciliary Use

ASTM F 1497 REV A

Standard Test Method for Determining Laser Resistance of the Shaft of Tracheal Tubes

ASTM F 1518

Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of the Hollow Viscera

ASTM F 1536

Standard Test Method for Determining Strength and Setting Time of Synthetic Water-Activated Polyurethane Fiberglass Orthopaedic Casting Tape

ASTM F 1538

Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation

ASTM F 1556

Standard Guide for Spinal Immobilization and Extrication (SPINE) Device Characteristics

ASTM F 1579

Standard Specification for Polyaryletherketone (PAEK) Polymers for Surgical Implant Applications

ASTM F 1580

Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants

ASTM F 1581

Standard Specification for Composition of Anorganic Bone for Surgical Implants

ASTM F 1582

Standard Terminology Relating to Spinal Implants

ASTM F 1585

Standard Guide for Integrity Testing of Porous Barrier Medical Packages

ASTM F 1608

Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)

ASTM F 1609

Standard Specification for Calcium Phosphate Coatings for Implantable Materials

ASTM F 1635 REV A

Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants

ASTM F 1670

Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood

ASTM F 1690

Standard Specification for Humidifiers for Medical Use - Part 1: General Requirements for Active Humidification Systems

ASTM F 1717

Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

ASTM F 1744

Standard Guide for Care and Handling of Stainless Steel Surgical Instruments

ASTM F 1798

Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants

ASTM F 1801

Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials

ASTM F 1839

Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments

ASTM F 1873

Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications

ASTM F 1875

Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface

ASTM F 1877

Standard Practice for Characterization of Particles

ASTM F 1886

Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection

ASTM F 1905

Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity

ASTM F 1906

Standard Practice for Evaluation of Immune Responses In Biocompatibility Testing Using ELISA Tests, Lymphocyte Proliferation, and Cell Migration

ASTM F 1929

Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

ASTM F 1980

Standard Guide for Accelerated Aging of Sterile Medical Device Packages

ASTM F 2042

Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication

ASTM F 2052

Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment

ASTM F 2062

Standard Specification for Square Drive Interconnections on Surgical Instruments

ASTM F 2063

Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants

ASTM F 2068

Standard Specification for Femoral ProsthesesMetallic Implants

ASTM F 2077

Test Methods For Intervertebral Body Fusion Devices

ASTM F 2079

Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon- Expandable Stents

ASTM F 2081

Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

ASTM F 2083

Standard Specification for Total Knee Prosthesis

ASTM F 2096

Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)

ASTM F 2097

Standard Guide for Design and Evaluation of Primary Packaging for Medical Products

ASTM F 2119

Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants

ASTM F 2129

Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices

ASTM F 2182 REV A

Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging

ASTM F 2210

Standard Guide for Processing Cells, Tissues, and Organs for Use in Tissue Engineered Medical Products

ASTM F 2211

Standard Classification for Tissue Engineered Medical Products (TEMPs)

ASTM F 2213

Standard Test Method for Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment

ASTM F 2394

Standard Guide for Measuring Securement of Balloon Expandable Stent Mounted on Delivery System

ASTM F 382

Standard Specification and Test Method for Metallic Bone Plates

ASTM F 451 REV A

Standard Specification for Acrylic Bone Cement

ASTM F 452

Standard Specification for Preformed Cranioplasty Plates

ASTM F 543

Standard Specification and Test Methods for Metallic Medical Bone Screws

ASTM F 560

Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)

ASTM F 561 REV A

Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids

ASTM F 564

Standard Specification and Test Methods for Metallic Bone Staples

ASTM F 565

Standard Practice for Care and Handling of Orthopedic Implants and Instruments

ASTM F 601

Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants

ASTM F 602 REV A

Standard Criteria for Implantable Thermoset Epoxy Plastics

ASTM F 603

Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application

ASTM F 619

Standard Practice for Extraction of Medical Plastics

ASTM F 621

Standard Specification for Stainless Steel Forgings for Surgical Implants

ASTM F 623

Standard Performance Specification for Foley Catheter

ASTM F 624 REV A

Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications

ASTM F 640

Standard Test Methods for Radiopacity of Plastics for Medical Use

ASTM F 641 REV A

Standard Specification for Implantable Epoxy Electronic Encapsulants

ASTM F 647

Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application

ASTM F 67

Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)

ASTM F 700

Standard Practice for Care and Handling of Intracranial Aneurysm Clips and Instruments

ASTM F 702 REV A

Standard Specification for Polysulfone Resin for Medical Applications

ASTM F 703

Standard Specification for Implantable Breast Prostheses

ASTM F 746

Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials

ASTM F 748

Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices

ASTM F 75

Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Coatings and Casting Alloy for Surgical Implants (UNS R30075)

ASTM F 750

Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse

ASTM F 754

Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Polymer Fabricated in Sheet, Tube, and Rod Shapes

ASTM F 755

Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants

ASTM F 763

Standard Practice for Short-Term Screening of Implant Materials

ASTM F 799

Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539)

ASTM F 86

Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants

ASTM F 88

Standard Test Method for Seal Strength of Flexible Barrier Materials

ASTM F 882

Standard Performance and Safety Specification for Cryosurgical Medical Instruments

ASTM F 895

Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity

ASTM F 897

Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws

ASTM F 899

Standard Specification for Stainless Steels for Surgical Instruments

ASTM F 90

Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten- 10 Nickel Alloy for Surgical Implant Applications (UNS R30605)

ASTM F 920

Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans

ASTM F 961

Standard Specification for 35Cobalt-35Nickel-20Chromium- 10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)

ASTM F 965

Standard Specification for Rigid Laryngoscopes for Tracheal Intubation - Hook-On Fittings for Laryngoscope Handles and Blades with Lamps

ASTM F 981

Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

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