New Health Care & Medical Devices Standards

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F2382-17: Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)

F2739-16: Standard Guide for Quantifying Cell Viability within Biomaterial Scaffolds

F2847-17: Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments

F366-17: Standard Specification for Fixation Pins and Wires

F382-17: Standard Specification and Test Method for Metallic Bone Plates

F2077-17: Test Methods For Intervertebral Body Fusion Devices

F2885-17: Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications

F2886-17: Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications

F1978-17: Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser

F2004-17: Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis

E2810-11(2017): Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units

F564-17: Standard Specification and Test Methods for Metallic Bone Staples

F732-17: Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses

F2213-17: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment

F2502-17: Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants

F2819-10(2015)e2: Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices

F1541-17: Standard Specification and Test Methods for External Skeletal Fixation Devices

F720-17: Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test

F2102-17: Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants

F2081-06(2017): Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents

F1830-97(2017): Standard Practice for Selection of Blood for in vitro Evaluation of Blood Pumps

F1841-97(2017): Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps

F2079-09(2017): Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents

F2394-07(2017): Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System

F2581-12(2017): Standard Specification for Wrought Nitrogen Strengthened 11Manganese-17Chromium-3Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29225)

E1714-07(2013): Standard Guide for Properties of a Universal Healthcare Identifier (UHID)

E1959-05(2011): Standard Guide for Requests for Proposals Regarding Medical Transcription Services for Healthcare Institutions

E2117-06(2011): Standard Guide for Identification and Establishment of a Quality Assurance Program for Medical Transcription

E2210-12: Standard Specification for Guideline Elements Model version 3 (GEM III)—Document Model for Clinical Practice Guidelines

E2344-04(2011): Standard Guide for Data Capture through the Dictation Process

E2364-04(2010): Standard Guide to Speech Recognition Technology Products in Health Care

E2369-12: Standard Specification for Continuity of Care Record (CCR)

E2457-07(2013): Standard Terminology for Healthcare Informatics

E2473-05(2011): Standard Practice for the Occupational/Environmental Health View of the Electronic Health Record

E2502-06(2011): Standard Guide for Medical Transcription Workstations

E2522-07(2013): Standard Guide for Quality Indicators for Health Classifications

E2538-06(2011): Standard Practice for Defining and Implementing Pharmacotherapy Information Services within the Electronic Health Record (EHR) Environment and Networked Architectures

E2553-07(2013): Standard Guide for Implementation of a Voluntary Universal Healthcare Identification System

E2682-09(2014): Standard Guide for Developing a Disaster Recovery Plan for Medical Transcription Departments and Businesses

F1635-16: Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants

F2172-02(2011): Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers

F2726-08: Standard specification for fixation devices for tracheal tubes and other airway devices

F2761-09(2013): Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model

D7709-12(2017): Standard Test Methods for Measuring Water Vapor Transmission Rate (WVTR) of Pharmaceutical Bottles and Blisters

F1671/F1671M-13: Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System

F1819-07(2013): Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood Using a Mechanical Pressure Technique

D6124-06(2017): Standard Test Method for Residual Powder on Medical Gloves

D6355-07(2017): Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves

F1831-17: Standard Specification for Cranial Traction Tongs and Halo External Spinal Immobilization Devices

F2848-17: Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns

F1147-05(2017)e1: Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings

F1538-03(2017): Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation

F621-12(2017): Standard Specification for Stainless Steel Forgings for Surgical Implants

F1862/F1862M-17: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)

D7102-17: Standard Guide for Determination of Endotoxin on Sterile Medical Gloves

E1838-17: Standard Test Method for Determining the Virus-Eliminating Effectiveness of Hygienic Handwash and Handrub Agents Using the Fingerpads of Adults

F2299/F2299M-03(2017): Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres

F2902-16e1: Standard Guide for Assessment of Absorbable Polymeric Implants

E2196-17: Standard Test Method for Quantification of Pseudomonas aeruginosa Biofilm Grown with Medium Shear and Continuous Flow Using Rotating Disk Reactor

E2562-17: Standard Test Method for Quantification of Pseudomonas aeruginosa Biofilm Grown with High Shear and Continuous Flow using CDC Biofilm Reactor

E2799-17: Standard Test Method for Testing Disinfectant Efficacy against Pseudomonas aeruginosa Biofilm using the MBEC Assay