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  • ASTM F 640 : 2012 : REDLINE

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Standard Test Methods for Determining Radiopacity for Medical Use

    Available format(s):  PDF

    Superseded date:  13-11-2020

    Language(s):  English

    Published date:  15-12-2012

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    CONTAINED IN VOL. 13.01, 2015 Defines the determination of the radiopacity of materials and products utilizing X-ray based techniques, including fluoroscopy, angiography, CT (computed tomography) and DEXA, also known as DXA, (dual energy X-ray absorptiometry), also known as DXA.

    Scope - (Show below) - (Hide below)

    1.1These test methods cover the determination of the radiopacity of materials and products utilizing X-ray based techniques, including fluoroscopy, angiography, CT (computed tomography) and DEXA (dual energy X-ray absorptiometry), also known as DXA, The results of these measurements are an indication of the likelihood of locating the product within the human body.

    1.2Radiopacity is determined by (a) qualitatively comparing image(s) of a test specimen and a user-defined standard, with or without the use of a body mimic, or (b) quantitatively determining the specific difference in optical density or pixel intensity between the image of a test specimen and the image of a user-defined standard, with or without the use of a body mimic.

    1.3The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

    1.4This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

    General Product Information - (Show below) - (Hide below)

    Committee F 04
    Document Type Redline
    Publisher American Society for Testing and Materials
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    DIN 13273-8:2012-09 CATHETER FOR MEDICAL USE - PART 8: EPIDURAL CATHETERS
    ISO 20697:2018 Sterile drainage catheters and accessory devices for single use
    CSA ISO 5361 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
    13/30276989 DC : 0 BS EN ISO 11070 - STERILE, SINGLE-USE INTRAVASCULAR CATHETER INTRODUCERS
    I.S. EN ISO 10555-1:2013 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013/AMD 1:2017)
    UNE-EN ISO 25539-3:2012 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)
    DIN EN ISO 7197:2009-08 NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS
    ASTM F 647 : 1994 : R2000 Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
    17/30336573 DC : 0 BS EN ISO 20696 - STERILE URETHAL CATHETERS FOR SINGLE USE
    17/30336577 DC : 0 BS EN ISO 20697 - STERILE DRAINAGE CATHETERS AND ACCESSORY DEVICES FOR SINGLE USE
    DIN EN ISO 8836:2015-02 Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014
    ASTM F 1828 : 2017 : REDLINE Standard Specification for Ureteral Stents
    DIN EN ISO 11070:2015-03 STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014)
    ISO 25539-3:2011 Cardiovascular implants Endovascular devices Part 3: Vena cava filters
    EN ISO 25539-3:2011 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)
    EN ISO 5366:2016 Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016)
    AAMI NS28 : 1988 : R2015 INTRACRANIAL PRESSURE MONITORING DEVICES
    17/30345938 DC : 0 BS ISO 20698 - CATHETER SYSTEMS FOR NEURAXIAL APPLICATION - STERILE AND SINGLE-USE CATHETERS AND ACCESSORIES
    BS EN ISO 8836:2014 Suction catheters for use in the respiratory tract
    11/30235362 DC : 0 BS EN ISO 10555-3 - INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 3: CENTRAL VENOUS CATHETERS
    ISO 20696:2018 Sterile urethral catheters for single use
    DIN EN ISO 8836 E : 2015 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
    DIN EN ISO 25539-3:2012-03 Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)
    15/30280904 DC : 0 BS ISO 18190 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT
    ANSI/AAMI/ISO 25539-1:2017 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES
    CSA Z8836 :2011 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
    BS EN ISO 10555-1 : 2013 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS
    I.S. EN ISO 5361:2016 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS (ISO/DIS 5361:2014)
    DIN EN ISO 25539-1:2015-07 (Draft) CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
    BS EN ISO 11070 : 2014 STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES
    AAMI ISO 8836 : 2015 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
    ASTM F 647 : 1994 : R2006 Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
    ISO 8836:2014 Suction catheters for use in the respiratory tract
    ONORM EN ISO 8836 : 2015 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
    DIN EN ISO 5366:2017-04 Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016); German version EN ISO 5366:2016
    DIN EN ISO 5366:2015-10 (Draft) ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES AND CONNECTORS (ISO 5366:2016)
    AAMI NS28 : 1988 : R2010 INTRACRANIAL PRESSURE MONITORING DEVICES
    BS EN ISO 7197:2009 Neurosurgical implants. Sterile, single-use hydrocephalus shunts and components
    11/30235365 DC : 0 BS EN ISO 10555-4 - INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 4: BALLOON DILATATION CATHETERS
    ASTM F 647 : 1994 : R2014 Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
    CSA Z8836 : 2011 : FR SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
    UNI EN ISO 8836 : 2015 A SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
    UNE-EN ISO 8836:2015 Suction catheters for use in the respiratory tract (ISO 8836:2014)
    CSA Z8836 : 2011 : R2015 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
    AAMI ISO 25539-3 : 2011 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS
    UNI EN ISO 5361 : 2013 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
    EN ISO 10555-1:2013/A1:2017 INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013/AMD 1:2017)
    I.S. EN ISO 11070:2014 STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014)
    I.S. EN ISO 25539-3:2011 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS (ISO 25539-3:2011)
    UNI EN ISO 25539-3 : 2012 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS
    I.S. EN ISO 7197:2009 NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS
    I.S. EN ISO 8836:2014 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
    ISO 7197:2006 Neurosurgical implants Sterile, single-use hydrocephalus shunts and components
    EN ISO 8836:2014 Suction catheters for use in the respiratory tract (ISO 8836:2014)
    UNE-EN ISO 5361:2017 Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
    UNI EN ISO 11070 : 2015 STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES
    BS EN ISO 25539-1:2017 Cardiovascular implants. Endovascular devices Endovascular prostheses
    BS ISO 18190:2016 Anaesthetic and respiratory equipment. General requirements for airways and related equipment
    14/30281859 DC : 0 BS ISO 5361 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
    15/30273269 DC : 0 BS EN ISO 5366 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES - PART: TUBES AND CONNECTORS FOR USE IN ADULTS
    DIN EN ISO 5366 E : 2017 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEOSTOMY TUBES AND CONNECTORS (ISO 5366:2016)
    BS EN ISO 5361:2016 Anaesthetic and respiratory equipment. Tracheal tubes and connectors
    AAMI NS28 : 1988 : R2006 INTRACRANIAL PRESSURE MONITORING DEVICES
    UNI EN ISO 7197 : 2009 NEUROSURGICAL IMPLANTS - STERILE, SINGLE-USE HYDROCEPHALUS SHUNTS AND COMPONENTS
    BS EN ISO 5366:2016 Anaesthetic and respiratory equipment. Tracheostomy tubes and connectors
    AAMI ISO 5361 : 2012 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
    I.S. EN ISO 25539-1:2017 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
    ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires
    ISO 5366:2016 Anaesthetic and respiratory equipment — Tracheostomy tubes and connectors
    ISO 5361:2016 Anaesthetic and respiratory equipment — Tracheal tubes and connectors
    EN ISO 5361:2016 Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
    EN ISO 7197:2009 Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)
    BS EN ISO 25539-3:2011 Cardiovascular implants. Endovascular devices Vena cava filters
    11/30235338 DC : 0 BS EN ISO 10555-5 - INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 5: OVER-NEEDLE PERIPHERAL CATHETERS
    BS ISO 7197:1997 Neurosurgical implants. Sterile, single-use hydrocephalus shunts and components
    ISO 10555-1:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
    ISO 18190:2016 Anaesthetic and respiratory equipment — General requirements for airways and related equipment
    UNE-EN ISO 5366:2017 Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (ISO 5366:2016)
    ASTM F 1242 : 1996 : EDT 1 Standard Specification for Cuffed and Uncuffed Tracheal Tubes (Withdrawn 2002)
    ISO 25539-1:2017 Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
    DIN EN ISO 25539-1:2017-09 CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)

    Standards Referencing This Book - (Show below) - (Hide below)

    ASTM D 3182 : 2016 : REDLINE Standard Practice for Rubber—Materials, Equipment, and Procedures for Mixing Standard Compounds and Preparing Standard Vulcanized Sheets
    ASTM B 209 : 2014 : REDLINE Standard Specification for Aluminum and Aluminum-Alloy Sheet and Plate
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