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  • AAMI ISO TIR 12417 : 2011

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS

    Available format(s):  Hardcopy, PDF

    Superseded date:  16-11-2016

    Language(s):  English

    Published date:  01-01-2011

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Table of Contents - (Show below) - (Hide below)

    Glossary of equivalent standards
    Committee representation
    Background of AAMI adoption of ISO/TS 12417:2011
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Intended performance
    6 Design attributes
    7 Materials
    8 Design evaluation
    9 Post-market surveillance
    10 Manufacturing
    11 Sterilization
    12 Packaging
    Annex A (informative) - Definitions of potential clinical
                            events
    Annex B (informative) - Information on device- and
                            drug-related aspects - Applicable
                            documents for local guidance
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes requirements for vascular device-drug combination products (VDDCPs) based upon current technical and medical knowledge.

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

    Committee WG 06
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

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

    ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires
    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 25539-2:2012 Cardiovascular implants Endovascular devices Part 2: Vascular stents
    CFR 21(PTS200-299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 200-299
    ISO 14160:2011 Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
    ISO 16054:2000 Implants for surgery Minimum data sets for surgical implants
    ISO 5840:2005 Cardiovascular implants Cardiac valve prostheses
    ISO 10555-2:1996 Sterile, single-use intravascular catheters Part 2: Angiographic catheters
    ISO 7198:2016 Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
    ASTM F 2503 : 2013 : REDLINE Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
    ISO 17475:2005 Corrosion of metals and alloys Electrochemical test methods Guidelines for conducting potentiostatic and potentiodynamic polarization measurements
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    ISO 25539-1:2017 Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 14630:2012 Non-active surgical implants General requirements
    ISO 5841-2:2014 Implants for surgery Cardiac pacemakers Part 2: Reporting of clinical performance of populations of pulse generators or leads
    ISO/TR 14283:2004 Implants for surgery Fundamental principles
    ASTM F 2052 : 2015 : REDLINE Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
    ISO/TS 15539:2000 Cardiovascular implants Endovascular prostheses
    ISO 13781:2017 Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing
    ISO 7199:2016 Cardiovascular implants and artificial organs Blood-gas exchangers (oxygenators)
    ASTM F 2213 : 2017 : REDLINE Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    ISO 10555-3:2013 Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters
    ISO 10555-1:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
    ISO 15814:1999 Implants for surgery Copolymers and blends based on polylactide In vitro degradation testing
    ISO 25539-3:2011 Cardiovascular implants Endovascular devices Part 3: Vena cava filters
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO 16428:2005 Implants for surgery — Test solutions and environmental conditions for static and dynamic corrosion tests on implantable materials and medical devices
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO 10555-4:2013 Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters
    ISO 16429:2004 Implants for surgery — Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods
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