We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
  • BS EN ISO 7198:2017

    Current The latest, up-to-date edition.
    Add to Watchlist
    This Standard has been added successfully to your Watchlist
    Please visit My Watchlist to see all standards that you are watching.
    Please log in or to add this standard to your Watchlist.
    We could not add this standard to your Watchlist.
    Please retry or contact support for assistance.
    We could not add this standard to your Watchlist.
    Please retry or contact support for assistance.
    You have already added this standard to your Watchlist.
    Visit My Watchlist to view the full list.

    Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-03-2017

    Publisher:  British Standards Institution

    Add to Watchlist

    Add To Cart

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

    Committee CH/150/2
    Development Note Supersedes 14/30281557 DC, BS ISO 7198 & BS EN 12006-2. (03/2017)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    ISO 25539-2:2012 Cardiovascular implants Endovascular devices Part 2: Vascular stents
    EN 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 (ISO 14937:2009)
    EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
    EN ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
    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 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
    EN ISO 10993-11:2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY (ISO 10993-11:2006)
    EN ISO 14155:2011/AC:2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
    EN ISO 10993-17 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES (ISO 10993-17:2002)
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
    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
    EN ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
    EN ISO 10993-10:2013 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)
    EN ISO 10993-7 : 2008 COR 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS (ISO 10993-7:2008/COR 1:2009)
    EN ISO 10993-4:2017 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD (ISO 10993-4:2017)
    ISO 25539-1:2017 Cardiovascular implants Endovascular devices Part 1: Endovascular prostheses
    CEN ISO/TS 17665-2 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - PART 2: GUIDANCE ON THE APPLICATION OF ISO 17665-1
    EN ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
    EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
    ISO 14630:2012 Non-active surgical implants General requirements
    EN ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
    ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products Part 1: General requirements
    EN ISO 11137-2:2015 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE (ISO 11137-2:2013)
    EN ISO 10993-18:2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS (ISO 10993-18:2005)
    EN ISO 11137-1:2015 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013)
    EN ISO 14971:2012 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01)
    EN ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    EN 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 17665-1:2006)
    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
    EN ISO 10993-15 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS (ISO 10993-15:2000)
    EN ISO 10993-14 : 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS (ISO 10993-14:2001)
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
    EN ISO 11137-3:2017 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL (ISO 11137-3:2017)
    EN 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 14160:2011)
    EN ISO 14630:2012 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012)
    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective