Skip to content
Please enter a keyword to search

  • EN 540 : 1993

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by

    CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS

    Available format(s): 

    Superseded date:  01-02-2003

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Comite Europeen de Normalisation

    Pure ENs are not available for sale, please purchase a suitable national adoption

    Sorry this product is not available in your region.

    Add To Cart

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

    Cooperating organizations
    National foreword
    Foreword
    0. Introduction
    1. Scope
    2. Normative references
    3. Terminology and definitions
    4. General requirements
    5. Methodology
    6. Presentation of results
    Annex A (informative) Bibliography
    National annex NA (informative) Committees responsible

    Abstract - (Show below) - (Hide below)

    Defines procedures to help manufacturers, regulatory authorities, sponsors and clinical investigators on the conduct and performance of the clinical investigation of medical devices. Also includes terminology and definitions.

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

    Committee CEN/TC 258
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

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

    BS EN 724:1995 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices
    BS EN 12006-2 : 1998 NON-ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS
    EN 12011 : 1998 INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    EN 13503-7 : 2001 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 7: CLINICAL INVESTIGATIONS
    BS 7208-16(1998) : 1998 OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - GUIDANCE FOR CLINICAL INVESTIGATIONS
    I.S. EN ISO 14727:1999 DENTAL IMPLANTS - PREFABRICATED PARTS CONNECTING SUPRASTRUCTURES TO DENTAL IMPLANTS - CONTENTS OF TECHNICAL FILE
    01/564791 DC : DRAFT NOV 2001 BS EN 14299 - NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS
    BS EN 50103:1996 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry
    BS EN 12523:1999 External limb prostheses and external orthoses. Requirements and test methods
    I.S. EN 12006-2:1998 NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS
    UNI EN 12006-2 : 2009 NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS
    I.S. EN 12011:1998 INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    ISO 14727:1998 Dental implants Prefabricated parts connecting suprastructures to dental implants Contents of technical file
    BS EN 12011:1998 Instrumentation to be used in association with non-active surgical implants. General requirements
    BS EN ISO 14727:1999 Dental implants. Prefabricated parts connecting suprastructures to dental implants. Contents of technical file
    EN ISO 14727:1998/AC:1998 DENTAL IMPLANTS - PREFABRICATED PARTS CONNECTING SUPRASTRUCTURES TO DENTAL IMPLANTS - CONTENTS OF TECHNICAL FILE
    EN 12006-2:1998+A1:2009 Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits
    DIN EN 12006-2:2009-08 NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS
    BS EN 13503-7:2002 Ophthalmic implants. Intraocular lenses Clinical investigations
    EN 12523 : 1999 EXTERNAL LIMB PROSTHESES AND EXTERNAL ORTHOSES - REQUIREMENTS AND TEST METHODS
    View more information

    • 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