• CEN/TR 15133:2005

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    Nomenclature - Collective terms and codes for groups of medical devices

    Available format(s): 

    Withdrawn date:  17-01-2024

    Language(s): 

    Published date:  15-06-2005

    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)

    Foreword
    Introduction
    1 Scope
    2 Lists of collective terms
      2.1 Application of Common Technology
      2.2 Using similar manufacturing procedures
      2.3 For similar medical procedures
      2.4 Using common materials
      2.5 Specific risk-associated considerations
    Bibliography

    Abstract - (Show below) - (Hide below)

    This Technical Report lists collective terms and codes for groups of medical devices having common features. The listing is structured so that the terms can be used for the purposes required in regulatory reporting and for communication relevant to the application of the medical device regulation.For certain purposes in the application of the Medical Devices Directives, there is an urgent need for the development of a list of collective terms based on the identified principles to be used, for examples, as follows:-to illustrate the scope of certificates issued by Notified Bodies when assessing which groups, families or types of medical devices are covered within a manufacturer's quality system,-to be used to identify the range of skills and general technological abilities for which a Notified Body has been approved, and is so appointed by the relevant Competent Authority,-for the exchanges of information between Competent Authorities when general information on individual manufacturers capabilities is notified for inclusion in the European Database for Medical Devices (EUDAMED).For the purpose of developing sets of collective terms, Accessories to medical devices are integrated de facto in the corresponding medical device collective term.

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

    Committee CEN/CLC/JTC 3
    Document Type Technical Report
    Publisher Comite Europeen de Normalisation
    Status Withdrawn

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

    I.S. EN 1041:2008+A1:2013 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
    06/30123163 DC : 0 BS EN 1041 - INFORMATION SUPPLIED BY THE MANUFACTURER WITH MEDICAL DEVICES
    I.S. EN 16844:2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
    13/30278952 DC : 0 BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES
    CEI UNI EN 1041 : 2014 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
    DIN EN 1041:2013-12 Information supplied by the manufacturer of medical devices (includes Amendment A1:2013)
    15/30317874 DC : 0 BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    UNE-EN 16372:2015 Aesthetic surgery services
    I.S. EN 16372:2014 AESTHETIC SURGERY SERVICES
    EN 16844:2017 Aesthetic medicine services - Non-surgical medical treatments
    UNI CEI EN 1041 : 2013 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
    I.S. EN 16844:2017+A2:2019 Aesthetic medicine services - Non-surgical medical treatments
    UNE-EN 1041:2009 Information supplied by the manufacturer of medical devices
    BS EN 1041 : 2008 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
    EN 16372:2014 Aesthetic surgery services
    BS EN 16372:2014 Aesthetic surgery services
    08/30159296 DC : DRAFT APR 2008 BS EN ISO 15225 - NOMENCLATURE - SPECIFICATION FOR A NOMENCLATURE SYSTEM FOR MEDICAL DEVICES FOR THE PURPOSE OF REGULATORY DATA EXCHANGE
    BS EN 16844 : 2017 AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS
    ONORM EN 1041 : 2013 INFORMATION SUPPLIED BY THE MANUFACTURER WITH MEDICAL DEVICES

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

    CR 14230 : 2001 GLOBAL MEDICAL DEVICE NOMENCLATURE FOR THE PURPOSE OF REGULATORY DATA EXCHANGE
    EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
    ISO 15225:2016 Medical devices Quality management Medical device nomenclature data structure
    ISO/TS 20225:2001 Global medical device nomenclature for the purpose of regulatory data exchange
    • 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