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  • PD 6630:1998

    Current The latest, up-to-date edition.

    Nomenclature system for medical devices for the purpose of regulatory data exchange. Rationale

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  15-09-1998

    Publisher:  British Standards Institution

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

    Introduction
    1 Background
    2 Overview
    3 Review of existing nomenclature systems
    4 Recommendations for nomenclature system design
    5 Recommendations for system generation and maintenance
    6 Conclusions
    Annexes
    A (informative) FDA SPN "DEFIB" references
    B (informative) ECRI UMDS "DEFIB" references
    C (informative) Computer search of directive for medical
       devices
    D (informative) General structure for nomenclature
    E (informative) Device categories - suggested list
    F (informative) Bibliography

    Abstract - (Show below) - (Hide below)

    Covers the work of CEN/TC 257/SC1, with proposals given for the further development of the nomenclature system.

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

    Committee CH/210/3
    Development Note Also numbered as CR 13217. (08/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Current

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

    ISO 1087-1:2000 Terminology work Vocabulary Part 1: Theory and application
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 1942:2009 Dentistry Vocabulary
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ISO 704:2009 Terminology work — Principles and methods
    EN 29999 : 1994 TECHNICAL AIDS FOR DISABLED PERSONS - CLASSIFICATION
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