Skip to content
Please enter a keyword to search

  • DIN EN ISO 15223-1:2015-08 (Draft)

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by

    MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS (ISO 15223-1:2016, CORRECTED VERSION 2017-03)

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-01-2021

    Language(s):  German

    Published date:  01-01-2015

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

    Add To Cart

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

    National foreword
    National Annex NA (informative) - Bibliography
    European foreword
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential Requirements
             of EU Directive 93/42/EEC [OJ L 169] on Medical
             Devices
    Annex ZB (informative) - Relationship between this
             European standard and the essential requirements
             of Directive 90/385/EEC [OJ L 189] aimed to be
             covered
    Annex ZC (informative) - Relationship between this
             European standard and the essential requirements
             of Directive 98/79/EC [OJ L 331] aimed to be
             covered
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Symbols
    Annex A (informative) - Examples
    Annex B (informative) - Use of general prohibition
            symbol and negation symbol
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices.

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

    Comment Closes On
    Development Note Available with CD-ROM. Supersedes DIN EN 980. (10/2012)
    Document Type Draft
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By
    Supersedes

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

    DIN EN ISO 12417-1:2016-02 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
    DIN EN ISO 13017:2016-05 DENTISTRY - MAGNETIC ATTACHMENTS (ISO 13017:2012 + AMD.1:2015)
    DIN EN ISO 13079:2011-10 Laboratory glass and plastics ware - Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method (ISO 13079:2011)
    DIN EN ISO 3826-4:2015-12 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)
    DIN EN ISO 18397:2016-09 DENTISTRY - POWERED SCALER (ISO 18397:2016)
    DIN HDBK 378 : 3ED 2014
    DIN EN ISO 8836:2015-02 Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014
    DIN EN ISO 11070:2015-03 STERILE SINGLE-USE INTRAVASCULAR INTRODUCERS, DILATORS AND GUIDEWIRES (ISO 11070:2014)
    DIN EN ISO 11499:2014-09 DENTISTRY - SINGLE-USE CARTRIDGES FOR LOCAL ANAESTHETICS (ISO 11499:2014)
    DIN EN ISO 1135-5:2016-06 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015)
    DIN EN ISO 80601-2-72:2016-04 Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)
    DIN EN ISO 81060-1:2012-08 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)
    DIN EN ISO 3826-1:2013-09 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 1: CONVENTIONAL CONTAINERS (ISO 3826-1:2013)
    DIN EN ISO 23747:2015-12 ANAESTHETIC AND RESPIRATORY EQUIPMENT - PEAK EXPIRATORY FLOW METERS FOR THE ASSESSMENT OF PULMONARY FUNCTION IN SPONTANEOUSLY BREATHING HUMANS (ISO 23747:2015)
    DIN EN ISO 1135-4:2016-06 TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015)
    DIN EN ISO 22674:2016-09 Dentistry - Metallic materials for fixed and removable restorations and appliances (ISO 22674:2016)
    DIN EN ISO 3630-2:2013-08 Dentistry - Endodontic instruments - Part 2: Enlargers (ISO 3630-2:2013)
    DIN EN ISO 4074:2016-05 NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015)
    DIN EN ISO 14408:2016-07 TRACHEAL TUBES DESIGNED FOR LASER SURGERY - REQUIREMENTS FOR MARKING AND ACCOMPANYING INFORMATION (ISO 14408:2016)
    DIN EN ISO 16672:2015-12 Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
    DIN EN ISO 11979-4 E : 2013 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008 + AMD.1:2012)
    DIN EN ISO 9680:2015-02 Dentistry - Operating lights (ISO 9680:2014)
    DIN EN ISO 7885:2010-06 Dentistry - Sterile injection needles for single use (ISO 7885:2010)
    DIN EN ISO 22413:2013-10 Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2010)
    DIN EN ISO 6873:2013-07 DENTISTRY - GYPSUM PRODUCTS (ISO 6873:2013)
    DIN EN ISO 7439:2015-08 Copper-bearing contraceptive intrauterine devices - Requirements and tests (ISO 7439:2015)
    DIN EN ISO 10079-3:2014-09 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014)
    DIN EN ISO 8536-10:2015-11 INFUSION EQUIPMENT FOR MEDICAL USE - PART 10: ACCESSORIES FOR FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-10:2015)
    DIN EN ISO 8536-9:2015-11 INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-9:2015)
    DIN EN ISO 13504:2012-10 DENTISTRY - GENERAL REQUIREMENTS FOR INSTRUMENTS AND RELATED ACCESSORIES USED IN DENTAL IMPLANT PLACEMENT AND TREATMENT (ISO 13504:2012)
    DIN EN ISO 20072:2013-10 AEROSOL DRUG DELIVERY DEVICE DESIGN VERIFICATION - REQUIREMENTS AND TEST METHODS (ISO 20072:2009)
    DIN HDBK 227/1 : 4ED 2013 MEDIZINISCHE EINMALPRODUKTE - TRANSFUSIONS-/INFUSIONS- UND INJEKTIONSGERAETE
    DIN EN ISO 1135-3:2014-12 (Draft) TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 3: BLOOD-TAKING SETS FOR SINGLE USE (ISO 1135-3:2016)
    DIN EN ISO 5367:2015-02 Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014)
    DIN EN ISO 10650:2016-02 DENTISTRY - POWERED POLYMERIZATION ACTIVATORS (ISO 10650:2015)
    DIN EN ISO 8536-11:2015-11 INFUSION EQUIPMENT FOR MEDICAL USE - PART 11: INFUSION FILTERS FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT (ISO 8536-11:2015)
    DIN EN ISO 10079-1:2016-05 MEDICAL SUCTION EQUIPMENT - PART 1: ELECTRICALLY POWERED SUCTION EQUIPMENT (ISO 10079-1:2015)
    DIN EN ISO 8536-4:2013-07 INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010 + AMD 1:2013)
    DIN EN ISO 14534:2015-08 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
    DIN EN ISO 10079-2:2014-09 Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:2014); German version EN ISO 10079-2:2014
    DIN EN ISO 11979-4:2013-01 OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION (ISO 11979-4:2008 + AMD.1:2012)
    DIN EN ISO 3665:2013-07 PHOTOGRAPHY - INTRA-ORAL DENTAL RADIOGRAPHIC FILM AND FILM PACKETS - MANUFACTURER SPECIFICATIONS (ISO 3665:2011)
    DIN 19403:2016-08 DENTISTRY - MULTIFUNCTION HANDPIECES
    DIN EN ISO 9687:2015-05 DENTISTRY - GRAPHICAL SYMBOLS FOR DENTAL EQUIPMENT (ISO 9687:2015)
    DIN ISO 8536-12:2013-04 Infusion equipment for medical use - Part 12: Check valves (ISO 8536-12:2007 + Amd. 1:2012)
    DIN HDBK 268 : 3ED 2015 NICHT AKTIVE MEDIZINPRODUKTE - HORIZONTALE, HARMONISIERTE EUROPAEISCHE NORMEN GEMAESS EU-RICHTLINIEN AUF DEM GEBIET DER MEDIZIN
    DIN EN ISO 80601-2-69:2014-12 Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)
    DIN EN ISO 25539-1:2015-07 (Draft) CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
    DIN EN ISO 23908:2013-10 SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS PROTECTION FEATURES FOR SINGLE-USE HYPODERMIC NEEDLES, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING (ISO 23908:2011)
    DIN EN ISO 11138-1:2015-10 (Draft) STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS (ISO 11138-1:2017)
    DIN EN ISO 8536-8:2015-11 INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 8536-8:2015)

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

    DIN ISO 7000:2008-12 Graphical symbols for use on equipment - Index and synopsis (ISO 7000:2004 + ISO 7000 Database:2008 up to ISO 7000-2750)
    DIN ISO 8601:2006-09 DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES
    ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
    ISO 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
    DIN ISO 3864-1:2012-06 Graphical symbols - Safety colours and safety signs - Part 1: Design principles for safety signs and safety markings (ISO 3864-1:2011)
    ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
    ISO 18113-4:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
    DIN EN ISO 18113-2:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE (ISO 18113-2:2009)
    DIN EN ISO 14971:2013-04 MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
    DIN EN ISO 18113-4:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING (ISO 18113-4:2009)
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    DIN EN ISO 18113-3:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 3: IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE (ISO 18113-3:2009)
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    DIN EN 80416-3:2003-08 BASIC PRINCIPLES FOR GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - PART 3: GUIDELINES FOR THE APPLICATION OF GRAPHICAL SYMBOLS
    DIN EN ISO 18113-5:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 5: IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING (ISO 18113-5:2009)
    IEC 80416-3:2002+AMD1:2011 CSV Basic principles for graphical symbols for use on equipment - Part 3: Guidelines for the application of graphical symbols
    IEC 80416-1:2008 Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration
    ISO 18113-2:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
    ISO 3864-1:2011 Graphical symbols Safety colours and safety signs Part 1: Design principles for safety signs and safety markings
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 18113-5:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
    ISO 18113-3:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
    DIN EN ISO 7010:2012-10 GRAPHISCHE SYMBOLE - SICHERHEITSFARBEN UND SICHERHEITSZEICHEN - REGISTRIERTE SICHERHEITSZEICHEN (ISO 7010:2011/AMD 5:2014)
    DIN EN ISO 18113-1:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
    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