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  • ISO 15223-2:2010

    Current The latest, up-to-date edition.

    Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English, French

    Published date:  15-01-2010

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 15223-2:2010 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1.

    The purpose of ISO 15223-2:2010 is to ensure that symbols included in ISO 15223-1 are readily understood by the target group.

    If the symbol validation process detailed in ISO 15223-2:2010 has been complied with, then the residual risks, as defined in ISO 14971 and IEC 62366, associated with the usability of a medical device symbol are presumed to be acceptable, unless there is objective evidence to the contrary.

    ISO 15223-2:2010 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling.

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

    Development Note Supersedes ISO/DIS 15223-2. Together with ISO 15223-1 supersedes ISO 15223. (01/2010)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current
    Supersedes

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

    15/30325469 DC : 0 BS EN ISO 15223-1 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS
    CSA ISO 5361 : 2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
    16/30331650 DC : 0 BS EN ISO 8637-1 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 1: HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
    DD ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products
    DIN EN ISO 8638:2014-03 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010)
    BS EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems. Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
    DIN EN ISO 8638 E : 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010)
    CSA ISO 8637 : 2012 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
    CSA ISO 8637 : 2012 : R2017 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
    AAMI HE75 : 2009(R2013) HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES
    ISO 8637:2010 Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
    ISO 8638:2010 Cardiovascular implants and extracorporeal systems Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
    EN ISO 8638:2014 Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
    I.S. EN ISO 15798:2013 OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013)
    BS EN ISO 8836:2014 Suction catheters for use in the respiratory tract
    14/30251609 DC : 0 BS EN ISO 12417-1 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
    ANSI/AAMI/ISO 15675:2016 CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS
    DIN EN ISO 8836 E : 2015 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
    15/30280904 DC : 0 BS ISO 18190 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - GENERAL REQUIREMENTS FOR AIRWAYS AND RELATED EQUIPMENT
    10/30195946 DC : DRAFT DEC 2010 BS ISO 27185 - CARDIAC RHYTHM MANAGEMENT DEVICES - SYMBOLS TO BE USED WITH CARDIAC RHYTHM MANAGEMENT DEVICE LABELS, AND INFORMATION TO BE SUPPLIED - GENERAL REQUIREMENTS
    DIN EN ISO 8836:2015-02 Suction catheters for use in the respiratory tract (ISO 8836:2014); German version EN ISO 8836:2014
    BS EN 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
    CSA Z8836 :2011 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
    ANSI/AAMI/ISO 15223-1:2016 MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS
    CSA ISO 8638 : 2012 : R2017 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
    I.S. EN ISO 5361:2016 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS (ISO/DIS 5361:2014)
    AAMI ISO 8638 : 2010 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS
    AAMI ISO 8836 : 2015 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
    AAMI ISO 8638 : 2010 : R2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS
    ISO 8836:2014 Suction catheters for use in the respiratory tract
    EN 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
    DIN EN ISO 4074:2016-05 NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015)
    ONORM EN ISO 8836 : 2015 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
    I.S. EN ISO 8537:2016 STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN (ISO 8537:2016)
    I.S. EN ISO 4074:2015 NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015)
    13/30260084 DC : 0 BS ISO 17256 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - RESPIRATORY THERAPY TUBING AND CONNECTORS
    BS ISO 17218:2014 Sterile acupuncture needles for single use
    ISO 8637-1:2017 Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
    17/30321202 DC : DRAFT MAY 2017 BS EN ISO 23500-4 - GUIDANCE FOR THE PREPARATION AND QUALITY MANAGEMENT OF FLUIDS FOR HAEMODIALYSIS AND RELATED THERAPIES - PART 4: CONCENTRATES FOR HAEMODIALYSIS AND RELATED THERAPIES
    DIN EN ISO 8637 E : 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1 2013-04-01)
    CSA Z8836 : 2011 : FR SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
    UNI EN ISO 8836 : 2015 A SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
    UNE-EN ISO 8836:2015 Suction catheters for use in the respiratory tract (ISO 8836:2014)
    BS EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems. Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
    CSA ISO 8637 : 2012 : INC : AMD 1 : 2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
    CSA Z8836 : 2011 : R2015 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT
    AAMI HE75 : 2009 HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES
    I.S. EN ISO 8637:2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1 2013-04-01)
    UNI EN ISO 5361 : 2013 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
    ISO 15675:2016 Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters
    I.S. EN ISO 8638:2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS (ISO 8638:2010)
    ISO 15798:2013 Ophthalmic implants Ophthalmic viscosurgical devices
    ISO 27185:2012 Cardiac rhythm management devices — Symbols to be used with cardiac rhythm management device labels, and information to be supplied — General requirements
    UNI EN ISO 8637 : 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
    I.S. EN ISO 8836:2014 SUCTION CATHETERS FOR USE IN THE RESPIRATORY TRACT (ISO 8836:2014)
    EN ISO 8836:2014 Suction catheters for use in the respiratory tract (ISO 8836:2014)
    ONORM EN ISO 15798 : 2013 AMD 1 2018 OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013)
    UNE-EN ISO 5361:2017 Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
    15/30282343 DC : 0 BS ISO 18746 - TRADITIONAL CHINESE MEDICINE - INTRADERMAL ACUPUNCTURE NEEDLES
    DIN EN ISO 8637:2014-03 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS (ISO 8637:2010, INCLUDING AMENDMENT 1:2013-04-01)
    05/30128342 DC : DRAFT AUG 2005 ISO 15223-1 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING, AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS
    15/30289037 DC : 0 BS EN ISO 7886-1 - STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE
    BS ISO 18190:2016 Anaesthetic and respiratory equipment. General requirements for airways and related equipment
    13/30259011 DC : 0 BS ISO 17218 - STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE
    14/30281859 DC : 0 BS ISO 5361 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
    AAMI ISO 8637 : 2010 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HEMODIALYZERS, HEMODIAFILTERS, HEMOFILTERS AND HEMOCONCENTRATORS
    I.S. EN 61010-2-040:2015 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 2-040: PARTICULAR REQUIREMENTS FOR STERILIZERS AND WASHER-DISINFECTORS USED TO TREAT MEDICAL MATERIALS
    BS EN ISO 5361:2016 Anaesthetic and respiratory equipment. Tracheal tubes and connectors
    16/30331653 DC : 0 BS EN ISO 8637-2 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 2: EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
    AAMI ISO 5361 : 2012 ANAESTHETIC AND RESPIRATORY EQUIPMENT - TRACHEAL TUBES AND CONNECTORS
    ISO/TR 12417-2:2017 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
    UNI EN ISO 8638 : 2014 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
    I.S. EN ISO 7886-1:1998 STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE (ISO 7886-1:2017)
    AAMI ISO 27185 : 2012 CARDIAC RHYTHM MANAGEMENT DEVICES - SYMBOLS TO BE USED WITH CARDIAC RHYTHM MANAGEMENT DEVICE LABELS, AND INFORMATION TO BE SUPPLIED - GENERAL REQUIREMENTS
    BS EN ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied General requirements
    I.S. EN ISO 15223-1:2016 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)
    EN ISO 8637:2014 Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (ISO 8637:2010, including Amendment 1 2013-04-01)
    UNE-EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    IEC 61010-2-040:2015 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
    UNE-EN ISO 4074:2016 Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015)
    UNE-EN ISO 15223-1:2017 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)
    BS EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
    ISO 5361:2016 Anaesthetic and respiratory equipment — Tracheal tubes and connectors
    ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
    ISO 4074:2015 Natural rubber latex male condoms Requirements and test methods
    EN ISO 5361:2016 Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016)
    EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
    EN ISO 4074:2015 Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015)
    16/30331656 DC : 0 BS ISO 8637-3 - EXTRACORPOREAL SYSTEMS FOR BLOOD PURIFICATION - PART 3: PLASMAFILTERS
    ISO 18746:2016 Traditional Chinese medicine — Sterile intradermal acupuncture needles for single use
    ISO 5910:2018 Cardiovascular implants and extracorporeal systems Cardiac valve repair devices
    BS ISO 27185:2012 Cardiac rhythm management devices. Symbols to be used with cardiac rhythm management device labels, and information to be supplied. General requirements
    12/30251858 DC : 0 BS ISO 4074 - NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS
    DIN EN ISO 15223-1:2015-08 (Draft) 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)
    16/30310949 DC : 0 BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES
    CSA ISO 8638 : 2012 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
    CSA ISO 8637 : 2012 : INC : AMD 1 : 2015 : R2017 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS
    CSA C22.2 No. 61010.2.040 : 2016 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 2-040: PARTICULAR REQUIREMENTS FOR STERILIZERS AND WASHER-DISINFECTORS USED TO TREAT MEDICAL MATERIALS
    ISO 18190:2016 Anaesthetic and respiratory equipment — General requirements for airways and related equipment
    ISO 17218:2014 Sterile acupuncture needles for single use
    EN ISO 15798:2013/A1:2017 OPHTHALMIC IMPLANTS - OPHTHALMIC VISCOSURGICAL DEVICES (ISO 15798:2013/AMD 1:2017)
    ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
    BS EN ISO 4074:2015 Natural rubber latex male condoms. Requirements and test methods

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

    ISO 7010:2011 Graphical symbols Safety colours and safety signs Registered safety signs
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    ISO 9186-1:2014 Graphical symbols Test methods Part 1: Method for testing comprehensibility
    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 80416-2:2001 Basic principles for graphical symbols for use on equipment — Part 2: Form and use of arrows
    ISO 15225:2016 Medical devices Quality management Medical device nomenclature data structure
    ISO/TR 7239:1984 Development and principles for application of public information symbols
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    EN 980:2008 Symbols for use in the labelling of medical devices
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