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Medical Device Labeling Definitions

Medical Device Labeling Definitions, Total:93 items.

In the international standard classification, Medical Device Labeling Definitions involves: Laboratory medicine, Graphical symbols, Medical equipment, Pharmaceutics, Vocabularies, Medical sciences and health care facilities in general.


British Standards Institution (BSI), Medical Device Labeling Definitions

  • BS EN ISO 18113-1:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Terms, definitions and general requirements
  • BS EN ISO 18113-1:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Terms, definitions and general requirements
  • BS EN 980:1997 Graphical symbols for use in the labelling of medical devices
  • BS EN 980:2003 Graphical symbols for use in the labelling of medical devices
  • BS EN 980:2008 Symbols for use in the labelling of medical devices
  • BS EN ISO 15223-1:2017 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
  • BS EN ISO 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
  • BS ISO 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Symbol development, selection and validation
  • 19/30401046 DC BS EN ISO 15223-1 AMD1. Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied - Part 1. General requirements
  • 20/30387822 DC 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
  • BS EN ISO 18113-3:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for professional use

Korean Agency for Technology and Standards (KATS), Medical Device Labeling Definitions

  • KS P ISO 15223-2007(2012) Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied
  • KS P ISO 15223-1:2019 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
  • KS P ISO 15223-2:2019 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
  • KS P ISO 18113-1:2018 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 1: Terms, definitions and general requirements
  • KS P ISO 18113-1:2012 In vitro diagnostic medical devices-Information supplied by the manufacturer(labelling)-Part 1:Terms, definitions and general requirements

Association Francaise de Normalisation, Medical Device Labeling Definitions

  • NF S99-015*NF EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates.
  • NF S99-004:2008 Symbols for use in the labelling of medical devices.
  • NF EN 15986:2011 Symbole à utiliser pour l'étiquetage des dispositifs médicaux - Exigences relatives à l'étiquetage des dispositifs médicaux contenant des phtalates
  • NF EN 556-1:2002 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage STERILE - Partie 1 : exigences relatives aux dispositifs médicaux stérilisés au stade terminal
  • NF EN 556-2:2015 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage "STÉRILE" - Partie 2 : exigences pour les dispositifs médicaux soumis à un traitement aseptique
  • NF S99-014-2*NF 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.
  • NF S99-014-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1 : general requirements.
  • NF ISO 15223-2:2010 Dispositifs médicaux - Symboles à utiliser avec les étiquettes, l'étiquetage et les informations à fournir relatifs aux dispositifs médicaux - Partie 2 : développement, sélection et validation de symboles
  • NF S92-010-1:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1 : terms, definitions and general requirements.
  • NF S92-010-1*NF EN ISO 18113-1:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1 : terms, definitions and general requirements
  • NF EN ISO 18113-1:2012 Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 1 : termes, définitions et exigences générales
  • NF S98-107-1*NF EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1 : requirements for terminally sterilized medical devices

European Committee for Standardization (CEN), Medical Device Labeling Definitions

  • EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
  • EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
  • CEN EN 980-2008 Symbols for use in the labelling of medical devices
  • EN 980:2003 Graphical Symbols for Use in the Labelling of Medical Devices
  • EN ISO 15223-1:2021 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
  • EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (Remains Current)
  • EN 980:1996/PRA2:1996 Graphical Symbols for Use in the Labelling of Medical Devices Amendment PRA2
  • EN ISO 18113-1:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
  • EN 556:1998 Sterilization of Medical Devices - Requirements for Terminally - Sterilized Medical Devices to Be Labelled "Sterile" Ratified European Text; Includes Amendment 1: 1994
  • EN 980:1996/A1:1996 AMD A1 Graphical Symbols for Use in the Labelling of Medical Devices Includes Amendment A1:1999
  • prEN ISO 18113-1:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO/DIS 18113-1:2021)
  • FprEN ISO 18113-1 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO/FDIS 18113-1:2022)

Danish Standards Foundation, Medical Device Labeling Definitions

  • DS/EN 556:1995 Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"
  • DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
  • DS/EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
  • DS/ISO 15223-2:2011 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
  • DS/EN ISO 15223-1 Bil. 1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements - Fact Sheet 1: Graphical symbols in electronic format
  • DS/EN ISO 15223-1 Bil. 1:2021 Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements – Fact Sheet 1: Graphical symbols in electronic format

Professional Standard - Medicine, Medical Device Labeling Definitions

  • YY 0466-2003 Medical devices-Symbols to be used with medical device labels,labelling and information to be supplied
  • YY/T 0466.1-2009 Medical devices.Symbols to be used with medical device labels,labelling and information to be supplied.Part 1:General requirements
  • YY/T 0466.1-2016 Medical devices.Symbols to be used with medical device labels,labelling and information to be supplied.Part 1:General requirements
  • YY/T 0466.2-2015 Medical devices.Symbols to be used with medical device labels, labelling,and information to be supplied.Part 2:Symbol development,selection and validation
  • YY/T 0995-2015 Medical devices for human assisted reproductive technology.Terminology and definitions

Lithuanian Standards Office , Medical Device Labeling Definitions

  • LST EN 15986-2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
  • LST EN 980-2008 Symbols for use in the labelling of medical devices
  • LST EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)

AENOR, Medical Device Labeling Definitions

  • UNE-EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
  • 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)
  • UNE-EN ISO 18113-1:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)

AT-ON, Medical Device Labeling Definitions

  • ONORM EN 980-1996 Graphical symbols for use in the labelling of medical devices
  • OENORM EN ISO 18113-1:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO/DIS 18113-1:2021)

VN-TCVN, Medical Device Labeling Definitions

  • TCVN 6916-2001 Medical devices.Symbols to be used with medical device labels, labelling and information to be supplied
  • TCVN 6916-1-2008 Medical devices.Symbols to be used with medical device labels, labelling and information to be supplied.Part 1: General requirements

International Organization for Standardization (ISO), Medical Device Labeling Definitions

  • ISO 15223:2000 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
  • ISO 15223-1:2021 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
  • ISO 15223:2000/Amd 2:2004 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied; Amendment 2
  • 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 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
  • ISO 15223-1:2007 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
  • 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
  • ISO 15223-1:2007/Amd 1:2008 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements; Amendment 1
  • ISO 18113-1:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
  • ISO 18113-1:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements

Japanese Industrial Standards Committee (JISC), Medical Device Labeling Definitions

  • JIS T 0307:2004 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied

German Institute for Standardization, Medical Device Labeling Definitions

  • DIN EN 15986:2011-05 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version EN 15986:2011, with CD-ROM
  • DIN EN ISO 15223-1/A1:2019 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016); German and English version EN ISO 15223-1:2016/prA1:2019
  • DIN EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version EN 15986:2011, with CD-ROM
  • DIN EN ISO 15223-1:2020 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2020); German and English version prEN ISO 15223-1:2020
  • DIN EN ISO 15223-1:2013 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012); German version EN ISO 15223-1:2012, with CD-ROM
  • DIN EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012); German version EN ISO 15223-1:2012, with CD-ROM

KR-KS, Medical Device Labeling Definitions

  • KS P ISO 15223-1-2019 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
  • KS P ISO 15223-2-2019 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
  • KS P ISO 18113-1-2018 In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 1: Terms, definitions and general requirements

ZA-SANS, Medical Device Labeling Definitions

  • SANS 15223:2006 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied

CEN - European Committee for Standardization, Medical Device Labeling Definitions

  • EN 980:1996 Graphical Symbols for Use in the Labelling of Medical Devices
  • EN ISO 18113-1:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms@ definitions and general requirements

US-AAMI, Medical Device Labeling Definitions

  • ANSI/AAMI/ISO 15223-1:2012 Medical devices.Symbols to be used with medical device labels, labeling, and information to be supplied.Part 1: General requirements

RU-GOST R, Medical Device Labeling Definitions

  • GOST R ISO 15223-1-2014 Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 1. General requirements
  • GOST R ISO 15223-2-2013 Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 2. Symbol development, selection and validation
  • GOST R ISO 18113-1-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 1. Terms, definitions and general requirements
  • GOST 25273-1982 X-ray image intensifier for medical apparatus. Terms and definitions

GOSTR, Medical Device Labeling Definitions

  • GOST R ISO 15223-1-2020 Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 1. General requirements

American National Standards Institute (ANSI), Medical Device Labeling Definitions

  • ANSI/AAMI/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

CZ-CSN, Medical Device Labeling Definitions

  • CSN 84 7106-1983 Medlcal eguipment. Methods, means and processes of sterllization and desinfection of items for medical use. Terms and definitions.

US-CFR-file, Medical Device Labeling Definitions

  • CFR 21-801.18-2013 Food and Drugs. Part801:Labeling. Section801.18:Format of dates provided on a medical device label.




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