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Medical device outer box label

Medical device outer box label, Total:186 items.

In the international standard classification, Medical device outer box label involves: Graphical symbols, Medical equipment, Pharmaceutics, Vocabularies, Medical sciences and health care facilities in general, Hospital equipment, Laboratory medicine, Microbiology, Products of non-ferrous metals.

Korean Agency for Technology and Standards (KATS), Medical device outer box label

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 18113-3-2015(2020) In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
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
KS P ISO 18113-5-2015(2020) In vitro diagnostic medical devices — Information supplied by the manufacturer(labelling) — Part 5: In vitro diagnostic instruments for self-testing

Association Francaise de Normalisation, Medical device outer box label

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 S90-133:1989 MEDICO-SURGICAL EQUIPMENT. RADIANT INCUBATORS. SPECIFICATIONS.
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 S92-010-5:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5 : in vitro diagnostic instruments for self-testing.
NF S92-010-5*NF EN ISO 18113-5:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5 : in vitro diagnostic instruments for self-testing
NF S92-010-3:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3 : in vitro diagnostic instruments for professional use.
NF S92-010-3*NF EN ISO 18113-3:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3 : in vitro diagnostic instruments for professional use
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 EN ISO 18113-3:2012 Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 3 : instruments de diagnostic in vitro à usage professionnel
NF S92-010-4:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4 : in vitro diagnostic reagents for self-testing.
NF S92-010-4*NF EN ISO 18113-4:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4 : in vitro diagnostic reagents for self-testing
NF EN ISO 18113-5:2012 Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 5 : instruments de diagnostic in vitro pour auto-tests
NF S92-010-2:2010 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2 : in vitro diagnostic reagents for professional use.
NF EN ISO 18113-2:2012 Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 2 : réactifs de diagnostic in vitro à usage professionnel
NF S92-010-2*NF EN ISO 18113-2:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2 : in vitro diagnostic reagents for professional use
NF EN ISO 18113-4:2012 Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 4 : réactifs de diagnostic in vitro pour auto-tests
NF S90-751:1990 MEDICO-SURGICAL EQUIPMENT. INTRA-OCULAR LENSES. GENERAL REQUIREMENTS FOR STERILIZATION,PACKAGING AND LABELLING.
NF S90-191:1986 MEDICO-SURGICAL EQUIPMENT. GLASS BOTTLES FOR PERFUSION. GEOMETRICAL CHARACTERISTICS AND MARKING.
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 S92-036*NF EN ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood
NF EN 12322/A1:2002 Dispositifs médicaux de diagnostic in vitro - Milieux de culture de microbiologie - Critères de performance des milieux de culture
NF EN 12322:1999 Dispositifs médicaux de diagnostic in vitro - Milieux de culture de microbiologie - Critères de performance des milieux de culture.
NF S90-449:1985 Medico-surgical equipment. Implants for surgery. Partial and total hip joint prostheses. Part 1 : classification, designation of dimensions and requirements.

European Committee for Standardization (CEN), Medical device outer box label

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 18113-5:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
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 ISO 18113-3:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
EN ISO 18113-2:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
EN ISO 18113-3:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use [Superseded: CEN EN 591]
EN ISO 18113-5:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing [Superseded: CEN EN 592]
prEN ISO 18113-3:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2021)
FprEN ISO 18113-3 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/FDIS 18113-3:2022)
EN ISO 18113-4:2011 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 980:1996/A1:1996 AMD A1 Graphical Symbols for Use in the Labelling of Medical Devices Includes Amendment A1:1999
EN ISO 18113-1:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
prEN ISO 18113-5:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/DIS 18113-5:2021)
FprEN ISO 18113-5 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/FDIS 18113-5:2022)
prEN ISO 18113-2:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/DIS 18113-2:2021)
FprEN ISO 18113-2 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/FDIS 18113-2:2022)
EN ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
prEN ISO 18113-4:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2021)
FprEN ISO 18113-4 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/FDIS 18113-4:2022)
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)
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

Danish Standards Foundation, Medical device outer box label

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
DS/EN 12322/A1:2002 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
DS/EN 12322:1999 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media

Professional Standard - Medicine, Medical device outer box label

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

Lithuanian Standards Office , Medical device outer box label

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)
LST EN 12322-2000 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
LST EN ISO 18113-4:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
LST EN ISO 18113-2:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)

AENOR, Medical device outer box label

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 18113-3:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
UNE-EN ISO 18113-5:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
UNE-EN ISO 18113-2:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
UNE-EN ISO 18113-4:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)
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)
UNE-EN 12322/A1:2002 In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media.

British Standards Institution (BSI), Medical device outer box label

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 EN ISO 18113-3:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for professional use
BS EN ISO 18113-5:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic instruments for self-testing
BS EN ISO 18113-4:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for self-testing
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
BS EN ISO 18113-2:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for professional use
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
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 ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
21/30416037 DC BS EN ISO 18113-3. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - Part 3. In vitro diagnostic instruments for professional use
21/30416045 DC BS EN ISO 18113-5. In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) - Part 5. In vitro diagnostic instruments for self-testing

AT-ON, Medical device outer box label

ONORM EN 980-1996 Graphical symbols for use in the labelling of medical devices
OENORM EN ISO 18113-3:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO/DIS 18113-3:2021)
OENORM EN ISO 18113-2:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO/DIS 18113-2:2021)
OENORM EN ISO 18113-4:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO/DIS 18113-4:2021)
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 outer box label

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 outer box label

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 15223-1:2007/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 18113-5:2009 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
ISO 18113-3:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use
ISO 18113-5:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
ISO 18113-4:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
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 18113-4:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
ISO 18113-2:2022 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use
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 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
ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood
ISO 16142-1:2016 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards

Japanese Industrial Standards Committee (JISC), Medical device outer box label

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 outer box label

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
DIN EN 12322:1999-06 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media; German version EN 12322:1999
DIN EN ISO 18113-3:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009); German version EN ISO 18113-3:2011
DIN EN ISO 18113-5:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009); German version EN ISO 18113-5:2011
DIN EN ISO 18113-4:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009); German version EN ISO 18113-4:2011
DIN 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); German version EN ISO 15223-1:2016, with CD-ROM
DIN EN ISO 18113-2:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009); German version EN ISO 18113-2:2011
DIN 96298-2:2016-10 Medical instruments - Terms, measuring methods and tests - Part 2: Measuring methods for the determination of basic measurements of surgical standard instruments
DIN EN ISO 18113-1:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011

KR-KS, Medical device outer box label

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 20916-2022 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice

ZA-SANS, Medical device outer box label

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 outer box label

EN 980:1996 Graphical Symbols for Use in the Labelling of Medical Devices
EN ISO 18113-2:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
EN ISO 18113-4:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
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 outer box label

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 outer box label

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 18113-5-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 5. In vitro diagnostic instruments for self-testing
GOST R ISO 18113-3-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 3. In vitro diagnostic instruments for professional use
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 18113-4-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 4. In vitro diagnostic reagents for self-testing
GOST R ISO 18113-2-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 2. In vitro diagnostic reagents for professional use
GOST R ISO 18113-1-2015 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Part 1. Terms, definitions and general requirements

GOSTR, Medical device outer box label

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
GOST R EN 12322-2010 In vitro diagnostic medical devices. Culture media for microbiology. Performance criteria for culture media

American National Standards Institute （ANSI), Medical device outer box label

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

US-CFR-file, Medical device outer box label

CFR 21-801.18-2013 Food and Drugs. Part801:Labeling. Section801.18:Format of dates provided on a medical device label.
CFR 21-801.128-2013 Food and Drugs. Part801:Labeling. Section801.128:Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile.

CH-SNV, Medical device outer box label

SN EN ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Medical device outer box label

GB/T 29791.3-2013 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 3:In vitro diagnostic instruments for professional use
GB/T 29791.5-2013 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 5:In vitro diagnostic instruments for selftesting
GB/T 29791.4-2013 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 4:In vitro diagnostic reagents for selftesting
GB/T 29791.2-2013 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 2:In vitro diagnostic reagents for professional use
GB/T 29791.1-2013 In vitro diagnostic medical devices.Information supplied by the manufacturer (labelling).Part 1:Terms, definitions and general requirements

American Society for Testing and Materials (ASTM), Medical device outer box label

ASTM F2063-05 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
ASTM F2063-00 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
ASTM F2063-12 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
ASTM F2063-18 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
ASTM F2633-13 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants
ASTM F3276-19 Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device
ASTM F3276-22 Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device
ASTM F2633-19 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants