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UNI CEI EN 980 : 2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
Superseded date

09-06-2012

Published date

01-01-2009

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

PREMESSA
INTRODUZIONE
1 SCOPO E CAMPO DI APPLICAZIONE
2 RIFERIMENTI NORMATIVI
3 TERMINI E DEFINIZIONI
4 REQUISITI GENERALI
5 SIMBOLI GIA IN USO
6 NUOVI SIMBOLI
APPENDICE A (informativa) - ESEMPI DI USO DI SIMBOLI RIPORTATI
  NELLA PRESENTE NORMA
APPENDICE B (informativa) - UTILIZZO DEL SIMBOLO DI DIVIETO
  GENERICO E DEL SIMBOLO DI NEGAZIONE
APPENDICE ZA (informativa) - PUNTI DELLA PRESENTE NORMA
  EUROPEA RIGUARDANTI I REQUISITI ESSENZIALI O ALTRE
  DISPOSIZIONI DELLA DIRETTIVA DEL CONSIGLIO 93/42/CEE
  CONCERNENTE I DISPOSITIVI MEDICI
APPENDICE ZB (informativa) - PUNTI DELLA PRESENTE NORMA
  EUROPEA RIGUARDANTI I REQUISITI ESSENZIALI O ALTRE
  DISPOSIZIONI DELLA DIRETTIVA DEL CONSIGLIO 90/385/CEE
  CONCERNENTE I DISPOSITIVI MEDICI IMPIANTABILI ATTIVI
APPENDICE ZC (informativa) - PUNTI DELLA PRESENTE NORMA
  EUROPEA RIGUARDANTI I REQUISITI ESSENZIALI O ALTRE
  DISPOSIZIONI DELLA DIRETTIVA DEL CONSIGLIO E DEL
  PARLAMENTO EUROPEO 98/79/CE SUI DISPOSITIVI
  MEDICO-DIAGNOSTICI IN VITRO
BIBLIOGRAFIA

Describes symbols for use in the information supplied by the manufacturer with medical devices.

DevelopmentNote
Supersedes UNI EN 980. (05/2009)
DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
EN 980:2008 Identical

UNI 11341 : 2010 BUBBLING HUMIDIFIERS FOR MEDICAL USE - FUNDAMENTAL REQUIREMENTS

EN 80416-3:2002/A1:2011 BASIC PRINCIPLES FOR GRAPHICAL SYMBOLS FOR USE ON EQUIPMENT - PART 3: GUIDELINES FOR THE APPLICATION OF GRAPHICAL SYMBOLS
EN 80416-2:2001 Basic principles for graphical symbols for use on equipment - Part 2: Form and use of arrows
EN 591 : 2001 INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE
ISO 80416-4:2005 Basic principles for graphical symbols for use on equipment — Part 4: Guidelines for the adaptation of graphical symbols for use on screens and displays (icons)
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
EN 592 : 2002 INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING
EN 376 : 2002 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
EN 375 : 2001 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
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
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
ISO 3864-1:2011 Graphical symbols Safety colours and safety signs Part 1: Design principles for safety signs and safety markings
ISO 15225:2016 Medical devices Quality management Medical device nomenclature data structure
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
EN 80416-1:2009 Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration
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 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
EN 12264:2005 Health informatics - Categorial structures for systems of concepts

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