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Superseded

Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES

Available format(s):

Superseded date: 05-09-2012

Language(s):

Published date: 31-12-2008

Publisher: Ente Nazionale Italiano di Unificazione (UNI)

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

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

Abstract - (Show below) - (Hide below)

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

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Development Note	Supersedes UNI EN 980. (05/2009)
Document Type	Standard
ISBN
Pages
Published
Publisher	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
Superseded By	UNI CEI EN ISO 15223-1 : 2012
Supersedes	UNI EN 980 : 2004

International Equivalents – Equivalent Standard(s) & Relationship - (Show below) - (Hide below)

Equivalent Standard(s)	Relationship
EN 980:2008	Identical

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

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

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

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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