UNI CEI EN 980 : 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
06-09-2012
01-01-2009
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Superseded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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