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CEI UNI EN 1041 : 2014

Current
Current

The latest, up-to-date edition.

INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
Available format(s)

Hardcopy , PDF

Language(s)

English - Italian

Published date

01-01-2014

Publisher

Comitato Elettrotecnico Italiano

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Requirements for provision of information
6 Documentation
Annex A (informative) - Requirements and guidance for
        Directives 93/42/EEC and 90/385/EEC, as amended
Annex B (informative) - Guidance on alternative labelling
        for instructions for use (IFU)
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EC
Annex ZB (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 90/385/EC
Bibliography

Defines requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices.

Committee
CT 62
DevelopmentNote
Classificazione CEI 62-151. (05/2009)
DocumentType
Standard
Pages
54
PublisherName
Comitato Elettrotecnico Italiano
Status
Current

Standards Relationship
EN 1041:2008+A1:2013 Identical
UNI EN 1041 : 2000 Identical

EN ISO 780:2015 Packaging - Distribution packaging - Graphical symbols for handling and storage of packages (ISO 780:2015)
ISO 639-1:2002 Codes for the representation of names of languages — Part 1: Alpha-2 code
EN 591 : 2001 INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR PROFESSIONAL USE
EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE" - Part 2: Requirements for aseptically processed medical devices
EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
EN 592 : 2002 INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING
2004/108/EC : 2004 DIRECTIVE 2004/108/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 15 DECEMBER 2004 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ELECTROMAGNETIC COMPATIBILITY AND REPEALING DIRECTIVE 89/336/EC
EN 376 : 2002 INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
CEN/TR 15133:2005 Nomenclature - Collective terms and codes for groups of medical devices
EN ISO 3166-1:2014 Codes for the representation of names of countries and their subdivisions - Part 1: Country codes (ISO 3166-1:2013)
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
ISO 780:2015 Packaging Distribution packaging Graphical symbols for handling and storage of packages
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
ISO 15225:2016 Medical devices Quality management Medical device nomenclature data structure
ISO 3166-1:2013 Codes for the representation of names of countries and their subdivisions Part 1: Country codes
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
EN 980:2008 Symbols for use in the labelling of medical devices
ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices

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Hardcopy - English - Italian
PDF - English - Italian
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