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I.S. EN 1041:2008+A1:2013

I.S. EN 1041:2008+A1:2013

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES

Available format(s)

Hardcopy , PDF

Superseded date

14-06-2021

Language(s)

English

Published date

01-01-2008

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.


Dates of withdrawal of national standards are available from NSAI.

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

Describes 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
TC 3
DevelopmentNote
2008 Edition Re-Issued in October 2013 & incorporates AMD 1 2013. (10/2013)
DocumentType
Standard
Pages
29
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

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
PDF - English
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