UNE-EN 1041:2009
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Information supplied by the manufacturer of medical devices
Available format(s)
Hardcopy , PDF
Language(s)
Spanish, Castilian, English
Published date
18-02-2009
Publisher
Superseded date
05-03-2014
€88.80
Excluding VAT
| Committee |
CTN 111
|
| DevelopmentNote |
2009 Edition Re-Issued in March 2014 & incorporates AMD 1 2014. (03/2014)
|
| DocumentType |
Standard
|
| Pages |
30
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Superseded
|
| Standards | Relationship |
| I.S. EN 1041:2008+A1:2013 | Identical |
| NBN EN 1041 : 2008 + A1 2013 | Identical |
| EN 1041:2008+A1:2013 | Identical |
| ONORM EN 1041 : 2013 | Identical |
| NS EN 1041 : 2008 + A1 2013 | Identical |
| DIN EN 1041:2013-12 | Identical |
| BS EN 1041 : 2008 | Identical |
| NEN EN 1041 : 2008 + A1 2013 | Identical |
| EN 1041:2008 | 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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