EN 376 : 2002
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING
Superseded date
01-12-2009
Superseded by
Published date
12-01-2013
Publisher
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirement for labels
4.1 Outer container
4.2 Immediate container
5 Requirement for instructions for use
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other
provisions of EU Directives
Bibliography
Specifies requirements for the labelling of in vitro diagnostic reagents which are meant for use in self-testing. Coverage includes definitions, instructions for use and additional information.
| Committee |
TC 140
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NEN EN 376 : 2002 | Identical |
| I.S. EN 376:2002 | Identical |
| NF EN 376 : 2002 | Identical |
| DIN EN 376:2002-06 | Identical |
| BS EN 376:2002 | Identical |
| NBN EN 12376 : 1999 | Identical |
| SN EN 376 : 2002 | Identical |
| NS EN 376 : 2002 | Identical |
| PN EN 376 : 2004 | Identical |
| NBN EN 376 : 2002 | Identical |
| UNI EN 376 : 2002 | Identical |
| UNE-EN 376:2002 | Identical |
| DIN EN ISO 18113-4:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009) |
| I.S. EN 1041:2008+A1:2013 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| 06/30123163 DC : 0 | BS EN 1041 - INFORMATION SUPPLIED BY THE MANUFACTURER WITH MEDICAL DEVICES |
| BS ISO 17593:2007 | Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
| BS EN ISO 18113-4:2011 | In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for self-testing |
| UNI EN ISO 18113-4 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING |
| UNI CEI EN 980 : 2009 | SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
| BS EN 13641:2002 | Elimination or reduction of risk of infection related to in vitro diagnostic reagents |
| EN 12376:1999 | In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology |
| ISO 17593:2007 | Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
| I.S. EN 592:2002 | INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING |
| 06/30146522 DC : 0 | BS ISO 18113-4 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING |
| UNE-EN ISO 18113-4:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009) |
| 00/563139 DC : DRAFT JUL 2000 | BS ISO 19001 - IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR STAINING IN BIOLOGY |
| CSA Z22870 : 2007 : R2013 | POINT-OF-CARE TESTING (POCT) - REQUIREMENTS FOR QUALITY AND COMPETENCE |
| CSA Z22870:2007 | POINT-OF-CARE TESTING (POCT) - REQUIREMENTS FOR QUALITY AND COMPETENCE |
| CEI UNI EN 1041 : 2014 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| UNE-EN ISO 18113-1:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| ISO/TR 18112:2006 | Clinical laboratory testing and in vitro diagnostic test systems In vitro diagnostic medical devices for professional use Summary of regulatory requirements for information supplied by the manufacturer |
| DIN EN 1041:2013-12 | Information supplied by the manufacturer of medical devices (includes Amendment A1:2013) |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| DD ENV 13607:2000 | Health informatics. Messages for the exchange of information on medicine prescriptions |
| 04/30090846 DC : DRAFT JUL 2004 | BS ISO 22870 - POINT-OF-CARE TESTING (POCT) - REQUIREMENTS FOR QUALITY AND COMPETENCE |
| I.S. ENV 13607:2000 | HEALTH INFORMATICS - MESSAGES FOR THE EXCHANGE OF INFORMATION ON MEDICINE PRESCRIPTIONS |
| ENV 13607:2000 | Health informatics - Messages for the exchange of information on medicine prescriptions |
| I.S. EN 12376:1999 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR STAINING IN BIOLOGY |
| 00/560160 DC : DRAFT JAN 2000 | BS ISO 15197 DETERMINATION OF PERFORMANCE CRITERIA FOR IN VITRO BLOOD GLUCOSE MONITORING SYSTEMS FOR MANAGEMENT OF HUMAN DIABETES MELLITUS |
| 02/563809 DC : DRAFT SEP 2002 | BS EN 980 - GRAPHICAL SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
| 09/30176675 DC : 0 | BS EN ISO 15223-1 - MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELLING AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS |
| UNI CEI EN 1041 : 2013 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| I.S. EN ISO 18113-1:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009) |
| 06/30146511 DC : 0 | BS ISO 18113-1 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
| DD ENV 12610:1998 | Medical informatics. Medical product identification |
| I.S. EN ISO 18113-4:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 4: IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING (ISO 18113-4:2009) |
| BS EN 13612:2002 | Performance evaluation of in vitro diagnostic medical devices |
| BS EN 13532:2002 | General requirements for in vitro diagnostic medical devices for self-testing |
| UNE-EN 1041:2009 | Information supplied by the manufacturer of medical devices |
| ISO 18113-4:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing |
| BS EN 1041 : 2008 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| ISO 18113-1:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
| BS EN 12376:1999 | In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology |
| EN 592 : 2002 | INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING |
| EN 13641:2002 | Elimination or reduction of risk of infection related to in vitro diagnostic reagents |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| EN ISO 18113-1:2011 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| I.S. EN 980:2008 | SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
| DIN EN ISO 18113-1:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009) |
| BS EN ISO 18113-1:2011 | In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements |
| 06/30122245 DC : 0 | EN 980 - SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
| UNI EN ISO 18113-1 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
| BS EN 592:2002 | Instructions for use for in vitro diagnostic instruments for self-testing |
| BS EN 980:2008 | Symbols for use in the labelling of medical devices |
| EN 13532:2002 | General requirements for in vitro diagnostic medical devices for self-testing |
| DIN EN 980:2003-08 | SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
| ENV 12610:1997 | Medical informatics - Medicinal product identification |
| EN 592 : 2002 | INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING |
| 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 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| EN 28601 : 1992 | DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES |
| ISO 3864:1984 | Safety colours and safety signs |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
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