EN 375 : 2001
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
Superseded date
12-01-2009
Superseded by
Published date
01-12-2013
Publisher
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements for labels
4.1 Outer container
4.2 Immediate container
5 Requirements for instructions for use
Annex ZA (informative) Relationship of this document
with EC Directives
Bibliography
Defines the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents that includes reagent products, calibrators, control materials and kits for professional use, hereafter called IVD reagents. Also applicable to accessories.
| Committee |
TC 140
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| UNE-EN 375:2001 | Identical |
| NF EN 375 : 2001 | Identical |
| UNI EN 375 : 2002 | Identical |
| NBN EN 12376 : 1999 | Identical |
| SN EN 375 : 2001 | Identical |
| NBN EN 375 : 2001 | Identical |
| BS EN 375:2001 | Identical |
| NS EN 375 : 2001 | Identical |
| PN EN 375 : 2004 | Identical |
| NEN EN 375 : 2001 | Identical |
| I.S. EN 375:2001 | Identical |
| DIN EN 375:2001-06 | Identical |
| BS EN ISO 18113-2:2011 | In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for professional use |
| I.S. EN 1041:2008+A1:2013 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| I.S. EN 13640:2002 | STABILITY TESTING OF IN VITRO DIAGNOSTIC REAGENTS |
| 06/30123163 DC : 0 | BS EN 1041 - INFORMATION SUPPLIED BY THE MANUFACTURER WITH MEDICAL DEVICES |
| EN ISO 17511:2003 | In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003) |
| UNE-EN ISO 18113-2:2012 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009) |
| 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 |
| BS EN 12306:1998 | Biotechnology. Guidance for quality control of diagnostic kits used in agriculture, plant and animal pest and disease control and environmental contamination |
| ISO 17511:2003 | In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials |
| EN 12287 : 1999 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - DESCRIPTION OF REFERENCE MATERIALS |
| EN 12376:1999 | In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology |
| EN 12306:1997 | Biotechnology - Guidance for quality control of diagnostic kits used in agriculture, plant and animal pest and disease control and environmental contamination |
| I.S. EN 14820:2004 | SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION |
| I.S. EN 592:2002 | INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING |
| ISO 17593:2007 | Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
| 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 |
| 06/30146515 DC : 0 | BS ISO 18113-2 - CLINICAL LABORATORY TESTING AND IN VITRO DIAGNOSTIC MEDICAL SYSTEMS - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE |
| I.S. EN ISO 17511:2003 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN BIOLOGICAL SAMPLES - METROLOGICAL TRACEABILITY OF VALUES ASSIGNED TO CALIBRATORS AND CONTROL MATERIALS |
| DIN EN ISO 18113-2:2013-01 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009) |
| 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) |
| DIN EN 1041:2013-12 | Information supplied by the manufacturer of medical devices (includes Amendment A1:2013) |
| BS ISO 15198:2004 | Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer |
| I.S. EN 376:2002 | INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING |
| 01/564180 DC : DRAFT OCT 2001 | BS EN 14254 - IN VITRO DIAGNOSTIC MEDICAL DEVICES - SINGLE-USE RECEPTACLES FOR THE COLLECTION OF SPECIMENS, OTHER THAN BLOOD, FROM HUMANS |
| 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 |
| I.S. ENV 13607:2000 | HEALTH INFORMATICS - MESSAGES FOR THE EXCHANGE OF INFORMATION ON MEDICINE PRESCRIPTIONS |
| BS EN 14820:2004 | Single-use containers for human venous blood specimen collection |
| BS EN 12287:1999 | In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Description of reference materials |
| EN 14136:2004 | Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures |
| 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) |
| 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 |
| UNI EN ISO 18113-2 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE |
| 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 |
| ISO 15198:2004 | Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer |
| UNI CEI EN 1041 : 2013 | INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
| 01/561148 DC : DRAFT MAR 2001 | BS EN 14136 - USE OF EXTERNAL QUALITY ASSESSMENT SCHEMES IN THE ASSESSMENT OF THE PERFORMANCE OF IN VITRO DIAGNOSTIC PROCEDURES |
| 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 14254:2004 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - SINGLE-USE RECEPTACLES FOR THE COLLECTION OF SPECIMENS, OTHER THAN BLOOD, FROM HUMANS |
| DIN EN ISO 17511:2003-11 | In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003) |
| ISO 18113-2:2009 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 2: In vitro diagnostic reagents for professional use |
| BS EN ISO 17511:2003 | In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values assigned to calibrators and control materials |
| BS EN 14254:2004 | In vitro diagnostic medical devices. Single-use receptacles for the collection of specimens, other than blood, from humans |
| UNE-EN 1041:2009 | Information supplied by the manufacturer of medical devices |
| BS EN 376:2002 | Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing |
| BS EN 591:2001 | Instructions for use for in vitro diagnostic instruments for professional use |
| 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 |
| BS EN 13975:2003 | Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects |
| EN 13640:2002 | Stability testing of in vitro diagnostic reagents |
| EN 592 : 2002 | INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING |
| EN 14820:2004 | Single-use containers for human venous blood specimen collection |
| EN 13641:2002 | Elimination or reduction of risk of infection related to in vitro diagnostic reagents |
| EN 376 : 2002 | INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING |
| EN 13975:2003 | Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
| 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 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 18113-1:2011 | In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements |
| I.S. EN ISO 18113-2:2011 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 2: IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE (ISO 18113-2:2009) |
| 06/30122245 DC : 0 | EN 980 - SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
| 00/565675 DC : DRAFT DEC 2000 | BS EN ISO 17511 - IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - METROLOGICAL TRACEABILITY OF VALUES ASSIGNED TO CALIBRATORS AND CONTROL MATERIALS |
| UNI EN ISO 18113-1 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
| EN 14254:2004 | In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans |
| BS EN 592:2002 | Instructions for use for in vitro diagnostic instruments for self-testing |
| BS EN 14136:2004 | Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures |
| BS EN 13640:2002 | Stability testing of in vitro diagnostic reagents |
| BS EN 980:2008 | Symbols for use in the labelling of medical devices |
| DIN EN 14136:2004-08 | Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures |
| DIN EN 14820:2004-11 | SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION |
| DIN EN 14254:2004-09 | In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans |
| DIN EN 980:2003-08 | SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
| ENV 12610:1997 | Medical informatics - Medicinal product identification |
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