BS EN ISO 18113-2:2011
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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
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INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
I.S. EN 13640:2002
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STABILITY TESTING OF IN VITRO DIAGNOSTIC REAGENTS |
06/30123163 DC : 0
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BS EN 1041 - INFORMATION SUPPLIED BY THE MANUFACTURER WITH MEDICAL DEVICES |
EN ISO 17511:2003
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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
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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
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SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
DIN EN 14254 E : 2004
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - SINGLE-USE RECEPTACLES FOR THE COLLECTION OF SPECIMENS, OTHER THAN BLOOD, FROM HUMANS |
BS EN 13641:2002
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Elimination or reduction of risk of infection related to in vitro diagnostic reagents |
BS EN 12306:1998
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Biotechnology. Guidance for quality control of diagnostic kits used in agriculture, plant and animal pest and disease control and environmental contamination |
ISO 17511:2003
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In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials |
EN 12287 : 1999
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - DESCRIPTION OF REFERENCE MATERIALS |
EN 12376:1999
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In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology |
EN 12306:1997
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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
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SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION |
I.S. EN 592:2002
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INSTRUCTIONS FOR USE FOR IN VITRO DIAGNOSTIC INSTRUMENTS FOR SELF-TESTING |
ISO 17593:2007
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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
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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
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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
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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
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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
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INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES |
UNE-EN ISO 18113-1:2012
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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
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Information supplied by the manufacturer of medical devices (includes Amendment A1:2013) |
BS ISO 15198:2004
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Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer |
I.S. EN 376:2002
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INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR SELF-TESTING |
01/564180 DC : DRAFT OCT 2001
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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
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Information supplied by the manufacturer of medical devices |
DD ENV 13607:2000
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Health informatics. Messages for the exchange of information on medicine prescriptions |
I.S. ENV 13607:2000
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HEALTH INFORMATICS - MESSAGES FOR THE EXCHANGE OF INFORMATION ON MEDICINE PRESCRIPTIONS |
BS EN 14820:2004
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Single-use containers for human venous blood specimen collection |
BS EN 12287:1999
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In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Description of reference materials |
EN 14136:2004
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Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures |
EN ISO 18113-1:2011
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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
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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
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BS EN 980 - GRAPHICAL SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES |
09/30176675 DC : 0
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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
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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
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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
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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 |
DIN EN 14820 E : 2004
|
SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION |
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 |