BS EN ISO 18113-1:2011

Cross References:
ISO 1000
ISO 13485
ISO 14971
ISO 15223-1
IEC 62366
EN 980
ISO 704:2000
ISO 1087-1:2000
ISO 3534-1:2006
ISO 3534-2:2006
ISO 5725-1:1994
ISO 5725-3:1994
ISO 8601
ISO 10241
ISO 15189:2007
ISO 15190:2003
ISO 15193:2002
ISO 15194
ISO 15197:2003
ISO 15198:2004
ISO/IEC 17025
ISO 17511:2003
ISO 17593:2007
ISO 18153
ISO 25680
IEC 60050
IEC 60601-1-6:2006
IEC 61010-2-101:2002
ISO/IEC 80000
ISO/IEC 80416-1:2001
ISO Guide 30:1992
ISO/IEC Guide 51:1999
ISO/IEC Guide 98-3:2008
GUM:1995
ISO/IEC Guide 99:2007
EN 375:2001
EN 376:2002
EN 591:2001
EN 592:2002
EN 13612:2002
EN 13640:2002
CLSI C28-A2:2000
CLSI EP9-A2
CLSI X5-R
CLSI EP12-A2
CLSI EP5-A2
CLSI C51-P
CLSI EP7-A2
CLSI EP17-A
CLSI EP6-A
CLSI GP10-A
ISO 5725-2
ISO 5725-5:1998
ISO 9000:2005
IEC 60050-300:2001
VIM:1993
IEC 60359
98/79/EC


All current amendments available at time of purchase are included with the purchase of this document.



Keywords: Diagnosis (medical); Medical equipment; Product information; Instructions for use; Labels; Labelling (process); Clinical investigation instruments; Diagnostic reagents; Clinical laboratory equipment ; Reagent solutions; Definitions; Measurement

Product Code(s): 30256217,30256217

This product references:ISO 5725-5:1998 - Accuracy (trueness and precision) of measurement methods and results - Part 5: Alternative methods for the determination of the precision of a standard measurement method
BS EN 376:2002 - Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
ISO 1087-1:2000 - Terminology work -- Vocabulary -- Part 1: Theory and application
ISO 704:2000 - Terminology work -- Principles and methods
ISO 3534-1:2006 - Statistics - Vocabulary and symbols - Part 1: General statistical terms and terms used in probability
BS EN 13640:2002 - Stability testing of in vitro diagnostic reagents
ISO 9000:2005 - Quality management systems - Fundamentals and vocabulary
ISO 5725-1:1994 - Accuracy (trueness and precision) of measurement methods and results - Part 1: General principles and definitions
ISO 5725-3:1994 - Accuracy (trueness and precision) of measurement methods and results - Part 3: Intermediate measures of the precision of a standard measurement method
ISO 15189:2007 - Medical laboratories - Particular requirements for quality and competence
ISO 15190:2003 - Medical laboratories - Requirements for safety
ISO 15193:2002 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Presentation of reference measurement procedures
ISO 15197:2003 - In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
ISO 15198:2004 - Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
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 17593:2007 - Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
ISO Guide 30:1992 - Terms and definitions used in connection with reference materials
ISO/IEC Guide 51:1999 - Safety aspects -- Guidelines for their inclusion in standards
ISO/IEC Guide 98-3:2008 - Uncertainty of measurement - Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
ISO/IEC Guide 99:2007 - International vocabulary of metrology - Basic and general concepts and associated terms (VIM)
BS EN 375:2001 - Information supplied by the manufacturer with in vitro diagnostic reagents for professional use
BS EN 591:2001 - Instructions for use for in vitro diagnostic instruments for professional use
BS EN 592:2002 - Instructions for use for in vitro diagnostic instruments for self-testing
BS EN 13612:2002 - Performance evaluation of in vitro diagnostic medical devices
ISO 3534-2:2006 - Statistics - Vocabulary and symbols - Part 2: Applied statistics
This product replaces:BS EN ISO 18113-1:2009 - In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Terms, definitions and general requirements
This product same asISO 18113-1:2009 - In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Terms, definitions and general requirements