DIN EN ISO 17511:2003-11

Superseded

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)

Available format(s)

Hardcopy , PDF

Superseded date

11-07-2021

Language(s)

German, English

Published date

11-01-2003

Publisher

DocumentType	Standard
Pages	35
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Superseded
SupersededBy	DIN EN ISO 17511:2021-11

DIN HDBK 378 : 3ED 2014
DIN EN ISO 14971:2013-04	MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
DIN EN ISO 15194:2009-10	IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CERTIFIED REFERENCE MATERIALS AND THE CONTENT OF SUPPORTING DOCUMENTATION
DIN 58964:2015-09	Quality assurance of POCT results - Assessment criteria for comparison measurement and implementation
DIN EN ISO 15193:2009-10	IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CONTENT AND PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES
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)
DIN EN ISO 15197:2015-12	IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS (ISO 15197:2013)

ENV 1614 : 1995	HEALTHCARE INFORMATICS - STRUCTURE FOR NOMENCLATURE, CLASSIFICATION AND CODING OF PROPERTIES IN CLINICAL LABORATORY SCIENCE
ISO 5725-1:1994	Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
ISO Guide 32:1997	Calibration in analytical chemistry and use of certified reference materials
EN 12286:1998/A1:2000	IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES
EN 12287 : 1999	IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - DESCRIPTION OF REFERENCE MATERIALS
ISO Guide 33:2015	Reference materials Good practice in using reference materials
ISO Guide 35:2017	Reference materials Guidance for characterization and assessment of homogeneity and stability
EN 375 : 2001	INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR PROFESSIONAL USE
ISO Guide 30:2015	Reference materials Selected terms and definitions
EN ISO 9000:2015	Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)
ISO 3534-1:2006	Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability