ГОСТ Р ЕН 13612-2010 Оценка функциональных характеристик медицинских изделий для диагностики in vitro
Библиография
Европейские и международные стандарты
ЕН 376:2002 | Информация, предоставляемая изготовителем с реагентами для диагностики in vitro для самотестирования (Information supplied by the manufacturer with in vitro diagnostic reagents for selftesting) |
EН 928 | Системы диагностики in vitro. Руководство по применению ЕН 29001 и ЕН 46001 и ЕН 29002 и ЕН 46002 к медицинским изделиям для диагностики in vitro (In vitro diagnostic systems. Guidance on the application of EN 29001 and EN 46001 and EN 29002 and EN 46002 for in vitro diagnostic medical devices) |
EН 12286 | Медицинские изделия для диагностики in vitro. Измерение величин в пробах биологического происхождения. Представление референтных методик измерения (In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Presentation of reference measurement procedures) |
EН 12287 | Медицинские изделия для диагностики in vitro. Измерение величин в пробах биологического происхождения. Описание референтных материалов (In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Description of reference materials) |
EН 46001 | Системы качества. Медицинские изделия. Частные требования к применению ЕН ИСО 9001 (Quality systems. Medical devices. Particular requirements for the application of EN ISO 9001) |
EН ИСO 9000:2000 | Системы менеджмента качества. Основные положения и словарь. (ИСО 9001:2000) (Quality management systems. Fundamentals and vocabulary (ISO 9000:2000)) |
EН ИСO 9001 | Системы качества. Требования (ИСO 9001:2000). (Quality management systems. Requirements (ISO 9001:2000) |
EН ИСO 13485 | Системы качества. Медицинские изделия. Частные требования к применению ЕН ИСО 9001 (Пересмотр ЕН 46001:1996) (Идентично ИСО 13485:1996) (Quality systems. Medical devices. Particular requirements for the application of EN ISO 9001 (Revision of EN 46001:1996) (Identical to ISO 13485:1996) |
ИСO 5725-1 | Точность (правильность и прецизионность) методов и результатов измерения. Часть 1. Общие принципы и определения (Accuracy (trueness and precision) of measurement methods and results. Part 1: General principles and definitions) |
Документы Европейского комитета клинических лабораторных стандартов
Guidelines for the Evaluation of Analysers in Clinical Chemistry, 1986, vol.3. no.2.
Guidelines for a User Laboratory to Evaluate and Select a Kit for its Own Use: 1986, vol.3 no.3
Guidelines for the Evaluation of Diagnostic Kits: Part 2: General Principles and Outline Procedures for the Evaluation of Kits for Qualitative Tests, 1990, no.1
Guidelines for Multi-centre Evaluation of Analysers for the Measurement of Blood pH, pCO2, and pO2
Guidelines for the Identification and Distribution of Patient Samples in the Medical Laboratory: 1990, vol. no.5
Документы Национального комитета клинических лабораторных стандартов (США)
NCCLS. Evaluation of the Linearity of Quantitative Analytical Methods: A Statistical Approach; Proposed Guideline. Second Edition. NCCLS Document EP6-P2. Wayne, PA: NCCLS; 2001.
NCCLS. Interference Testing in Clinical Chemistry; Proposed Guideline. NCCLS Document EP7-P. Wayne, PA: NCCLS; 1986
NCCLS. Blood Gas and pH Analysis and Related Measurements; Approved Guideline. NCCLS Document C46-A. Wayne, PA: NCCLS; 2001
NCCLS. Immunoprecipitin Analyses: Procedures for Evaluating the Performance of Materials; Approved Guideline. Second Edition. NCCLS Document DI2-A2. Wayne, PA: NCCLS; 1993.
NCCLS. Ancillary (Bedside) Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline. NCCLS Document C30-A. Wayne, PA: NCCLS; 1994
NCCLS. Specifications for Immunological Testing for Infectious Diseases; Approved Guideline. Second Edition. NCCLS Document I/LA18-A2. Wayne, PA: NCCLS; 2001
NCCLS. Laboratory Statistics. Standard Deviation; A Report. NCCLS Document EP13-R. Wayne, PA: NCCLS; 1995
NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS Document EP9-A. Wayne, PA: NCCLS; 1995
NCCLS. How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline. Second Edition. NCCLS Document C28-A2. Wayne, PA: NCCLS; 2000
NCCLS. Uniformity of Claims For in Vitro Diagnostic Tests; Proposed Guideline. NCCLS Document EP11-P. Wayne, PA: NCCLS; 1996
NCCLS. Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Specimen Handling, and Use of Test Products in the Clinical Laboratory; Approved Guideline. NCCLS Document I/LA6-A. Wayne, PA: NCCLS; 1997
NCCLS. Preliminary Evaluation of Quantitative Clinical Laboratory Methods; Approved Guideline. NCCLS Document EP10-A. Wayne, PA: NCCLS; 1998
NCCLS. User Demonstration of Performance for Precision and Accuracy; Approved Guideline. NCCLS Document EP15-A. Wayne, PA: NCCLS; 2001
NCCLS. Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline. NCCLS Document EP5-A. Wayne, PA: NCCLS;1999
NCCLS. Clinical Evaluation of Immunoassays; Approved Guideline. NCCLS Document I/LA21-A.Wayne,PA: NCCLS; 2001
NCCLS. Quality Management for Unit-Use Testing; Proposed Guideline. NCCLS Document EP18-P. Wayne, PA: NCCLS; 1999
NCCLS. Evaluation of Matrix Effects; Approved Guideline. NCCLS Document EP14-A. Wayne, PA: NCCLS; 2001
NCCLS. User Protocol for Evaluation of Qualitative Test Performance; Proposed Guideline. NCCLS Document EP12-P. Wayne, PA: NCCLS; 2000