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BS ISO 17593:2022 – TC

BS ISO 17593:2022 – TC

$258.95

Tracked Changes. Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

Published By Publication Date Number of Pages
BSI 2022 152
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PDF Catalog

PDF Pages PDF Title
1 30453681
91 A-30402426
92 undefined
97 Foreword
98 Introduction
99 1 Scope
2 Normative references
100 3 Terms and definitions
106 4 Design and development
4.1 General requirements
4.2 Measuring interval
4.3 Safety
4.4 Risk management
4.4.1 Identification of hazards
107 4.4.2 Risk management
4.5 Ergonomic and human factor aspects
108 4.6 Quality assurance and risk controls
4.6.1 General
4.6.2 Measurement verification
4.6.3 Control of system performance
4.6.4 Verification of self-testing performance
4.7 Metrological traceability
109 5 Information supplied by the manufacturer
5.1 General requirements
110 5.2 Instructions for use of the oral-anticoagulation monitoring system
111 5.3 Labels for the reagents and control(s)
112 5.4 Instructions for use of reagents and control materials
6 Safety and reliability testing
6.1 General requirements
6.1.1 Protocol
113 6.1.2 Instruments and reagents
6.1.3 Acceptance criteria
6.2 Protection against electric shock
6.3 Protection against mechanical hazards
6.4 Electromagnetic compatibility
6.5 Resistance to heat
6.6 Resistance to moisture and liquids
6.7 Protection against liberated gases, explosion, and implosion
6.8 Instrument components
6.9 Performance test
114 6.10 Mechanical resistance to shock, vibration, and impact
6.10.1 Vibration test protocol
6.10.2 Drop test protocol
6.11 Temperature exposure limits
6.11.1 High-temperature test protocol
115 6.11.2 Low-temperature protocol
6.12 Humidity-exposure test protocol
6.13 Reagent and storage and use testing
116 7 Training and education programs
7.1 Training of healthcare providers
7.2 Education of lay persons
117 7.3 Evaluation of user conformance in following the manufacturer’s and the physician’s instructions
8 System performance validation
8.1 General
8.2 Contributors to measurement uncertainty
8.3 System performance validation study
118 8.4 Validation of measurement precision
8.4.1 General
119 8.4.2 Validation of measurement repeatability
8.4.3 Validation of intermediate precision
121 8.4.4 Data analysis
124 8.5 Validation of system accuracy
8.5.1 General requirements
8.5.2 Study population
125 8.5.3 Samples/Specimen
126 8.5.4 Instruments and reagents
8.5.5 Comparator measurement procedure
8.5.6 Study design
127 8.5.7 Procedure
128 8.5.8 Data analysis
131 8.6 Minimum acceptable system accuracy
8.6.1 System accuracy requirement
132 8.6.2 System accuracy assessment
8.6.3 Data presentation
133 9 Lay person performance evaluation
9.1 General
9.2 Study overview
135 9.3 Study sites
9.4 Subjects
9.5 Instruments and materials
9.6 Evaluation of lay person proficiency
9.6.1 Initial evaluation
136 9.6.2 Home use
9.6.3 Mid and final evaluation
9.7 Evaluation of instructions for use
137 9.8 Acceptance criteria and data assessment
138 Annex A (normative) Additional requirements for electromagnetic compatibility
140 Annex B (informative) Traceability chain examples
144 Annex C (informative) Examples of an uncertainty calculation for a prothrombin INR determination using an oral anticoagulation monitoring system
148 Annex D (informative) Elements of quality assurance of oral-anticoagulation monitoring systems
149 Bibliography

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BS ISO 17593:2022 - TC
$258.95