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BS ISO 17593:2022

BS ISO 17593:2022

$198.66

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 62
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PDF Catalog

PDF Pages PDF Title
2 undefined
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
10 3 Terms and definitions
16 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
17 4.4.2 Risk management
4.5 Ergonomic and human factor aspects
18 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
19 5 Information supplied by the manufacturer
5.1 General requirements
20 5.2 Instructions for use of the oral-anticoagulation monitoring system
21 5.3 Labels for the reagents and control(s)
22 5.4 Instructions for use of reagents and control materials
6 Safety and reliability testing
6.1 General requirements
6.1.1 Protocol
23 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
24 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
25 6.11.2 Low-temperature protocol
6.12 Humidity-exposure test protocol
6.13 Reagent and storage and use testing
26 7 Training and education programs
7.1 Training of healthcare providers
7.2 Education of lay persons
27 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
28 8.4 Validation of measurement precision
8.4.1 General
29 8.4.2 Validation of measurement repeatability
8.4.3 Validation of intermediate precision
31 8.4.4 Data analysis
34 8.5 Validation of system accuracy
8.5.1 General requirements
8.5.2 Study population
35 8.5.3 Samples/Specimen
36 8.5.4 Instruments and reagents
8.5.5 Comparator measurement procedure
8.5.6 Study design
37 8.5.7 Procedure
38 8.5.8 Data analysis
41 8.6 Minimum acceptable system accuracy
8.6.1 System accuracy requirement
42 8.6.2 System accuracy assessment
8.6.3 Data presentation
43 9 Lay person performance evaluation
9.1 General
9.2 Study overview
45 9.3 Study sites
9.4 Subjects
9.5 Instruments and materials
9.6 Evaluation of lay person proficiency
9.6.1 Initial evaluation
46 9.6.2 Home use
9.6.3 Mid and final evaluation
9.7 Evaluation of instructions for use
47 9.8 Acceptance criteria and data assessment
48 Annex A (normative) Additional requirements for electromagnetic compatibility
50 Annex B (informative) Traceability chain examples
54 Annex C (informative) Examples of an uncertainty calculation for a prothrombin INR determination using an oral anticoagulation monitoring system
58 Annex D (informative) Elements of quality assurance of oral-anticoagulation monitoring systems
59 Bibliography

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BS ISO 17593:2022
$198.66