BS-ISO-17593-2007.pdf
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1、BRITISH STANDARD BS ISO 17593:2007 Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy ICS 11.100.10 ? Licensed Copy: London South Bank University, London South Bank University, Wed May 16 03:42:30 GMT+0
2、0:00 2007, Uncontrolled Copy, (c) BSI BS ISO 17593:2007 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2007 BSI 2007 ISBN 978 0 580 50737 3 National foreword This British Standard was published by BSI. It is the UK implementation of I
3、SO 17593:2007. The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users
4、are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. DateComments Licensed Copy: London South Bank University, London South Bank University, Wed May 16 03:42:30 GMT+00:00 2007, Unco
5、ntrolled Copy, (c) BSI Reference number ISO 17593:2007(E) INTERNATIONAL STANDARD ISO 17593 First edition 2007-04-15 Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy Laboratoires danalyses de biologie
6、mdicale et dispositifs mdicaux de diagnostic in vitro Exigences relatives aux systmes dautosurveillance des traitements par anti-coagulant oraux BS ISO 17593:2007 Licensed Copy: London South Bank University, London South Bank University, Wed May 16 03:42:30 GMT+00:00 2007, Uncontrolled Copy, (c) BSI
7、 ii Licensed Copy: London South Bank University, London South Bank University, Wed May 16 03:42:30 GMT+00:00 2007, Uncontrolled Copy, (c) BSI iii Contents Page Foreword. v Introduction. vi 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 2 4 Design and development . 8 4.1 General requi
8、rements. 8 4.2 Measuring interval 8 4.3 Safety . 8 4.4 Risk management. 8 4.4.1 Acceptability of risks 8 4.4.2 Risk assessment. 8 4.5 Ergonomic and human factor aspects . 9 4.6 Quality assurance and risk controls. 9 4.6.1 General. 9 4.6.2 Measurement verification 10 4.6.3 Control of system performan
9、ce 10 4.6.4 Verification of self-testing performance. 10 4.6.5 Evaluation of user compliance in following the manufacturers and the physicians instructions . 10 4.7 Metrological traceability. 10 5 Information supplied by the manufacturer 11 5.1 General requirements. 11 5.2 Labels for the oral-antico
10、agulation monitoring instrument. 11 5.3 Instructions for use of the oral-anticoagulation monitoring system 12 5.4 Labels for the reagents and control material. 13 5.5 Instructions for use for reagents and control material. 13 6 Safety and reliability testing 14 6.1 General requirements. 14 6.1.1 Pro
11、tocol . 14 6.1.2 Instruments and reagents 15 6.1.3 Acceptance criteria. 15 6.2 Protection against electric shock . 15 6.3 Protection against mechanical hazards. 15 6.4 Electromagnetic compatibility. 15 6.5 Resistance to heat 15 6.6 Resistance to moisture and liquids 15 6.7 Protection against liberat
12、ed gases, explosion and implosion. 15 6.8 Instrument components. 15 6.9 Performance test. 15 6.10 Mechanical resistance to shock, vibration and impact 16 6.10.1 Vibration test protocol 16 6.10.2 Drop test protocol. 16 6.11 Temperature exposure limits. 16 6.11.1 High-temperature test protocol. 16 6.1
13、1.2 Low-temperature test protocol 17 6.12 Humidity-exposure test protocol 17 6.13 Reagent storage and use testing 17 BS ISO 17593:2007 Licensed Copy: London South Bank University, London South Bank University, Wed May 16 03:42:30 GMT+00:00 2007, Uncontrolled Copy, (c) BSI iv 7 Training and education
14、 programs.17 7.1 Training of healthcare providers.17 7.2 Education of patients and other users .18 8 System performance verification 19 8.1 General.19 8.2 Contributors to measurement uncertainty.19 8.3 System performance verification study19 8.4 Verification of measurement precision.20 8.4.1 General
15、.20 8.4.2 Verification of measurement repeatability .20 8.4.3 Verification of intermediate measurement precision21 8.4.4 Data analysis .22 8.5 Verification of system accuracy24 8.5.1 General requirements.24 8.5.2 Study population.24 8.5.3 Samples25 8.5.4 Instruments and reagents25 8.5.5 Manufacturer
16、s selected measurement procedure26 8.5.6 Study design26 8.5.7 Procedure.27 8.5.8 Data analysis .28 8.6 Minimum acceptable system accuracy.31 8.6.1 System accuracy requirement.31 8.6.2 System accuracy assessment.31 8.6.3 Data presentation32 9 User performance evaluation.32 9.1 General.32 9.2 Study si
17、tes.32 9.3 Subjects .33 9.4 Instruments and materials .33 9.5 Evaluation of user proficiency.33 9.6 Acceptance criteria and data assessment .34 9.7 Evaluation of instructions for use.34 Annex A (normative) Additional requirements for electromagnetic compatibility35 Annex B (informative) Traceability
18、 chain examples37 Annex C (informative) Sample size calculation to estimate bias (42 in the Bibliography) 40 Annex D (informative) Example of an uncertainty calculation for a prothrombin INR determination using an oral anticoagulation monitoring system.41 Annex E (informative) Elements of quality as
19、surance of oral-anticoagulation monitoring systems 45 Annex F (informative) Application of performance criteria to published evaluations of oral- anticoagulation monitoring systems 46 Bibliography .51 BS ISO 17593:2007 Licensed Copy: London South Bank University, London South Bank University, Wed Ma
20、y 16 03:42:30 GMT+00:00 2007, Uncontrolled Copy, (c) BSI v Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committ
21、ees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the Int
22、ernational Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International
23、Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the s
24、ubject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 17593 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems. BS ISO 17593:2007 Licensed Copy: London South Bank University, London
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