ДСТУ ISO 14971:2009
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1 2 4 —? —? —? —? ISO (International Organization for Standardization, —? —? —? —? —? —? —? MEDICAL DEVICES
1 2 2.1 2.2 [ISO/IEC Guide 51:1999, 2.3 [ISO/IEC Guide 51:1999, 2.4 2.5 2.6 2.7 2.8 2.9 —? —? —? —? [ISO 13485:2003, —? —? —? —? —? 2.10 [ISO 9000:2005, 2.11 2.12 [ISO 9000:2005, 2.13 2.14 [ISO 9000:2005, 2.15 2.16 [ISO/IEC Guide 51:1999, 2.17 2.18 [ISO/IEC Guide 51:1999, 2.19 2.20 2.21 2.22 2.23 2.24 [ISO/IEC Guide 51:1999, 2.25 2.26 2.27 [ 2.28 —? —? —? —? [ISO 9000:2005, З? 3.1 —? —? —? —? 3.2 —? —? —? ►? •? •? •? •? •? •? •? 3.3 3.4 а?) Ь?) с?) d) е?) f) —? —? У? 3.5 —? —? —? —? 4 4.1 а?) Ь?) с?) 4.2 4.3 4.4 а?) Ь?) с?) d) е?) f) h) 5 6 6.1 6.2 а?) Ь?) с?) 6.3 6.4 6.5 6.6 6.7 7 8 —? —? —? 9 а?) Ь?) —? —? 1) 2) —? —? —? ISO/IEC Guide 51:1999 Safety aspects — Guidelines for the inclusion in standards ( —? ISO 9000:2005 Quality management system — Fundamentals and vocabulary ( —? ISO 13485:2003 Medical devices — Quality management system — Requirements for regulatory purposes ( а?) Ь?) с?) d) —? —? —? —? —? а?) Ь?) с?) —? —? —? —? —? —? а?) Ь?) с?)
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X — D.2 D.2.1 D.2.2 D.2.2.1 D.2.2.2 —? —? —? D.2.2.3 —? —? —? —? —? —? —? D.3 D.3.1 —? —? —? —? —? —? — D.3.2 D. 3.2.1 D.3.2.2 — — — — —? —? —? —? —? — — D.3.2.3 —? —? — — D.3.3 D.3.4 D. 3.4.1
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D.4 —? —? —? —? —? —? —?
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D.5 D.5.1 а?) —? —? —? Ь?) —? —? с?) —? —? —? —? —? —? —? D.5.2 D.5.3 D.5.4 —? —? —? —? D.5.5 D.6 D.6.1 D.6.2 —? —? —? —? —? D.6.3 D.6.4 —? —? —? —? — D.6.5 D.7 D.7.1 D.7.2 D.7.3 D.7.4 D.7.5 D.7.6 D.7.7 D.7.8 D.8 D.8.1 а?) Ь?) с?) D.8.2 D.8.3 —? —? D.8.4 —? —? —? —? —? —? —? D.8.5
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Е?.2 — —? —? —? Е?.З? — — — — —? —? —? —? —? —? —? —? —? —? —? —? —? —? (2) (2) (2) ESD (3) (2) F.1 F.2 F.3 F.4 F.5 F.6 F.7 G.1 G.2 а?) Ь?) с?) d) е?) G.3 G.4 G.5 —? —? —? —? —? G.6 1. 2. 3. 4. 5. 6. 7. Ь?) 1) 2) 3) 4) с?) 1) 2) 3)
— — —? —? —? —? —? —? Н? .2.2.3 —? —? —? Н? .2.2.4 —? —? —? —? — —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? — —? —? —? —? —? —? —? —? —? — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — — а?) Ь?) с?) —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? —? — —? —? —? —? —? —? —? —? —? —? —? —? —? 1.1 1.2 1.2.1 —? —? —? —? 1.2.2 —? —? 1.2.3 1.2.4 J.1 —? —? J.2 —? —? —? —? —? —? —? J. —? —? —? —? 1 ISO/IEC Guide 2:1996 Standardization and related activities — General vocabulary ( 2 ISO/IEC Guide 51:1999 Satety aspects — Guidelines for the inclusion in standards ( 4 ISO 9000:2005 Quality management system — Fundamentals and vocabulary ( 5 ISO 10993-1. Biological evaluation of medical devices — Part 1. Evaluation and testing within a risk managemet system ( 6 ISO 10993-2 Biological evaluation of medical devices — Part 2. Animal welfare requirements ( 7 ISO 10993-17 Biological evaluation of medical devices — Part 17. Establishment of allowable limits for leachable substances ( 8 ISO 13485:2003 Medical devices — Quality management system — Requirements for regulatory purposes ( 9 ISO/TR 14969 Medical devices. Quality management system. Guidance on the application of ISO 13485:2003 ( 10 ISO 14155-1 Clinical investigation of medical devices for human subjects — Part 1. General requirements ( 11 ISO 14155-2 Clinical investigation of medical devices for human subjects — Part 2. Clinical investigation plans ( 12 ISO 15189 Medical laboratories — Particular requirements for quality and competence ( 13 ISO 15197 In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus ( 14 ISO 15198 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user guality control procedures by the manufacturer ( 15 ISO 17511 In vitro diagnostic medical devices — Measurement of quantities in biological sampies Metrological traceability of values assigned to calibrators and control materials ( 16 ISO 17593 3) Clinical laboratory testing and in vitro diagnostic test systems — Requirements for in vitro monitoring systems for self-testing of oral-anticoagulant therapy ( 17 ISO 18153 In vitro diagnostic medical devices — Measurement of quantities in biological sampies. Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials ( 18 ISO 19001 In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology ( 19 ISO 22442 (all parts) Medical devices utilizing animal tissues and their denvatives ( 20 21 22 IEC/TR 60513 Fundamental aspects of safety standards for medical electrical equipment ( 23 24 25 26 27 28 29 31 EN 1441:1997 3 32 EN 12442-1 Animal tissues and their derivatives utilized in the manufacture of medical devices. Part 1. Analysis and management of risk ( 33 90/285/EEC Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC) as amended by Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and Council Directive 93/68/EEC of 22 July 1993 ( 34 93/42/ 35 98/79/ 36 CLARKE W.L. et al, Evaluating Clinical Accuracy of Systems for Self-Monitoring of Blood Glucose, Diabetes Care; 10(5) pp. 622-628, 1987 ( 37 The Codex Alimentarius Commission and the FAO/WHO Food Standards Programme Complete Texts e-mail: [email protected] ( 38 Global Harmonization Task Force (GHTF) — Study Group 1 (SG1) Document No. N029R11, dated 2 Feb. 2002 ( 39 Medical Device Risk Management Training Using HACCP Principles, 2 nd Edition, June 2003, Medical HACCP Alliance, Editors George Flick, Joseph L. Salyer, et al ( 40 Hazard Analysis and Critical Control Points Principles and Application Guidelines, Adopted, August 14, 1997, National Advisory Committee on Microbiological Criteria for Foods: htth//vm.cfsan.fda.gov/~comm/ nacmcfp.html. ( 41 PARKES, J. L. et al. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose, Diabetes Care 2, 3, pp. 1143-1148, 2000 (Parkes, J. L. et al. 42 ISO 18113-1 > 1 2 4 5 6 7
