「医療機器ソフトウェアにおけるユーザビリティ」 中里
Contents
1. e amp IEC TC62 SNAG 2014 HF Usability BH 5663 005 W gt i18n VOV gt EATp 60878 Ed 3 CD gt gt gt P ls gt LT T uus IEC 60601 1 8 WT2. 2014 3 7H IEC TC62 SNAG Expert TC62 SC62A JWQ3 Expert TC62 SC62A JWG Expert IEC TC62 SNAG 2014 Agenda HF IEC TC62 SNAG 2013 3 ISO TC210 2013 4 JWG3 2013 4 IEC TC62 2013 5 JWG7 2013 5 AAMI 2013 6 ICS CERT 2013 10 JWG3 2013 10 JWG7 2014 1 JWG3 2014 5 JWG7 e ISO 13485 2CD e EC 62304 am1 Ed 1 CDV e EC 82304 1 2CD e IEC 80002 3 PRM DTR e IEC 62366 1 CDV IMDRF SaMD Key Definitions e FDA Cybersecurity draft Guidance FDA RF Wireless Technology in MD draft Gu
3. EM _ Bie 18n IEC TC62 SNAG 2014 12 HF IEC TC62 SNAG 2014 HF m Use related hazard e use HF fts FDA Draft Guidance Applying Human Factor and Usability Engineering to Optimize Medical Device Design e e
4. IECTR 60878 ISO IR ISO 2022 UTF GB 18030 IHE DICOM HL7 ISO IEC 8859 1 x0 x1 x2 x3 x4 x5 x6 x x8 x9 xA xB xC xD xE xF Ox IEC 60601 1 8 SD EU L72 28 r Poa iR 7X pi q ris t ju viw x y z t I e MDD nnaBnunngoHHE D Bx i igni Til l l X e lu e MDR ZIRREREREHIIII Fx 6 f56j 50 j6 j6 6j 5 o Ybiy IEC TC62 SNAG 2014 11 BH e i18n Internationalization e
5. Healthcare Healthcare E 3E 0D ER E23 EPI AL T ISO 13485 IMDRF MDR IEC TC62 SNAG 2014 4 m e e AET DORS ETEME a qi J N ad AW EF UE w p pe D 0S IEC TC62 SNA
6. E e x an TET SERE L NI AM IEC 62304 e e 5 1 cn avin 5 5 N 52 23 5 4 o vos zen Mm rh ho 1 IEC 62366 za sii me OTS UDI Unique Device Identification IEC TC62 SNAG 2014 19
7. 2014
8. JJ 2009 9 B 1 RE nat i EH nih Im ci AM tani R DECSOXOIC U 5 ENTM ILE p ai zL IEC TC62 SNAG 2014 23 IEC TC62 SNAG 2014
9. Qua up IEC TC62 SNAG 2014 6 WHO HEALTH QEA B WHO HEALTH physical Guide51 HEALTH a state of complete physical mental and social well being and not merely the absence of disease or SOURCE WHO definition WHO 1946 Harm physical injury or damage to the health of people or damage to property or the environment Hazard potential source of HARM SOURCE ISO 14971 2007 2 3 modified amended meaning of HARM Note 1 to entry Potential sources of harm include degradation of DATA AND SYSTEMS SECURITY and reduction of effectiveness DATA AND SYSTEM SECURITY operational state of networked health technology in which information assets data and systems are reasonably protected from degradation of confidentiality integrity and availability Note 1 to entry Security when mentioned in this standard includes DATA AND SYSTEMS SECURITY Note 2 to entry DATA AND SYSTEMS SECURITY is assured through
10. ISO 14971 E IEC TR 80002 1 Medical device software Guidance on the application of ISO 14971 to medical device software 4 2 2 ar MEI Iz A TTE X a D c d e
11. n preset Configuration USABILITY TESTING e oF MEDICAL DEVICES gt EU OUT REALEN ALLISON Y STROCHLIC 9 December 20 2010 by CRC Press e IEC 62366 IEC 60601 1 6 IEC 62366 1 IEC TC62 SNAG 2014 15 m ERTA mapai e Ver 2 0 JIS X8341 E e Wi TM T T TERS HH U m nn Bak HESS BEH szoget LMS 3204 f MS 200i LS 2208tik http www eizo co jp products ce uc index2 html Cm PE DA http www cu
12. pam uet f duJes usvsm P Mo GOES g 3 xci ae x Bi NV SE iR ISO 14971 IEC 62366 3E 4 3 REPORT d
13. 24 B e m e E HF e e mg e e e TR IEC TC62 SNAG 2014 29 CL GEH Bi 45 U 74A C IEC TC62 SNAG
14. ore evaluation IEC 62366 1 3 8 TAS o HF e Agile e e IEC TC62 SNAG 2014 20 HFE HFE e AAMI ANSI HE75 2009 Human factor engineering Design of medical devices AAMI ANSI HE75 2009 American National e General considerations and Standard principles Managing the risk
15. G 2014 E e IEC 82304 1 PERMER NEATIS O e IEC 62304 Ed 2 IEC 62304 am1 Ed 1 IEC 62304 2006 Ed 1 CDV 2014 3 ISO 13485 E Health Software ISO 14971 E Ren P Medical Software for a MP x Other Health IEC 62304 a SEMER e IEC 62304 am1 L oftware IEC 62366 1 RA iyu iii 447 i siye http www softbank jp mobile service softbankhealthcare ISO 13485 ISO 9001 ISO 13485 ISO 14971 IEC 62304 IEC 62304 am1 IEC 62366 1 IEC 82304 1 Software as a Software for a dn ISO 14971 a ii gem IEC 62304 Ed 2 2 i IEC 62366 1 TT og Scope of IEC 62304 IEC 60950 1 http www wellnesslink jp IEC 60950 1
16. a framework of policy processes guidance infrastructure and services designed to protect information assets and the systems that acquire transmit store and use information in pursuit of the organization s mission EFFECTIVENESS ability to produce the intended result for the patient and the RESPONSIBLE ORGANIZATION SOURCE IEC 80001 1 IEC TC62 SNAG 2014 m e e HFE Human Factor Engineering Sem TE Medical BV Is Patients IEC ISO IEC TC62 ISO TC215 IEC TC62 SNAG 2014 8 IEC 62304 am1 Ed 1 4 4 E IEC 62304 Gap IEC 62304 3 29 SOUP software of unknown provenance acronym SOFTWARE ITEM that is already developed and gene
17. do jp colorud color vision peculiar color vison types IEC TC62 SNAG 2014 16 ISO 9241 EH UX e Usability ISO 9241 11 1998 Universal Design ISO 13407 1999 User Experience ISO 9241 210 2010 60 70 80 90 IEC TC62 SNAG 2014 17 Formative Evaluation IEC TC62 SNAG 2014 85 0212942 g e QMS
18. idance e FDA UDI System e FDA Global UDI Database draft Guidance e FDA MD Use Safety incorporating HFE into RM e FDA Applying HF and Usability Engineering to Optimize MD Design 2014 2 IEC TC62 SNAG 2014 3 IEC TC62 2011 9 B TC62 To prepare international standards and other publications concerning electrical equipment electrical systems and software used in healthcare and their effects on patients operators other persons and the environment NOTE This scope includes items that are also within the scopes of other committees and will be addressed through cooperation Attention will focus on safety and performance e g radiation protection data security data integrity data privacy and environmental aspects and will contribute to regulatory frameworks Healthcare includes medical practice as well as emergency medical services homecare and support of persons with disabilities in their daily lives I e Ambient Assisted Living
19. of use error Usability testing e Design elements Controls Software e Integrated solutions Mobile medical devices Home health care Human factors engineering Design of medical devices IEC TC62 SNAG 2014 21 Agile E IEC 62304 V e AAMI TIR45 2012 lt FDA gt Guidance on the use of AGILE practices in the development of medical device software Technical Agile Goals Information _ Report Processes that did not respond well to changing business needs Low visibility into actual project progress Focus on Quality the correctness of the product Improve on Productivity efficiency and speed of development while reducing development cosi AAMI TIR45 Improve Predictability through estimation and planning 2012 e Product Effectiveness through defined roles and continual feedback Guidance on the use of AGILE practices in the development of medical device software Align the goals of Quality Productivity and Predictability to be supportive of one another IEC TC62 SNAG 2014 22
20. rally available and that has not been developed for the purpose of being incorporated into the MEDICAL DEVICE also known as off the shelf software or SOFTWARE ITEM previously developed for which adequate records of the development PROCESSES are not available Note 1 This does not include an entire MEDICAL DEVICE SOFTWARE SYSTEM 3 40 LEGACY SOFTWARE MEDICAL DEVICE SOFTWARE which was legally placed on the market but for which there 1s insufficient objective evidence that it was developed in conformance with the current version of the standard OTS Off the shelf Software includes open source shareware and free software software previously developed for which adequate records of the development processes are not available IEC 62304 am1 Ed1 IEC TC62 SNAG 2014 9 IEC TC62 SNAG 2014 Interoperability m Minimum requirements e
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