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Medical and non-medical applications PREAMBLE The fundamental reasons for standards: • Following the mainstream development • Facilitating interoperation • Clarifying legal issues • Ensuring user safety THE CURIOUS CASE OF MEDICAL ROBOTS Incorporating different areas • Visiting robots • Patient carriers • Medical delivery • Rehabilitation robotics • Surgical robotics Part of service robots, regulated ambiguously EC Machinery Directive • Non-medical personal care robots “machines performing aiding actions, and actions contributing directly towards improvement in the quality of life of humans, except medical application” Medical intended use EC Medical Device Directive: • Medical robots are classified and will be regulated as medical electrical equipment and systems which are to be used to diagnose, treat or rehabilitate patients from medical conditions The authors acknowledge the support and ongoing effort of the ISO TC 184/SC 2 workgroups. TH is supported by the Hungarian OTKA CK80316 grant, connected to the New Széchenyi Plan TÁMOP- 4.2.1/B-09/1/KMR-2010-0002. CURRENT TRENDS ISO TC 184/SC 2/WG 7 (Personal care robot safety) • personal care robots -> medical and non-medical sectors ISO/DIS 2 13482 [WG7] for non-medical personal (due in Aug 2013) IEC SC 62A & ISO TC 184/SC 2/JWG 9 • Medical electrical equipment and systems using robotic technology for Medical robot • basic safety and essential performance req. for medical robots IEC 60601-1 updates • supportive medical data as evidence for the safety and performance • risk assessment and analysis even for OEMs • from June 2012 in the EU, planned from 2013 in the USA CURRENT STANDARDS AND REGULATIONS • IEC 60812 Intl. Standard on Fault Mode and Effects Analysis (1985) • IEC 1508 Functional Safety: Safety-Related Systems (1995) • European Norm (EN) 1441 on risk management (1997) • American National Standards Institute (ANSI) R15.06 standard for industrial robot safety (1999) • GHTF/SG3/N99-10:2004 Quality Management Systems Process Validation Guidance (2004) • IEC 62304 on Medical Device Software—Softw. Life Cycle Processes (2006) • IEC 61025 Fault Tree Analysis (Ed. 2.0, 2006) • ISO 14971 Application of Risk Management to Medical Devices (2007) • IEC 60601 Intl. Standard on Medical Electrical Equipment (Ed. 3.0, 2010) • IEC 1508 draft standard on Functional Safety for software developers ACKNOWLEDGEMENT Credit: Intuitive, ROBODOC, I See You Credit:Ri-MAN REGULATORY BODIES ARE RULING European Commission • CE mark (Conformité Européenne), by independent Notified Bodies • ISO 9000 Quality Standards (ISO 9001:2000)—possibility of self-certification • New: 2007/47/EC extension to 1993/42/EEC Medical Device Directive • more clinical data required U.S. Food and Drug Administration • Pre-Market Approval (PMA): long, expensive • Premarket notification, 510(k): doctrine of “substantially equivalency” • FDA Quality System Regulations (QSR) • All surgical robots went down 510(k) CATEGORIZATION OF ROBOTS In accordance with ISO 8373: based on application CONTACT • G.S. Virk: [email protected] • T. Haidegger: [email protected]
