Objectives. IEC 60601-1:2005. 10/22/2012. 2. • Understand 2nd Edition to 3rd
Edition Transition Dates. • Major Changes from IEC 60601-1, 2nd Edition to IEC.
IEC 60601-1 3rd Edition
Presenter Daniel Ruth: TUV Rheinland NA
Objectives
• Understand 2nd Edition to 3rd Edition Transition Dates • Major Changes from IEC 60601-1, 2nd Edition to IEC 60601-1, 3rd Edition • Risk Management • IEC/UL 61010-1, 3rd Edition and Ramifications
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IEC 60601-1:2005 IEC 60601-1, Edition 3 Published December 2005 9 years to develop International consensus standard - Adopted or used to develop national standards Represents new state of the art for safety requirements - Compliance can be presumed to verify acceptable risk unless there’s objective evidence to the contrary
- Included in Official Journal (OJ) http://ec.europa.eu/enterprise/policies/europeanstandards/documents/harmonised-standards-legislation/listreferences/medical-devices/index_en.htm
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IEC 60601-1:2005 United States - ANSI/AAMI ES 60601-1:2005, which is IEC 60601-1:2005 with US deviations - The FDA now officially recognizes ANSI/AAMI ES 60601-1:2005 in the Federal Register
- FDA will accept declarations of conformity, in support of premarket submissions to IEC 60601, 2nd Edition until June 30, 2013 - Existing Equipment is “grandfathered” - After this transitional period, new declarations of conformity to IEC 60601-1, Ed. 2 will not be accepted - OSHA still using 2nd Ed. for NRTL
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IEC 60601-1:2005 Canada - CSA published CSA‐C22.2 NO. 60601‐1:08, which is IEC 60601-1:2005 with Canadian deviations - June 1, 2012 cessation date when 2nd edition no longer valid - Existing Equipment is “grandfathered” - Several exemptions for MEE with particular standards (IEC 60601-2-xx).
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IEC 60601-1:2005 Europe - All products must meet current state of the art - EN 60601-1, which is IEC 60601-1:2005 with European deviations - The Date of Withdrawal in the OJ is June 1, 2012 - Existing Equipment is NOT “grandfathered” - Several exemptions for MEE with particular standards (IEC 60601-2-xx).
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IEC 60601-1:2005 Structure General Standard IEC 60601-1 Collateral (-1-xx) - Requirements for specific technologies and/or hazards
General Standard 60601-1
Collateral Standards 60601-1-1 Systems (Obsolete)
60601-1-2 EMC
60601-1-4 PESS (Obsolete)
60601-1-6 Usability
60601-1-8 Alarms
60601-1-11 Home Healthcare
Particular Standards Requirements for specific equipment types 60601-2-1 Medical Electron Accelerators
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60601-2-2 High Frequency Surgical Equipment
IEC 60601-1:2005
60601-52 Electrically Operated Hospital Beds
ISO 80601-2-12 Critical Care Ventilators
...Many More...
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Major Difference 2nd to 3rd Ed Clause 4.2 - Risk Management Process Required (ISO 14971) 3rd Ed. Still a Test Standard with Pass/Fail Criteria - But RM allows flexibility within a hazard-based framework
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Major Difference 2nd to 3rd Ed
Clause 4.2 - Risk Management Process Required (ISO 14971) 3rd Ed. Still a Test Standard with Pass/Fail Criteria - But RM allows flexibility within a hazard-based framework
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Risk Management affects which tests are performed
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Risk Management In 3rd Edition
To understand the 3rd Edition, we must understand ISO 14971
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Risk Management In 3rd Edition To understand the 3rd Edition, we must understand ISO 14971 - Total Life Cycle Approach - Does Not Specify Acceptable Risk
- Acceptability is determined by the manufacturer for each device using the risk management policy - Provide Framework for Management of Risk
- Defines Management Responsibilities - Intended For Integration With Quality System
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Risk Management
Hazard: “potential source of harm”
Risk = Probability * Severity Harm: “physical injury or damage to health or property”
HAZARD
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RISK
HARM
Frequent
Intolerable ALARP
Improbable
Probability
Risk Management (see Fig E.1)
Broadly Acceptable
Negligible
Severity
Catastrophic
ALARP = As Low As Reasonably Practicable (Further Investigation Needed) 14
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RM Summary Risk Assessment Process Determines How a Product is Evaluated to 3rd Edition - A risk management process defined in ISO 14971 is necessary to demonstrate compliance - Though there are baseline requirements, RM can be used to tailor the requirements in the standard to the device
- Risk management process may add requirements/tests or may eliminate or modify requirements/tests
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IEC 60601-1 3rd Edition EN 61010-1:2010 has a mandatory compliance date of October 1st 2013 in the EU Aligns standard to match other modern standards such as IEC 60950-1 and IEC 60601-1. • Clarifications and corrections • Definitions (Reinforced, Dynamic to Impact test etc.) • Test Procedures and Limits(Bonding Impedance, Corner drop/Face Drop renamed) • Updated standard references • Clearance and Creepage is simplified (including PCB and through insulation) • Moving parts now have defined requirements on speed and gaps and risks must be assessed • Loading requirements on castors and handles and wall mounts • Now BOP defined similar to IEC 60601-1. Separates terminal and probes into their own Part 2’s New limits and contact definitions of temperature limits to touchable parts Hazards defined for unattended controls. Ergonomic requirements implemented. Finally, Risk Management (ISO 14971) is now required on hazards not fully addressed elsewhere in the standards
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The End
Thank you for Attending!
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