IEC 60601-1 3rd Edition
Presenter
Daniel Ruth: TUV Rheinland NA
OBJECTIVE
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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 60601-1:2005
 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/european-standards/documents/harmonisedstandards-legislation/list-references/medical-devices/index_en.htm
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IEC 60601-1:2005
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 previously stated they will accept declarations of conformity, in
support of premarket submissions to IEC 60601, 2nd Edition until June
30, 2013. This has been since modified to December 31, 3013.
- 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
FDA Excerpt from Website
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IEC 60601-1:2005
IEC 60601-1:2005
 Canada
- CSA published CSA‐C22.2 NO. 60601‐1:08, which is IEC 606011:2005 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- June 1, 2012 cessation date when 2nd edition no longer valid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
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
IEC 60601-1:2005 Structure
 General Standard IEC 60601-1 Collateral (-1-xx) - Requirements for
specific technologies and/or hazards
General
Standard
60601-1
60601-1-1
Systems
(Obsolete)
60601-1-2
EMC
Collateral
60601-1-4
Standards
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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IEC 60601-1:2005
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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IEC 60601-1:2005
Risk Management affects which tests are performed
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IEC 60601-1:2005
Risk Management In 3rd Ed
 To understand the 3rd Edition, we must understand ISO 14971
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IEC 60601-1:2005
Risk Management In 3rd Ed
 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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IEC 60601-1:2005
Risk Management
 Hazard: “potential source of harm”
 Risk = Probability * Severity
 Harm: “physical injury or damage to health or property”
 HAZARD
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IEC 60601-1:2005
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)
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IEC 60601-1:2005
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 60601-1:2005
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.
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Clarifications and corrections
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Definitions (Reinforced, Dynamic to Impact test etc.)
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Test Procedures and Limits(Bonding Impedance, Corner drop/Face Drop renamed)
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Updated standard references
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Clearance and Creepage is simplified (including PCB and through insulation)
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Moving parts now have defined requirements on speed and gaps and risks must
be assessed
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Loading requirements on castors and handles and wall mounts
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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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IEC 60601-1:2005
The End
Thank you for Attending!
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