IEC 60601-1 3rd Edition

Presenter

Daniel Ruth: TUV Rheinland NA

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

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/european-

standards/documents/harmonised-standards-legislation/list-

references/medical-devices/index_en.htm

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

7

Collateral Standards

Particular Standards

Requirements for specific equipment types

60601-2-1

Medical

Electron

Accelerators

General

Standard

60601-1

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

60601-2-2 High Frequency Surgical Equipment

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 HARM RISK

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Risk Management (see Fig E.1)

Intolerable

Severity Negligible Catastrophic

Pro

babili

ty

Impro

bable

F

requent

ALARP

ALARP = As Low As Reasonably Practicable (Further Investigation Needed)

Broadly

Acceptable

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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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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

IEC 60601-1 3rd Edition

The End

Thank you for Attending!

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