How to Test to IEC 60601-1, 3rd Edition - Platformaami.confedge.com/asset/confEdge/aami/_warehouse/files/Slides_60601.pdfHow to Test to IEC 60601‐1, 3rd Edition RISK MANAGEMENT –

How to Test to IEC 60601‐1, 3rd Edition

How to Test to IEC 60601-1, 3rd Edition

Joe Murnane, BSEE, Underwriters Laboratory, Inc.Frank O'Brien, BSEE, MS, O'Brien Compliance

Management, LLCBrodie Pedersen, Nonin Medical

15/22/2012 © 2012 Association for the Advancement of Medical Instrumentation

UL and the UL logo are trademarks of UL LLC © 2012

IEC 60601-1:2005 AM1RISK MANAGEMENT

Overview of AM1 RM Changes

Presented by Joseph Murnane


DEFINITIONS

• Clause 3 NOTE 3 (new) • When the term "safety" is used in this document in roman or italic type, it

does not mean "safety" as defined in ISO 14971, but rather is used with its normal English meaning.

• SAFETY (ISO 14971) - freedom from unacceptable risk

• 3.72 OBJECTIVE EVIDENCE• Data supporting the existence or verity of something

- NOTE Objective evidence can be obtained through observation, measurement, testing or other means. [ISO 14971:2007, definition 2.10]

3

DEFINITIONS Continued

• 3.88 PROCEDURE• Specific way to carry out an activity or PROCESS [ISO 14971:2007,

definition 2.12]

• 3.89 PROCESS• Set of interrelated or interacting activities which transform inputs into

outputs [ISO 14971:2007, definition 2.13]

• 3.100 RESIDUAL RISK• RISK remaining after RISK CONTROL measures have been taken [ISO

14971:2007, definition 2.15]

4


DEFINITIONS Continued

• 3.106 RISK EVALUATION• Process of comparing the estimated RISK against given RISK criteria to determine

the acceptability of the RISK [ISO 14971:2007, definition 2.21]• 3.107 RISK MANAGEMENT – (note added)

• NOTE For the purposes of this standard, RISK MANAGEMENT does not include planning for or monitoring of production and post-production information, whereas this is required for compliance with ISO 14971 (see 4.2.2).

• 3.138 VERIFICATION• Confirmation, through the provision of OBJECTIVE EVIDENCE, that specified

requirements have been fulfilled- NOTE 1 The term “verified” is used to designate the corresponding status.- NOTE 2 Confirmation can comprise activities such as:

• performing alternative calculations;• comparing a new design specification with a similar proven design specification• undertaking tests and demonstrations;• reviewing documents prior to issue.

- [ISO 14971:2007, definition 2.28]

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RISK MANAGEMENT – 4.2 • 4.2 has been rewritten to fill 3 pages where the existing is 1 page and

divided into separate sub-clauses as follows:

• 4.2.1 Introduction to RISK MANAGEMENT – Explains that the RM Process is to serve the following purposes:1. To see if all applicable requirements in ALL the applicable standards

address the applicable hazards associated with the MEE2. Identify how some particular tests should be applied3. Establish risk levels and evaluate residual risks4. Evaluate risk control strategies by comparing residual risk with that

achieved by applying the full requirements of the standards

6


RISK MANAGEMENT – 4.2 Continued

• 4.2.2 General requirement for RM• ISO 14971:2007 is to be applied except for:

- The planning for and execution of production and post-production monitoring- Periodic reviews of the suitability of the RISK MANAGEMENT PROCESS.

• Note 1 Includes that the RM process should identify not only those hazards identified by this standard but all hazards, their associated risks and their risk control measures.

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• 4.2.2 Compliance is checked by• inspection of the MANUFACTURER'S policy for determining criteria for

RISK acceptability;• inspection of an index containing references or pointers to the RISK

MANAGEMENT documentation required by this standard;• inspection of the RISK MANAGEMENT plan for the particular ME

EQUIPMENT or ME SYSTEM under consideration; and• confirming the MANUFACTURER has prepared a RISK MANAGEMENT

FILE containing the RISK MANAGEMENT documentation required by this standard for the particular ME EQUIPMENT or ME SYSTEM under consideration.

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• 4.2.3 Evaluating Risk• 4.2.3.1 HAZARDS identified in the IEC 60601 series

a) if the 60601 series of standards requirements and acceptance criteria are applied there is a presumption that the residual risks are satisfied unless evidence to the contrary

b) if no acceptance criteria the RESIDUAL RISK shall be evaluated using the criteria for RISK acceptability recorded in the RISK MANAGEMENT plan.

• Compliance is checked by confirming that the documentation in the RISK MANAGEMENT FILE demonstrates that after applying the specific requirements of this standard the RESIDUAL RISK is acceptable using the criteria for RISK acceptability recorded in the RISK MANAGEMENT plan, i.e. no unacceptable RISK remains.

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c) Where this standard or its collateral or particular standards identify particular HAZARDS that have to be investigated without providing specific technical requirements:

• The MANUFACTURER shall determine whether such HAZARDS exist for the ME particular EQUIPMENT or ME SYSTEM

• Where such HAZARDS exist for the particular ME EQUIPMENT or ME SYSTEM, the MANUFACTURER shall evaluate and if necessary control these RISKS following the RISK MANAGEMENT PROCESS specified in 4.2.2.

Example 5: subclause 10.2, Alpha, beta, gamma, neutron and other particle radiation

Compliance is checked by confirming that the documentation in the RISK MANAGEMENT FILE demonstrates that the RESIDUAL RISK is acceptable using the criteria for RISK acceptability recorded in the RISK MANAGEMENT plan, i.e. no unacceptable RISK remains.

NOTE When ME EQUIPMENT or an ME SYSTEM has been designed in such way that for a certain type of HAZARD no HAZARDOUS SITUATION exists, no further RISK ASSESSMENT for that HAZARD is necessary. This can be verified by tests or inspections.

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• 4.2.3.2 HAZARDS not identified in the IEC 60601-series• For HAZARDS that are identified for the particular ME EQUIPMENT or ME

SYSTEM but are not specifically addressed in this standard or its collateral or particular standards, the MANUFACTURER shall address those HAZARDS in the RISK MANAGEMENT PROCESS as specified in 4.2.2.

• Example: ME EQUIPMENT or an ME SYSTEM for which there are particular RISKS but no particular standard

Compliance is checked by inspection of the RISK MANAGEMENT FILE.

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Testing options, and IEC 60601-1, 3rd ed gap

Frank O'Brienobcompman.com

May 22, 2012


Overview

- Safety testing options- IEC 60601-1:2005, 3rd ed

gap testing

13

Safety testing hierarchy

Design verification Test Reports from ISO 13485 medical device manufacturer

Test Report from IEC 17025 test lab using IECEE CB Test Report Form

Test Report from NRTL/SCC and CB test lab using IECEE CB Test Report Form

IECEE CB Scheme Test Report and Certificate

Higher Confidence

14


Regulatory acceptance of Test Reports

Test Report Type Agency Acceptance

CB Report & Cert Korea FDA

NRTL/SCC Test Report OSHA, SCC

IEC 17025 test lab Test Report

FDA, NB, Health Canada

Manufactuer's Test Report (ideally CB format)

FDA, NB, Health Canada

Level for acceptance

15

NRTL/SCC and CB Organizations

All NRTL marks are here, http://www.osha.gov/dts/otpca/nrtl/nrtlmrk.html16


IECEE CB Scheme Members (MED category)

• Austria, Australia, Belgium, Brazil, Bulgaria, Canada, (China), Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, S. Korea, Latvia, Lithuania, Luxembourg, Malaysia, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Russia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States

Full details are here, http://wwwcbscheme.org17

Demand Drivers for IECEE CB Scheme Certificate

• Global Conformity Assessment Policy and Procedureso IEC 17025 test laboratory quality managemento OD, OP, operating docs, procedureso Peer Audits, Round robin testingo DSH decision sheets (interpretations)o CTL ETF-3, IEC SC62A WG14 for new interpretations

• Global Test Report Forms• Acceptance of test data

o National Safety Marks (less with CE countries)o Regulatory reviews/approvals

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Hypothetical Global CB National Cert Body (NCB) Structure

NCB Americ

a

CBTL Central

CBTL West

CBTL East

NCB Europe

CBTL DE

CBTL PL

CBTL UK

NCB Asia

CBTL KR

CBTL CN

CBTL JP

Global Mgt

Each NCB has their own CB scope for standards, e.g. -2-xx particulars

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Test Data Acceptance Programs (CB and NRTL/SCC)

NCB/CBTL Audit

Testing on Manufacturer's Premises (TMP)

Supervised Manufacturer's Testing (SMT)

Recognized Manufacturer's Testing (RMT)

Full CBTL Testing Product and info

Test Lab responsibility Manufacturers' responsibility

Witnessed Manufacturer's Testing (WMT)

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Test Data Acceptance Overview

Mfr Data Program Test Acceptance Overview

RMT Manufacturer prepares "cert ready" data and test report package

SMT CBTL audits manufacturer conducting tests (10%)

WMT CBTL witnessess manufacturer conducting tests (100%)

TMP CBTL conducts tests (100%)

In all cases NCB/CBTL, on-going controls and audits, (e.g IEC 17025, CB OD's)21

Manufacturer participates in data acceptance program

Advantages• Direct control of

scheduling• Early notice of any

test problems• In house expertise

Disadvantages• Can be higher

costs than out sourcing to test lab

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CB Certification Process

Mfr participates in evaluation

Test lab conducts evaluation

Test lab audit

Type Testing: Conduct testing, document safety critical components (CC)

Mfr qualified?

YesNo

Start

CB guidance states that CB Test Reports and Certificates are acceptable for up to 3 years. (Erode in confidence over time that they no longer represent current production. Practice is to not accept after 3 to 5 year.)

CB Scheme FCS (full cert service) option looking to add Factory Surveillance Body rules. Up to now, service has seen no demand.

Test report w/CC delivered23

NRTL/SCC Certification Process

Mfr participates in evaluation

Test lab conducts evaluation

Test lab audit

Type Testing: Conduct testing, document safety critical components (CC)

Production surveillance

Mfr keeps ECO/BOM

sync'd to CC

Test lab audits

production

Mfr qualified?

YesNo

Yes

No

Start 2x to 4x Annually

Device CC

change?

NoDevice CC

change?

Test report w/CC delivered24


Notified Bodies (MDD, 93/42/EEC)

USAUK DE PL

CA CACA

NB

NB

FDA

NB

NB

NB

NB FDA

Competent Authorities accredit Notified Bodies to carry out regulatory responsibilities (FDA is similar to both CA and NB)

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Use of Particulars and Collaterals

• Regulators (FDA, EU NB, etc)o Collaterals required, Particulars required, Differences

required

• NRTL (US) and Standards Council of Canadao Collaterals optional, Particulars required, Differences

required, Efficacy requirements left to FDA and Health Canada

o Check with particular cert org to be sure of policy

• CB Scheme (PAC/1727/DSH)o Optional: -1-2 emc, -1-6 use, -1-9 envir, 10993 bioo Required: (-1-1 sys), -1-3 xray, (-1-4 sw), -1-8 alarm, -1-

10 loop, -1-11 home, particulars26


Implementation of IEC 60601-1:2005, 3rd ed

Country, AgencyUse 3rd ed Now? Must use by when? Details

Europe, CA/NB Yes 1 Jun 12, or particular date

New and Legacy

US FDA Yes 30 Jun 13 New only

US OSHA No no announced date New only

Health Can Yes 1 Jun 12 New only

Stds Cncl of Can Yes no announced date New only

Brazil Yes 1 Jan 14 (New only)?

ROW No no announced date ? 27

Important 3rd ed test requirements more severe than 2nd ed

• RM during design process 4.2; CB OD-2044 has RM results candidates to add to existing RM hazard table

• Essential Performance 4.3• Expected Service Life 4.4• Marking legibility 7.9.1• New refer to IFU sign/symbol marking 7.2.3• No Y1 cap as 2 MOPP 8.5.1.2• Defib-proof energy reduction 8.5.5.2

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Important 3rd ed test requirements more severe than 2nd ed - con't

• Reinforced or supplementary > 71 Vp, 0.4 mm thickness 8.8.2

• Total patient leakage 8.7.3• 1000 V DS for 2 MOOP for < 60 Vdc 8.8.3• Thermal cycling, cemented joints (xfrs) 8.9.3• Mobile stability, brakes 9.4 • Int. fuel and bottom opening limits if employ

Fire Enclosure 11.3• UE during design process 12.2• Alarm priorities and interface 12.3 29

Important 3rd ed test requirements more severe than 2nd ed - con't 2

• Surface temperature limits in SFC 13.1, 13.2• 250 N Enclosure push test, 15.3• Mobile rough handling 15.3• Non-mains safety xfrs need overload 15.5.3

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• RM scope limited to design controls (similar to OD-2044 guidance), 4.2

• Clarifies process to establish and verify Essential Performance, 3.27, 4.3

• Mobile push over, 15% (25%), max 150 N (220 N), 9.4.2.3.a

• Threshold pass over, 10 mm (20 mm) high, 0.8 m/s (0.4 m/s), 9.4.2.4.3

• Mobile Braking, 15% (25%), max 150 N (220 N), 9.4.3.2.b

Important 3rd ed Amendment 1 corrections

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Implementation of IEC 60601-1 3rd Edition a Manufacturers View

Presented by:Brodie PedersenSr. Regulatory Engineer Nonin Medical Inc.

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Compliance with new standards, editions

Identify Changes Start with early drafts of new documentsEvaluate new requirements, scope changesEvaluate changes to modified requirementsLook for removals of requirements

Participate in standards developmentIt is the best way to be aware of changes before they happen.It is the only way to affect change before it happens.

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Compliance with new standards, editions

Review with respect to collateral standards.IEC 60601-1:2005 covers the aspects of IEC 60601-1-1,

and IEC 60601-1-4.Since publication of IEC 60601-1:2005 there are new or updated applicable collateral standards:

IEC 60601-1-2IEC 60601-1-6IEC 60601-1-8IEC 60601-1-9IEC 60601-1-10IEC 60601-1-11

Other Horizontal requirement for risk management and usability engineering processes.

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Processes for design inputs

Risk Management required by IEC 60601-1.Most regulators also look for compliance with the whole of ISO 14971 for medical device listing.Most effective when implemented with the Quality System.

Usability Engineering required by IEC 60601-1-6.Uses the methods outlined in IEC 62366.Heavily related to risk management activities.This is an area of increased focus of many regulators.

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Compliance with regard to particular standards

IEC 60601-1 is a General Standard.Particular standards guide users in the specific application of general requirements for specific technologies.Example Pulse Oximeters:

ISO 9919 referenced IEC 60601-1 2nd Ed.Replaced by ISO 80601-2-61:2011 references IEC 60601-1 3rd Ed.

EU affectivity is guided by:Frequently asked Questions related to the Implementation

of EN 60601-1:2006 with respect to MDD 93/42/EEC.

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IEC 60601-1 3rd Ed. Compliance

In the US:FDA has recognized the standard for use in premarket notification. It will be required for submissions after June 30, 2013.Many test labs are ready to test to it;

including the Risk Management provisions.OSHA has not approved it for NRTL marking.

Recent reply to one manufacturer from DOL-OSHA“OSHA’s NRTL program staff is currently looking at ANSI/AAMI ES60601-1 (based on IEC60601-1 3rd Ed) to determine if it meets the requirements of an ‘Appropriate Test Standard’.”

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IEC 60601-1 3rd Ed. Compliance

In Canada:Health Canada was one of the first to recognize and require use of IEC 60601-1 3rd Ed. Required in device license applications beginning June 1, 2012.Health Canada licenses are valid until a product is changed or altered requiring a license amendment.

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Methods for Certification

In the EU, the MDD Annex II allows an EC Declaration of Conformity.

Requires an audited quality system.The manufacturer declares and ensures the applicable ER are fulfilled before applying the CE mark.

In house testing can save time.Test labs lend credibility to results.CB Scheme reports can be updated now, however you will likely need to support two editions of your file (2nd

and 3rd editions of IEC 60601-1) at least for the US.

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Recommendations

Participate on standards development activities for standards affecting your product line.

Provides early notice of changesAllows you to impact the changes

Start designing for new versions of standards during the final ballot stages.Identify gaps to new requirements early.

Allows updates as other changes occur in products with lower impact to cost and significance of changes.Provides time for regulatory clearance activities.

You may be best off waiting for OSHA recognition to update US NRTL files.

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References

http://www.team-nb.org/index.php?option=com_docman&task=cat_view&gid=17&Itemid=38&lang=enhttp://obcompman.com/documents.htmhttp://medicaldevicehumanfactors.org/index.php

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Questions?

• To submit a question, please type your question in the Q&A box on the left side of your screen and press “Enter,” or press *1 on your telephone keypad



Closing Reminders

• Please be sure to fill out the evaluation form at:http://aami.confedge.com/ap/survey/s.cfm?s=60601

• AAMI offers the following educational programs that may be of interest to you:• Enemy at the Gates: Security for Medical Devices Webinar,

June 12• AAMI/FDA Interoperability Summit: From Interoperability to

Integration In and Around Medical Devices: Getting Patient Safety Right, October 2-3, Herndon, VA


Documents

How to Test to IEC 60601-1, 3rd Edition - Platformaami.confedge.com/asset/confEdge/aami/_warehouse/files/Slides_60601.pdfHow to Test to IEC 60601‐1, 3rd Edition RISK MANAGEMENT –