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IEC 60601 Training Seminar 2012
Designing to comply with IEC 60601-1, 2nd & 3rd Editions, Medical electrical equipment, Part 1: General requirements for basic safety and essential performance
What You Will Learn in 3 Days
This
course is not an overview; it's an intense 3 day training course. Gain
practical knowledge you can directly apply to your new medical
device designs.
Our course has been redesigned for 2011 based on feedback from our past 850 participants. We've expanding the time to allow for more group exercises, greater depth of all material, and more time for your questions.
All important topics covered:
- 3rd edition Effective Dates for all markets and impact
- How IEC 60601 supports regulatory approvals (e.g. FDA, CE), and third party certifications (e.g. NRTL/SCC Marks)
- How your RM
process must support use of IEC 60601-1, e.g. determine requirements
for:
- Essential performance,
- Surface temperatures,
- Fire enclosure,
- Liquid ingress
- Recent Amendment 1
changes:
- Reduced scope of Risk Management assessment
- Clarified process for determining essential performance
- Reduced mobile stability and rough handling testing
- How third party
test labs will be assessing RM processes
- Sep 2010 CB Guidance
- Sep 2010 Test Report Form, ver g
- New RMF Summary Form, made from CB Guidance
- Insulation diagrams
- MOOP, MOPP insulation
- Using computer equipment with medical systems
- Electrical safety testing demonstration at nearby OBCM Laboratory
- Evaluate motion systems for single fault safe
- Evaluate tensile safety factors
- Home health care changes
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Who Should Attend
The course is keyed to Electrical Medical Equipment:
- Technical design engineers,
- Compliance engineers,
- Regulatory/quality system specialists, and
- Any staff responsible for device safety.
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Background on IEC 60601-1, 2nd & 3rd Editions
The
Part 1 general standard serves as the foundation for the international
electrical medical equipment series of safety standards. The
series includes horizontal collateral standards, IEC 60601-1-xx, for
specific equipment technologies or other general issues; and vertical
particular standards, IEC 60601-2-xx, for specific types of medical equipment. The
series forms the basis for the consensus safety standards for most
markets in the world, including, US, Europe, Japan, Canada, Australia,
China, Korea, Brazil, and Argentina.
Currently medical devices are evaluated to the 2nd edition. The new 3rd Edition, was published in December 2005. National/regional versions aligned with the 3rd edition have been published by the US/AAMI, EU/CENELEC, and Canada/CSA. The publication of these standards means they're official consensus standards, providing state of the art safety requirements for verifying acceptable risk.
Are you ready?
Canada
and Europe are requiring compliance with the 3rd edition by 1 June 2012.
The US FDA is requiring compliance by 30 Jun 2013. For details,
see
here.
While the major jurisdictions are moving to the 3rd edition, some
jurisdictions will transition slower. For example, Japan, Brazil, Korea,
Australia, New Zealand, South Africa, and China have not
announced similar transition plans.
Therefore, an electrical medical device manufacturer will need to comply
with both versions of 2nd and 3rd editions of IEC 60601-1, and it's
applicable collaterals and particulars.
What's New?
The 2nd edition is a Basic Safety standard, which provides verification tests for judging whether a medical device poses acceptable risk during normal use, reasonably foreseeable misuse, and single fault conditions. Within this scope the 3rd edition is very similar.
The 3rd edition has some new verification tests, such as a reduced energy test for defib-proof equipment, and rough handling tests for mobile equipment. The 3rd edition also has some areas where requirements are more relaxed, such as electrical insulation for operator protection, lower tensile safety factors for well defined support parts, and higher surface temperature limits for short durations.
The biggest impact with the 3rd edition is to expand on the scope of the 2nd edition to require, during the design process, Risk Management and Usability Engineering (Human Factors). Reference standards that define minimum requirements for these processes are in ISO 14971 and IEC 62366 (or the older, IEC 60601-1-6).
The Risk Management process defines Essential Performance. Essential Performance and Basic Safety are the broad spectrum of hazards which must be controlled to an acceptable risk. Things like an enclosure thickness, flame rating of material, and separation of mains from operator accessible circuits are risk controls for the Basic Safety end of hazards. Essential Performance will be at the other end, and normally associated with intended use/purpose of device (therapeutic, diagnostic, or monitoring function). You must ask, to what extend will loss or degradation of our device's intended use/purpose result in unacceptable risk? Sometimes there will be no Essential Performance, as loss is obvious and results in acceptable delay in intended use/purpose. Sometimes there will be a need for your device to check for errors and alarm errors, and when no error, to deliver min. acceptable performance/accuracy. As with Basic Safety, Essential Performance must pose acceptable risk during normal use, reasonably foreseeable misuse, and single fault conditions.
The Risk Management process identifies surfaces that require Means of Patient Protection (MOPP), or Means of Operator Protection (MOOP). MOPP is similar to 2nd edition insulation requirements. MOOP is the same as that required for IT Equipment by IEC 60950-1.
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Course Overview
The training course focuses on the new 3rd edition. The assumption is that unchanged requirements from the 2nd edition are also presented, as a refresher. Areas where 3rd edition is more stringent or less stringent are highlighted. The assumption is that designs will want to meet both 2nd & 3rd editions, with emphasis on the newer 3rd edition.
Emphasis is on:
- Practical application to typical medical device designs,
- Avoiding safety pitfalls,
- Supporting regulatory requirements,
- Integrating risk management and usability engineering into the design process,
- Learning how to apply practical risk-based superset of 2nd & 3rd editions to new designs,
- Leaning how to apply practical risk-based 3rd edition delta to existing designs already complying with 2nd edition,
- Documenting verification to IEC 60601-1 with both traditional test reports, and design process records for auditors.
 |
After introducing new concepts, skill implementation work group exercises are included in most modules to allow
small groups to apply newly acquired knowledge by performing design
review and documentation activities on typical medical devices. Groups
are given 1 of 3 hypothetical devices, and asked to decide on best
safety strategy, resolve safety critical issues, and provide safety
feedback about possible areas of noncompliance or where additional
info/testing will be needed. After each work group exercise,
groups report their finding to the full class. During all topics, staff is encouraged to ask questions about the safety requirements, and how they apply to products currently under development. The training medium is PowerPoint slides, with frequent references to source standards. Not covered: in-depth details about EMC requirements (Clause 17, IEC 60601-1-2) nor biocompatibility (Clause 11.7, ISO 10993). |
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Course Agenda
Day 1
Registration 8:15 AM with Continental Breakfast - Start 8:30 AM - Ending 5:00 PM
| Module | Description |
|---|---|
| 1 | Regulatory Overview, Role of IEC 60601-1 |
| 2 | Introduction
to IEC 60601 Skill Implementation Work Group Exercise: Consider device, MDD Essential Requirement (ER) list, (q-sys, risk, bio, sterile, device safety, emc, software, etc), list applicable stds to support compliance. |
| 3 | Risk
Management, Usability Engineering, Essential Performance,
Alarms, Software Skill Implementation Work Group Exercise: Consider device, and hypothetical risk management procedures provided, conduct risk assessment meeting. Document with risk table. Where risk controls are needed will document if software, hardware, mechanical, bio, or training/labeling. |
Day 2
Start 8:30 AM with Continental Breakfast - Ending 5:00 PM
| Module | Description |
|---|---|
| 4 | General
Requirements Skill Implementation Work Group Exercise: Consider device, define Classifications. Document in check list test report. |
| 5 | Designing
Electrical Insulation, Creating Insulation Diagrams Skill Implementation Work Group Exercise: Consider device, work out insulation diagram, MOOP=Means of Operator Protection, MOPP=Means of Patient Protection, CR=Creepage, CL=Clearance, DS=Dielectric Strength, DTI=Distance Through Insulation. Document in check list test report. |
| 6 | Verifying Electrical
Insulation Demonstration: Photo walk through of CR, CL, verification; and earthing, leakage, dielectric testing. Show how to document in (simplified) check list test report. |
Day 3
Start 8:30 AM with Continental Breakfast - Ending 5:00 PM
| Module | Description |
|---|---|
| 7 | Medical Systems Skill Implementation Work Group Exercise: Consider device, work out suitable feasible solutions, and suitable MSO construction. |
| 8 | Protection Against Mechanical
Hazards Skill Implementation Work Group Exercise: Consider enclosure strength, unwanted movement, and support examples. Document in (simplified) check list test report. |
| 9 | Protection
Against Thermal and Other Hazards Skill Implementation Work Group Exercise: consider device, consider check list test report, establish what's not applicable, what's to be verified by review of paperwork, what's to be verified by measurements. Indicate any possible problem areas, list critical components. Some groups will have new designs, other groups will have a device that already complies with 2nd edition. |
| 10 | How Test Laboratories will be Assessing Risk Management (RM) Review CB OD-2044, Guidance for Assessing Risk Management, and CB Test Report Form, ver g. Learn how to fill out RM Results Tables, or alternatively the Table 1 and Attachment Table 1 from CB guidance. OBCM provides a RM File Checklist form based on OD-2044. Skill Implementation Work Group Exercise: consider device, fill in the RMF checklist indicating records and conclusions that would be expected in your design team's RM records. Course evaluation form. Hand out participation certificates. |
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Included in course registration fee
are:
- Participant guide with all PowerPoint slides,
- Skill implementation exercise booklet, with support material, including templates for essential requirement matrix, risk table, and 3rd & 2nd Edition test report form.
- Answer booklet
- Certificate of Participation for 24 hours of instruction and exercises
- Continental breakfast, lunch, and break snacks (both days)
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Participant requirements:
- Course begins 8:15a first day, 8:30a other days.
- Bring own copy of 3rd edition version of safety standard for hands-on reference. Recommended is either AAMI ES 60601-1:2005, or EN 60601-1:2006. This gives you generic IEC requirements, and national/regional differences.
- Optional are 2nd edition version, and free 2nd & 3rd edition mapping document, IEC TR 62348:2006.
- There are no course prerequisites, although some familiarity with quality management and risk management procedures is helpful
- Course registration including prepayment
- Any hotel, and travel arrangements (see below)
Standards can be purchased from many sources, including:
- http://www.AAMI.org (185 USD, ES 60601-1:2005); specific link for purchasing standards ES 60601-1, and IEC TIR62348, http://www.aami.org/publications/standards/60601.html)
- http://www.IHS.com (542 USD, BSI BS EN 60601-1:2006),
- http://www.BSI-global.com (252 GBP, (500 USD), BS EN 60601-1:2006)
IEC TR 62348:2006 is available as a free download from http://www.IEC.ch.
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Background on Instructors
|
|
Frank O'Brien has experience working with medical device manufacturers
since 1980; evaluating medical devices. He's been teaching IEC 60601-1 courses
since 1996 for organizations
including IEC, AAMI, UL, Quadtech, and OBCM. Frank is one of the committee members responsible for writing the new 3rd edition, and is currently on the committee drafting the new home healthcare collateral. As an instructor he is often credited with bringing a degree of fun to learning otherwise serious topics. For details about his background, see About Us Page. |
|
|
Since 1993, Ulrich Walz has been testing and certifying equipment to IEC 60601-1 for the VDE Test and Certification Institute. Since 1997, he has been a Notified Body auditor for VDE and DQS. Since 2004, Mr. Walz has given a number of seminars on IEC 60601-1, 3rd edition. |
Participant Feedback
We've provided public and private seminars on IEC 60601-1, 3rd edition to over 1000 participants. In 2011 public training poccured in Valencia, Spain, Korea, Boston, Frankfurt, Boston again, and San Jose. In 2010 public training occurred in Boston, London, Frankfurt, Huntington Beach, and again in Boston. In 2009 public training occurred in Orlando, Boston, Galway, Minneapolis, Bangalore, and San Jose. In 2008 public training occurred in San Diego, CA; Boston, MA; San Jose, CA; Auckland, NZ; Tokyo and Osaka, JP and London, UK. In 2007, public training occurred in Dublin, and Boston. Private training has been provided to Covidien (CT), GE India, Medtronic, Covidien (CO), Philips Healthcare, Gyrus, Zoll, Cytyc, Axya Medical, XP Power, Spacelabs, and Codman J&J. Participant feedback for the course has been very positive. In total, the average feedback score for "Would you recommend to others?" has been 4.6 out of 5.
We always do one in Boston area, we alternate between southern (SD/LA) and northern California (SJ/SF), we alternate between Galway/London, and we do one in Germany. We will consider locations in Philadelphia, Chicago, Minneapolis, Toronto, Bangalore, or Sydney, if there is sufficient interest. Private seminars at your location can also be booked. Please contact us for pricing and availability.