Risk Based Testing, HALT, and IEC/EN 60601-1 3 Edition · Risk Based Testing, HALT, and IEC/EN...
Transcript of Risk Based Testing, HALT, and IEC/EN 60601-1 3 Edition · Risk Based Testing, HALT, and IEC/EN...
Proprietary and Confidential
Risk Based Testing, HALT, and IEC/EN 60601-1 3rd Edition
Mike Silverman and Tom Prudent, OPS A LA CARTEDave Vaughan, CHART
Proprietary and Confidential
AGENDA–Introduction – 5 minutes–Webinar – 45 minutes–Q&A – 10 minutes
Proprietary and Confidential
• Who Are We?– Ops A La Carte
• HQ in Santa Clara, CA• Presenters: Mike Silverman, Managing
Partner• Tom Prudent, Senior Rel. Engineer
– Chart• HQ in Minnesota• Presenter: Dave Vaughan, National
Sales Manager, HALT/HASS Systems
Proprietary and Confidential
Ops A La Carte– Founded in 2001– Named top 10 fastest growing, privately-held
companies in the Silicon Valley in 2006 and 2009 by the San Jose Business Journal.
– Over 1350 projects completed in 10 years– Over 500 Customers in over 30 countries– Over 100 different industries, 6 main verticals
• CleanTech, MedTech, Telecom, Defense, Oil/Gas, Consumer
– We run FREE monthly webinars.
Proprietary and Confidential
• Ops Medical Reliability Division– We are the industry leader in reliability solutions in the
Medical market. We are committed to saving lives through higher reliable products.
– We provide Confidence in Reliability. – We offer a flexible method of engagement:
• End-to-end reliability solutions• solving specific problems• providing individual services• Over 30 different training courses in reliability
– We consult in every life cycle phase, train in every aspect of reliability, and test in our state-of-the-art HALT and HASS LabsTM
Proprietary and Confidential
• Ops Solutions – Ops provides end-to-end solutions that target the corporate product reliability objectives • Ops Individual “A La Carte” Consulting – Ops identifies and solves the missing key ingredients needed for a fully integrated reliable product• Ops Training – Ops’ highly specialized leaders and experts in the industry train others in both standard and customized training seminars• Ops Testing – Ops’ state-of-the-artprovides comprehensive testing services
Proprietary and Confidential
• Ops Medical Projects• 3M Health Care - Reliability Plan and data analysis for drug
delivery systems and devices• Abbott - ALT for glucose monitoring system• Accuray - Reliability Assessment and program plan for
stereotactic radiosurgery device for tumors • Applied Biosystems - HALT and RoHS services for DNA
sequencing products. • Boston Scientific - HALT, V&V, and CRE/CQE Training for
minimally invasive medical devices • Cardiac Assist - HALT for cardiac surgery device• Cardinal Health - ALT for neonatal CPAP device, root cause
analysis for nebulizer• Carestream - DfR Training for mammography solutions company• Cochlear - ALT Training for implantable hearing aids• Covidien - Reliability plan and predictions for drug delivery systems• Fisher and Paykel Healthcare - ALT for sleep apnea device• Flextronics Medical - Software reliability for medical systems• Hospira - Complete reliability program for infusion pumps
Proprietary and Confidential
• Ops Medical Projects, continued• Intuitive Surgical - HALT, V&V, Reliability Improvement Plan, &
Vendor Quality for medical robotics• Lifescan/Johnson+Johnson - HALT for glucose monitoring
system• Luminetx - ALT for vein finding system• Mako Surgical - Reliability plan for robotic knee surgery system• Next Safety - Reliability prediction for pulmonary drug delivery
devices• OmniCell - HALT and ALT for medical dispensing systems• Ortho-Clinical/Johnson+Johnson - HALT for transfusion
medicine • Perfint Healthcare Devices - Reliability test plan for image
guided procedure system• Perkin-Elmer - HALT and HASS for medical illumination system• Philips Medical - Cable qualification testing for sonogram
system• Proteus Biomedical Inc. - HALT and environmental testing for
in-body computing (implantable)
Proprietary and Confidential
• Ops Medical Projects, continued• Pulmonetic - HALT for ventilator system• Philips Medical (formerly Respironics) - Reliability plan, HALT,
ALT, and teardown analysis for sleep apnea device• Siemens Medical (formerly Acuson) - Reliability prediction for
nuclear medicine system• Solta Medical (formerly Thermage) - HALT for radiofrequency
cosmetic procedure systems• Stryker - HALT for medical illumination system• Suni Medical - Quality system review for dental medical imaging
systems• Tecan Systems - HALT and root cause analysis for laboratory
instrument• Terumo Medical (formerly Mission Medical) - Reliability plan,
FMEA, HALT, and ALT for blood collection system• Thoratec - HALT and ALT for heart pump devices• Ventana Medical – HALT and environmental testing for
automated immunohistochemistry (IHC) system• World Heart - HALT for pulsatile ventricular device
Proprietary and Confidential
Chart Inc.– Largest Cryogenic Equipment Supplier in
the world– Building quality products since 1963– HALT/HASS chamber manufacturer since
1997– ISO 9001 Certified– Only HALT/HASS supplier that can offer
you a true Turn-Key solution with Tank, Pipe and Chamber.
– Hundreds of HALT/HASS chambers worldwide
Proprietary and Confidential
Chart Inc.
Proprietary and Confidential
Upcoming Medical Events we are atBIOMEDevice Show - Dec 6-7, 2011, San Jose, CA• We will be giving a seminar called "Managing
Design Risk“ on Dec 7 at 2:30pm PSThttp://www.canontradeshows.com/expo/biomed11/IB.htmlWe also will be at the PRG Booth (#1015)
MD&M Webinar - Dec 15, 2011, 8:45-9:30am PST• We will be giving a seminar called "When the
Standard Doesn't Fit: How to test using a guidance vs. a standard".http://www.canontradeshows.com/expo/mdmonline11/conference_E2b.html
Proprietary and Confidential
Upcoming Medical Events we are atMD&M West – Feb 13-16, 2012, Anaheim, CA• We will be giving a 1 day seminar called “Medical
Reliability Testing” on Dec 16 from 9-4pmhttp://www.canontradeshows.com/expo/west12/conference_403.html
Proprietary and Confidential
Other Reliability EventsCertified Reliability Engineer Preparation ClassDate(s): Jan 17 - Feb 28, 2012Time: 6pm-10pm one night a week, 7 weeksLocation: San Jose, CA and Webinarhttp://www.opsalacarte.com/Pages/education/edu_9cre.htm
Reliability and Maintainability SymposiumDate(s): Jan 23 - 26, 2012Location: Reno, NVWe will be presenting 6 papers and have a boothhttp://www.rams.org
Proprietary and Confidential
Other Reliability EventsDesign of Experiments WebinarDate: Feb 1, 2012, 8:30amLocation: WebinarThis is our next webinar in our free webinar seriesSee details in our newsletter coming out next week
IPC APEXDate(s): Feb 28 – Mar 1, 2012Location: San DiegoWe will be presenting on HALT for RoHShttp://www.ipcapexexpo.org/html/main/technical-conference.htm
Proprietary and Confidential
Presenter 1: Mike Silverman– Founder and managing partner at Ops A La Carte– 25 years of experience in Reliability/Quality– World expert on HALT/HASS/ALT– Offers “HALT Calculator” to predict field failure rate from
HALT results – being used by many medical companies– Author of “How Reliable Is Your Product: 50 Ways to
Improve Product Reliability”, Dec 2010– Book soon to be released in Mandarin– International speaker in 10 different countries– BSEE, CRE– IEEE Reliability Society Silicon Valley Chapter Chair
Proprietary and Confidential
Presenter 2: Dave Vaughan– National Sales Manager HALT/HASS Systems, Chart
Inc.– 5 years experience designing HALT/HASS Systems in
– Medical– Aerospace– Automotive– Electronics– Defense
Proprietary and Confidential
Presenter 3: Tom Prudent• 20+ Years Engineering experience in the
following industries– Aerospace / Defense– Semiconductor Equipment– Medical Devices
• Education– BSME, MSME, MBA (Operations & materials
MGMT, Financial MGMT)• License / Certification
– PE– ASQ CRE
• Consulting Part Time past 5 years
Proprietary and Confidential
Webinar Stats• This is our 19th Webinar (see Ops site
for past webinar topics/content)• We run these webinars once a month• We partner with other companies
(Chart is our co-sponsor for this one)• We partner with societies (IEEE, ASQ,
and others for broader reach)
Proprietary and Confidential
Webinar Stats• Some of the past topics
– Solar Reliability– Root Cause Analysis– Green Reliability– Soft Errors– Software Reliability– Prognostics– Best Reliability Testing– Lead Free and Reliability– Simulation and Reliability
Proprietary and Confidential
Webinar Stats• Future Topics
– Design of Experiments (February)– FMEA/TS16949– Return on Investment for Design for Reliability– Software Reliability
• What would you like to see?– Let us know at [email protected]
Proprietary and Confidential
Registration Demographics• For this webinar we have signed up
– 163 Registrants– 17 Countries
Proprietary and Confidential
Registration Questions1. Are you currently developing medical
products ?2. Have you ever used the methods of
risk based testing ?3. What is your current timeline for
complying with IEC60601 ?
Proprietary and Confidential
Registration Questions• Are you currently developing medical products ?
Yes, for years 49%
No, just interested 43%
Yes and this is our first one 9%
Proprietary and Confidential
Registration Questions• Have you ever used the methods of risk based
testing ?
Don't know 38%
Yes all the time 35%
Never 19%
We tried once 9%
Proprietary and Confidential
Registration Questions• What is your current timeline for complying with
IEC60601 ?
Not applicable 42%
We already comply 35%
In the next 1-2 years 12%
In the next 6 months 11%
We must comply immediately 2%
Proprietary and Confidential
Agenda• Risk Based Testing vs. Standard’s Based
Testing - Mike• Importance of HALT in Risk Based Testing -
Dave • IEC / EN 60601-1 3rd edition - Tom
– Safety of Medical Electrical Eqpmt & Systems– Implementation Dates– The process starts with Risk Management– Highlights– Relation Collateral & Particular Standards
Proprietary and Confidential
Risk Based Testing
Proprietary and Confidential
Developing Better Test Plans
Proprietary and Confidential
Developing Better Test Plans Introduction
In order to write better test plans, we must first understand;- the use environment - the key risks to the design
The best tool for this is FMEA
Proprietary and Confidential
Developing Better Test Plan
Failure Modes and Effects Analysis (FMEA) is the process by which we explore potential failure modes and then prioritize by key risks
Proprietary and Confidential
Once the risks have been identified and prioritized, it is time to develop mitigations.
Often times the best mitigations are with reliability testing.
Developing Better Test Plan
Proprietary and Confidential
Developing Better Test Plans
Stated another way, we cannot know what to test for unless we understand the key risks.
Therefore, FMEA is one of the best sources of input for a Reliability Test Plan.
Proprietary and Confidential
Case Study - Inhaler
Proprietary and Confidential
Developing a Test Plan without FMEA
• What types of tests can you think of for this device?
Proprietary and Confidential
Developing a Test Plan without FMEA
• We used the IEC standards and came up with a number of environmental tests:– High/Low Temperature– Temperature Cycling– Vibration– Drop– Shock– Crush– Humidity– Altitude– Did we miss any?
Proprietary and Confidential
FMEA Generated Tests• For each test, we had the option of following
the spec or going beyond using HALT.• We performed an FMEA to determine the
risks associated with each environment.• We then chose the following test types for
each environment.HALT/TEST TO FAILURE IEC/SPEC TEST– High/Low Temperature - Humidity– Temperature Cycling - Altitude– Vibration– Drop– Shock
Proprietary and Confidential
FMEA Generated Tests• During the FMEA, we also came up
with several other types of tests not found in IEC– Cleaning/sterilization test– Disassembly/reassembly test– Material compatibility test– Clogging test– Poking test– Cap Tether test– Battery Life test– Cyclic Loading on Buttons test– Dosage Knob Locking test– Bystander Hazard test
Proprietary and Confidential
FMEA Generated Tests -Summary
• As you can see by this one example, we would have missed many of the potential failure modes had we not used a risk-based testing methodology.
Proprietary and Confidential
FMEA Generated Tests -Summary
• We also illustrated how we can start with spec based environmental tests such as temperature, vibration, and drop testing, and then go beyond the required specs and test to failure if the risk analysis dictates it.
• This is the essence of HALT.
Proprietary and Confidential
POLLING QUESTION 1Do you currently use your risk analysis to drive your testing ?
a. Yes, alwaysb. For some types of testsc. Rarelyd. Never
Proprietary and Confidential
HALT and HASS
Proprietary and Confidential
HALT - HASSWhat is HALT –HASSH – HighlyA – Accelerated L – LifeT – TestingHALT Testing is conducted in the design stage
H – HighlyA – Accelerated S – StressS – Screening HASS Testing is a Manufacturing Screening Process
Proprietary and Confidential
Why do HALTWhat HALT/HASS does for your Company
Your Products – Defect/Problem Free?• New Products
– Expedite the Development of New Products– Understand the Operational Parameters of Product and widen them– Ruggedize the product and remove design related weaknesses
• Mature Products– Warranty Concerns– Find Manufacturing Defects/Process Changes– Look for Continuous Product Improvement
• Savings, Savings, Savings– Defects Cost Money– Eliminate Costly Warranty Issues– Reduce Valuable R & D Time– Expedite Time To Market
HALT is a design process ruggedization tool for the designers
Proprietary and Confidential
Why Do HALT?
HALT is a design process ruggedization tool for the designers
Proprietary and Confidential
HALT PROCESS
Proprietary and Confidential
HALT/HASS System
Proprietary and Confidential
POLLING QUESTION 2Do you use the methodology of HALT ?
a. We use it all the time and have our own HALT equipment
b. We use it all the time and use an outside lab service
c. We occasionally use it d. We used it once or twicee. We have never used it
Proprietary and Confidential
Role of IEC60601-1 Rev 3 in Risk Based Testing
• Now that we understand the basics of Risk Based Testing and how HALT plays a role in this, let’s look at the role of the new IEC60601-1 Rev 3 document.
Proprietary and Confidential
IEC60601-1 Rev 3
Proprietary and Confidential
Agenda
• IEC / EN 60601-1 3rd edition– Safety of Medical Electrical Eqpmt & Systems– Implementation Dates– The process starts with Risk Management– Highlights– Relation Collateral & Particular Standards
Proprietary and Confidential
IEC/EN 60601-1 General Std.• Part 1: General Requirement for Basic Safety
and Essential Performance for MEE– Electrical Safety
• Basic Safety• Leakage Currents• Dielectric Potential• Levels depend on Mains Voltage Connection(s)
– Mechanical Safety• Push, Drop, Impact, Rough Handling, Molding Stress
Relief, Expelled and Suspended Parts
– Material Safety• Biocompatibility, Sterility• Flammability
– Accompanying Documents / Labeling
Proprietary and Confidential
IEC/EN 60601-1 3rd Edition
• 2nd Edition of the 60601-1 withdrawn dates– Europe / most of world: June 2012– US: June 2013– Canada: June 2012 or Jan. 2013 ??– Europe date is firm– US date not set in concrete
Proprietary and Confidential
IEC/EN 60601-1 3rd Edition• For 3rd Edition Highlights
– It starts with Risk Management (work with Notifying Body / Test House, Regulatory Agencies, Regulatory Affairs Department)
– FMECAs, FTAs, Fishbone, etc. (Haz. & Risks)
• Use, Design, Process, and Software FMECAs are typically used
• System HA• RMF – Summarizes the highest risks
– ISO 14971:2009 Application of Risk Management to Medical Devices
Proprietary and Confidential
3rd Edition Highlights– Clearly define:
• Basic Safety (BS)– Relates to a device not harming the Patient incidental
to its operation (often passive such as radiation shielding or electrical grounding).
• Essential Performance (EP)– Features or functions that does not perform properly
could degrade the ME Eqmt or ME System to a point that it is no longer suitable for its intended use.
• Applied Parts (AP) and Non-Applied Parts• Components with High-Integrity Characteristics
(Reliability)– Usability Engineering File (IEC 62366)
Proprietary and Confidential
3rd Edition Highlights• Clause 4: General Rqmts
– RMF (ID’ing Hazards & Risks)– Define: BS, EP, AP, Hi-Rel Components
Proprietary and Confidential
3rd Edition Highlights• Clause 5: Gen. Test Rqmts
– Type Tests, No. of Samples– Define least favorable operating conditions
(voltage, temp., humidity from IFU or RMF)• Clause 6: Classification
– Class I or II (depending upon insulation)– Type B, BF, or CF
• Clause 7: IFU (DFU), Labeling– Accompanying Documents, Safety signs,
Symbols, Labeling
Proprietary and Confidential
3rd Edition Highlights• Clause 8: Protection vs. Elec. Hazards
– Leakage Current& Dielectric Strength
– Creepage Distances & Air Clearances
Proprietary and Confidential
3rd Edition Highlights• Clause 9: Protection vs. Mech. Hazards
– Moving parts (crush haz.), edges/corners– Instability & Expelled Parts– Acoustic / Vibration– Pressure Vessels & Support Systems
Proprietary and Confidential
3rd Edition Highlights• Clause 10: Protection vs. Excessive Rad.
– X-Rays, Particle, µ-wave, Laser, IR, UV• Clause 11: Protection vs. Excess Temp.
– Touch Temp., Fire prevention– Flammable agents / gases– Ingress protection / classification– Material Biocompatibility / Sterilization
• Clause 12: Controls / Instruments Accuracy– Accuracy & Usability of Controls / Alarms
Proprietary and Confidential
3rd Edition Highlights• Clause 13: Hazardous Situations
– Specific Hazards & SFC Definitions• Clause 14: PEMS
– Software / Firmware in the Medical Device– Tied closely with RMF– S/W Life Cycle, Architecture, V&V, Network /
Data Coupling (IEC 60304)
Proprietary and Confidential
3rd Edition Highlights• Clause 15: Gen. MEE Construction
– Mech. Strength (Push, Impact, Drop, Rough Handling, Molding Stress Relief)
– General Assy of components
Proprietary and Confidential
3rd Edition Highlights• Clause 16: MES
– System - Connection of the Equipment(s)– Power supply(ies), Enclosure, Separation of
Devices (leakage currents)– Connections / Wiring
• Clause 17: EMC– Test to IEC/EN 60601-1-2:2007
• Annexes– Annex A: Guidance & Rationale– Annex B: Recommended Test Sequence– Work with 3rd Party Testing House & Notifying Body
early in the project
Proprietary and Confidential
IEC/EN 60601-1 3rd Edition• Relationship to Collateral and Particular
Standards to the General Standard
Proprietary and Confidential
POLLING QUESTION 3Where are you at with the transition to IEC60601-1 Rev 3 ?
a. We are behind on the transitionb. We are on trackc. We are ahead of scheduled. Doesn’t apply
Proprietary and Confidential
SummaryWe covered• Risk Based Testing vs. Standard’s Based
Testing• Importance of HALT in Risk Based Testing• IEC / EN 60601-1 3rd edition
– Safety of Medical Electrical Eqpmt & Systems– Implementation Dates– The process starts with Risk Management– Highlights– Relation Collateral & Particular Standards
Proprietary and Confidential
Special offer for webinar participants:
Free 1 hour Reliability Consultation
Offer expires on 12/31/11
Proprietary and Confidential
Dave VaughanNational Sales ManagerHALT/HASS Systems
Chart Inc.+1 612-221-4598 office
Mike SilvermanManaging Partner
Ops A La Carte LLC+1 408-472-3889 mobile
+1 408-654-0499x204 [email protected]
www.opsalacarte.com
Q&A
Proprietary and Confidential
Our Next FREE Webinar will be on February 1st on
Design of Experiments
(Chapter 25 of Mike’s Book)
Proprietary and Confidential
POLLING QUESTION 4Are there any aspects of DOE you are most interested in ?a. DOE as it relates to material selectionb. DOE as it relates to design tradeoffsc. DOE as it relates to reliability testingd. DOE as it relates to manuf. screeninge. All aspects of DOEf. I’m not interested in DOE and
probably will not attend
Proprietary and Confidential
After signing off the webinar, you will be asked to take a
quick 3 minute survey
If you fill out survey, you will receive a link to the slides and
to the broadcast.
Proprietary and Confidential
Thank you for your timeLooking forward to working with you in
2011-2012Dave Vaughan
National Sales ManagerHALT/HASS Systems
Chart Inc.+1 612-221-4598 office
Mike SilvermanManaging Partner
Ops A La Carte LLC+1 408-472-3889 mobile
+1 408-654-0499x204 [email protected]
www.opsalacarte.com