risk based testing, halt, and iec/en 60601-1 3 edition · risk based testing, halt, and iec/en...

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Risk Based Testing, HALT, and IEC/EN 60601-1 3rd Edition

Mike Silverman and Tom Prudent, OPS A LA CARTEDave Vaughan, CHART

AGENDA–Introduction – 5 minutes–Webinar – 45 minutes–Q&A – 10 minutes

• 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

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.

• 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

• 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

• 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

• 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)

• 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

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

Chart Inc.

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

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

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

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

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

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

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

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)

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

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 info@opsalacarte.com

Registration Demographics• For this webinar we have signed up

– 163 Registrants– 17 Countries

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 ?

Registration Questions• Are you currently developing medical products ?

Yes, for years 49%

No, just interested 43%

Yes and this is our first one 9%

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%

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%

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

Risk Based Testing

Developing Better Test Plans

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

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

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

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.

Case Study - Inhaler

Developing a Test Plan without FMEA

• What types of tests can you think of for this device?

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?

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

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

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.

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.

POLLING QUESTION 1Do you currently use your risk analysis to drive your testing ?

a. Yes, alwaysb. For some types of testsc. Rarelyd. Never

HALT and HASS

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

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

Why Do HALT?

HALT is a design process ruggedization tool for the designers

HALT PROCESS

HALT/HASS System

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

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.

IEC60601-1 Rev 3

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

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

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

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

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)

3rd Edition Highlights• Clause 4: General Rqmts

– RMF (ID’ing Hazards & Risks)– Define: BS, EP, AP, Hi-Rel Components

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

3rd Edition Highlights• Clause 8: Protection vs. Elec. Hazards

– Leakage Current& Dielectric Strength

– Creepage Distances & Air Clearances

3rd Edition Highlights• Clause 9: Protection vs. Mech. Hazards

– Moving parts (crush haz.), edges/corners– Instability & Expelled Parts– Acoustic / Vibration– Pressure Vessels & Support Systems

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

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)

3rd Edition Highlights• Clause 15: Gen. MEE Construction

– Mech. Strength (Push, Impact, Drop, Rough Handling, Molding Stress Relief)

– General Assy of components

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

IEC/EN 60601-1 3rd Edition• Relationship to Collateral and Particular

Standards to the General Standard

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

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

Special offer for webinar participants:

Free 1 hour Reliability Consultation

Offer expires on 12/31/11

Dave VaughanNational Sales ManagerHALT/HASS Systems

Chart Inc.+1 612-221-4598 office

Dave.Vaughan@chartindustries.comwww.chartchambers.com

Mike SilvermanManaging Partner

Ops A La Carte LLC+1 408-472-3889 mobile

+1 408-654-0499x204 officemikes@opsalacarte.com

www.opsalacarte.com

Our Next FREE Webinar will be on February 1st on

Design of Experiments

(Chapter 25 of Mike’s Book)

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

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.

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

Dave.Vaughan@chartindustries.comwww.chartchambers.com

Mike SilvermanManaging Partner

Ops A La Carte LLC+1 408-472-3889 mobile

+1 408-654-0499x204 officemikes@opsalacarte.com

www.opsalacarte.com

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