medical battery webinar handouts

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Rich Byczek, Intertek 12/9/2010

Welcome to our webinar!

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Agenda

• Intertek Introduction: Who we are, what we do.

• Battery Standards Arena

• IEC 62133 adoption, transition

• Certification options for Lithium Batteries

• Transportation requirements for Lithium Batteries

• Battery Performance Validation

• Selecting the proper battery for your application

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Our industries

3

Supporting our customers in their global trade…..

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Intertek’s Global Network

Revenue split

Americas

EMEA

Asia Pacific

29%

37%34%

Strong growth market exposure Floated May 2002 – LSE: ITRKFTSE 100, Support Services Sector

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Our Roots

• As one of Thomas Edison’s companies, we began testing light bulbs in 1896.

• Over 100 years later, we have built the largest network of product safety and EMC laboratories.

1896 1925 1955 1965 1989 2004 2007

1896: Edison’s Testing Bureau est; later

named ETL

1925: SEMKO est

1927: Chas Warnock Co. founded

1961: SEMKO joins CB Scheme: today’s largest issuer

1965: WH successfully challenges UL, CSA in Canada: sets precedent

1989: ETL OSHA recognized NRTL 2004: Entela acquired

as entrée into automotive

2006: ETL is the fastestGrowing certification

Mark in North America1992: Inchcape

issues first ISO 9000 certificate

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Commercial & Electrical Services

Conformity Assessment Services

• Largest network of safety and EMC laboratories

• Fastest growing US certification mark

Performance & Benchmark Testing

• Widest range of performance testing capabilities in Industry

• Patented, proprietary processes (FMVT)

• World’s largest independent HVAC performance testing lab

Global approvals

• Market access to over 124 countries

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The Intertek Service DifferenceWe help you grow your business

The fastest, most responsive testing and certificat ion services

• We work to your schedules and deadlines, not ours

• Shorter queue times, faster turnaround

• Promised completion times

Flexible, customized services

• Off-premise testing, witness testing, or “test at your desk” (web-camera-monitoring solutions)

• MyTestCentral, on-line report management

World’s largest network of laboratories

• Testing where you need it, with over 60 locations globally

Efficient and cost-effective follow-up services pro gram

• Less interruption to your business

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Local Capabilities Livonia, MI

BATTERY PERFORMANCE

- Over 500 small format test positions

- 28 Module positions (up to 80V, up to 600Amp)

- 8 pack position (up to 900V, up to 1000Amp)

- Temperature/Humidity Conditioning

- UN-DOT 38.3 testing: Altitude, Temp/Humidity, Vibration, Shock.

- Abuse testing: Short, Over charge, Crush

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Local Capabilities Livonia, MI

EV COMPONENT TESTING

- Charge Stations

- Chargers

- Connectors

- Cordsets

- Service Disconnects

- BMS (Battery Management Systems)

AUTOMOTIVE COMPONENT PERFORMANCE (DV/PV)

ELECTRICAL PRODUCT SAFETY

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North American Certification Capabilities

IEC 62133: Cortland, New York (CBTL)

Detroit CBTL submission 2011

UL 2054: Detroit, MI and Cortland, NY

UL 1642: Detroit, MI and Cortland, NY

UN-DOT: Detroit, MI

Battery Performance: Detroit, MI

Battery Advisory Service: Detroit/ Cleveland

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BATTERY STANDARDS ARENA

What is

“THE STANDARD”

for Batteries?

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What is “THE STANDARD” for batteries?

- Depends on who you ask

- Depends on the type/ chemistry of battery

- Non-rechargeable (PRIMARY)

- Rechargeable (SECONDARY)

- Lithium / Lithium-ion is the focus of current standard development.

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Why Lithium?

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Battery Chemistries: Why Lithium/ Li-ion?

2-1010-302-8

Self discharge

(% per month at 20C)

1000450250 (800)cycles

Cycle life

(100% DOD)

1500850200W/kgSpecific Power

400 (450)240 (300)70 (115)Wh/lEnergy density

150 (240)7535 (80)Wh/kgSpecific energy

2-41.22VNominal Voltage

Li-IonLITHIUM ION

NiMH

NICKEL METAL

HYDRIDE

Pb/Ac

LEAD ACID

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Battery Chemistries: Why Lithium/ Li-ion?

2-1010-302-8

Self discharge

(% per month at 20C)

1000450250 (800)cycles

Cycle life

(100% DOD)

1500850200W/kgSpecific Power

400 (450)240 (300)70 (115)Wh/lEnergy density

150 (240)7535 (80)Wh/kgSpecific energy

2-41.22VNominal Voltage

Li-IonLITHIUM ION

NiMH

NICKEL METAL

HYDRIDE

Pb/Ac

LEAD ACID

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US- Based Standards:

UL-1642: Lithium Batteries

- Focus on single-cells

- Used for evaluation of Lithium-Metal (PRIMARY)

- Used for evaluation of Lithium-Ion (SECONDARY)

UL-2054: Household and Commercial Batteries

- Focus on Portable Batteries

- Typically Battery Packs

- References UL 1642 for Lithium Cells

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US- Based Standards:

UL-1642: Lithium Batteries

- 4th edition, September 2005 (With Nov. 2009 updates)

- Several revisions currently in proposal

- Intention to harmonize with IEC 62133

UL-2054: Household and Commercial Batteries

- 2nd edition, October 2004 (With Nov. 2009 updates)

- Several revisions currently in proposal

- Intention to harmonize with IEC 62133

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IEC - Based Standards:

IEC-60086

- Primary Batteries (Non-rechargeable)

- Covers Performance and Safety

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IEC - Based Standards:

IEC-60086

- Primary Batteries (Non-rechargeable)

- Covers Performance and Safety

IEC-62133

- Secondary Batteries (Rechargeable)

- Focus on Lithium-ion Batteries

- First Edition, October 2002

- Second Edition in process, potential 2011 release

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Which of the

“THE STANDARD’s”

Does my product need?

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IEC 62133 ADOPTION, TRANSITION

BACKGROUND:

- For many years, IECEE (“CB SCHEME”), has accepted the UL Standard as the basis for accepting batteries.

- Based on common usage of UL 1642/ 2054 for battery packs.

- Proposal in place to fully accept IEC 62133 within IECEE, as standard has been released since 2002.

- Proposal includes transition period.

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Portable Battery

IEC 62133

Medical Devices

IEC60601

Powertools

IEC60745

Audio Video

IEC60065ICT

IEC60950Household App

IEC60335

Who is affected by this regulatory change?

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• At the moment, IEC is working with product level groups to enforce the IEC62133 standard into the product level standard

• Some product level committees are making revision changes to their standard to comply with battery requirement

• CMC accepted a firm and final enforcement date of May 1, 2011 for battery standard IEC 62133, phasing out UL 1642 entirely, except for standards IEC 60950-1 and 60065, at the request of TC 108, responsible for those twostandards.

Example

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TRANSITION TESTING:

- Assuming battery is already tested and certified to UL-1642:

- “Delta” testing to be performed from May 2010.

- From May 1, 2012, full testing to IEC 62133 required

- NOTE: IEC 62133 2nd edition is in revision. Release date may affect transition period. Currently expecting release in 2011.

Transition:Additional

Test to UL1642must be performed

to meet IEC62133

Full Implementation:Test must be performedaccording to IEC62133

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DELTA TESTING: Per May 2010 IECEE Decision, the fol lowing additional clauses of IEC 62133 must be tested on U L-1642 tested batteries. (16 clauses)

1.4 IEC - Parameters measurement tolerances:

Tolerances are provided for various test parameters.

2 IEC - General Safety Considerations:

Requirements intended to address safety during intended use and unintended use.

Cells and batteries

2.1 IEC - Insulation and Wiring:

Insulation resistance check between wiring and external battery pack case. Insulated wiring shall be suitable for current voltage and temperature requirements

2.2 IEC - Venting: ·

A cell vent is required

2.4 IEC 62133 – Terminals Contacts:

terminal requirements such as polarity markings and construction to prevent

inadvertent short-circuiting, etc.

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2.5 IEC – Assembly of Cells into Batteries:

Use of same cells with matched capacities from same manufacturer. When portions

of series connected cells are selectively discharged, separate circuitry shall be

utilized to prevent forced discharge.

2.6 IEC – Quality Plan:

Requires the manufacturer to have quality plan that defines procedures for the

inspection of materials, components, cells and batteries covering the process of

producing each type of cell or battery.

3 IEC – Type test conditions:

Batteries should be no more than three months old test ambient is 20+5C

Sample size is 5 samples for most of the tests.

4.2.1IEC – Continuous Low Rate Charging –

cell test

requires fully charged cells to be subjected to a low rate charge as specified by the

manufacturer for 28 days

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4.2.3 IEC – Moulded case stress at high ambient temperature

Battery pack enclosure test

70 ± 2°C conditioning

7 hours, then return to ambient

4.3.3 IEC – Free Fall

Cell and Battery

Each sample dropped 3 times from 1.0 m height to concrete floor

4.3.6 IEC – Crushing of cells

• Cell test

• Cell crushed between two flat surfaces

• 13 kN 1 kN force

• force removed after obtaining 13 kN or voltagedrop of 1/3 of original

• prismatic and cylindrical tested

4.3.9 IEC - Overcharge for lithium systems

Charging for longer periods

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5. Annex A and B

IEC - Information for Safety

Information for the safe use of batteries with guidance provided in IEC 61438 for

nickel batteries (not enforceable) and informative Annex A (equipment manufacturers and battery assemblers) and informative Annex B (end users)

6.1 IEC – Cell Marking

Cells shall be marked per cell specification standards - (IEC 61960, IEC 61951-1, -2, IEC 61436, IEC 61440, 60285

Cells used in pack need not be marked

6.2 IEC – Battery Marking

Batteries shall be marked per battery specification standards - (IEC 61960, IEC

61951-1, -2, IEC 61436, IEC 61440, 6028

Provided with appropriate caution statements

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CERTIFICATION OPTIONS

Options:

EXISTING BATTERIES WITH UL-1642 Certification:

- Delta testing (previous slides)

- Full IEC 62133 (1st edition) evaluation, with CB report

NEW BATTERIES:

- Full IEC 62133 Evaluation, with CB report

- UL-1642 + Delta test

- UL-1642 + UL-2054 + Delta Test (provides US listing to UL-2054)

NOTE: As UL-1642/2054 and IEC 62133 are not harmonized, separate samples should be used for each standard in the above cases.

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CERTIFICATION OPTIONS :Urgency!

• European customers WILL require IEC62133. � Be first

• IEC62133 means higher quality – low risk. � Market your quality, market your compliance

• When implementation begins there will be waiting lines at the testing houses� Avoid long lead times and queue

�� Avoid disruption to your business

• UL1642 is being harmonized with IEC62133� Opens up 2 markets (US/EU)

• IEC62133 can be a way to source lower cost/high quality batteries.� Save money by requiring proper documentation

� Validate the performance of your suppliers’ batterie s

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TRANSPORTATION REQUIREMENTS

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UN / USDOT Battery Designations for Lithium/ Li-Ion Batteries

- Class 9 Material

- Present a hazard during transportation, but do not meet the definition of any other hazard.

- UN3090: Lithium (Lithium Metal) Batteries

- UN3091: Lithium Batteries contained in equipment

- UN3480: Lithium-Ion Batteries

- UN3481: Lithium-Ion Batteries contained in equipment

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According to DOT and FAA

- Since 1991:

- 44 “incidents” related to Lithium/ Lithium-ion batteries

- 23 of 44 in Cargo Aircraft

- 21 of 44 in Passenger Aircraft

- 1 in checked luggage

- 16 in passenger cabin/carry-on

- Total Battery incidents (all chemistries): 112

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LATEST and GREATEST UN MANUAL:

Recommendations on the Transport of Dangerous Goods. Manual of Tests and Criteria. 5th Revised Edition

(Issued December 2009)

Section 38.3 refers to “Lithium Battery Testing Requirements”

Per Federal register 49 CFR sections 171.7

- Currently references 4th Edition Revised

- 5th edition to be specifically required by January 2011

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AKA:

- UN/DOT Testing

- 38.3 Tests

- T1 – T8 Testing

- UN ST/SG/AC.10/27/Rev. 4

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UN Manual of Tests and Criteria

Samples Needed: PRIMARY CELLS/ BATTERIES (5th edition)

4

25

FULLY DISCHARGED

84PRIMARY BATTERIES

4015PRIMARY CELLS

TOTALUNDISCHARGED

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Samples Needed: SECONDARY CELLS (5th edition)

10

10

1st Cycle 50% CHARGE

10

10

50 Cycle FULLY DISCHARGED

401010Prismatic Cells

5

1st Cycle FULLY DISCHARGED

3510Cylindrical Cells

TOTAL1st Cycle CHARGED

Cylindrical

(18650, Canister)

Prismatic

(Pouch)

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Samples Needed: SECONDARY BATTERIES (5th edition)

4

25 Cycle CHARGED

8

50 Cycle CHARGED

84Large Batteries

168Small Batteries

TOTAL1st Cycle CHARGED

SMALL BATTERY: Gross Mass up to 12 kg

LARGE BATTERY: Gross Mass over 12 kg

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Samples Needed: additional criteria

- Lithium Metal Primary Packs

- Up to 500g total Lithium content

- Cells/ Modules already tested

- 1 sample only:

- Tests 3,4,5 only

- Lithium Ion Rechargeable Packs

- Up to 6,200 Wh rating

- Cells/ Modules already tested

- 1 (or 2) sample(s) only, cycled 25 times, fully charged

- Tests 3,4,5 and 7 only

- More than 500g Lithium or 6,200 Wh Rating

- No testing required if BMS in place

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Tests T1 – T8

T1-T5 (Same Samples, Tested in Order, All Types)

T1: Altitude Simulation

T2: Thermal Test

T3: Vibration

T4: Shock

T5: External Short Circuit

T6: Impact (Cells Only)

T7: Overcharge (Rechargeable Batteries Only)

T8: Forced Discharge (Cells Only)

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BATTERY TESTING INFO NEEDED

Basic information needed to quote your test program :

- Nominal Voltage and Capacity (Ah) rating

- Maximum charging current and voltage

- Maximum discharge current and voltage

- Normal discharge current

- Cutoff voltage (voltage at which output is cut off or battery is considered "dead")

- Fully charged current/voltage (current and voltage points where battery is considered fully charged)

- Schematics of battery packs and protection circuitry (if applicable)

- For UL 2054 Limited Power Source test on Request only

- Existing certifications on cells or packs

- Chemistry used (MSDS, Shipping requirements)

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BATTERY PERFORMANCE TESTING

Does the data sheet describe the use –profile of your product??

Single Cell Primary Batteries: ANSI C18, IEC 60086: standardizedperformance profiles.

Rechargeable: Data sheet verification

- capacity

- charge cycle life

- case temperature

- performance at non-standard temperatures (+37 C, for example)

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SELECTING THE PROPER BATTERY

Intertek’s Advisory Services Group: over 50 years experience.

- Test Plan Development

- SOR (Statement of Requirements) review

- Usage profile verification and development

- Paper Audit:

- How are you currently selecting your batteries?

- What parameters are important?

- How do you decipher the data provided?

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SELECTING THE PROPER BATTERY

Intertek’s Advisory Services Group: over 50 years experience.

- Factory Audits

- How reliable is the supplier’s manufacturing?

- Is ISO-9000 enough?

- Safety as well as performance concerns.

- Most known Lithium Battery incidents caused by internal short circuit.

- Manufacturing controls

- Raw material supplier chain controls

- Lot Variability

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Intertek: Medical Device Services

Intertek is the Medical Device industry’s premier resource for regulatory insight and expert guidance on product testing, inspection and certification.

Responsiveness to inquiries

Expertise in global requirements

Global network of accredited laboratories

Flexible to meet your needs and schedule

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• FDA 3rd Party Reviews • Systems Certification

• Product Safety • EMC Testing

• CB Scheme • Performance Testing

• ETL (EU) • Environmental Services

• Satellite Data Acceptance Program

• Analytical Services

Intertek: Medical Device Services

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Rich Byczek,

Site Manager, Intertek Detroit

734-591-9161

[email protected]

Thank You.

medical battery webinar handouts

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