15.3.3 Ball Impact Test requirements in IEC 60601-1

M

monty007

#1
Hi all. I have a question about the ball impact test requirements in IEC 60601-1. For body worn devices the ball impact test applies. How about if the device is tiny, like a hearing aid or something similar? Surely such a tiny device cannot withstand a 0.5kg ball impact from 1.3m? Does this apply to all body work devices or do you think this is usually excluded from such devices?
Any advice would be appreciated.
Thanks in advance.
 
Last edited by a moderator:
Elsmar Forum Sponsor

Pads38

Trusted Information Resource
#2
Hi Monty,

The impact test sets out to show "...sufficient resistance to impact to protect against unacceptable risk." Note it doesn't say "must not break".

If you have a look at the assessment criteria set out in 15.3.1 they are all concerned about the risks of damage to the enclosure allowing access to electrically live parts. But with a hearing aid you won't have any hazardous voltages, so you have no risk of electrical shock whatever happens.

Now, if you check the rationale to 15.3.3, in Annex A, there is an example given of the use of risk management where the manufacturer decides that the subclause does not mitigate an unacceptable risk. (The example given is for installed equipment - but the concept is the same).

I would suggest that you could justify that the impact test is not relevant. But instead you could look to the drop test of 15.3.4 to provide a more relevant test. For hand held it suggests a drop height of 1m or more. Now, if you were to perform some drop tests from 'ear height' (say a near worst case of 1.8m) I think that might be more relevant.

There is a 'Particular' standard for hearing aids - 60601-2-66. I believe that this modifies some of the test requirements, to be more relevant.

From an IEC web page about -2-66
Many subclauses of the general Standard are not applicable to hearing aids – for instance they do not present electrical, fire or heat hazards owing to their low voltage and low energy characteristics.

However, protection against mechanical hazards is given special attention in the particular Standard and devices are submitted to drop tests. The Standard states that hearing instruments "shall have mechanical strength and shall not result in an unacceptable risk due to moulding stress or when subjected to mechanical stress caused by pushing, impact, dropping, and rough handling".

As a hearing instrument is frequently installed entirely or partially in ear canals "rough surfaces, sharp corners and edges that could result in an unacceptable risk shall be avoided or covered".
http://iecetech.org/issue/2013-05/Ensuring-safer-design-for-hearing-aids
 
M

monty007

#3
Thank you for your reply. The hearing aid was the only example of a small wearable that I could think of. The device im working on isn't a hearing aid but is a small usb chargeable device which if impacted by the .5kg ball end up with a cracked enclosure. The crack in the enclosure isn't itself a problem but because its also has an IP22 requirement this may cause a problem.
There isn't anything that gives guidance on the size of device that this applies to so I guess its a risk management thing as you have suggested.
Thanks again you your reply.
 
Thread starter Similar threads Forum Replies Date
J IEC 60601 (Steel Ball Impact Test) Other ISO and International Standards and European Regulations 1
Marc Golf Ball Parts for Breakfast! World News 8
W Profilometer Surface Roughness Tester Issue - Ball Bearings ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J Ball Bearing V-Blocks to ensure Lobing and Roundness are Minimal Manufacturing and Related Processes 1
A JEDEC Std to use as reference for a package of size of 29x29mm with 0.8mm ball pitch Design and Development of Products and Processes 6
S Minitab and Crystal Ball Statistical Analysis Software Using Minitab Software 13
Wes Bucey Did somebody drop the ball at Boeing? Quality Manager and Management Related Issues 38
smryan Does the NIST certificate that came with my new ball-bar have any value? General Measurement Device and Calibration Topics 8
C Sunday Morning Curve Ball - Auditing Racing Stables or Similar ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T AS9102 FAI - What is a distributor of ball bearings supposed to do? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J Scrap, Control or Marking - Ball Bearing Distribution and Re-Lubrication AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Marc Happy 100th birthday to Lucille Ball World News 3
M DFAR Ball Bearings - DFARS 252.225.7014 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
D Ring Gauges P.D Formula using "Ball Rounded Teeth" General Measurement Device and Calibration Topics 13
G Effects of CMM Probe Tip Ball Size measuring a Round Part OD - CMM Help Inspection, Prints (Drawings), Testing, Sampling and Related Topics 18
Sidney Vianna AS9100 Revision C Transition - A curve ball AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
bobdoering How's this for a probability function? Player Hits Own Mom With Foul Ball Funny Stuff - Jokes and Humour 7
P Sample Manufacturing Method for Ball Drop Test of Automotive Tempered Glass General Measurement Device and Calibration Topics 5
D ASTM E-18 Annex A3 - Ball and Diamond Indenters Requirements General Measurement Device and Calibration Topics 9
N Score One for the Team - I had to ball up and tell the bosses Coffee Break and Water Cooler Discussions 7
Z Injection Molding cycle time benchmarking - Ball State University student Benchmarking 10
Sidney Vianna Ball Memorial Hospital - The first Indiana hospital to receive NIAHO accreditation Hospitals, Clinics & other Health Care Providers 1
I How Must Safety Integrity Level (SIL) For Ball Valves Be Calculated? Reliability Analysis - Predictions, Testing and Standards 3
J Large CMM Calibration - Tetronom or Giant Ball Bar General Measurement Device and Calibration Topics 6
G Ball Grid Array (BGA) component Incoming Inspection IPC-7095 Various Other Specifications, Standards, and related Requirements 3
K Play this game. Try to kick the ball & beat me !! Coffee Break and Water Cooler Discussions 20
K Crystal Ball Methodology - reading customers' minds? IATF 16949 - Automotive Quality Systems Standard 24
R Impact of changing manufacturer post clinical investigation CE Marking (Conformité Européene) / CB Scheme 3
Ed Panek Corona Virus impact on Supplier Audits and Received Parts ISO 13485:2016 - Medical Device Quality Management Systems 4
F Will the EU postpone 2017/745 MDR Implementation - COVID-19 Impact Medical Device and FDA Regulations and Standards News 11
R Revalidation machine line and Stability Studies impact. Medical Device and FDA Regulations and Standards News 3
M MDR Impact on MDSAP Countries Other Medical Device Regulations World-Wide 16
Watchcat Impact of MDR on Availability of Medical Devices in EU EU Medical Device Regulations 5
Judy Abbott Can any one help me with an urgent BIOCOMPATIBILITY Impact assessment? Internal Auditing 9
G Is impact test according to IEC 60601-1 applicable for HAND-HELD equipment if also classified as BODY-WORN? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A IEC 60601-1 Impact test on glass touch controller IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
qualprod The Perfect audit? External Audit causes a significant negative impact in a company General Auditing Discussions 9
Ashok sunder Is it possible to reduce Risk likelihood and impact Post control Ranking after corrective action taken for risk? FMEA and Control Plans 1
E MDR Article 117 / Impact to New Marketing Authorization Applications Other Medical Device Regulations World-Wide 1
C Lithium battery powered Medical Device - 15.3.3 Impact test, broken enclosure IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
R Impact of an MDSAP certificate with all countries coverage Other Medical Device Regulations World-Wide 8
Edward Reesor Canadian News article on impact of MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 10
qualprod Propose Aspects to evaluate risk impact? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
qualprod Risk impact can be modified? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R Brexit - European Commission - The impact of the Brexit per March 29, 2019 EU Medical Device Regulations 3
B The impact of IoT in ISO documentation IT (Information Technology) Service Management 1
J Business Impact Analysis SOP Business Continuity & Resiliency Planning (BCRP) 2
T GDPR impact on ISO 9001 and Quality ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Raffy What is the first step in doing PIA (Privacy Impact Assessment)? IEC 27001 - Information Security Management Systems (ISMS) 3
Sidney Vianna IATF 16949 Areas of Impact - Rules 5th Edition Document (February 2017) IATF 16949 - Automotive Quality Systems Standard 0

Similar threads

Top Bottom