"Permanent hearing loss" could also mean a reduction of hearing across the spectrum that can be received or only in a particular frequency band within it.
For this hypothetical case the benefits have to outweigh the risks when using the device. The risk of "Permanent hearing loss" would need to be addressed in the risk management process if it is determined that "Permanent hearing loss" exists as a risk when using the device as intended and for its intended purpose. It maybe that the undesirable result of some (some would have to be defined) hearing loss is an acceptable risk with regards to this device because of the "benefit" it provides, while total loss of hearing in one or both ears is not acceptable and mitigations would have to be put in place. The risk management process for medical devices has to be able to take into account everything from the result of "no hearing loss" to "complete hearing loss" as an acceptable risk. Its all dependent on the "benefit" to the patient outweighing the risk to the patient when using the device as intended. Only individual(s) with detailed knowledge of the intended use and the medical purpose for the device will be able to determine were that crossover point is. Have you looked at annex D of ANSI/AAMI/ISO 14971 Medical devices—Application of risk management to medical devices it may give more guidance. Bill From: "[email protected]<mailto:[email protected]>" <[email protected]<mailto:[email protected]>> Date: Wed, 7 Mar 2012 09:25:21 -0700 To: William Morse <[email protected]<mailto:[email protected]>> Cc: "[email protected]<mailto:[email protected]>" <[email protected]<mailto:[email protected]>> Subject: RE: [PSES] 60601 Severity Level - Permanent impairment Yes, but “permanent hearing loss” to some may mean in both ears, to others it may mean in one ear. What was the intention of 60601?? John Allen President Product Safety Consulting, Inc. 605 Country Club Drive, Suites I & J Bensenville, IL 60106 P - 630 238-0188 / F - 630 238-0269 1-877-804-3066 [email protected]<mailto:[email protected]> http://www.productsafetyinc.com<http://www.productsafetyinc.com/> Although PSC maintains the highest level of virus protection, this e-mail and any attachments should be scanned by your virus protection software. It is the responsibility of the recipient to check that it is virus free. PSC does not accept any responsibility for data loss or systems damage arising in any way from its use. This message is confidential and intended only for the individual to whom or entity to which it is addressed. If you are not the intended recipient or addressee, or an employee or agent responsible for delivering this message to the addressee, you are hereby notified that any dissemination, distribution, or copying, in whole or part, of this message is strictly prohibited. If you believe that you have been sent this message in error, please do not read it. Please immediately reply to sender that you have received this message in error. Then permanently delete all copies of the message. Thank you. From: Morse, William [mailto:[email protected]] Sent: Wednesday, March 07, 2012 10:22 AM To: [email protected]<mailto:[email protected]> Subject: Re: [PSES] 60601 Severity Level - Permanent impairment Hello John, Would that not be defined in the risk management process used by the manufacture for the equipment in question? Bill From: "[email protected]<mailto:[email protected]>" <[email protected]<mailto:[email protected]>> Reply-To: "[email protected]<mailto:[email protected]>" <[email protected]<mailto:[email protected]>> Date: Wed, 7 Mar 2012 08:58:50 -0700 To: <[email protected]<mailto:[email protected]>> Subject: [PSES] 60601 Severity Level - Permanent impairment Hi, I cannot find that 60601 (none of them) indicate the difference in severity if you loss hearing in one ear or both. What about losing one finger vs all? Any insight here would be greatly appreciated. Thanks, John Allen President Product Safety Consulting, Inc. 605 Country Club Drive, Suites I & J Bensenville, IL 60106 P - 630 238-0188 / F - 630 238-0269 1-877-804-3066 [email protected]<mailto:[email protected]> http://www.productsafetyinc.com<http://www.productsafetyinc.com/> Although PSC maintains the highest level of virus protection, this e-mail and any attachments should be scanned by your virus protection software. It is the responsibility of the recipient to check that it is virus free. PSC does not accept any responsibility for data loss or systems damage arising in any way from its use. This message is confidential and intended only for the individual to whom or entity to which it is addressed. If you are not the intended recipient or addressee, or an employee or agent responsible for delivering this message to the addressee, you are hereby notified that any dissemination, distribution, or copying, in whole or part, of this message is strictly prohibited. If you believe that you have been sent this message in error, please do not read it. Please immediately reply to sender that you have received this message in error. Then permanently delete all copies of the message. Thank you. - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]<mailto:[email protected]>> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]<mailto:[email protected]>> Mike Cantwell <[email protected]<mailto:[email protected]>> For policy questions, send mail to: Jim Bacher <[email protected]<mailto:[email protected]>> David Heald <[email protected]<mailto:[email protected]>> - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]>
