Re: [PSES] Date of cessation of 60601-1 edition 2 in EU
I am not in the office right at the moment otherwise I would dig up the dates but for the EU the date of withdraw was last month for the 2nd edition but for those products that have a particular 2-x standard associated with them that has not been transcribed to the 3rd edition there is an extension of the 2nd. FDA accepts both the 2nd and 3rd editions until 2013 (not sure of the month but it is early 2013) then only the 3rd edition will be a recognized standard. Canada follows the EU and Australia has not announced. Bill From: McInturff, Gary [gary.mcintu...@esterline.com] Sent: Friday, July 13, 2012 7:18 AM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] Date of cessation of 60601-1 edition 2 in EU I’m trying to support boss hog just a bit on a product. I’m looking in OJ for the dates of withdrawal for the 2nd edition of the medical safety standard, and I think I can find that, is there anything more clear that just simple says it’s can’t be used after such and such a date. We’re putting something on hold until it finishes a standards change and a bit of a fight, and I’m just trying to put a stake in the vampires heart and just referencing the docopos etc is going to take further explaination for those that don’t deal with it all the time. So I’m also looking for a paragraph in plain English (US or EK :) ) Thanks Gary McInturff Reliability/Compliance Engineer Esterline Interface Technologies Featuring ADVANCED INPUT, MEMTRON, and LRE MEDICAL products 600 W. Wilbur Avenue Coeur d’Alene, ID 83815-9496 Office:208-635-8306 Cell: 509 868 2279 Toll Free: 800-444-5923 X 1238 gary.mcintu...@esterline.commailto:brian.s...@esterline.com www.esterline.com/interfacetechnologieshttp://www.esterline.com/advancedinput Technology, Innovation, Performance... - 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 emc-p...@ieee.orgmailto:emc-p...@ieee.org 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 emcp...@radiusnorth.netmailto:emcp...@radiusnorth.net Mike Cantwell mcantw...@ieee.orgmailto:mcantw...@ieee.org For policy questions, send mail to: Jim Bacher j.bac...@ieee.orgmailto:j.bac...@ieee.org David Heald dhe...@gmail.commailto:dhe...@gmail.com - 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 emc-p...@ieee.org 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 emcp...@radiusnorth.net Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald: dhe...@gmail.com
Re: [PSES] 60601 Severity Level - Permanent impairment
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: jral...@productsafetyinc.commailto:jral...@productsafetyinc.com jral...@productsafetyinc.commailto:jral...@productsafetyinc.com Date: Wed, 7 Mar 2012 09:25:21 -0700 To: William Morse william.mo...@careinnovations.commailto:william.mo...@careinnovations.com Cc: EMC-PSTC@LISTSERV.IEEE.ORGmailto:EMC-PSTC@LISTSERV.IEEE.ORG EMC-PSTC@LISTSERV.IEEE.ORGmailto:EMC-PSTC@LISTSERV.IEEE.ORG 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 jral...@productsafetyinc.commailto:jral...@productsafetyinc.com http://www.productsafetyinc.comhttp://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:william.mo...@careinnovations.com] Sent: Wednesday, March 07, 2012 10:22 AM To: jral...@productsafetyinc.commailto:jral...@productsafetyinc.com 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: jral...@productsafetyinc.commailto:jral...@productsafetyinc.com jral...@productsafetyinc.commailto:jral...@productsafetyinc.com Reply-To: jral...@productsafetyinc.commailto:jral...@productsafetyinc.com jral...@productsafetyinc.commailto:jral...@productsafetyinc.com Date: Wed, 7 Mar 2012 08:58:50 -0700 To: EMC-PSTC@LISTSERV.IEEE.ORGmailto:EMC-PSTC@LISTSERV.IEEE.ORG 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 jral...@productsafetyinc.commailto:jral...@productsafetyinc.com http://www.productsafetyinc.comhttp://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
Re: [PSES] Mandatory NRTL certification
interesting aspects of this topic 1) Authorities Having Jurisdiction (AHJ) that has adopted the National Electrical Code (NEC) also place a requirement for an NRTL mark on a device. So while there maybe no state requirements there are AHJs (City, County,…) requirements for devices to have an NTRL mark. Los Angeles http://www.ladbs.org/ FUNCTION OF THE LOS ANGELES ELECTRICAL TESTING LABORATORY The California Electrical Code requires under Sections 110.2 and 110.3 that electrical equipment be safety approved by the authority having jurisdiction or listed by an approved testing laboratory. In addition, the City of Los Angeles Municipal Code Section 93.0402 also requires approval for these equipment, if a listing cannot be secured, either by the Los Angeles Electrical Testing Laboratory (LAETL) or third party testing agencies recognized by the City. 2) Do not assume that Federal Regulations preempt state or local requirements for NRTL listing. For example medical devices. 21 CFR §808.1 (d)(1) SUBCHAPTER H--MEDICAL DEVICES PART 808 -- EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICEREQUIREMENTS Subpart A--General Provisions (1) Section 521(a) does not preempt State or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices (e.g., requirementssuch as general electrical codes, and the Uniform Commercial Code (warranty of fitness)), or to unfair trade practices in which the requirements are not limited to devices. 3) State laws are unique in scope: http://www.bcd.oregon.gov/rules_statutes/compilations/oar/306.pdf http://egov.sos.state.or.us/division/archives/rules/OARS_900/OAR_918/918_306.html 918-306- Scope and Authority for Rule (1) The rules in OAR 918-306- to 918-306- 0530 deal with the different ways to qualify an electrical product for sale, disposal and installation in Oregon. (2) Authority for rules. (a) ORS 479.540 authorizes partial and complete product exemptions; (b) ORS 479.610 requires products for sale in Oregon to be certified; and (c) ORS 479.730 authorizes creation of procedures for product certifications, administration and enforcement and field evaluation of electrical products. 918-306-0010 Overview (1) ORS 479.610 establishes certification requirements for electrical products. (2) The certification process generally involves inspection, testing and evaluation of the product. This is done through: (a) Listing and application of listing label by a Nationally Recognized Testing Laboratory (NRTL); Oregon Law 479.610 479.610 Sale or disposal of uncertified or unevaluated electrical product prohibited. Except as provided under ORS 479.540http://www.paperadvantage.org/ORS/479.html#479.540#479.540, no person shall sell or dispose of by gift or otherwise in connection with the person’s business an electrical product that is not certified or evaluated under the requirements of ORS 479.510http://www.paperadvantage.org/ORS/479.html#479.510#479.510 to 479.945http://www.paperadvantage.org/ORS/479.html#479.945#479.945 and 479.995http://www.paperadvantage.org/ORS/479.html#479.995#479.995. [1959 c.406 §9; 1981 c.815 §12; 1995 c.706 §2] Bill Opinions expressed are my own and not necessarily those of my employer, use at your own risk From: Tyra, John john_t...@bose.commailto:john_t...@bose.com Reply-To: Tyra, John john_t...@bose.commailto:john_t...@bose.com Date: Fri, 6 Jan 2012 09:34:16 -0500 To: EMC-PSTC@LISTSERV.IEEE.ORGmailto:EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] Mandatory NRTL certification While there are no Federal laws requiring NRTL certification and marking of electronic products there are laws in 16 States which require anNRTL mark for mains connected electronic products…and laws in 4 otherStates which specify consumer products only. CEA commissioned a State survey, which was updated in 2010, which outlines the legal requirement or lack of for all 50 States……….. From: emc-p...@ieee.orgmailto:emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Ron Wellman Sent: Thursday, January 05, 2012 11:49 PM To: peterh...@aol.commailto:peterh...@aol.com; EMC-PSTC@LISTSERV.IEEE.ORGmailto:EMC-PSTC@LISTSERV.IEEE.ORG Subject: RE: Mandatory NRTL certification NRTL certification/listing is not mandatory for product Manufacturers. This is a Customer driven requirement so your Customers can comply with local OSHA requirements. If you don’t want to list or certify your product that’s really a Marketing call. Also, it is my experience that most large Companies require third party approvals as a condition of sale. Therefore, unless you want to be reactive to Customer sales I would make sure your Marketing people understand the risk of losing a sale if your product is not certified/listed by an NRTL. Best regards, Ron Wellman From: emc-p...@ieee.orgmailto:emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of
