Hi Regarding the ISO 14971 question, there´s seems to be a misunderstanding. The risk analysis (a part of the whole risk management process described in ISO 14971) shall be made based on the normal use of the equipment (and single fault if deemed necessary). Two explanations follow.
First, ISO 14971, generally speaking, is a standard that uses a risk managent framework to assess the quality in the design of a equipment. Tthe manufacturer has to use this framework to show that all risk (in normal use AND single fault conditions AND reasonable foreseeable misuse) is kept below a residual risk level (previously chosen). This concept comes from IEC 60513 second edition - the base for the third edition of IEC 60601-1 - where it is stated that some risks cannot be assessed by the norma pass / fail criteria. IEC 60513 also includes the concept of essential performance, i.e., safety of medical electrical equipment not only comprises basic safety but also minimum performance requirements (e.g. accuracy on the output of a electrical stimulator). This whole risk management concept is one of the most important points in medical electrical equipment standards development these days (compliance to the third edition of IEC 60601-1 will only be achievable by compliance to ISO 14971 too, and particular and colateral standards will have this same need - this will be implemented in the near future). If you want another standard that is already published that uses risk analysis (and management) in normal use (and in the two other situations) look no further than 60601-2 sister IEC 60601-1-4 on programmable electrical medical systems - it doesn´t use ISo 14971 because it was deeveloped before, but it´s the same thing. A recent example that can use ISO 14971 is IEC 60601-2-12 2002, which let an equivalent degree of safety in all tests be demonstrated by means of a risk analysis in acordance with ISO 14971. Second, IEC 60601-1-2 asks for a risk analysis from the manufacturer to show which functions of the equipment are considered essential performance, ie, which function must behave normally for the equipment to be considered operating - so it clearly means normal use. If the risk analysis is not performed, all functions are considered essential. This means that all functions will have to be tested, and worse, all function shall retain their performance and remais safe. This could lead to a lot of problems during testing. Regards -- Marcelo de Moraes Antunes - [email protected] IPT - Technological Research Institute - Brazil Electrical Evaluation Laboratory LAE-ATEE-DME Phone+55 (11) 3767-4948 Fax +55 (11)3767-4007 ________________________________________________ Message sent using UebiMiau 2.7.8 ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
