Joel, To the best of my knowledge, there are no specific environmental standards for medical equipment.
IEC 60601-1, (the product safety standard), clause 10.1, states " Equipment shall be capable, while packed for transport and storage, of being exposed to environmental conditions as stated by the manufacturer". Clause 10.2.1 specifies ambient temperature, relative humidity and atmospheric pressure ranges for operation in normal use. Particular types of medical equipment, which are required to comply with one of the IEC 60601-2-XX standards, may be subject to additional or different environmental requirements. Regards, Jon Griver http://www.601help.com The Medical Device Developer's Guide to IEC 60601-1 >Hi All > Can anybody help me out with Environmental testing requirement/Standards >(Temp,Vibration) for medical devices? >Thank You >Joel Mandel >Reliability Dept >ADC Israel ------------------------------------------- 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] All emc-pstc postings are archived and searchable on the web at: http://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list"
