Hello Massimo, The use of devices in oxygen enriched environments is not a trivial question. Many materials that are fire retardant at 21% O2 are highly combustible in enriched environments. If your product has not been specifically designed and evaluated for use in such environments, one would be taking a great risk in using them there. Every year there are fires reported in hyperbaric chambers. Remember the Apollo One fire in 1967?
IEC 60601-1 (second edition) does not have appropriate requirements for oxygen enriched environments. Work on the third edition is planned to address this issue. There is an excellent article on oxygen environments in the current issue of the ASTM Standardization News (November 1998) and the work of ASTM Committee G-4, Compatibility and Sensitivity of Materials in Oxygen-Enriched Atmospheres. You can contact ASTM at http://www.astm.org Best regards, Dave Osborn Hewlett-Packard Company Medical Products Group dosb...@hp.com _______________________________________________________________________ I am currently testing a new e-mail client called Outlook. If present, please disregard the "winmail.dat" attachment. _______________________________________________________________________ -----Original Message----- From: Non-HP-regrsfi /HP-ColSprings,mimegw3/dd.HPMEXT1=regr...@esaote.com Sent: Tuesday, November 24, 1998 3:24 AM To: Non-HP-emc-pstc /HP-ColSprings,mimegw3/dd.HPMEXT1=emc-p...@majordomo.ieee.org Cc: Non-HP-regrsfi /HP-ColSprings,mimegw3/dd.HPMEXT1=regr...@esaote.com Subject: Medical Devices in Hyperbaric Chamber A distributors of ours asks us about the suitability of our ECG device for use into a Hyperbaric Chamber. Does anybody know any reference safety standard for medical devices in hyperbaric chamber? Are the environmental conditions similar to those in presence of a "flammable anaesthetic mixture with air or with oxygen or nitrous oxide" (IEC 601-1)? Thanks for any help. m.p. ------------------------------------------------------- ESAOTE S.p.A. Massimo Polignano Research & Product Development Regulatory Affairs Via di Caciolle,15 tel:+39.055.4229402 I- 50127 Florence fax:+39.055.4223305 e-mail: regr...@esaote.com --------- This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: "unsubscribe emc-pstc" (without the quotes). For help, send mail to ed.pr...@cubic.com, j...@gwmail.monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators). << File: Medical Devices in Hyperbaric Chamber.TXT >>
