Medisinsk utstyr

Komité: ISO/TC 210 (Quality management and corresponding general aspects for medical devices)
Opprinnelse:
Sluttdato: 20. mai 2019
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Komité: CEN/CLC/JTC 3 (Quality management and corresponding general aspects for medical devices)
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Sluttdato: 21. mai 2019
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Komité: CEN/TC 215 (Respiratory and anaesthetic equipment)
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Sluttdato: 6. jun 2019
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EN ISO 80601-2-13 was published in 2011. Amendment 1 to EN ISO 80601-2-13:2011 will update this standard with regard to references to IEC 60601-1:2005 (EN 60601-1:2006) and applicable collateral standards. The Amendment 1 also introduces technical modifications to clarify the relationship between this standard and IEC 60601-2-49 and to further specify accessories. It amends requirements on the following aspects, in part due to the publication of amendments that have been published in 2012 and 2013 respectively to IEC 60601-1:2005 and its collateral standards: — addition of a definition on interchangeable anaesthetic vapour delivery system; — marking the mass of mobile me equipment; — movement over a threshold; — rough handling test; — multiple socket-outlets; — specific requirements on anaesthetic gas delivery systems and anaesthetic breathing systems including instructions for use; — vapour concentration during and after oxygen flush; — inspiratory pause. Where appropriate, amendment 1 also includes modifications of specific informative annexes related to the amended requirements as listed above. Finally, minor editorial updates were made.