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ISO EN DIN 7396

 

 

Overview:

The draft amendment clarifies the requirements for air supply systems in Section 5.5.1.3. Here are examples of applications for which medical air and air for operating surgical tools may not be used, exemplified and beyond other applications that could provide unforeseen requirements and affect the availability and / or quality of the air for the usual patient care excluded.
The draft Amendment (EN ISO 7396-1: 2007 / prA2: 2009) has been prepared by ISO / TC 121 / SC 6 "Medical gas systems" (secretariat: ANSI, USA) in collaboration with CEN / TC 215 "Respiratory and anesthetic equipment" ( Secretariat: BSI, United Kingdom) with the participation of German experts. The working committee NA 053-03-06 AA "Central Gas Supply Systems" in the NARK was responsible for this in DIN.

Change note:

With respect to DIN EN ISO 7396-1: 2007-07, the following changes have been made: a) incorporation of amendment A1, which was set out in subsection 5.5.1.3, for which applications medical air and air must not be used to operate surgical tools; (b) incorporation of amendment A2 clarifying the information on pressure changes at vacuum extraction points in subsection 12.6.4 and, moreover, in Table ZA.1 of Annex ZA, the relation between subsection 5.5.2.12 and the essential requirements 3 and 9.2 of Directive 93/42 / EEC on medical devices has been deleted; c) The standard has been editorially revised.

Languages ​​German

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