Norm

ISO 80601-2-67:2014 en

Medische elektrische apparatuur - Deel 2-67: Specifieke eisen voor de basisiveiligheid en essentiƫle prestaties van het zuurstofbehoud van apparatuur

131,28

Over deze norm

Status Definitief
Aantal pagina's 43
Commissie Anesthesie- en beademingssystemen
Gepubliceerd op 01-06-2014
Taal Engels
ISO 80601-2-67 is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of oxygen CONSERVING EQUIPMENT, hereafter referred to as ME EQUIPMENT, in combination with its ACCESSORIES intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the PATIENT'S inspiratory cycle, when used in the HOME HEALTHCARE ENVIRONMENT. Oxygen CONSERVING EQUIPMENT is typically used by a LAY OPERATOR. This particular standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to CONSERVING EQUIPMENT, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the CONSERVING EQUIPMENT. This particular standard is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas).

Details

ICS-code 11.040.10
Nederlandse titel Medische elektrische apparatuur - Deel 2-67: Specifieke eisen voor de basisiveiligheid en essentiƫle prestaties van het zuurstofbehoud van apparatuur
Engelse titel Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment
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