Blood-gas exchangers Ingestion-build-46800 falling under the scope of

falling under the scope of this standard

for purposes connected with their manufacture and use

Vibration hazards

management and use of buildings is defined by regulation and described in a number of documents including BS 9999 and the BS 7974 series

This standard does not give complete validation requirements for programmable electronic systems and therefore can require the use of other standards

Blood-gas exchangers Ingestion-build-46800 falling under the scope of1 Scope This European Standard specifies requirements for sterile, single use, extracorporeal blood gas exchangers intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans. This European Standard also applies to heat exchangers that are integral parts of blood gas exchangers and to external equipment unique to the use of the device. This European Standard does not apply to: implanted blood gas exchangers; liquid