1.1 This Standard specifies the basic requirements for sterilized, single-use extracorporeal blood-gas exchange devices (oxygenators) used to supply oxygen to, and remove carbon dioxide from, the blood of human patients.
1.2 This Standard applies to heat exchangers which are integral components of the blood-gas exchange devices, and external equipment unique to the use of the device.
1.3 This Standard does not apply to ancillary equipment or separate heat exchanger devices which are not part of the blood- gas exchange device.
1.4 Language Requirements
All cautionary warnings and other safety-related markings appearing on, or accompanying, any part of the device, its packaging, wrapping, or shipping container shall be in English and French.
1.5 The measurements given in SI (metric) are to be considered the standard values except where the generally accepted expression of measurement is other than metric. In these instances the generally accepted expression of measurement is the standard value.
Note: There are some test results (eg, blood gases) that do not readily convert to metric measurements.
1.6 In this Standard, shall indicates a mandatory requirement; should indicates a recommendation, or that which is advised but not mandatory.
Notes accompanying clauses do not include mandatory or alternative requirements. The purpose of a note accompanying a clause is to separate from the text explanatory or informative material that is not properly a part of the Standard. Notes to figures and tables are considered to be part of the figure or table and are written as mandatory requirements.