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CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
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Available format(s): Hardcopy, PDF
Superseded date: 01-03-2012
Language(s): English
Published date: 01-01-2008
Publisher: Canadian Standards Association
1 Scope2 Normative references3 Terms and definitions4 Requirements 4.1 Biological safety 4.2 Sterility 4.3 Nonpyrogenicity 4.4 Mechanical characteristics 4.5 Expiration date 4.6 Tubing compliance5 Test methods 5.1 General 5.2 Biological safety 5.3 Sterility 5.4 Nonpyrogenicity 5.5 Mechanical characteristics 5.6 Expiration date 5.7 Tubing compliance6 Labelling 6.1 Labelling on the device 6.2 Labelling on the unit container 6.3 Labelling on the outer container 6.4 Accompanying documentationBibliography
Specifies requirements for single-use extracorporeal blood circuits (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration.
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