SN EN 1283 : 1996

Committees responsible
National foreword
Foreword
0 Introduction
1 Scope
2 Normative reference
3 Definitions
4 Requirements
5 Test methods
6 Packaging
7 Information provided by the manufacturer
Annex A (informative) Bibliography
Figures
1 Main fitting dimensions of blood inlet and outlet
   connections
2 Main fitting dimensions of extracorporeal circuit
   connector to blood ports of haemodialyser, haemofilter,
   or haemoconcentrator
3 Length of engagement of male and female cones of
   blood inlet and outlet connectors
4 Main fitting dimensions of dialysing fluid inlet
   and outlet port
5 Schematic test circuit for determination of the
   clearances of haemodialysers and haemodiafilters
6 Schematic test circuit for determination of sieving
   coefficients of haemodiafilters, haemofilters and
   haemoconcentrators
7 Schematic test circuit for the determination of the
   ultrafiltration rate

States requirements for sterile, single use haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and the extracorporeal circuits for these devices intended for renal care and cardiovascular use on humans. (includes any integral accessory lines, eg fluid and infusion lines and lines for connecting to pressure monitors).