This clause of the General Standard applies except as follows:
1.1 Scope
Addition:
This Particular Standard specifies the safety requirements for single patient single pass haemodialysis equipment as defined in Sub-clause 2.1.26. These devices are intended for use either by medical staff or under the supervision of medical expertise, including haemodialysis equipment operated by the patient. These Particular Requirements do not apply to blood lines, haemodialysers, dialysing fluid concentrate or water purification equipment.