JSA - JIS T 3248
Extracorporeal blood circuit
|Publication Date:||1 October 2012|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
This Standard specifies extracorporeal blood circuits (hereafter referred to as "circuits") which are intended to be used for extracorporeal blood circulation connected to haemodialysers, haemodiafilters or haemofilters.
In addition, this Standard applies to the following devices constructing the circuit:
- transducer protector:
- cleaning set of fluid for dialysis:
- extension tubing for aid of blood circuit; - Monitoring set for blood circuit
This Standard is not applicable to
- haemodialysers, haemodiafilters or haemofilters,
- haemoperfusion devices,
- vascular access devices,
- blood pumps,
- pressure monitors for the extracorporeal blood circuit,
- air detection devices,
- systems to prepare, maintain or monitor dialysing fluid,
- systems intended to perform haemofiltration or haemoconcentration.
NOTE 1 The requirements for haemodialysers, haemodiafilters and haemofilters are specified in JIS T 3250.
NOTE 2 The International Standard corresponding to this Standard and the symbol of degree of correspondence are as follows.
ISO 8638:2010 Cardiovascular implants and extracorporeal system~ Extracorporeal blood circuit for haem odialysers, haemodiafilters and haemofilters (MOD)
In addition, symbols, which denote the degree of correspondence in the contents between the relevant International Standard and JIS, are IDT (identical), MOD (modified), and NEQ (not equivalent) according to ISO/lEC Guide 21-1.
JIS T 3248:2011 may be applied until September 30 in 2015.