IEC TR 62653:2012 pdfダウンロード

IEC TR 62653:2012 pdfダウンロード Guideline for safe operation of medical equipment used for haemodialysis treatments
1 Scope
This technical report describes the technical requirements for use of equipment in HAEMODIALYSIS , HAEMOFILTRATION and HAEMODIAFILTRATION .
These principles should be complied with to ensure safe, permissible and proper application. The physician is responsible for the HAEMODIALYSIS treatment prescription. However, the ORGANIZATION administering the treatment is responsible for all resources, structures and processes used in connection with the treatment.
These responsibilities will not be described here.
If applicable, the scope may be applicable to the use of the equipment in paediatrics, home HAEMODIALYSIS , acute and SORBENT DIALYSIS SYSTEMS .
The requirements of IEC 60601 -2-1 6 ensure that equipment used for extracorporeal renal replacement therapy operates with a high level of safety. Despite that high level of safety, however, some residual risk remains, related to medical-biological, physical-chemical and technical HAZARDS .
The ORGANIZATION administering the treatment is responsible for managing the residual risk. This technical report is not intended to be used as the basis of regulatory inspection or certification assessment activities.
2 Normative references
None.
NOTE Informative references including IEC and ISO standards are listed in the Bibliography on page 28.
3 Terms and definitions
For the purpose of this document, the following terms and definitions apply.
NOTE An index of defined terms is found on page 30.
3.1
ACCESSORY
additional part for use with equipment in order to:
– achieve the INTENDED USE,
– adapt it to some special use,
– facilitate its use,
– enhance its performance, or
– enable its functions to be integrated with those of other equipment
Note 1 to entry: Accessories can be objects, substances, preparations of substances and software which do not constitute any medical devices themselves.
[SOURCE: IEC 60601 -1 :2005, 3.3, modified – a note to entry has been added.]
3.2
ARTERIAL PRESSURE
pressure measured in the blood withdrawal line of the EXTRACORPOREAL CIRCUIT
Note 1 to entry: A difference can be made between the pre-pump pressure, which is upstream of the blood pump,and post-pump pressure, which is downstream of the blood pump.
[SOURCE: IEC 60601 -2-1 6:201 2, 201 .3.201 ]
3.3
BLOOD LEAK
leakage of blood from the blood compartment to the DIALYSIS FLUID compartment of the DIALYSER
Note 1 to entry: Not to be mistaken for blood loss to the environment.
[SOURCE: IEC 60601 -2-1 6:201 2, 201 .3.202, modified – the original note to entry has been replaced.]
3.4
DIALYSER
a device containing a semi-permeable membrane that is used to perform HAEMODIALYSIS ,HAEMODIAFILTRATION or HAEMOFILTRATION
[SOURCE: IEC 60601 -2-1 6:201 2, 201 .3.204]