CSA Z364.2.1-13:2018 pdf download.Monitoring systems for hemodialysis equipment
Dialysis fluid (dialysing fluid)一aqueous fluid, containing electrolytes and usually buffer and glucose,that is intended to exchange solutes with blood during hemodialysis.
Notes:
1) The term "dialysis fluid" is used throughout this document to mean the fluid made from dialysis water and concentrates, which is delivered to the dialyser by the dialysis fluid delivery system. Such phrases as "dialysate" or "dialysis solution" could be used in place of "dialysis fluid".
2) The dialysis fluid entering the dialyser is referred to as "fresh dialysis fluid", while the fluid leaving the dialyser is referred to as "spent dialysis fluid".
3) Dialysis fluid does not include prepackaged parenteral fluids used in some renal replacement therapies, such as hemodiafiltration and hemofiltration.
Dialysis provider一a health care facility responsible for the care of a patient undergoing hemodialysis.
Manufacturer一 an entity (i.e., natural or legal person) with responsibility for the design and/or manufacture of a medical device with the intention of making the medical device available for use under its name, whether or not such a medical device is designed and/or manufactured by that entity itself or on its behalf by another entity.
Sterile一free from viable micro-organisms with a sterility assurance level (SAL) of 6.
Notes:
1) "Sterile" can be used to describe a packaged solution that was prepared using a terminal sterilization process that has been demonstrated to achieve a 10-6 microbial survivor probability, i.e., assurance of less than one chance in one million that viable micro-organisms are present in the sterilized article.
2) Alternatively, "sterile" can be used to describe a solution prepared for immediate use by a continuous process that has been validated to produce a solution free from viable micro-organisms with a SAL of at least 6. This SAL applies to the total volume of solution used in a single application.
4.2.1.1 The dialysis provider shall establish and maintain standard operating procedures (SOPs) for each activity that affects the safety, quality, and efficacy of hemodialysis and the safety of personnel and patients. The operating procedures shall include, but not be limited to, the areas covered by this Standard as they apply to the specific activities and functions.
4.2.1.2 The dialysis provider's SOPs shall be reviewed and approved by its senior management. Senior management shall ensure that all of the dialysis provider's personnel follow its operating procedures.
Note: The specific level of management responsible for the activities referred to in this Clause will depend on the size and organizational structure of the dialysis provider. The dialysis provider's overall policies should define the lines of authority, as well as delegation of responsibilities (where applicable).CSA Z364.2.1-13 pdf download.