1. Scope

1.1

This Standard details the essential elements of good practice for reprocessing haemodialysers. It is intended to p rovide the administrator with a standard practice regarding the reprocessing of haemodialysers. Notes: (1) This Standard does not endorse either single-use or reuse of haemodialysers. (2) There are various haemodialysis systems. Some are single-use and some are reusable. (3) Haemodialyser characteristics such as biocompatibility and clearance of larger molecules are beyond the scope of this Standard.

1.2

The objective of this Standard is to help ensure device safety and effectiveness. Note: This Standard is not intended to address all risks and hazards that may be associated with reprocessing. It is imperative that the administrator be aware of the latest developments in this area.

1.3

This Standard does not address the reprocessing of blood tubing sets, or the labelling and performance requirements for first-use haemodialysers or transducer protectors.

1.4

In this Standard, ""shall"" indicates a mandatory requirement; ""should"" indicates a recommendation, or that which is advised but not mandatory. Notes accompanying clauses do not include mandatory or alternative requirements. The purpose of a note accompanying a clause is to separate from the text explanatory or informative material that is not properly a part of the Standard. Notes to figures and tables are considered to be a part of the figure or table and are written as mandatory requirements.