BS EN 13867:2002+A1:2009 PDF

Scope: This European Standard specifies requirements for dry and liquid concentrates to be diluted for use as dialysing fluids in haemodialysis or related therapies. It addresses chemical and microbiological quality and purity, handling and labelling of concentrates, the requirements for containers and the tests to monitor chemical and microbiological contents and quality of such concentrates. This European standard does not address the final mixing and use of these concentrates or the treated water used in connection with haemodialysis and related therapies. This European standard does not apply to dialysing fluid regeneration systems.

BS EN 13867:2002+A1:2009 Referenced Document

EN 1174-1 Sterilization of Medical Devices - Estimation of the Population of Micro- Organisms on Product - Part 1: Requirements
EN 1174-2 Sterilization of Medical Devices - Estimation of the Population of Micro-Organisms on Product - Part 2: Guidance
EN 1174-3 Sterilization of Medical Devices - Estimation of the Population of Micro-Organisms on Product - Part 3: Guide to the Methods for Validation of Microbiological Techniques
EN 556 Sterilization of Medical Devices - Requirements for Terminally - Sterilized Medical Devices to Be Labelled "Sterile" Ratified European Text; Includes Amendment 1: 1994
EN 980 Graphical Symbols for Use in the Labelling of Medical Devices*， 2003-04-01 Update

2002 BS EN 13867:2002+A1:2009 Concentrates for haemodialysis and related therapies
2002 BS EN 13867:2002 Concentrates for haemodialysis and related therapies