ISO 8637, the standard for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, has been withdrawn. It has been replaced with the new ISO 8637-1, Extracorporeal systems for blood purification – Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. This is the first of a planned 3-part series for blood purification systems. It is a technical revision, so you will need to migrate from the old edition to the new one.
What does the ISO 8637-1 cover? Of course it is for devices used in haemodialysis, haemodiafiltration, haemofiltration and haemoconcentration in humans. It addresses safety issues and functionality. Dimensions of blood and other ports are specified. These design and dimension requirements are intended to reduce the risk of leakage of blood and the intake of air. The standard does not include information on applicable materials for construction. You’ll use materials that have been tested for biocompatibility, etc. Results of this testing should be available upon request.
What are the technical changes? The committee notes that this is a technical revision. They also point out that the Figures 1, 2, and 3 have been revised.
What are the other planned parts for the new ISO 8637 series?
ISO 8637-2, Extracorporeal systems for blood purification — Part 2:
Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters
This part is currently at the final draft stage and should be available soon. It will replace the existing ISO 8638 on the same subject.
ISO 8637-3, Extracorporeal systems for blood purification — Part 3: Plasmafilters
Again, this is currently a final draft, which means publication will occur soon. This part will replace the current ISO 13960 on the same topic.
Please note: The ISO 8637 has been adopted by the European Union as EN ISO 8637. Expect that adoption of the replacement document will happen shortly. Supersession information will be available as the administrative process of the EU is completed.
Now you’ll want to get your copy of the new standard. Use Document Center Inc. for your purchase — you’ll find these publications at our webstore, www.document-center.com. Here is a direct link to the order page for the ISO 8637-1 for your convenience. Remember, we are an authorized distributor for ISO standards and your purchases from us are in compliance with all copyright laws.
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