95.99 Withdrawal of Standard May 31, 2024
ISO
ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems
International Standard
11.040.40 Implants for surgery, prosthetics and orthotics
This document specifies requirements and acceptance criteria (including test methods) for safety related parameters for plasmafilters. Only those requirements that are specific to plasmafilters have been included.
It specifies requirements for sterile, single-use plasmafilters, intended for use on humans.
This document does not cover matters related to toxicity. Such issues are covered in relevant parts of ISO 10993.
It does not apply to the extracorporeal circuits that can be used for plasmapheresis vascular access devices, oxygenators or active medical devices. This document does not address the replacement fluid.
WITHDRAWN
ISO 13960:2010
WITHDRAWN
ISO 8637-3:2018
95.99
Withdrawal of Standard
May 31, 2024