Extracorporeal systems for blood purification — Part 3: Plasmafilters
NORMA vydána dne 17.7.2018
Označení normy: ISO 8637-3:2018
Datum vydání normy: 17.7.2018
Počet stran: 14
Přibližná hmotnost: 42 g (0.09 liber)
Země: Mezinárodní technická norma
Kategorie: Technické normy ISO
Description / Abstract: 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.