0 Stavka
Moj nalog
Telefon: (011) 7541-421, 3409-301, 3409-335, 6547-293, 3409-310
E-mail: Prodaja standarda: prodaja@iss.rs Seminari, obuke: iss-edukacija@iss.rs Informacije o standardima: infocentar@iss.rs
Stevana Brakusa 2, 11030 Beograd
Glavni meni

ISO 8637-3:2018

Extracorporeal systems for blood purification — Part 3: Plasmafilters
17. 7. 2018.
95.99   Povučen   31. 5. 2024.

Опште информације

95.99     31. 5. 2024.

ISO

ISO/TC 150/SC 2

Međunarodni standard

11.040.40  

engleski  

Kupovina

Povučen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 13960:2010

TRENUTNO

POVUČEN
ISO 8637-3:2018
95.99 Povučen
31. 5. 2024.

REVIDIRAN OD

NAPUŠTEN
ISO/CD 8637-3

OBJAVLJEN
ISO 8637-3:2024