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Norm
ÖNORM EN ISO 8638
Issue date: 2014 03 01
Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010)
This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators (hereafter referred to as "the device") and (...
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Withdrawn
: 2018 11 15
Publisher:
Austrian Standards International
Format:
Digital | 21 Pages
Language:
German
| English
Currently valid:
Optionally co-design standards:
ICS
This International Standard specifies requirements for haemodialysers, haemodiafilters, haemofilters and
haemoconcentrators (hereafter referred to as "the device") and (integral and non-integral) transducer
protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration.
This International Standard does not apply to:
- haemodialysers, haemodiafilters or haemofilters;
- plasmafilters;
- haemoperfusion devices;
- vascular access devices;
- blood pumps;
- pressure monitors for the extracorporeal blood circuit;
- air detection devices;
- systems to prepare, maintain or monitor dialysis fluid;
- systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or
haemoconcentration.
ÖNORM EN ISO 8637-2
2018 11 15
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialys...
Norm
ÖNORM EN ISO 8638
2014 03 01
Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers...
Norm
↖
ÖNORM EN 1283
1996 10 01
Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
Norm
Norm
ISO 594-2:1998
Issue date :
1998 09 03
Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings
Draft
ISO/DIS 7864
Issue date :
2014 12 04
Sterile hypodermic needles for single use — Requirements and test methods
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ISO 10993-1:2009
Issue date :
2009 10 13
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
Norm
ISO 10993-4:2002
Issue date :
2002 10 22
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
Norm
ISO 10993-7:2008
Issue date :
2008 10 13
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
Norm
ISO 10993-11:2006
Issue date :
2006 08 15
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
Norm
ISO 7864:2016
Issue date :
2016 08 02
Sterile hypodermic needles for single use — Requirements and test methods
Norm
ISO 10993-7:2008
Issue date :
2008 10 13
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
Norm
ISO 10993-11:2017
Issue date :
2017 09 14
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
Norm
ÖNORM EN ISO 8637-2
Issue date :
2018 11 15
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
Norm
ISO 8638:2010
Issue date :
2010 06 28
Cardiovascular implants and extracorporeal systems — Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters