Name: UNI EN ISO 8638 : 2014
Brand: UNI

UNI EN ISO 8638 : 2014

Superseded

CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS

Superseded date

31-05-2022

Published date

01-01-2014

Publisher

Ente Nazionale Italiano di Unificazione (UNI)

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Labelling
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC on
         medical devices

Defines requirements for the single-use extracorporeal blood circuit and (integral and non-integral) transducer protectors which are intended for use in haemodialysis, haemodiafiltration and haemofiltration.

Committee	U42.01
DevelopmentNote	Supersedes UNI EN 1283. (03/2014)
DocumentType	Standard
PublisherName	Ente Nazionale Italiano di Unificazione (UNI)
Status	Superseded
SupersededBy	UNI EN ISO 8637-2:2018
Supersedes	UNI EN 1283 : 1998

Standards	Relationship
ISO 8638:2010	Identical
EN ISO 8638:2014	Identical

ISO 11137-1:2006	Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 10993-4:2017	Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 15223-2:2010	Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
ISO 8637:2010	Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators
ISO/TS 17665-2:2009	Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
ISO 14937:2009	Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 11135-1:2007	Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 10993-11:2017	Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 11137-3:2017	Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
ISO 10993-7:2008	Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
ISO 7864:2016	Sterile hypodermic needles for single use — Requirements and test methods
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO/TS 11135-2:2008	Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1
ISO 7000:2014	Graphical symbols for use on equipment Registered symbols
ISO 594-2:1998	Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
ISO 17665-1:2006	Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices