Customer Support: 131 242

i2i Intertek.com
  • There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Go to AMERICAS site
Dismiss alert
Please enter a keyword to search
Advanced search

EN 1283 : 1996

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS, HAEMOCONCENTRATORS AND THEIR EXTRACORPOREAL CIRCUITS
Superseded date

01-01-2014

Published date

12-01-2013

Publisher

Comite Europeen de Normalisation

Foreword
0 Introduction
1 Scope
2 Normative references
3 Definitions
4 Requirements
5 Test methods
6 Packaging
7 Information provided by the manufacturer
Figures
Annex A (informative) Bibliography

States requirements for sterile, single use haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and the extracorporeal circuits for these devices intended for renal care and cardiovascular use on humans. (includes any integral accessory lines, eg fluid and infusion lines and lines for connecting to pressure monitors).

Committee
TC 205
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

Standards Relationship
UNE-EN 1283:1996 Identical
I.S. EN 1283:1996 Identical
BS EN 1283:1996 Identical
NBN EN 1283 : 1996 Identical
PN EN 1283 : 2002 Identical
SN EN 1283 : 1996 Identical
NF EN 1283 : 1996 Identical
UNI EN 1283 : 1998 Identical
NEN EN 1283 : 1996 Identical
NS EN 1283 : 1ED 1996 Identical
DIN EN 1283:1996-06 Identical

I.S. EN 12022:1999 BLOOD GAS EXCHANGERS
EN 12022 : 1999 BLOOD GAS EXCHANGERS
BS EN 12022:1999 Blood-gas exchangers

EN 556:1994 + A1:1998 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
HD 395.2.16 : 200S1 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE SAFETY OF HAEMODIALYSIS EQUIPMENT
EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
EN 46002 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
PREN 980 : DRAFT 2002 GRAPHICAL SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
EN 30993-1 : 1994 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - GUIDANCE ON SELECTION OF TESTS

View more information
Sorry this product is not available in your region.

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

or

Get in touch with us

Need help?
Call us on 131 242, then click here to start a Screen Sharing session
so we can help right away! Learn more