• 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.
Dismiss alert

BS 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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Available format(s)

Hardcopy , PDF

Superseded date

31-03-2014

Language(s)

English

Published date

15-11-1996

Committees responsible
National foreword
Foreword
0 Introduction
1 Scope
2 Normative reference
3 Definitions
4 Requirements
5 Test methods
6 Packaging
7 Information provided by the manufacturer
Annex A (informative) Bibliography
Figures
1 Main fitting dimensions of blood inlet and outlet
   connections
2 Main fitting dimensions of extracorporeal circuit
   connector to blood ports of haemodialyser, haemofilter,
   or haemoconcentrator
3 Length of engagement of male and female cones of
   blood inlet and outlet connectors
4 Main fitting dimensions of dialysing fluid inlet
   and outlet port
5 Schematic test circuit for determination of the
   clearances of haemodialysers and haemodiafilters
6 Schematic test circuit for determination of sieving
   coefficients of haemodiafilters, haemofilters and
   haemoconcentrators
7 Schematic test circuit for the determination of the
   ultrafiltration rate

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
CH/150/2
DevelopmentNote
Supersedes BS 7297-1(1990), BS 7297-2(1990) and 94/501163 DC. (08/2005)
DocumentType
Standard
Pages
20
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
I.S. EN 1283:1996 Identical
NBN EN 1283 : 1996 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
EN 1283 : 1996 Identical
UNE-EN 1283:1996 Identical
DIN EN 1283:1996-06 Identical

EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
BS EN ISO 10993-11:2009 Biological evaluation of medical devices Tests for systemic toxicity
BS 5750-2:1987 Quality systems Specification for production and installation
BS EN 46002:1997 Specification for application of EN ISO 9002 to the manufacture of medical devices
BS EN 980:2008 Symbols for use in the labelling of medical devices
EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
BS EN 30993-1:1994 Biological evaluation of medical devices Guidance on selection of tests
BS 5750-1:1987 Quality systems Specification for design/development, production, installation and servicing
BS EN ISO 10993-7:2008 Biological evaluation of medical devices Ethylene oxide sterilization residuals
BS EN 556:1995 Sterilization of medical devices. Requirements for terminally-sterilized devices to be labelled \'Sterile\'
BS EN 46001:1997 Specification for application of EN ISO 9001 to the manufacture of medical devices
BS 3930-2:1991 Conical fittings with a 6% (Luer) taper for syringes, needles and other medical equipment Specification for lock fittings
BS EN 1041 : 2008 INFORMATION SUPPLIED BY THE MANUFACTURER OF MEDICAL DEVICES
EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT

View more information
£142.00
Excluding VAT

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.