BS EN 1283:1996
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
Hardcopy , PDF
31-03-2014
English
15-11-1996
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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Superseded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 |
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