I.S. 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
25-01-2014
English
01-01-1996
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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
Provides requirements for sterile, single use haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and the extracorporeal circuits for these devices (including any integral accessory lines, such as fluid and infusion lines and lines for connection to pressure monitors) intended for renal care and cardiovascular use on humans.
| DocumentType |
Standard
|
| Pages |
80
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NS EN 1283 : 1ED 1996 | Identical |
| EN 1283:1996 | Identical |
| SN EN 1283 : 1996 | Identical |
| UNE-EN 1283:1996 | Identical |
| UNI EN 1283 : 1998 | Identical |
| BS EN 1283:1996 | Identical |
| NF EN 1283 : 1996 | Identical |
| NBN EN 1283 : 1996 | Identical |
| NEN EN 1283 : 1996 | Identical |
| DIN EN 1283:1996-06 | Identical |
| 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 |
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