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I.S. 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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date

01-25-2014

Language(s)

English

Published date

01-01-1996

Publisher

National Standards Authority of Ireland

Preview

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.

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Superseded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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PDF - English
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