02/564515 DC : DRAFT OCT 2002
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BS EN ISO 8536-8 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION SETS FOR USE WITH PRESSURE INFUSION EQUIPMENT
19-08-2004
23-11-2012
Foreword
1 Scope
2 Normative references
3 Designation
4 Materials
5 Physical requirements
5.1 Particulate contamination
5.2 Breaking strength
5.3 Tightness
5.4 Adapter with male conical fitting
5.5 Injection site
5.6 Fluid fitter
5.7 Flow rate of infusion fluid
5.8 Closure-piercing device
5.9 Air inlet device
5.10 Drip chamber and drip tube
5.11 Tubing
5.12 Flow regulator
5.13 Protective caps
5.14 Storage volume
6 Chemical requirements
7 Biological requirements
8 Packaging
9 Labelling
9.1 Unit container
9.2 Shelf or multi-unit container
Annex A (normative) Tests
A.1 Physical tests
A.1.1 Test for particulate contamination
A.1.2 Test of breaking strength
A.1.3 Test for tightness
A.1.4 Testing of adapter with male conical fitting
for tightness
A.1.5 Test of injection site
A.1.6 Test for efficiency of the fluid fitter
A.2 Chemical tests
A.3 Biological tests
BS EN ISO 8536-8
| Committee |
CH/212
|
| DocumentType |
Draft
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| DIN 1314:1977-02 | PRESSURE; BASIC CONCEPTS, UNITS |
| ISO 8536-4:2010 | Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed |
| IEC 60601-2-24:2012 | Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
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