I.S. EN ISO 1135-4:2015
Current
The latest, up-to-date edition.
TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 4: TRANSFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 1135-4:2015)
Hardcopy , PDF
English
01-01-2015
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.
Dates of withdrawal of national standards are available from NSAI.
National Foreword
European foreword
Foreword
1 Scope
2 Normative references
3 General requirements
4 Materials
5 Physical requirements
6 Chemical requirements
7 Biological requirements
8 Labelling
9 Packaging
10 Disposal
Annex A (normative) - Physical tests
Annex B (normative) - Chemical tests
Annex C (normative) - Biological tests
Bibliography
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC on medical devices
Provides requirements for single-use transfusion gravity sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.
| DocumentType |
Standard
|
| Pages |
36
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NF EN ISO 1135-4 : 2016 | Identical |
| NBN EN ISO 1135-4 : 2016 | Identical |
| BS EN ISO 1135-4:2015 | Identical |
| NEN EN ISO 1135-4 : 2016 | Identical |
| ISO 1135-4:2015 | Identical |
| DIN EN ISO 1135-4:2016-06 | Identical |
| NS EN ISO 1135-4 : 2012 | Identical |
| EN ISO 1135-4 : 2015 COR 2016 | Identical |
| EN ISO 1135-4:2015 | Equivalent |
| UNE-EN ISO 1135-4:2016 | Identical |