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.
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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 |
| UNI EN ISO 1135-4 : 2012-06 | Identical |
| UNE-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 |
| ISO 3826-2:2008 | Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets |
| ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
| EN 15986:2011 | Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| EN ISO 10993-4:2017 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) |
| EN ISO 3826-2:2008 | Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008) |
| EN ISO 7864:2016 | Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016) |
| ISO 3826-1:2013 | Plastics collapsible containers for human blood and blood components Part 1: Conventional containers |
| ISO 7864:2016 | Sterile hypodermic needles for single use — Requirements and test methods |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 291:2008 | Plastics Standard atmospheres for conditioning and testing |
| IEC 80416-1:2008 | Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration |
| ISO 14644-1:2015 | Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration |
| ISO 3696:1987 | Water for analytical laboratory use — Specification and test methods |
| EN ISO 3696:1995 | Water for analytical laboratory use - Specification and test methods (ISO 3696:1987) |
| EN ISO 3826-1:2013 | Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013) |
| 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 |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |
| EN ISO 14644-1:2015 | Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015) |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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