EN ISO 1135-5:2015
Current
The latest, up-to-date edition.
Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2015)
23-12-2015
European foreword
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Materials
6 Physical requirements
7 Chemical requirements
8 Biological requirements
9 Labelling
10 Packaging
11 Disposal
Annex A (normative) - Physical tests
Annex B (normative) - Chemical tests
Annex C (normative) - Biological tests
Annex D (normative) - Storage volume
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC on
Medical devices
ISO 1135-5:2015 specifies requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures up to 200 kPa (2 bar). This International Standard ensures compatibility with containers for blood and blood components as well as intravenous equipment.Secondary aims of ISO 1135-5:2015 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with red cell and plasma blood components.Platelet components should not be transfused under pressure using these sets.In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-5:2015.
| Committee |
CEN/TC 205
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| BS EN ISO 1135-5:2015 | Identical |
| NS EN ISO 1135-5 : 2015 | Identical |
| SN EN ISO 1135-5 : 2016 | Identical |
| NF EN ISO 1135-5 : 2016 | Identical |
| ISO 1135-5:2015 | Identical |
| PN EN ISO 1135-5 : 2016 | Identical |
| DIN EN ISO 1135-5:2016-06 | Identical |
| NBN EN ISO 1135-5 : 2016 | Identical |
| I.S. EN ISO 1135-5:2015 | Identical |
| NEN EN ISO 1135-5 : 2016 | Identical |
| UNE-EN ISO 1135-5:2016 | Identical |
| UNI EN ISO 1135-5 : 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 |
| 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 |
| 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 |
| 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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