UNE-EN ISO 8536-11:2015
Current
The latest, up-to-date edition.
Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015)
Hardcopy , PDF
Spanish, Castilian, English
11-11-2015
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1 Scope
2 Normative references
3 Designation
4 Design
5 Materials
6 Physical requirements
6.1 Transparency
6.2 Particulate contamination
6.3 Tensile strength
6.4 Leakage
6.5 Adapters with female and/or male conical fittings
6.6 Protective caps
7 Chemical requirements
8 Biological requirements
8.1 Sterility
8.2 Pyrogens
8.3 Haemolysis
9 Packaging
10 Labelling
10.1 Unit container
10.2 Shelf or multi-unit container
Annex A (normative) Physical tests
Annex B (normative) Chemical tests
Annex C (normative) Biological tests
Bibliography
Pertains to sterilized infusion filters for single use up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536-8.
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
Asociacion Espanola de Normalizacion
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 8536-11:2015 | Identical |
| NBN EN ISO 8536-11 : 2015 | Identical |
| NF EN ISO 8536-11 : 2015 | Identical |
| NEN EN ISO 8536-11 : 2015 | Identical |
| NS EN ISO 8536-11 : 2004 | Identical |
| I.S. EN ISO 8536-11:2015 | Identical |
| SN EN ISO 8536-11:2015 | Identical |
| UNI EN ISO 8536-11 : 2005 | Identical |
| BS EN ISO 8536-11:2015 | Identical |
| EN ISO 8536-11:2015 | Identical |
| DIN EN ISO 8536-11:2015-11 | Identical |
| ISO 11137-1:2006 | Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| 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 8536-8:2015 | Infusion equipment for medical use Part 8: Infusion sets for single use with pressure infusion apparatus |
| EN ISO 8536-8:2015 | Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015) |
| EN ISO 10993-4:2017 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| ISO 8536-4:2010 | Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed |
| 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 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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