UNE-EN ISO 8536-10:2015
Current
The latest, up-to-date edition.
Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015)
Hardcopy , PDF
Spanish, Castilian, English
11-11-2015
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1 Scope
2 Normative references
3 Designation
4 Materials
5 Physical requirements
5.1 Avoidance of air bubbles
5.2 Particulate contamination
5.3 Tensile strength
5.4 Leakage
5.5 Adapters with female and/or male conical fittings
5.6 Protective caps
5.7 Manipulation of stopcocks
5.8 Unit with injection site
5.9 Unit with check valve
6 Chemical requirements
7 Biological requirements
7.1 Sterility
7.2 Pyrogens
7.3 Haemolysis
8 Packaging
9 Labelling
9.1 Unit container
9.2 Shelf or multi-unit container
Annex A (normative) Physical tests
Annex B (normative) Chemical tests
Annex C (normative) Biological tests
Bibliography
Pertains to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8.
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
Asociacion Espanola de Normalizacion
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 8536-10:2015 | Identical |
| NBN EN ISO 8536-10 : 2015 | Identical |
| NF EN ISO 8536-10 : 2015 | Identical |
| NEN EN ISO 8536-10 : 2015 | Identical |
| NS EN ISO 8536-10 : 2004 | Identical |
| I.S. EN ISO 8536-10:2015 | Identical |
| SN EN ISO 8536-10 : 2015 | Identical |
| UNI EN ISO 8536-10 : 2005 | Identical |
| BS EN ISO 8536-10:2015 | Identical |
| EN ISO 8536-10:2015 | Identical |
| DIN EN ISO 8536-10:2015-11 | 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 8536-12:2007 | Infusion equipment for medical use Part 12: Check valves |
| 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 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 11135-1:2007 | Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| 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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