I.S. 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
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.
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Foreword
1 Scope
2 Normative references
3 Design
4 Materials
5 Physical requirements
6 Chemical requirements
7 Biological requirements
8 Packaging
9 Labelling
10 Disposal
Annex A (normative) - Physical tests
Annex B (normative) - Chemical tests
Annex C (normative) - Biological tests
Annex ZA (informative) - Relationship between this
European Standard and the Essential Requirements
of EU Directive 93/42/EEC on Medical devices
Bibliography
Pertains to sterilized infusion filters for single use used up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536-8.
| DocumentType |
Standard
|
| Pages |
26
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 8536-11:2015-11 | Identical |
| NEN EN ISO 8536-11 : 2015 | Identical |
| NF EN ISO 8536-11 : 2015 | Identical |
| UNE-EN ISO 8536-11:2015 | Identical |
| NS EN ISO 8536-11 : 2004 | Identical |
| EN ISO 8536-11:2015 | Identical |
| ISO 8536-11:2015 | Identical |
| NBN EN ISO 8536-11 : 2015 | Identical |
| UNI EN ISO 8536-11 : 2005 | Identical |
| BS EN ISO 8536-11:2015 | Identical |
| SN EN ISO 8536-11:2015 | 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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