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AENOR-UNE
UNE-EN ISO 8536-11:2015

UNE-EN ISO 8536-11:2015

Current

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)

Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

11-11-2015

Publisher

Asociacion Espanola de Normalizacion

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

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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Hardcopy - Spanish
PDF - Spanish
Hardcopy - English
PDF - English
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