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BSI - BS EN ISO 8536-11

Infusion equipment for medical use Part 11: Infusion filters for single use with pressure infusion equipment

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Organization: BSI
Publication Date: 30 June 2015
Status: active
Page Count: 22
ICS Code (Transfusion, infusion and injection equipment): 11.040.20

Document History

BS EN ISO 8536-11
June 30, 2015
Infusion equipment for medical use Part 11: Infusion filters for single use with pressure infusion equipment
A description is not available for this item.
BS EN ISO 8536-11
December 21, 2004
Infusion equipment for medical use Part 11: Infusion filters for use with pressure infusion equipment
A description is not available for this item.

References

This document references:
ISO 10993-4 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
Published by ISO on April 1, 2017
This document specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical devices that are intended for use in contact...
This document references:
ISO 11135 - Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Published by ISO on July 15, 2014
Inclusions This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial...
This document references:
ISO 8536-4 - Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
Published by ISO on September 1, 2019
This document specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous...
This document references:
ISO 8536-8 - Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus
Published by ISO on June 15, 2015
This part of ISO 8536 gives users information on sterilized infusion sets for single use with pressure infusion apparatus up to a maximum of 200 kPa (2 bar). In some countries, the national...
This document is referenced by:
BS EN ISO 8536-9 - Infusion equipment for medical use Part 9: Fluid lines for single use with pressure infusion equipment
Published by BSI on June 30, 2015
A description is not available for this item.
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