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BSI - BS EN ISO 8536-8 - TC

Tracked Changes (Redline) - Infusion equipment for medical use Part 8: Infusion sets for single use with pressure infusion apparatus

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Organization: BSI
Publication Date: 26 February 2020
Status: active
Page Count: 52
ICS Code (Transfusion, infusion and injection equipment): 11.040.20

Document History

BS EN ISO 8536-8 - TC
February 26, 2020
Tracked Changes (Redline) - Infusion equipment for medical use Part 8: Infusion sets for single use with pressure infusion apparatus
A description is not available for this item.

References

This document references:
ISO 8536-9 - Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment
Published by ISO on June 15, 2015
This part of ISO 8536 applies to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar). The following items are covered by this part of ISO...
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 11137-2 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
Published by ISO on June 1, 2013
This part of ISO 11137 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the...
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:
EN 15986 - Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
Published by CEN on March 1, 2011
This European Standard specifies requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates, when required by Annex I of Directive...
This document references:
ISO 11137-2 - Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
Published by ISO on June 1, 2013
This part of ISO 11137 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the...
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:
EN 15986 - Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
Published by CEN on March 1, 2011
This European Standard specifies requirements for the labelling of a medical device or parts of a medical device to indicate the presence of phthalates, when required by Annex I of Directive...
This document references:
ISO 8536-9 - Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment
Published by ISO on June 15, 2015
This part of ISO 8536 applies to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar). The following items are covered by this part of ISO...
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