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BSI - BS EN ISO 8536-9 - TC

Tracked Changes (Redline) - Infusion equipment for medical use Part 9: Fluid lines for single use with pressure infusion equipment

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Organization: BSI
Publication Date: 26 February 2020
Status: active
Page Count: 51
ICS Code (Transfusion, infusion and injection equipment): 11.040.20

Document History

BS EN ISO 8536-9 - TC
February 26, 2020
Tracked Changes (Redline) - Infusion equipment for medical use Part 9: Fluid lines for single use with pressure infusion equipment
A description is not available for this item.

References

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 references:
ISO 8536-11 - Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment
Published by ISO on June 15, 2015
This part of ISO 8536 applies 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. It...
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 11137-1 - Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2
Published by ISO on November 1, 2018
A description is not available for this item.
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 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 11137-1 - Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2
Published by ISO on November 1, 2018
A description is not available for this item.
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 8536-8 - 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 references:
ISO 8536-11 - Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment
Published by ISO on June 15, 2015
This part of ISO 8536 applies 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. It...
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