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ISO 8536-4

Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed

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Organization: ISO
Publication Date: 1 September 2019
Status: active
Page Count: 24
ICS Code (Transfusion, infusion and injection equipment): 11.040.20
scope:

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 equipment.

Secondary aims of this document are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.

Document History

ISO 8536-4
September 1, 2019
Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
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...
ISO 8536-4
March 1, 2013
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed AMENDMENT 1
A description is not available for this item.
ISO 8536-4
October 1, 2010
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
This part of ISO 8536 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...
ISO 8536-4
April 1, 2007
Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
A description is not available for this item.
ISO 8536-4
August 15, 2004
Infusion Equipment for Medical Use - Part 4: Infusion Sets for Single Use, Gravity Feed
A description is not available for this item.
ISO 8536-4
February 15, 1998
Infusion Equipment for Medical Use - Part 4: Infusion Sets for Single Use, Gravity Feed
A description is not available for this item.
ISO 8536-4
January 1, 1987
Infusion Equipment for Medical Use - Part 4: Infusion Sets for Single Use First Edition
A description is not available for this item.
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References

This document references:
80369-7 - Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
Published by ISO on May 1, 2021
This document specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic...
This document references:
ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Published by ISO on August 1, 2018
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on 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:
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:
80369-7 - Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
Published by ISO on May 1, 2021
This document specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic...
This document is referenced by:
BS EN ISO 8536-10 - Infusion equipment for medical use Part 10: Accessories for fluid lines for single use with pressure infusion equipment
Published by BSI on June 30, 2015
A description is not available for this item.
This document is referenced by:
BS EN ISO 8536-11 - Infusion equipment for medical use Part 11: Infusion filters for single use with pressure infusion equipment
Published by BSI on June 30, 2015
A description is not available for this item.
This document is referenced by:
BS EN ISO 8536-5 - Infusion equipment for medical use Part 5: Burette infusion sets for single use, gravity feed
Published by BSI on February 28, 2013
A description is not available for this item.
This document is referenced by:
BS EN ISO 8536-8 - Infusion equipment for medical use Part 8: Infusion equipment for use with pressure infusion apparatus
Published by BSI on June 30, 2015
A description is not available for this item.
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