11.040.20 - Transfusion, infusion and injection equipment
ICS 11.040.20 Details
Transfusion, infusion and injection equipment
Transfusions-, Infusions- und Injektionsgerate
Matériel de transfusion, de perfusion et d'injection
Transfuzijska, infuzijska in injekcijska oprema
General Information
e-Library Subscription
Create subscription and get permanent access to documents within 11.040.20 - Transfusion, infusion and injection equipment
Currently subscription includes documents marked with .We are working on making all documents available within the subscription.
This document specifies requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures. It ensures compatibility with containers for blood and blood components as well as intravenous equipment.
This document also provides guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with red cell and plasma blood components.
NOTE In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.
- Draft29 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for single use transfusion gravity sets for medical use to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.
It also provides guidance on specifications relating to the quality and performance of materials used in transfusion sets, presents designations for transfusion set components, and ensures the compatibility of sets with a range of cellular and plasma blood components.
NOTE In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.
- Draft24 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies general interface requirements for small-bore connectors that form part of a medical device or accessory that conveys liquids or gases to a patient. This document also identifies the applications for which these small-bore connectors are intended to be used, which include, but are not limited to:
- respiratory;
- enteral;
- limb cuff inflation;
- neural;
- intravascular or hypodermic;
- other use cases utilizing an ISO 80369-7 small-bore connector.
This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that can be developed under future parts of the ISO and IEC 80369 series.
NOTE Clause A.2 contains guidance or rationale for this Clause.
- Standard41 pagesEnglish languagesale 15% off
This document specifies general interface requirements for small-bore connectors that form part of a medical device or accessory that conveys liquids or gases to a patient. This document also identifies the applications for which these small-bore connectors are intended to be used, which include, but are not limited to: — respiratory; — enteral; — limb cuff inflation; — neural; — intravascular or hypodermic; — other use cases utilizing an ISO 80369-7 small-bore connector. This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that can be developed under future parts of the ISO and IEC 80369 series. NOTE Clause A.2 contains guidance or rationale for this Clause.
- Standard41 pagesEnglish languagesale 15% off
- Standard41 pagesFrench languagesale 15% off
This document specifies the requirements for sterilized, single-use, gravity feed infusion sets, used together with the volumetric infusion controllers of IEC 60601-2-24.
- Standard19 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the requirements for sterilized, single-use, gravity feed infusion sets, used together with the volumetric infusion controllers of IEC 60601-2-24.
- Standard19 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the requirements for sterilized, single-use, gravity feed infusion sets, used together with the volumetric infusion controllers of IEC 60601-2-24.
- Standard12 pagesEnglish languagesale 15% off
- Standard13 pagesFrench languagesale 15% off
This document specifies requirements for single use transfusion gravity sets for medical use to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment. It also provides guidance on specifications relating to the quality and performance of materials used in transfusion sets, presents designations for transfusion set components, and ensures the compatibility of sets with a range of cellular and plasma blood components. NOTE In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.
- Standard15 pagesEnglish languagesale 15% off
- Standard15 pagesFrench languagesale 15% off
This document specifies requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures. It ensures compatibility with containers for blood and blood components as well as intravenous equipment. This document also provides guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with red cell and plasma blood components. NOTE In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.
- Standard20 pagesEnglish languagesale 15% off
- Standard21 pagesFrench languagesale 15% off
This document specifies requirements and test methods for functional parameters of closures used in combination with vials and when pierced by an injection needle.
NOTE Functional testing with spikes is specified in ISO 8536-2, ISO 8536-6, ISO 8362-1 and ISO 8362-4.
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, that is used in connection with the freeze-drying (or lyophilization) of drugs and biological materials. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this document are intended for single use only. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be strongly affected by the nature and performance of the primary packaging.
- Standard16 pagesEnglish languagesale 15% off
This document specifies requirements and test methods for functional parameters of closures used in combination with vials and when pierced by an injection needle.
NOTE Functional testing with spikes is specified in ISO 8536-2, ISO 8536-6, ISO 8362-1 and ISO 8362-4.
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and test methods for functional parameters of closures used in combination with vials and when pierced by an injection needle. NOTE Functional testing with spikes is specified in ISO 8536-2, ISO 8536-6, ISO 8362-1 and ISO 8362-4.
- Standard11 pagesEnglish languagesale 15% off
- Standard11 pagesFrench languagesale 15% off
IEC 60601-2-16:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT. It applies to HAEMODIALYSIS EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including HAEMODIALYSIS EQUIPMENT operated by the PATIENT, regardless of whether the HAEMODIALYSIS EQUIPMENT is used in a hospital or domestic environment. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. This document does not take into consideration specific safety details of the DIALYSIS FLUID control system of HAEMODIALYSIS EQUIPMENT using regeneration of DIALYSIS FLUID or CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID. It does, however, take into consideration the specific safety requirements of such HAEMODIALYSIS EQUIPMENT concerning electrical safety and PATIENT safety. This document specifies the minimum safety requirements for HAEMODIALYSIS EQUIPMENT. These HAEMODIALYSIS EQUIPMENT are intended for use either by medical staff or for use by the PATIENT or other trained personnel under medical supervision. This document includes all ME EQUIPMENT that is intended to deliver a HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION treatment to a PATIENT, independent of the treatment duration and location. If applicable, this document applies to the relevant parts of ME EQUIPMENT intended for other extracorporeal blood purification treatments.
The particular requirements in this document do not apply to:
– EXTRACORPOREAL CIRCUITS (see ISO 8637-2),
– DIALYSERS (see ISO 8637-1 [2]),
– DIALYSIS FLUID CONCENTRATES (see ISO 23500-4),
– pre-manufactured DIALYSIS FLUID bags,
– DIALYSIS WATER supply systems (see ISO 23500-2),
– CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID CONCENTRATES (see ISO 23500-4), described as systems for bulk mixing concentrate at a dialysis facility,
– equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39).
IEC 60601-2-16:2024 cancels and replaces the fifth edition published in 2018. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) update of references to IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020, of references to IEC 60601‑1‑2:2014 and IEC 60601‑1‑2:2014/AMD1:2020, of references to IEC 60601‑1‑8:2006, IEC 60601‑1‑8:2006/AMD1:2012 and IEC 60601‑1‑8:2006/AMD2:2020, of references to IEC 60601‑1‑9:2007, IEC 60601‑1‑9:2007/AMD1:2013 and IEC 60601‑1‑9:2007/AMD2:2020, of references to IEC 60601‑1‑10:2007, IEC 60601‑1‑10:2007/AMD1:2013 and IEC 60601‑1‑10:2007/AMD2:2020 and of references to IEC 60601‑1‑11:2015 and IEC 60601‑1‑11:2015/AMD1:2020;
b) consideration of ESSENTIAL PERFORMANCE in SINGLE FAULT CONDITION regarding IEC 60601‑1:2005/AMD1:2012/ISH1:2021;
c) including the information given in the document 62D/1771A/INF regarding 201.11.8;
d) including withdrawn IEC PAS 63023 as Annex CC;
e) including SECURITY (CYBERSECURITY) requirements;
f) consideration of HAEMODIALYSIS EQUIPMENT using pre-manufactured DIALYSIS FLUID bags;
g) improvements for labelling;
h) other minor technical improvements;
i) editorial improvements.
- Standard106 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 60601-2-40:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT.
The following ME EQUIPMENT are excluded:
- ME EQUIPMENT intended for therapeutic application;
- ME EQUIPMENT intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators (ME EQUIPMENT covered by IEC 60601-2-10).
IEC 60601-2-40:2024 cancels and replaces the second edition published in 2016. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) added requirements for constant voltage stimulators;
b) clarified requirements for VISUAL STIMULATORS.
- Standard33 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 60601-2-16:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT. It applies to HAEMODIALYSIS EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including HAEMODIALYSIS EQUIPMENT operated by the PATIENT, regardless of whether the HAEMODIALYSIS EQUIPMENT is used in a hospital or domestic environment. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. This document does not take into consideration specific safety details of the DIALYSIS FLUID control system of HAEMODIALYSIS EQUIPMENT using regeneration of DIALYSIS FLUID or CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID. It does, however, take into consideration the specific safety requirements of such HAEMODIALYSIS EQUIPMENT concerning electrical safety and PATIENT safety. This document specifies the minimum safety requirements for HAEMODIALYSIS EQUIPMENT. These HAEMODIALYSIS EQUIPMENT are intended for use either by medical staff or for use by the PATIENT or other trained personnel under medical supervision. This document includes all ME EQUIPMENT that is intended to deliver a HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION treatment to a PATIENT, independent of the treatment duration and location. If applicable, this document applies to the relevant parts of ME EQUIPMENT intended for other extracorporeal blood purification treatments. The particular requirements in this document do not apply to: – EXTRACORPOREAL CIRCUITS (see ISO 8637-2), – DIALYSERS (see ISO 8637-1 [2]), – DIALYSIS FLUID CONCENTRATES (see ISO 23500-4), – pre-manufactured DIALYSIS FLUID bags, – DIALYSIS WATER supply systems (see ISO 23500-2), – CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID CONCENTRATES (see ISO 23500-4), described as systems for bulk mixing concentrate at a dialysis facility, – equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39). IEC 60601-2-16:2024 cancels and replaces the fifth edition published in 2018. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) update of references to IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020, of references to IEC 60601‑1‑2:2014 and IEC 60601‑1‑2:2014/AMD1:2020, of references to IEC 60601‑1‑8:2006, IEC 60601‑1‑8:2006/AMD1:2012 and IEC 60601‑1‑8:2006/AMD2:2020, of references to IEC 60601‑1‑9:2007, IEC 60601‑1‑9:2007/AMD1:2013 and IEC 60601‑1‑9:2007/AMD2:2020, of references to IEC 60601‑1‑10:2007, IEC 60601‑1‑10:2007/AMD1:2013 and IEC 60601‑1‑10:2007/AMD2:2020 and of references to IEC 60601‑1‑11:2015 and IEC 60601‑1‑11:2015/AMD1:2020; b) consideration of ESSENTIAL PERFORMANCE in SINGLE FAULT CONDITION regarding IEC 60601‑1:2005/AMD1:2012/ISH1:2021; c) including the information given in the document 62D/1771A/INF regarding 201.11.8; d) including withdrawn IEC PAS 63023 as Annex CC; e) including SECURITY (CYBERSECURITY) requirements; f) consideration of HAEMODIALYSIS EQUIPMENT using pre-manufactured DIALYSIS FLUID bags; g) improvements for labelling; h) other minor technical improvements; i) editorial improvements.
- Standard106 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 60601-2-40:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT. The following ME EQUIPMENT are excluded: - ME EQUIPMENT intended for therapeutic application; - ME EQUIPMENT intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators (ME EQUIPMENT covered by IEC 60601-2-10). IEC 60601-2-40:2024 cancels and replaces the second edition published in 2016. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) added requirements for constant voltage stimulators; b) clarified requirements for VISUAL STIMULATORS.
- Standard33 pagesEnglish languagesale 10% offe-Library read for1 day
IEC 60601-2-16:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT. It applies to HAEMODIALYSIS EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including HAEMODIALYSIS EQUIPMENT operated by the PATIENT, regardless of whether the HAEMODIALYSIS EQUIPMENT is used in a hospital or domestic environment. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. This document does not take into consideration specific safety details of the DIALYSIS FLUID control system of HAEMODIALYSIS EQUIPMENT using regeneration of DIALYSIS FLUID or CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID. It does, however, take into consideration the specific safety requirements of such HAEMODIALYSIS EQUIPMENT concerning electrical safety and PATIENT safety. This document specifies the minimum safety requirements for HAEMODIALYSIS EQUIPMENT. These HAEMODIALYSIS EQUIPMENT are intended for use either by medical staff or for use by the PATIENT or other trained personnel under medical supervision. This document includes all ME EQUIPMENT that is intended to deliver a HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION treatment to a PATIENT, independent of the treatment duration and location. If applicable, this document applies to the relevant parts of ME EQUIPMENT intended for other extracorporeal blood purification treatments.
The particular requirements in this document do not apply to:
– EXTRACORPOREAL CIRCUITS (see ISO 8637-2),
– DIALYSERS (see ISO 8637-1 [2]),
– DIALYSIS FLUID CONCENTRATES (see ISO 23500-4),
– pre-manufactured DIALYSIS FLUID bags,
– DIALYSIS WATER supply systems (see ISO 23500-2),
– CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID CONCENTRATES (see ISO 23500-4), described as systems for bulk mixing concentrate at a dialysis facility,
– equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39).
IEC 60601-2-16:2024 cancels and replaces the fifth edition published in 2018. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) update of references to IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020, of references to IEC 60601‑1‑2:2014 and IEC 60601‑1‑2:2014/AMD1:2020, of references to IEC 60601‑1‑8:2006, IEC 60601‑1‑8:2006/AMD1:2012 and IEC 60601‑1‑8:2006/AMD2:2020, of references to IEC 60601‑1‑9:2007, IEC 60601‑1‑9:2007/AMD1:2013 and IEC 60601‑1‑9:2007/AMD2:2020, of references to IEC 60601‑1‑10:2007, IEC 60601‑1‑10:2007/AMD1:2013 and IEC 60601‑1‑10:2007/AMD2:2020 and of references to IEC 60601‑1‑11:2015 and IEC 60601‑1‑11:2015/AMD1:2020;
b) consideration of ESSENTIAL PERFORMANCE in SINGLE FAULT CONDITION regarding IEC 60601‑1:2005/AMD1:2012/ISH1:2021;
c) including the information given in the document 62D/1771A/INF regarding 201.11.8;
d) including withdrawn IEC PAS 63023 as Annex CC;
e) including SECURITY (CYBERSECURITY) requirements;
f) consideration of HAEMODIALYSIS EQUIPMENT using pre-manufactured DIALYSIS FLUID bags;
g) improvements for labelling;
h) other minor technical improvements;
i) editorial improvements.
- Standard311 pagesEnglish languagesale 15% off
IEC 60601-2-40:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT.
The following ME EQUIPMENT are excluded:
- ME EQUIPMENT intended for therapeutic application;
- ME EQUIPMENT intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators (ME EQUIPMENT covered by IEC 60601-2-10).
IEC 60601-2-40:2024 cancels and replaces the second edition published in 2016. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) added requirements for constant voltage stimulators;
b) clarified requirements for VISUAL STIMULATORS.
- Standard94 pagesEnglish languagesale 15% off
NOTE Clause A.2 contains guidance or rationale for this clause.
This document specifies the common test methods to evaluate the performance requirements for small-bore connectors specified in the ISO and IEC 80369 series as well as the ISO 18250 series.
- Standard41 pagesEnglish languagesale 10% offe-Library read for1 day
NOTE Clause A.2 contains guidance or rationale for this clause.
This document specifies the common test methods to evaluate the performance requirements for small-bore connectors specified in the ISO and IEC 80369 series as well as the ISO 18250 series.
- Standard41 pagesEnglish languagesale 10% offe-Library read for1 day
NOTE Clause A.2 contains guidance or rationale for this clause. This document specifies the common test methods to evaluate the performance requirements for small-bore connectors specified in the ISO and IEC 80369 series as well as the ISO 18250 series.
- Standard32 pagesEnglish languagesale 15% off
- Standard32 pagesFrench languagesale 15% off
This document specifies requirements for non-sterile, single-use graduated flow regulators used as subcomponents in sterilized infusion sets for single use to control the flow of intravenous infusion solutions with fluid contact under gravity feed conditions.
- Standard13 pagesEnglish languagesale 10% offe-Library read for1 day
This document — provides information on the determination of particulate loads; — reports on established methods for a comprehensive risk analysis on potential particle sources and related risks in design, manufacturing, and application of devices. This document is applicable to medical devices that are used to provide intravenous access to patients to deliver liquids. NOTE For routes of administration that are not intravenous, the information in this document might be relevant to assist in the identification of sources of potential particulate contamination.
- Technical report9 pagesEnglish languagesale 15% off
This document specifies requirements for non-sterile, single-use graduated flow regulators used as subcomponents in sterilized infusion sets for single use to control the flow of intravenous infusion solutions with fluid contact under gravity feed conditions.
- Standard13 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the design and dimensions for two small-bore connectors intended to be used for connections in respiratory applications of medical devices and accessories. One connector (R1) is intended for use on medical devices and accessories subjected to pressures up to 15 kPa (e.g. a breathing system). The other connector (R2) is intended for use on medical devices and accessories subjected to higher pressures between 15 kPa and 600 kPa (e.g. oxygen therapy tubing).
NOTE 1 The pressure is related to pressure available at the source to which the medical device is connected.
NOTE 2 The intended application does not preclude the use of other connectors on medical devices or accessories within this application.
NOTE 3 Requirements for alternative connectors for this intended application are specified in ISO 80369-1.
This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in device-specific standards.
NOTE 4 If a device-specific standard does not exist, the performance and material requirements specified in ISO 80369-1 can be used as guidance.
- Standard63 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for non-sterile, single-use graduated flow regulators used as subcomponents in sterilized infusion sets for single use to control the flow of intravenous infusion solutions with fluid contact under gravity feed conditions.
- Standard6 pagesEnglish languagesale 15% off
- Standard7 pagesFrench languagesale 15% off
This document specifies the design and dimensions for two small-bore connectors intended to be used for connections in respiratory applications of medical devices and accessories. One connector (R1) is intended for use on medical devices and accessories subjected to pressures up to 15 kPa (e.g. a breathing system). The other connector (R2) is intended for use on medical devices and accessories subjected to higher pressures between 15 kPa and 600 kPa (e.g. oxygen therapy tubing).
NOTE 1 The pressure is related to pressure available at the source to which the medical device is connected.
NOTE 2 The intended application does not preclude the use of other connectors on medical devices or accessories within this application.
NOTE 3 Requirements for alternative connectors for this intended application are specified in ISO 80369-1.
This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in device-specific standards.
NOTE 4 If a device-specific standard does not exist, the performance and material requirements specified in ISO 80369-1 can be used as guidance.
- Standard63 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the design and dimensions for two small-bore connectors intended to be used for connections in respiratory applications of medical devices and accessories. One connector (R1) is intended for use on medical devices and accessories subjected to pressures up to 15 kPa (e.g. a breathing system). The other connector (R2) is intended for use on medical devices and accessories subjected to higher pressures between 15 kPa and 600 kPa (e.g. oxygen therapy tubing). NOTE 1 The pressure is related to pressure available at the source to which the medical device is connected. NOTE 2 The intended application does not preclude the use of other connectors on medical devices or accessories within this application. NOTE 3 Requirements for alternative connectors for this intended application are specified in ISO 80369-1. This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in device-specific standards. NOTE 4 If a device-specific standard does not exist, the performance and material requirements specified in ISO 80369-1 can be used as guidance.
- Standard50 pagesEnglish languagesale 15% off
- Standard50 pagesEnglish languagesale 15% off
- Standard50 pagesEnglish languagesale 15% off
- Standard50 pagesFrench languagesale 15% off
- Standard50 pagesFrench languagesale 15% off
- Standard50 pagesFrench languagesale 15% off
This document specifies the design and dimensions for two small-bore connectors intended to be used for connections in respiratory applications of medical devices and accessories. One connector (R1) is intended for use on medical devices and accessories subjected to pressures up to 15 kPa (e.g. a breathing system). The other connector (R2) is intended for use on medical devices and accessories subjected to higher pressures between 15 kPa and 600 kPa (e.g. oxygen therapy tubing).
NOTE 1 The pressure is related to pressure available at the source to which the medical device is connected.
NOTE 2 The intended application does not preclude the use of other connectors on medical devices or accessories within this application.
NOTE 3 Requirements for alternative connectors for this intended application are specified in ISO 80369-1.
This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in device-specific standards.
NOTE 4 If a device-specific standard does not exist, the performance and material requirements specified in ISO 80369-1 can be used as guidance.
- Standard50 pagesEnglish languagesale 15% off
This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration.
This document does not apply to:
— haemodialysers, haemodiafilters or haemofilters;
— plasmafilters;
— haemoperfusion devices;
— vascular access devices.
NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.
NOTE 2 Requirements for plasmafilters are specified in ISO 8637-3.
- Standard36 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration.
This document does not apply to:
— haemodialysers, haemodiafilters or haemofilters;
— plasmafilters;
— haemoperfusion devices;
— vascular access devices.
NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.
NOTE 2 Requirements for plasmafilters are specified in ISO 8637-3.
- Standard36 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this document are intended for single use only.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this document are intended for single use only.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this document are intended for single use only. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.
- Standard6 pagesEnglish languagesale 15% off
- Standard6 pagesFrench languagesale 15% off
This document specifies a test method to assess bacterial retention ability of finished stand-alone and integrated air-inlet filters on administration devices for infusion and transfusion applications.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies a test method to assess bacterial retention ability of finished stand-alone and integrated air-inlet filters on administration devices for infusion and transfusion applications.
- Standard14 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies a test method to assess bacterial retention ability of finished stand-alone and integrated air-inlet filters on administration devices for infusion and transfusion applications.
- Standard6 pagesEnglish languagesale 15% off
- Standard7 pagesFrench languagesale 15% off
- Amendment7 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this document are intended for single use only.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the requirements for infusion sets for single use that use light-protective agents in the fluid path materials (henceforth abbreviated as "light-protective infusion sets”).
This document also provides guidelines for performance and quality specifications of materials used in light-protective infusion sets.
- Amendment7 pagesEnglish languagesale 10% offe-Library read for1 day
This document applies to safety and performance and testing requirements for single-use and multiple-use Needle-Free Injection Systems (NFISs) intended for human use in clinics and other medical settings and for personal use by patients.
The dose chamber of the NFIS is often disposable and intended to be replaced after either a single use or a limited number of uses. It is sometimes separable from the injection mechanism and often termed a “cartridge”, “ampoule”, “syringe”, “capsule” or “disc”. In contrast, the dose chamber can also incorporate a permanent internal chamber designed to last through the claimed life of the device, and an additional member or members which eliminate the risk of cross-contamination.
Excluded from this document are drug delivery methods which:
— involve penetration of a part of the device itself into or through skin or mucous membranes (such as needles, tines, micro-needles, implantable slow-release drug devices);
— generate aerosols, droplets, powders or other formulations for inhalation, insufflation, intranasal or oral deposition (such as sprays, inhalers, misters);
— deposit liquids, powders, or other substances on the surface of skin or mucosal surfaces for passive diffusion or ingestion into the body (such as transdermal patches, liquid drops);
— apply sonic or electromagnetic energy (such as ultrasonic or iontophoretic devices);
— infusion systems for adding or metering medication into or through systems of artificial tubes, catheters, and/or needles which themselves enter the body.
- Standard46 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment7 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the requirements for infusion sets for single use that use light-protective agents in the fluid path materials (henceforth abbreviated as "light-protective infusion sets”).
This document also provides guidelines for performance and quality specifications of materials used in light-protective infusion sets.
- Amendment7 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard1 pageEnglish languagesale 15% off
- Standard1 pageFrench languagesale 15% off
- Standard1 pageEnglish languagesale 15% off
- Standard1 pageFrench languagesale 15% off
This document specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this document are intended for single use only.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
This document applies to safety and performance and testing requirements for single-use and multiple-use Needle-Free Injection Systems (NFISs) intended for human use in clinics and other medical settings and for personal use by patients.
The dose chamber of the NFIS is often disposable and intended to be replaced after either a single use or a limited number of uses. It is sometimes separable from the injection mechanism and often termed a “cartridge”, “ampoule”, “syringe”, “capsule” or “disc”. In contrast, the dose chamber can also incorporate a permanent internal chamber designed to last through the claimed life of the device, and an additional member or members which eliminate the risk of cross-contamination.
Excluded from this document are drug delivery methods which:
— involve penetration of a part of the device itself into or through skin or mucous membranes (such as needles, tines, micro-needles, implantable slow-release drug devices);
— generate aerosols, droplets, powders or other formulations for inhalation, insufflation, intranasal or oral deposition (such as sprays, inhalers, misters);
— deposit liquids, powders, or other substances on the surface of skin or mucosal surfaces for passive diffusion or ingestion into the body (such as transdermal patches, liquid drops);
— apply sonic or electromagnetic energy (such as ultrasonic or iontophoretic devices);
— infusion systems for adding or metering medication into or through systems of artificial tubes, catheters, and/or needles which themselves enter the body.
- Standard46 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this document are intended for single use only. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.
- Standard12 pagesEnglish languagesale 15% off
- Standard12 pagesFrench languagesale 15% off
This document applies to safety and performance and testing requirements for single-use and multiple-use Needle-Free Injection Systems (NFISs) intended for human use in clinics and other medical settings and for personal use by patients. The dose chamber of the NFIS is often disposable and intended to be replaced after either a single use or a limited number of uses. It is sometimes separable from the injection mechanism and often termed a “cartridge”, “ampoule”, “syringe”, “capsule” or “disc”. In contrast, the dose chamber can also incorporate a permanent internal chamber designed to last through the claimed life of the device, and an additional member or members which eliminate the risk of cross-contamination. Excluded from this document are drug delivery methods which: — involve penetration of a part of the device itself into or through skin or mucous membranes (such as needles, tines, micro-needles, implantable slow-release drug devices); — generate aerosols, droplets, powders or other formulations for inhalation, insufflation, intranasal or oral deposition (such as sprays, inhalers, misters); — deposit liquids, powders, or other substances on the surface of skin or mucosal surfaces for passive diffusion or ingestion into the body (such as transdermal patches, liquid drops); — apply sonic or electromagnetic energy (such as ultrasonic or iontophoretic devices); — infusion systems for adding or metering medication into or through systems of artificial tubes, catheters, and/or needles which themselves enter the body.
- Standard36 pagesEnglish languagesale 15% off
- Standard38 pagesFrench languagesale 15% off