11.040.25 - Syringes, needles an catheters
ICS 11.040.25 Details
Syringes, needles an catheters
Seringues, aiguilles et cathéters
Injekcijske brizge, igle in katetri
General Information
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This part of ISO 11608 specifies requirements and test methods for needle-based injection systems with automated functions (referred to in the standard as NIS-AUTO), for the administration of medicinal products in humans. This document does not cover remote communication from the NIS-AUTO.
- Standard30 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft27 pagesEnglish languagesale 10% offe-Library read for1 day
This part of ISO 11608 specifies requirements and test methods for needle-based injection systems with automated functions (referred to in the standard as NIS-AUTO), for the administration of medicinal products in humans. This document does not cover remote communication from the NIS-AUTO.
- Standard30 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft27 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment12 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft9 pagesEnglish languagesale 10% offe-Library read for1 day
- Amendment12 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft9 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software (NIS-Es).
The needle-based injection system containing electronics can be single use or reusable and can be operated with or without electrical/conductive connections to other devices. The system is intended to deliver medication to a patient by self-administration or by administration by one other operator (e.g. caregiver or health care provider).
This document applies to electronic accessories that are intended to be physically connected to a NIS or NIS-E according to the NIS/NIS-E intended use.
This document also applies to electronic accessories that are intended to have electrical/conductive connections to a NIS or NIS-E according to the NIS/NIS-E intended use.
This document does not specify requirements for software in programmable NIS-E.
NOTE IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 14 addresses software life cycle processes.
This document does not specify requirements for cybersecurity.
- Standard72 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft56 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1.
It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture.
This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022).
This document is not applicable to the following products:
— sterile hypodermic needles;
— sterile hypodermic syringes;
— sterile single-use syringes, with or without needle, for insulin;
— containers that can be refilled multiple times;
— containers intended for dental use;
— catheters or infusion sets that are attached or assembled separately by the user.
- Standard35 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft31 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and test methods for single-use, double-ended, sterile needles intended to be used with some needle-based injection systems (NISs) that use a non-integrated double-ended needle according to ISO 11608-1.
This document is not applicable to the following:
— needles for dental use;
— pre-attached syringe needles;
— hypodermic needles;
— needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular);
— materials that form the medicinal product contact surfaces of the primary container closure.
However, while this document is not intended to directly apply to these needle products, it does contain requirements and tests methods that can be used to help design and evaluate them.
NOTE Needles provided by the manufacturer integrated into the fluid path or container are covered in ISO 11608‑3, and hypodermic needles provided separately are covered in ISO 7864.
- Standard40 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft29 pagesEnglish languagesale 10% offe-Library read for1 day
This document gives requirements for labels attached to syringes so that the contents can be identified just before use during anaesthesia. It covers the colour, size, design and general properties of the label and the typographical characteristics of the wording for the drug name.
NOTE National or regional regulations might require additional labelling, which can include bar coding. No requirements for this additional labelling are given.
- Standard16 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft13 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and test methods for design verification of containers and
integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1.
It is applicable to single and multi-dose containers either filled by the manufacturer (primary container
closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated
with the NIS at the point of manufacture.
This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also
scope of ISO 11608-1:2022).
This document is not applicable to the following products:
— sterile hypodermic needles;
— sterile hypodermic syringes;
— sterile single-use syringes, with or without needle, for insulin;
— containers that can be refilled multiple times;
— containers intended for dental use;
— catheters or infusion sets that are attached or assembled separately by the user
- Standard35 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft31 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and test methods for Needle-Based Injection Systems (NISs)
for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, which can
be delivered through needles or soft cannulas for intradermal, subcutaneous and/or intramuscular
delivery, incorporating pre-filled or user-filled, replaceable or non-replaceable containers.
This document applies in cases where the NIS incorporates a prefilled syringe. However, stand-alone
prefilled syringes defined by ISO 11040-8 are not covered by this document (see exclusions below).
It is important to note that other functions and characteristics of the prefilled syringe, such as dose
accuracy, are subject to the requirements (delivered volume) in ISO 11040-8 and not this document,
unless the addition impacts the delivery function (e.g. a mechanism that intends to restrict or stop
the plunger movement, which would limit the dose delivered). In that case, the system is completely
covered by this document and applicable requirements of the ISO 11608 series.
Excluded from the scope are:
— stand-alone prefilled syringes defined by ISO 11040-8 (with noted exceptions above);
— NISs that provide continuous delivery and require a delivery rate clinically specified in the medicinal
product labelling or determined by a physician based on clinical relevance (i.e. medication efficacy)
as would be the case with insulin patch pumps or traditional infusion pumps (e.g. IEC 60601-2-24,
ISO 28620) associated with continuous delivery of medicinal products (e.g. insulin);
— NISs with containers that can be refilled multiple times;
— requirements relating to methods or equipment associated with user filling of containers unless
they are dedicated accessories (a component necessary for primary function, whether included in
the original kitted product or not);
— NISs intended for dental use;
— NISs intended for different routes of administration (e.g. intravenous, intrathecal, intraocular).
NOTE These products that are excluded might benefit from elements in this document but might not
completely fulfil the basic safety and effectiveness of such products.
- Standard81 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft69 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and test methods for needle-based injection systems (NISs)
containing electronics with or without software (NIS-Es).
The needle-based injection system containing electronics can be single use or reusable and can be
operated with or without electrical/conductive connections to other devices. The system is intended to
deliver medication to a patient by self-administration or by administration by one other operator (e.g.
caregiver or health care provider).
This document applies to electronic accessories that are intended to be physically connected to a NIS or
NIS-E according to the NIS/NIS-E intended use.
This document also applies to electronic accessories that are intended to have electrical/conductive
connections to a NIS or NIS-E according to the NIS/NIS-E intended use.
This document does not specify requirements for software in programmable NIS-E.
NOTE IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 14 addresses software life cycle processes.
This document does not specify requirements for cybersecurity.
- Standard72 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft56 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and test methods for single-use, double-ended, sterile needles
intended to be used with some needle-based injection systems (NISs) that use a non-integrated doubleended needle according to ISO 11608-1.
This document is not applicable to the following:
— needles for dental use;
— pre-attached syringe needles;
— hypodermic needles;
— needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular);
— materials that form the medicinal product contact surfaces of the primary container closure.
However, while this document is not intended to directly apply to these needle products, it does contain
requirements and tests methods that can be used to help design and evaluate them.
NOTE Needles provided by the manufacturer integrated into the fluid path or container are covered in
ISO 11608-3, and hypodermic needles provided separately are covered in ISO 7864.
- Standard40 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft29 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the particular requirements for the basic safety and essential performance of roller-type dermal needles for single use. It applies to roller-type dermal needles that have the capacity to penetrate the skin. It specifies structure and dimension, materials, and performance requirements for appearance and cleanliness, corrosion resistance, sterility, packaging and identification, transit and storage of roller-type dermal needles. It does not apply to tapping-type dermal needles or reusable roller-type dermal needles.
- Standard9 pagesEnglish languagesale 15% off
NEW!IEC 60601-2-16:2018 is available as IEC 60601-2-16:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-16:2018 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16:2018 does not take into consideration the dialysis fluid control system of Haemodialysis equipment using regeneration of dialysis fluid and central delivery systems. It does however take into consideration the specific safety requirements of such haemodialysis equipment concerning electrical safety and patient safety. IEC 60601-2-16:2018 specifies the minimum safety requirements for haemodialysis equipment. These devices are intended for use either by medical staff or for use by the patient or other trained personnel under the supervision of medical expertise. IEC 60601-2-16:2018 includes all electromedical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. This fifth edition cancels and replaces the fourth edition of IEC 60601-2-16, published in 2012. This edition includes the following significant technical changes with respect to the previous edition: a) update of references to IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, of references and requirements to IEC 60601-1-2:2014, of references to IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013, of references and requirements to IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, of references to IEC 60601-1-9:2007 and IEC 60601-1-9:2007/AMD1:2013, of references to IEC 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013 and of references to IEC 60601-1-11:2015; b) widening of the scope; c) editorial improvements; d) addition of requirements for anticoagulant delivery means; e) other few small technical changes.
- Standard80 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the particular requirements for the basic safety and essential performance of tapping-type dermal needles for single use. It applies to tapping-type dermal needles that have the capacity to penetrate the skin. It specifies structure and dimension, materials, and performance requirements for appearance and cleanliness, corrosion resistance, sterility, packaging and identification, transit and storage of tapping-type dermal needles. It does not apply to roller-type dermal needles, reusable tapping-type dermal needles or devices incorporating a detachable tapping head.
- Standard10 pagesEnglish languagesale 15% off
This document specifies requirements and test methods for Needle-Based Injection Systems (NISs) for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, which can be delivered through needles or soft cannulas for intradermal, subcutaneous and/or intramuscular delivery, incorporating pre-filled or user-filled, replaceable or non-replaceable containers.
This document applies in cases where the NIS incorporates a prefilled syringe. However, stand-alone prefilled syringes defined by ISO 11040-8 are not covered by this document (see exclusions below).
It is important to note that other functions and characteristics of the prefilled syringe, such as dose accuracy, are subject to the requirements (delivered volume) in ISO 11040-8 and not this document, unless the addition impacts the delivery function (e.g. a mechanism that intends to restrict or stop the plunger movement, which would limit the dose delivered). In that case, the system is completely covered by this document and applicable requirements of the ISO 11608 series.
Excluded from the scope are:
— stand-alone prefilled syringes defined by ISO 11040-8 (with noted exceptions above);
— NISs that provide continuous delivery and require a delivery rate clinically specified in the medicinal product labelling or determined by a physician based on clinical relevance (i.e. medication efficacy) as would be the case with insulin patch pumps or traditional infusion pumps (e.g. IEC 60601-2-24, ISO 28620) associated with continuous delivery of medicinal products (e.g. insulin);
— NISs with containers that can be refilled multiple times;
— requirements relating to methods or equipment associated with user filling of containers unless they are dedicated accessories (a component necessary for primary function, whether included in the original kitted product or not);
— NISs intended for dental use;
— NISs intended for different routes of administration (e.g. intravenous, intrathecal, intraocular).
NOTE These products that are excluded might benefit from elements in this document but might not completely fulfil the basic safety and effectiveness of such products.
- Standard81 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft69 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements and test methods for single-use, double-ended, sterile needles intended to be used with some needle-based injection systems (NISs) that use a non-integrated double-ended needle according to ISO 11608-1. This document is not applicable to the following: — needles for dental use; — pre-attached syringe needles; — hypodermic needles; — needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular); — materials that form the medicinal product contact surfaces of the primary container closure. However, while this document is not intended to directly apply to these needle products, it does contain requirements and tests methods that can be used to help design and evaluate them. NOTE Needles provided by the manufacturer integrated into the fluid path or container are covered in ISO 11608‑3, and hypodermic needles provided separately are covered in ISO 7864.
- Standard30 pagesEnglish languagesale 15% off
- Standard33 pagesFrench languagesale 15% off
- Draft30 pagesEnglish languagesale 15% off
- Draft33 pagesFrench languagesale 15% off
This document specifies requirements and test methods for automated functions in needle-based injection systems with automated functions (NIS-AUTO). General requirements are provided for all automated functions. In addition, specific requirements are provided for the following automated functions: a) medicinal product preparation (e.g. reconstitution); b) needle preparation; c) needle hiding; d) priming; e) dose setting; f) needle insertion; g) injection depth control; h) injection of the medicinal product; i) recording of device functions; NOTE This document does not cover remote communication from the NIS-AUTO (pertains to wired and wireless communication transfer from the NIS auto). j) disabling the NIS-AUTO; k) needle retraction; l) needle shielding; m) needle removal. All references to "function" in this document are by definition construed as automated functions (see 3.2). This document does not apply to functions that are performed manually by the user.
- Standard22 pagesEnglish languagesale 15% off
- Standard24 pagesFrench languagesale 15% off
- Standard24 pagesFrench languagesale 15% off
- Draft22 pagesEnglish languagesale 15% off
This document specifies requirements and test methods for Needle-Based Injection Systems (NISs) for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, which can be delivered through needles or soft cannulas for intradermal, subcutaneous and/or intramuscular delivery, incorporating pre-filled or user-filled, replaceable or non-replaceable containers. This document applies in cases where the NIS incorporates a prefilled syringe. However, stand-alone prefilled syringes defined by ISO 11040-8 are not covered by this document (see exclusions below). It is important to note that other functions and characteristics of the prefilled syringe, such as dose accuracy, are subject to the requirements (delivered volume) in ISO 11040-8 and not this document, unless the addition impacts the delivery function (e.g. a mechanism that intends to restrict or stop the plunger movement, which would limit the dose delivered). In that case, the system is completely covered by this document and applicable requirements of the ISO 11608 series. Excluded from the scope are: — stand-alone prefilled syringes defined by ISO 11040-8 (with noted exceptions above); — NISs that provide continuous delivery and require a delivery rate clinically specified in the medicinal product labelling or determined by a physician based on clinical relevance (i.e. medication efficacy) as would be the case with insulin patch pumps or traditional infusion pumps (e.g. IEC 60601-2-24, ISO 28620) associated with continuous delivery of medicinal products (e.g. insulin); — NISs with containers that can be refilled multiple times; — requirements relating to methods or equipment associated with user filling of containers unless they are dedicated accessories (a component necessary for primary function, whether included in the original kitted product or not); — NISs intended for dental use; — NISs intended for different routes of administration (e.g. intravenous, intrathecal, intraocular). NOTE These products that are excluded might benefit from elements in this document but might not completely fulfil the basic safety and effectiveness of such products.
- Standard69 pagesEnglish languagesale 15% off
- Standard72 pagesFrench languagesale 15% off
- Draft70 pagesEnglish languagesale 15% off
- Draft78 pagesFrench languagesale 15% off
This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1. It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture. This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022). This document is not applicable to the following products: — sterile hypodermic needles; — sterile hypodermic syringes; — sterile single-use syringes, with or without needle, for insulin; — containers that can be refilled multiple times; — containers intended for dental use; — catheters or infusion sets that are attached or assembled separately by the user.
- Standard27 pagesEnglish languagesale 15% off
- Standard28 pagesFrench languagesale 15% off
- Draft27 pagesEnglish languagesale 15% off
- Draft28 pagesFrench languagesale 15% off
This document specifies requirements and test methods for On-Body Delivery Systems (OBDS) needle-based injection systems (NISs) for single patient use, intended for subcutaneous, intramuscular or intradermal delivery of a discrete volume (bolus) of medicinal product, through needles or soft cannulas, incorporating pre-filled or user-filled, replaceable or non-replaceable containers. NOTE 1 Although technically a device using a soft cannula is not “needle-based”, the soft cannula is placed by a needle and can be included in this classification. NOTE 2 Some requirements and methods are already established and included in other parts of the ISO 11608 series. Infusion pumps that are designed for continuous delivery at a specific rate required to achieve and/or maintain a desired plasma medicinal product concentration are excluded from this document. However, while this document is not intended to directly apply to these pump products, it does contain requirements and test methods that can be used to help design and evaluate them. NOTE 3 They are covered by IEC 60601-2-24 (if electronic) or ISO 28620 (if non-electronic).
- Standard20 pagesEnglish languagesale 15% off
- Draft20 pagesEnglish languagesale 15% off
- Draft20 pagesEnglish languagesale 15% off
This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software (NIS-Es). The needle-based injection system containing electronics can be single use or reusable and can be operated with or without electrical/conductive connections to other devices. The system is intended to deliver medication to a patient by self-administration or by administration by one other operator (e.g. caregiver or health care provider). This document applies to electronic accessories that are intended to be physically connected to a NIS or NIS-E according to the NIS/NIS-E intended use. This document also applies to electronic accessories that are intended to have electrical/conductive connections to a NIS or NIS-E according to the NIS/NIS-E intended use. This document does not specify requirements for software in programmable NIS-E. NOTE IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 14 addresses software life cycle processes. This document does not specify requirements for cybersecurity.
- Standard63 pagesEnglish languagesale 15% off
- Standard66 pagesFrench languagesale 15% off
- Draft63 pagesEnglish languagesale 15% off
- Draft68 pagesFrench languagesale 15% off
This document gives requirements for labels attached to syringes so that the contents can be identified just before use during anaesthesia. It covers the colour, size, design and general properties of the label and the typographical characteristics of the wording for the drug name.
NOTE National or regional regulations might require additional labelling, which can include bar coding. No requirements for this additional labelling are given.
- Standard16 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft13 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies an analytical method to quantitatively determine the water-soluble amount of tungsten (W) from the inner surface of glass syringes. The method can be applied to Luer cone, staked needle or Luer lock syringes.
- Standard8 pagesEnglish languagesale 15% off
- Draft8 pagesEnglish languagesale 15% off
2021-06-25 - IEC Corrected version
- Corrigendum3 pagesEnglish and French languagesale 10% offe-Library read for1 day
DOW = DAV + 36 months
- Amendment7 pagesEnglish languagesale 10% offe-Library read for1 day
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 connections in hypodermic applications of medical devices and accessories.
EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors and Luer lock connectors.
NOTE 1 See Annex A.
NOTE 2 The Luer connector was originally designed for use at pressures up to 300 kPa.
This document does not specify requirements for themedical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories.
This document does not specify requirements for the following small-bore connectors, which are specified in other documents:
- haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 [5] and applicable portion of ISO 8638 [ 6] referencing blood compartment ports);
- haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637 [5]);
- infusion system closure piercing connectors (ISO 8536-4 [4]).
NOTE 3 Manufacturers are encouraged to incorporate thesmall-bore connectors specified in this document into medical devices or accessories, even if currently not required by the relevant particular medical device documents. It is expected that when the relevant particular medical device documents are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included.
NOTE 4 ISO 80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-1:2018, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not conform with this document.
- Standard55 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft50 pagesEnglish languagesale 10% offe-Library read for1 day
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
connections in hypodermic applications of medical devices and accessories.
EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip
connectors and Luer lock connectors.
NOTE 1 See Annex A.
NOTE 2 The Luer connector was originally designed for use at pressures up to 300 kPa.
This document does not specify requirements for the medical devices or accessories that use these
connectors. Such requirements are given in particular documents for specific medical devices or
accessories.
This document does not specify requirements for the following small-bore connectors, which are
specified in other documents:
— haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 [5] and
applicable portion of ISO 8638 [6] referencing blood compartment ports);
— haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637 [5]);
— infusion system closure piercing connectors (ISO 8536-4 [4]).
NOTE 3 Manufacturers are encouraged to incorporate the small-bore connectors specified in this document into
medical devices or accessories, even if currently not required by the relevant particular medical device documents.
It is expected that when the relevant particular medical device documents are revised, requirements for smallbore
connectors, as specified in ISO 80369, will be included.
NOTE 4 ISO 80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-1:2018, for
small-bore connectors intended for use with intravascular applications or hypodermic application medical devices
or accessories, which do not conform with this document.
- Standard55 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft50 pagesEnglish languagesale 10% offe-Library read for1 day
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 connections in hypodermic applications of medical devices and accessories.
EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors and Luer lock connectors.
NOTE 1 See Annex A.
NOTE 2 The Luer connector was originally designed for use at pressures up to 300 kPa.
This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories.
This document does not specify requirements for the following small-bore connectors, which are specified in other documents:
- haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 [5] and applicable portion of ISO 8638 [6] referencing blood compartment ports);
- haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637 [5]);
- infusion system closure piercing connectors (ISO 8536-4 [4]).
NOTE 3 Manufacturers are encouraged to incorporate the small-bore connectors specified in this document into medical devices or accessories, even if currently not required by the relevant particular medical device documents. It is expected that when the relevant particular medical device documents are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included.
NOTE 4 ISO 80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-1:2018, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not conform with this document.
- Standard47 pagesEnglish languagesale 15% off
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 connections in hypodermic applications of medical devices and accessories. EXAMPLES Hypodermic syringes and needles or intravascular (IV) cannulae with male and female Luer slip connectors and Luer lock connectors. NOTE 1 See Annex A. NOTE 2 The Luer connector was originally designed for use at pressures up to 300 kPa. This document does not specify requirements for themedical devices or accessories that use these connectors. Such requirements are given in particular documents for specific medical devices or accessories. This document does not specify requirements for the following small-bore connectors, which are specified in other documents: - haemodialyser, haemodiafilter and haemofilter blood compartment ports (ISO 8637 [5] and applicable portion of ISO 8638 [ 6] referencing blood compartment ports); - haemodialysis, haemodiafiltration and haemofiltration equipment connectors (ISO 8637 [5]); - infusion system closure piercing connectors (ISO 8536-4 [4]). NOTE 3 Manufacturers are encouraged to incorporate thesmall-bore connectors specified in this document into medical devices or accessories, even if currently not required by the relevant particular medical device documents. It is expected that when the relevant particular medical device documents are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included. NOTE 4 ISO 80369-1:2018, Clause 7, specifies alternative methods of conformance with ISO 80369-1:2018, for small-bore connectors intended for use with intravascular applications or hypodermic application medical devices or accessories, which do not conform with this document.
- Standard47 pagesEnglish languagesale 15% off
- Standard51 pagesFrench languagesale 15% off
- Draft47 pagesEnglish languagesale 15% off
This document specifies the properties and performance of sterile single-use hypodermic syringes with an auto-disable syringe feature intended to deliver a fixed dose of vaccine immediately after filling. The syringes can be made of plastic, rubber or other materials and can be with or without needle and needle protection feature.
This document does not specify the design of the auto-disable syringe feature.
This document is not applicable to syringes for use with insulin (covered by ISO 8537), syringes for use with power-driven syringe pumps (covered by ISO 7886-2), reuse prevention syringes (covered by ISO 7886-4) or syringes designed to be prefilled (covered by the ISO 11040 series). It does not address compatibility with injection fluids/vaccines.
- Standard24 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft21 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for sterile single-use hypodermic syringes of nominal capacity 1 ml and above, made of plastic materials and intended for use with power-driven syringe pumps.
This document does not apply to syringes with auto-disable syringe features (ISO 7886-3[2]), syringes for use with insulin (ISO 8537[3]), single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. It does not address compatibility with injection fluids.
- Standard27 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft25 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies dimensions and requirements for both open and closed suction catheters made
of flexible materials and intended for use in suctioning of the respiratory tract.
Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical
equipment are not covered by this document.
NOTE For guidance on airway management during laser surgery of the upper airway, see ISO/TR 11991[4].
- Standard32 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft34 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies dimensions and requirements for both open and closed suction catheters made of flexible materials and intended for use in suctioning of the respiratory tract.
Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are not covered by this document.
NOTE For guidance on airway management during laser surgery of the upper airway, see ISO/TR 11991[4].
- Standard32 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft34 pagesEnglish languagesale 10% offe-Library read for1 day
This document gives requirements for labels attached to syringes so that the contents can be identified just before use during anaesthesia. It covers the colour, size, design and general properties of the label and the typographical characteristics of the wording for the drug name. NOTE National or regional regulations might require additional labelling, which can include bar coding. No requirements for this additional labelling are given.
- Standard9 pagesEnglish languagesale 15% off
- Standard9 pagesFrench languagesale 15% off
This document specifies requirements and test methods for cartridge syringes used in dentistry. These syringes are of the non-aspirating, aspirating and self-aspirating types using cartridges with dental local anaesthetics.
This document is not applicable to cartridge syringes having a mechanical-advantage action for creating high pressure.
This document specifies requirements for cartridge syringes with ISO metric thread sizes. However, attention is drawn to the existence of a variety of syringes with imperial thread sizes (see Annex A).
- Standard16 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft13 pagesEnglish languagesale 10% offe-Library read for1 day
EN-ISO 7886-2 specifies requirements for sterile single-use hypodermic syringes of nominal capacity 1 ml and above, made of plastic materials and intended for use with power-driven syringe pumps. This document does not apply to syringes with auto-disable syringe features (ISO 7886-3[2]), syringes for use with insulin (ISO 8537[3]), single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. It does not address compatibility with injection fluids.
- Standard27 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft25 pagesEnglish languagesale 10% offe-Library read for1 day
EN-ISO 7886-3 specifies the properties and performance of sterile single-use hypodermic syringes with an auto-disable syringe feature intended to deliver a fixed dose of vaccine immediately after filling. The syringes can be made of plastic, rubber or other materials and can be with or without needle and needle protection feature.This document does not specify the design of the auto-disable syringe feature.This document is not applicable to syringes for use with insulin (covered by ISO 8537), syringes for use with power-driven syringe pumps (covered by ISO 7886-2), reuse prevention syringes (covered by ISO 7886-4) or syringes designed to be prefilled (covered by the ISO 11040 series). It does not address compatibility with injection fluids/vaccines.
- Standard24 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft21 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the safety requirements for the thread-embedding acupuncture needle. It is applicable to only the needle part of thread-embedding acupuncture needles and excludes medical thread.
- Standard10 pagesEnglish languagesale 15% off
- Standard10 pagesEnglish languagesale 15% off
This European Standard specifies requirements for the design and testing of single-use enteral feeding catheters, single-use enteral giving sets and their connection systems.
Requirements for radiodetectable enteral feeding catheters are not given in this standard.
- Standard52 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the properties and performance of sterile single-use hypodermic syringes with an auto-disable syringe feature intended to deliver a fixed dose of vaccine immediately after filling. The syringes can be made of plastic, rubber or other materials and can be with or without needle and needle protection feature. This document does not specify the design of the auto-disable syringe feature. This document is not applicable to syringes for use with insulin (covered by ISO 8537), syringes for use with power-driven syringe pumps (covered by ISO 7886-2), reuse prevention syringes (covered by ISO 7886-4) or syringes designed to be prefilled (covered by the ISO 11040 series). It does not address compatibility with injection fluids/vaccines.
- Standard15 pagesEnglish languagesale 15% off
- Standard16 pagesFrench languagesale 15% off
ISO 10555-6:2015 specifies requirements, performance, and user safety issues related to subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition and intended for single use.
ISO 10555-6:2015 does not specify requirements, performance, and user safety issues related to non-coring needles.
- Amendment7 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft4 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for sterile single-use hypodermic syringes of nominal capacity 1 ml and above, made of plastic materials and intended for use with power-driven syringe pumps. This document does not apply to syringes with auto-disable syringe features (ISO 7886-3[2]), syringes for use with insulin (ISO 8537[3]), single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. It does not address compatibility with injection fluids.
- Standard17 pagesEnglish languagesale 15% off
- Standard18 pagesFrench languagesale 15% off
IEC TR 62653:2020 is available as IEC TR 62653:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC TR 62653:2020 describes the technical recommendations for use of medical equipment in chronic Haemodialysis, Haemofiltration and Haemodiafiltration. These principles are important to be complied with to ensure safe, permissible and appropriate application. The term Haemodialysis is used in this document as synonym for all therapy modalities.
The scope can be applicable to the use of the medical equipment in home, acute and pediatrics environment. The scope may also be applicable to Sorbent Dialysis Systems.
The physician is responsible for the treatment prescription. However, the Organization administering the treatment is responsible for all resources, structures and processes used in connection with the treatment. These responsibilities will not be described here. The requirements of IEC 60601-2-16 ensure that medical electrical equipment used for extracorporeal renal replacement therapy operates with a high level of safety. Despite that high level of safety, however, some residual risk remains, related to medical-biological, physical-chemical and technical Hazards. The Organization administering the treatment is responsible for managing the residual risk. This document is not intended to be used as the basis of regulatory inspection or certification assessment activities. IEC TR 62653:2020 cancels and replaces the first edition published in 2012. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) update the relevant references to the new numbering scheme of the ISO 23500 family;
b) alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, IEC 62353:2014 and 60601-2-16:2018;
c) technical additions in several sections.
- Technical report36 pagesEnglish languagesale 15% off
This document specifies requirements for enteral feeding systems comprising enteral giving sets, enteral extension sets, enteral syringes, enteral feeding catheters, and enteral accessories.
This document is not applicable to oral syringes.
- Standard52 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for enteral feeding systems comprising enteral giving sets, enteral extension sets, enteral syringes, enteral feeding catheters, and enteral accessories. This document is not applicable to oral syringes.
- Standard43 pagesEnglish languagesale 15% off
- Standard44 pagesFrench languagesale 15% off
EN-ISO 9997 specifies requirements and test methods for cartridge syringes used in dentistry. These syringes are of the non-aspirating, aspirating and self-aspirating types using cartridges with dental local anaesthetics.This document is not applicable to cartridge syringes having a mechanical-advantage action for creating high pressure.This document specifies requirements for cartridge syringes with ISO metric thread sizes. However, attention is drawn to the existence of a variety of syringes with imperial thread sizes (see Annex A).
- Standard16 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft13 pagesEnglish languagesale 10% offe-Library read for1 day
- Standard3 pagesEnglish languagesale 15% off
- Standard3 pagesFrench languagesale 15% off
This document specifies requirements and test methods for cartridge syringes used in dentistry. These syringes are of the non-aspirating, aspirating and self-aspirating types using cartridges with dental local anaesthetics. This document is not applicable to cartridge syringes having a mechanical-advantage action for creating high pressure. This document specifies requirements for cartridge syringes with ISO metric thread sizes. However, attention is drawn to the existence of a variety of syringes with imperial thread sizes (see Annex A).
- Standard9 pagesEnglish languagesale 15% off
- Standard9 pagesFrench languagesale 15% off
This document specifies dimensions and requirements for both open and closed suction catheters made of flexible materials and intended for use in suctioning of the respiratory tract. Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are not covered by this document. NOTE For guidance on airway management during laser surgery of the upper airway, see ISO/TR 11991[4].
- Standard24 pagesEnglish languagesale 15% off
- Standard24 pagesFrench languagesale 15% off