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].

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    • Standard
      32 pages
      English language
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      1 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.

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    • Standard
      9 pages
      English language

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 pharma...view more

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    • Standard
      27 pages
      English language
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      1 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), sy...view more

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    • Standard
      24 pages
      English language
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      1 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.

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    • Standard
      10 pages
      English language
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    • Standard
      10 pages
      English language

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.

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    • Standard
      52 pages
      English language
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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), ...view more

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    • Standard
      15 pages
      English language
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    • Standard
      16 pages
      French language

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 pharma...view more

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    • Standard
      17 pages
      English language
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    • Standard
      18 pages
      French language

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 ...
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    • Technical report
      36 pages
      English language

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.

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    • Standard
      52 pages
      English language
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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.

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    • Standard
      43 pages
      English language
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    • Standard
      44 pages
      French language

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 w...view more

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    • Standard
      16 pages
      English language
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    • Standard
      3 pages
      English language
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    • Standard
      3 pages
      French language

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 syri...
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    • Standard
      16 pages
      English language
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      1 day

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 syring...view more

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    • Standard
      9 pages
      English language
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    • Standard
      9 pages
      French language

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].

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    • Standard
      24 pages
      English language
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    • Standard
      24 pages
      French language

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.

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    • Amendment
      7 pages
      English language
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      1 day
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    • Amendment
      4 pages
      English language
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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.

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    • Amendment
      7 pages
      English language
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      1 day
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    • Amendment
      4 pages
      English language
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    • Standard
      1 page
      English language
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    • Standard
      1 page
      French language

This document specifies the shape, dimensions, material, performance requirements and labelling of seals for pen-injectors for medical use. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be significantly affected by the nature and performance of the primary packaging.

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    • Standard
      7 pages
      English language

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 flui...view more

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    • Standard
      80 pages
      English language
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      1 day

This document specifies a test method for characterizing the corrosion resistance of single-use acupuncture needles intended for use in electro-acupuncture treatment. This document is applicable only to testing of acupuncture needles that conform with ISO 17218. This document does not specify pass/fail criteria. Also, it is not intended to provide safety information for real clinical practice.

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    • Standard
      10 pages
      English language

This document specifies requirements for sterile single-use hypodermic syringes made of plastic and
rubber materials with or without needle, and intended for the aspiration of fluids or for the injection of
fluids immediately after filling and of design such that the syringe can be rendered unusable after use.
This document is not applicable to syringes made of glass [specified in ISO 595 (withdrawn)], autodisable
syringes for fixed dose immunization (ISO 7886-3) and syringes designed to be ...
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    • Standard
      19 pages
      English language
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This document specifies the connectors recommended for the outlet ports of neural reservoirs and inlet ports of neural giving sets.

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    • Standard
      6 pages
      English language

This document specifies requirements for sterile single-use hypodermic syringes made of plastic and rubber materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use.
This document is not applicable to syringes made of glass [specified in ISO 595 (withdrawn)], auto-disable syringes for fixed dose immunization (ISO 7886‑3) and syringes designed to be pr...
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    • Standard
      19 pages
      English language
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      1 day
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    • Standard
      6 pages
      English language
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    • Standard
      6 pages
      French language

This document specifies materials, dimensions, quality, and performance requirements, as well as test methods for polymer barrels and sterilized subassembled syringes ready for filling, intended for single use only. This document also specifies those components that are part of the sterilized subassembled syringe ready for filling. Polymer barrels and sterilized subassembled syringes ready for filling in accordance with this document are intended for single use only. Components to complete the s...view more

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    • Standard
      53 pages
      English language
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    • Standard
      55 pages
      French language

This document specifies the interface dimensions and requirements for the design and functional performance of connectors intended to be used to connect intravascular infusion sets to intravascular infusion reservoirs. This document does not specify the dimensions and requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular international standards for specific medical devices or accessories. EXAMPLES Medical devices which may use in...view more

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    • Standard
      34 pages
      English language

This document specifies general requirements for reservoir connectors, which convey fluids in healthcare applications. These reservoir connectors are used in medical devices or accessories intended for use with a patient. This document also specifies the healthcare fields in which these reservoir connectors are intended to be used. These healthcare fields of use include, but are not limited to, applications for — respiratory, — enteral, — neural, — intravascular, — citrate-based anticoagulant so...view more

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    • Standard
      52 pages
      English language

This document specifies requirements for sterile single-use hypodermic syringes made of plastic and rubber materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use. This document is not applicable to syringes made of glass [specified in ISO 595 (withdrawn)], auto-disable syringes for fixed dose immunization (ISO 7886‑3) and syringes designed to be pre...view more

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    • Standard
      10 pages
      English language
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    • Standard
      11 pages
      French language

This document specifies the design, materials, performance and test methods, and gives recommendations for dimensions for glass cylinders used with pen-injectors for medical use. It applies to the primary containers used in direct contact with the drug.

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    • Standard
      5 pages
      English language

This standard specifies requirements for sterile, single-use urethral catheters, with and without balloons.

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    • Standard
      43 pages
      English language
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      1 day

This standard specifies requirements for sterile,single use drainage catheters, wound drainage systems and components thereof designed for drainage of fluids tothe exterior by means of gravity or negative pressure. This E. S. does not applyto: -catheters of less than 2 mm outside diameter;-suction catheters for use in the respiratory tract (see prEN 1733);-tracheal catheters (tracheal tubes) (see prEN 1782). NOTE: Urinary tract catheters are covered in prEN 1616.

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    • Standard
      46 pages
      English language
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This document specifies dimensions and requirements for the design and functional performance of apheresis anticoagulant (AC) reservoir connectors. This document does not specify the dimensions and requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular International Standards for specific medical devices or accessories. The following examples of medical devices are intended to use the connectors of this document: — Apheresis tubin...view more

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    • Standard
      24 pages
      English language

This document specifies general requirements and test methods for catheter systems intended to be used in neuraxial applications. This document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate conformity with these requirements. Catheters for neuraxial applications are intended to administer medications directly into neuraxial sites, to del...view more

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    • Standard
      20 pages
      English language
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    • Standard
      21 pages
      French language

This document specifies requirements for sterile, single use drainage catheters, wound and fluid accumulation drainage systems, surgical drainage catheters and their components, where the catheter is placed in a body cavity or wound, surgically or percutaneously, for drainage of fluid or air to the exterior.
The drainage catheter is left to drain naturally or connected to a suction source for faster tissue granulation.
This document is not applicable to:
a) suction catheters;
b) tracheal cat...
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    • Standard
      46 pages
      English language
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This document specifies requirements and test methods for sterile urethral catheters for single use, with or without a balloon.
This document does not include drainage catheters covered by ISO 20697, e.g. ureteral catheters, nephrostomy catheters, and suprapubic catheters. This document also excludes ureteral stents.
NOTE Ureteral stents are covered in ASTM F1828‑97.

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    • Standard
      43 pages
      English language
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This document specifies dimensions and requirements for the design and functional performance of connectors intended to be used on enteral reservoirs. This document does not specify the dimensions and requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular International Standards for specific medical devices or accessories. NOTE 1 Manufacturers are encouraged to incorporate the connectors specified in this document into enteral med...view more

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    • Standard
      39 pages
      English language

This document specifies requirements and test methods for sterile urethral catheters for single use, with or without a balloon. This document does not include drainage catheters covered by ISO 20697, e.g. ureteral catheters, nephrostomy catheters, and suprapubic catheters. This document also excludes ureteral stents. NOTE Ureteral stents are covered in ASTM F1828‑97.

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    • Standard
      33 pages
      English language
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    • Standard
      33 pages
      English language
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    • Standard
      36 pages
      French language

This document specifies requirements for sterile, single use drainage catheters, wound and fluid accumulation drainage systems, surgical drainage catheters and their components, where the catheter is placed in a body cavity or wound, surgically or percutaneously, for drainage of fluid or air to the exterior. The drainage catheter is left to drain naturally or connected to a suction source for faster tissue granulation. This document is not applicable to: a) suction catheters; b) tracheal cathete...view more

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    • Standard
      37 pages
      English language
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    • Standard
      37 pages
      English language
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    • Standard
      38 pages
      French language
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    • Standard
      2 pages
      English language
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    • Standard
      2 pages
      French language

This document specifies requirements and test methods for verifying the design of empty sterile singleuse
hypodermic syringes, with or without needle, made of plastic or other materials and intended for
the aspiration and injection of fluids after filling by the end-users. This document does not provide
requirements for lot release. The syringes are primarily for use in humans.
Sterile syringes specified in this document are intended for use immediately after filling and are not
intended to...
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    • Standard
      40 pages
      English language
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      1 day

IEC 60601-2-16:2018 is also 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...
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    • Standard
      156 pages
      English and French language

ISO 7886-1:2017 specifies requirements and test methods for verifying the design of empty sterile single-use hypodermic syringes, with or without needle, made of plastic or other materials and intended for the aspiration and injection of fluids after filling by the end-users. This document does not provide requirements for lot release. The syringes are primarily for use in humans.
Sterile syringes specified in this document are intended for use immediately after filling and are not intended to ...
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    • Standard
      40 pages
      English language
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ISO 13926-2:2017 specifies the material, performance requirements and labelling and gives recommendations for shape and dimensions of plunger stoppers for pen-injectors for medical use. 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.

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    • Standard
      7 pages
      English language