ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use

This document specifies the material, performance requirements and labelling, and gives recommendations for shape and dimensions of glass cylinders used in cartridge-type needle-based injection systems (NIS) for medical use, according to ISO 11608-3. This document applies to the glass cylinders as supplied by the manufacturer.

This document is applicable to aseptically processed or terminally sterilized finished prefilled syringes (intended for single use only) based on syringe barrel components addressed in ISO 11040-4 or ISO 11040-6, together with a plunger stopper (sealing the back end) based on components addressed in ISO 11040-5 and a front end closure for parenteral preparations with focus on quality, functional performance and safety requirements, as well as relevant test methods. Finished prefilled syringes which have undergone an additional preparation step by the user before injection (e.g. diluent-containing syringes that have been emptied for reconstitution and in which the reconstituted injectable product has been aspirated after reconstitution) are excluded from the scope of this document. NOTE 1 This document can also be used as a guidance for other types, designs and/or sizes of finished prefilled syringes, for example dual chamber prefilled syringes. NOTE 2 For finished prefilled syringes that are used in needle-based injection systems, see also ISO 11608 (all parts). NOTE 3 Attention is drawn to applicable national or regional regulations and pharmacopoeias, such as Ph.Eur. [2], USP [3] or JP [4]. NOTE 4 Finished prefilled syringes for parenteral preparations which are medical devices or which, according to the principal mode of action of the product (i.e. the means by which the product achieves its principal intended action), are borderline between medical devices and medicinal products fall within the scope of this document, even if they are not always regulated as medicinal products.

This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals. This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions. NOTE 1 In some countries, national or regional pharmacopoeias or other government regulations are legally binding, and these requirements take precedence over this document. NOTE 2 Annex E provides explanations about the history of the development of the standard and summarises the different arguments discussed within ISO/TC 76 during the elaboration of the document. NOTE 3 Annex F provides recommendations regarding sustainability. NOTE 4 Annex G provides information on attributive and variable testing.

This document specifies the shape, dimensions, material, performance requirements and labelling of seals for dental local anaesthetic cartridges intended for single use only. 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.

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.

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.

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.

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.

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.

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.

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.

This document specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods. This document also specifies components that are part of the sterilized subassembled syringe ready for filling. This document is applicable to — tubing-glass barrels (single-chamber design) for injection preparations, and — sterilized subassembled syringes ready for filling. Glass barrels and sterilized subassembled syringes ready for filling in accordance with this document are intended for single use only. Components to complete the subassembled syringe, such as plunger stopper and plunger rod, are outside the scope of this document. NOTE National or regional regulations such as Ph.Eur., USP, or JP can apply.

This document specifies a packaging system that is used to deliver sterilized subassembled syringes ready for filling in tubs and nests. Downstream processes (processes after filling such as in house/outside transport, reprocessing) can result in specific requirements on the packaging system used to deliver sterilized subassembled syringes ready for filling. However, these requirements are not within the scope of this document. NOTE 1 Glass barrels and sterilized subassembled syringes ready for filling, plunger stoppers, and plastic barrels for injectables are specified in ISO 11040-4, ISO 11040-5 and ISO 11040-6. NOTE 2 ISO 11607-2 addresses validation requirements of sealing and packaging processes for medical devices.

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.

This document specifies: a) a method for determining the hydrolytic resistance of the interior surfaces of glass containers when subjected to attack by water at (121 ± 1) °C for (60 ± 1) min. The resistance is measured by titration of a known aliquot portion of the extraction solution produced with hydrochloric acid solution, in which case the resistance is inversely proportional to the volume of acid required; b) a classification of glass containers according to the hydrolytic resistance of the interior surfaces determined by the methods specified in this document.

This document specifies: a) a method for determining the hydrolytic resistance of the interior surfaces of glass containers when subjected to attack by water at (121 ± 1) °C for (60 ± 1) min. The resistance is measured by determining the amount of sodium and other alkali metal or alkaline earth oxides in the extraction solution using flame atomic emission or absorption spectrometry (flame spectrometry); b) a classification of glass containers according to the hydrolytic resistance of the interior surfaces determined by the methods specified in this document. The test method specified in this document might not be applicable to containers whose surfaces have been treated for functional modifications, e.g. silicone (e.g. containers that are ready for direct filling).

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.

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.

This document specifies general requirements and test methods for aluminium caps and aluminium/plastic caps intended for use on infusion bottles and/or injection vials.

This document specifies the shape, dimensions, fill capacities and performance requirements of plastic bottles for metering pumps. It also specifies the material for the manufacturing of such containers as well as the secondary packaging. The document provides requirements for packaging of the plastic bottles and addresses nonsterile, ready to sterilize or sterile as three possible options. This document is applicable to colourless or coloured containers moulded from plastic and intended to be used in the packaging, storage or transportation of products intended for medicinal use.

This document specifies the shape, dimensions, fill capacities and performance requirements of moulded glass bottles for metering pumps. It also specifies the material for the manufacturing of such containers as well as the secondary packaging. This document also provides requirements for packaging of the moulded glass bottles and addresses nonsterile, ready to sterilize or sterile as three possible options. This document is applicable to colourless or amber glass containers moulded from borosilicate or soda-lime-silica glass and intended to be used in the packaging, storage or transportation of products intended for medicinal use.

This document specifies the shape, dimensions, fill capacities and performance requirements of tubular glass vials for metering pumps. It also specifies the material for the manufacturing of such containers as well as the secondary packaging. This document provides also requirements for packaging of the tubular glass vials and addresses nonsterile, ready to sterilize or sterile as three possible options. This document is applicable to colourless or amber containers made of tubular glass and intended to be used for packaging, storage or transportation of products intended for medicinal use.

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.

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.

This document specifies requirements and test methods for specialized single-use evacuated and non-evacuated containers, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination. It is not intended to cover specimen containers for forensic investigations. Examples of such specimens include, but are not limited to, cerebral spinal fluid (CSF), faeces, infected bodily fluids, saliva, ejaculate, sputum, urine, tissue samples. Specimens and types of devices specifically excluded are specialized containers for cryo-preservation, samples for nucleic acid testing and swabs. NOTE Requirements and test methods for evacuated and non-evacuated single-use human venous blood specimen collection containers are specified in ISO 6710. This document does not specify requirements for auxiliary devices used in conjunction with specimen containers.

This document specifies requirements and test methods for sterilized single-use transfer sets that are used for pharmaceutical preparations.

This document specifies requirements for check valves intended for single use and used with infusion equipment both with gravity-feed infusion and with pressure infusion apparatus. The functional requirements in this document also apply to inline check valves.

This document specifies a) a method for determining the hydrolytic resistance of glass grains at 98 °C. The resistance is measured and expressed by the volume of acid required for titration of the alkali extracted from the unit mass of glass, and can also be expressed by the amount of sodium oxide equivalent to this volume of acid, and b) a classification of glass according to the hydrolytic resistance determined by the method of this document. This document is intended for use on the less resistant types of glass, such as soda-lime glass. NOTE 1 For the more resistant glasses, e.g. borosilicate glass, the method specified in ISO 720 is more suited. NOTE 2 It is emphasized that there is no exact correlation between the classification laid down in this document and that laid down in ISO 720, and it is, therefore, essential to identify which classification is being used.

This document specifies a) a method for determining the hydrolytic resistance of glass grains at 121 °C. The resistance is measured and expressed by the volume of acid required for titration of the alkali extracted from the unit mass of glass, and can also be expressed by the amount of sodium oxide equivalent to this volume of acid, and b) a classification of glass according to the hydrolytic resistance determined by the method of this document. This document is intended for use on the more resistant types of glass, e.g. borosilicate glass. NOTE 1 For the less resistant glasses, e.g. soda-lime, the method specified in ISO 719 is more suited. NOTE 2 It is emphasized that there is no exact correlation between the classification laid down in this document and that laid down in ISO 719, and it is, therefore, essential to identify which classification is being used.

This document specifies identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices. The physical and chemical test procedures specified in this document permit the determination of the typical characteristics of elastomeric parts including coatings and surface treatments and can serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. Depending upon the type of elastomer and its application, an appropriate set of tests is selected.

This document specifies essential requirements and related test methods for non-electrically driven portable infusion devices, thereafter called "device". It is applicable to devices designed for continuous (fixed or adjustable) flow and/or for bolus neuraxial and intravascular or hypodermic applications. NOTE Sites for the neuraxial application include the spine, intrathecal or subarachnoid space, ventricles of the brain and the epi-, extra- or peri-dural space. Neuraxial application anaesthetics can be administered regionally, affecting a large part of the body, such as a limb, and include plexus blocks, such as the branchial plexus blocks or single nerve blocks. Neuraxial application procedures include continuous infusion of wounds with local anaesthetic agents. These devices can be used in health care and non-health care settings. They can be applied or administered by health care professionals or by the intended patient. These devices can be pre-filled by the manufacturer or filled before use by a health care professional or the intended patient. This document does not apply to — electrically driven or electrically controlled infusion pumps that are covered by IEC 60601-2-24, — devices for single patient use intended to deliver discrete volumes (bolus) of medicinal product that are covered by the ISO 11608 series, — implantable devices, — enteral devices, — transdermal delivery devices, and — devices where the energy for infusion is not provided by the device or through active intervention by the patient (e.g. devices only powered by gravity).

This document details suitable equipment, a test method, acceptance criteria and advisable limits to help to ensure that there is compatibility (by measuring the insertion force) between a transfusion set closure piercing device (referred to in this document by the abbreviation 'spike') and a blood bag outlet port. The test procedure in its entirety is complex and beyond the scope of each of the relevant transfusion set and blood bag standards. This document was therefore developed to support the implementation of the existing standards for blood bags and transfusion sets. The procedure described in this document can be used by manufacturers of blood bags to test the compatibility with transfusion set spikes available on the market or by manufacturers of the transfusion set spikes to test the compatibility with blood bags available on the market.

This document specifies the characteristics of sterile and ready for filling empty glass vials for injectable preparations, including the minimum requirements of materials, packaging systems and analytical test methods.

This document specifies the characteristics of sterile and ready for filling empty glass cartridges for injectable preparations, including the minimum requirements of materials, packaging systems and analytical test methods.

This document specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment. Secondary aims of this document are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components.

This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers (known as plastics containers) complete with collecting tube outlet port(s), integral needle, and with optional transfer tube(s), for the collection, storage, processing, transport, separation, and administration of blood and blood components. The plastics containers can contain anticoagulant and/or preservative solutions, depending on the application envisaged. This document is also applicable to multiple units of plastics containers, e.g. to double, triple, quadruple, or multiple units. Unless otherwise specified, all tests specified in this document apply to the plastics container as prepared ready for use. This document is not applicable to plastics containers with an integrated filter.

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.

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 subassembled syringe, such as plunger and rod, are not specified in this document. Prefilled syringes can be produced on dedicated and specifically designed processing equipment such as inline moulding and filling. This document does not apply but can be used also for such dedicated prefilled syringes.

This document specifies the form, dimensions and capacities of glass vials for injectable preparations. It also specifies the material from which such containers are made and the performance requirements of those containers. This document is applicable to colourless or amber glass containers made from borosilicate or soda-lime glass, made from glass tubing, whether internally surface-treated or not, and intended to be used in the packaging, storage or transportation of products intended for injection.

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.

ISO 15378:2017 specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides. NOTE 1 In this International Standard, the terms "product" or "service" only apply to products and services intended for, or required by, a customer. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. In addition to ISO 9001, this document specifies Good Manufacturing Practice (GMP) requirements applicable to primary packaging materials for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards. In ISO 15378:2017 the term "if appropriate" is used several times. When a requirement is qualified by this phrase, it is deemed to be "appropriate" unless the organization can document a justification otherwise. ISO 15378:2017 is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products.

ISO/TR 19727:2017 provides a method of measuring, analysing and assessing the particle shedding from an infusion pump set during pumping.

ISO 6710:2017 specifies requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers. It does not specify requirements for blood collection needles, needle holders, blood culture receptacles or "arterial" blood gas collection devices that can be used for venous blood.