CEN/TC 205/WG 11 - Transfusion, infusion and injection equipment

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.

This part of ISO 11608 specifies the functional and design considerations for containers to be used with
needle-based injection systems (NIS) that fulfil the specifications of ISO 11608-1. It is applicable to single and
multi-dose containers (either filled by the manufacturer or by the end-user) which can be provided to the enduser
integrated in the NIS or assembled with the NIS at the time of use.
This part of ISO 11608 includes specifications and test methods to describe and evaluate cartridges for use
in NIS with pen needles (as defined in ISO 11608-2) and outlines design considerations for other potential
containers, including syringes to be used with a NIS.
This part of ISO 11608 is not applicable to cartridges intended for dental use.
Syringes and needles that are sold separately and not intended for use in a NIS are outside the scope of this
part of ISO 11608.
NOTE See ISO 7864 (needles), ISO 8537 (insulin syringes) and ISO 7886-1 (manual syringes).

ISO 11608-2:2012 specifies requirements and test methods for single-use, double-ended, sterile needles for needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1.

Specifies requirements for sterile single-use hypodermic syringes of nominal capacity 5 ml and above, made of plastics materials and intended for use with power-driven syringe pumps. Does not apply to syringes for use with insulin, single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a doctors kid.

Specifies requirements (cleanliness, limits for acidity and alkalinity, limits for extractable metals, lubricant, tolerance on graduated capacity, graduated scale, barrel, piston/plunger assembly, nozzle, performance, packaging, labelling) for sterile single-use hypodermic syringes made of plastic materials and intended for the aspiration of fluids or for the injection of fluids immediately after filling. Excludes e.g. syringes for use with insulin, single-use syringes made of glass.

Migrated from Progress Sheet (TC Comment) (2000-07-10): Contact Mr Vyze ext 850 when processing this project through each stage

Specifies the following requirements for needles of nominal outside diameters 0,3 mm and 1,2 mm: nomenclature for components, cleanliness, limits for acidity and alkalinity, size designation, colour coding, needle hub, sheath, needle tube, needle point, performance, packaging, labelling, storage container, transport wrapping.

Specifies the dimensions, surface and mechanical properties of normal- and thin-walled tubing of designated metric sizes 3,4 mm to 0,3 mm, and of extra-thin-walled tubing of designated metric sizes 2,1 mm to 0,6 mm.

DOW = DAV + 36 months
2011-07-20 ANP: Text received in ISO/CS (see notification from 2011-07-20 in dataservice).
2010-08-18 EMA: ENQ draft received in ISO/CS according to notification received in dataservice on 2010-08-18.

This European Standard specifies requirements for sterile, single-use, extracorporeal blood gas exchangers intended for supply of oxygen to, and removal of carbon dioxid from, the blood of humans. This European Standard also applies to heat exchangers that are integral parts of blood gas exchangers and to external equipment unique to the use of the device. This European Standard does not apply to: - implanted blood gas exchangers; - liquid exchangers; - extracorporeal circuits (blod tubing); - separate heat exchangers; - separate ancillary devices.

This European Standard specifies requirements for sterile, single use hemodialysers, hemodiafilters, hemofilters, hemoconcentrators and the extracorporeal circuits for these devices (including any integral accessory lines, such as fluid and infusion lines and lines for connection to pressure monitors) intended for renal care and cardiovascular use on humans.

ISO 3826-1:2003 specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile 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 may contain anticoagulant and/or preservative solutions, depending on the application envisaged.
ISO 3826-1:2003 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 ISO 3826-1:2003 apply to the plastics container as prepared ready for use.
ISO 3826-1:2003 is not applicable to plastics containers with an integrated filter.

Specifies performance and interchangeability dimensions of single use cartridges for drugs for use with pen-injectors

Specifies performance and interchangeability dimensions of needles for use with pen-injectors

Specifies accuracy, performance and interchangeability dimensions of pen- injectors for use with insulin and other drugs

Specifies dimensions and performance of single use transfusion sets for use in transfusing human blood

This European Standard applies to dry and liquid concentrates to be diluted for use as dialysing fluids in haemodialysis or related therapies. It addresses chemical and microbiological quality and purity, handling and labelling of concentrates, the requirements for containers and the tests to monitor chemical and microbiological contents and quality of such concentrates. This Standard does not address the final mixing and use of these concentrates or the treated water used in connection with haemodialysis and related therapies. This European Standard does not apply to dialysing fluid regeneration systems.

To amend EN ISO 8537 so as to include thinner and shorter needles.

Specifies dimensions and performance of single use devices for use in giving infusions to the vascular systems of humans.