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  • Draft
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This document specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.

  • Standard
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This document specifies minimum requirements for concentrates used for haemodialysis and related
therapies.
This document is addressed to the manufacturer of such concentrates. In several instances in this
document, the dialysis fluid is addressed, which is made by the end user, to help clarify the requirements
for manufacturing concentrates. Because the manufacturer of the concentrate does not have control
over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of
the manufacturer.
This document includes concentrates in both liquid and powder forms. It also includes additives, also
called spikes, which are chemicals that can be added to the concentrate to supplement or increase the
concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid.
This document also specifies requirements for equipment used to mix acid and bicarbonate powders
into concentrate at the user's facility.
Concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility
are excluded from the scope of this document. Although references to dialysis fluid appear herein,
this document does not address dialysis fluid as made by the end user. This document also excludes
requirements for the surveillance frequency of water purity used for the making of dialysis fluid by the
dialysis facility. This document does not address bags of sterile dialysis fluid or sorbent dialysis fluid
regeneration systems that regenerate and recirculate small volumes of the dialysis fluid.
This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid
is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and
water at the bedside or in a central dialysis fluid delivery system. Although the label requirements
for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure
proper use.
This document does not cover haemodialysis equipment, which is addressed in IEC 60601-2-16:2012.

  • Standard
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This document is addressed to the manufacturer and/or supplier of water treatment systems and/or
devices used for the express purpose of providing water for haemodialysis or related therapies.

  • Standard
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This document is the base standard for a number of other standards dealing with water treatment
equipment, water, dialysis water, concentrates, and dialysis fluid (ISO 23500 series) and provides
dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and
related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and
haemofiltration. As such, this document functions as a recommended practice.
This document does not address clinical issues that might be associated with inappropriate usage of the
water, dialysis water, concentrates, or dialysis fluid. Healthcare professionals involved in the provision
of treatment for kidney failure should make the final decision regarding the applications with which
these fluids are used, for example, haemodialysis, haemodiafiltration, high-flux haemodialysis, and the
reprocessing of dialysers, and need to be aware of the issues that the use of inappropriate fluid quality
raises in each of the therapies.
The concepts incorporated in this document should not be considered inflexible or static. The
recommendations presented here should be reviewed periodically in order to assimilate increased
understanding of the role of dialysis fluid purity in patient outcomes and technological developments.

  • Standard
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This document specifies minimum quality requirements for dialysis fluids used in haemodialysis and
related therapies.
This document includes dialysis fluids used for haemodialysis and haemodiafiltration, including
substitution fluid for haemodiafiltration and haemofiltration.
This document excludes the water and concentrates used to prepare dialysis fluid or the equipment
used in its preparation. Those areas are covered by other International Standards.
Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of
dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and
systems and solutions for peritoneal dialysis are excluded from this document.

  • Standard
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This document specifies minimum requirements for water to be used in haemodialysis and related
therapies.
This document includes water to be used in the preparation of concentrates, dialysis fluids for
haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.
This document excludes the operation of water treatment equipment and the final mixing of treated
water with concentrates to produce dialysis fluid. Those operations are the sole responsibility of
dialysis professionals. This document does not apply to dialysis fluid regenerating systems.

  • Standard
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This document specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.

  • Standard
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  • Standard
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This draft European Standard applies to type 1 to type 3 hose assemblies with hoses made of silicone rubber for the transport of liquid or powdry substances in the pharmaceutical and the biotechnological industries. It specifies the classification, manufacturing and testing of as well as the materials, requirements and quality surveillance for hose assemblies.
These hose assemblies are intended to be used with the relevant substances at temperatures in the range from −40 °C ) to +150 °C and at operating pressures from −0,9 bar (vacuum) to 10 bar (see Table 1). These hose assemblies are not electrically conductive. The danger of static charging shall be considered on a case-by-case basis.
Hose assemblies in accordance with this standard are classified into two designs, A and B (see 3.2).
Attention is called to the fact that for certain applications the relevant legal regulations such as the Pressure Equipment Directive 97/23/EC (PED) need to be complied with.

  • Standard
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This draft European Standard applies to type D and type SD hose assemblies with hoses made of elastomers and plastics for the transport of gaseous, vaporous, liquid or powdry substances in the pharmaceutical and the biotechnological industries. It specifies the classification, manufacturing and testing of as well as the materials, requirements and quality surveillance for hose assemblies.
These hose assemblies are intended to be used with the relevant substances at temperatures in the range from −30 °C to +100 °C, depending on the medium, and at operating pressures from −0,9 bar (vacuum) to 10 bar (see Tables 2 and 3). For hoses with inliners made of PTFE and derivatives, temperatures from −30 °C to +140 °C are permissible.
Hose assemblies in accordance with this standard are classified into two designs, A and B (see 3.3).
Attention is called to the fact that for certain applications the relevant legal regulations such as the Pressure Equipment Directive 97/23/EC (PED) need to be complied with.

  • Standard
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ISO 11418-1:2016 specifies the design, dimensions, material and requirements of drop-dispensing glass bottles. Drop-dispensing glass bottles are applicable to primary packs used in direct contact with a drug. It is applicable to drop-dispensing glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.

  • Standard
    4 pages
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ISO 11418-3:2016 specifies the design, dimensions, material and requirements of screw-neck glass bottles (veral) for pharmaceutical preparations in solid and liquid dosage forms. Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug. It is applicable to screw-neck glass bottles (veral) used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations in solid and liquid dosage forms which are not intended for parenteral use.

  • Standard
    6 pages
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ISO 11418-2:2016 specifies the design, dimensions, material and requirements of screw-neck glass bottles for pharmaceutical preparations in liquid form (syrups). Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug. It is applicable to screw-neck glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.

  • Standard
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This European Standard specifies performance requirements and methods of test for non-reclosable packaging that have been designated child-resistant. This European Standard is intended for type approval only (see 3.5) and is not intended for quality assurance purposes.

  • Standard
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ISO 11418-7:2016 specifies the design, dimensions, material and requirements of screw-neck vials for pharmaceutical preparations. Screw-neck vials are applicable to primary packs used in direct contact with a drug. It applies to colourless or amber glass vials made from borosilicate or soda-lime-silica glass, made from glass tubing and intended to be used in the packaging, storage or transportation of pharmaceutical products. NOTE The potency, purity, stability and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.

  • Standard
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  • Standard
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ISO 11418-5:2015 specifies the design, dimensions, material, and requirements of dropper assemblies consisting of a screw cap, dropper bulbs, and pipettes for the application and dosage of liquid pharmaceutical preparations. This part of ISO 11418 is applicable to dropper assemblies used in the medical field in order to deliver pharmaceutical preparations contained in screw neck bottles according to ISO 11418-1. Dropper assemblies are applicable to primary packs used in direct contact with the drug. NOTE The potency, purity, stability, and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.

  • Standard
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This European Technical Report addresses the provision of information for medicinal products in alternative formats suitable for blind and partially sighted people.

  • Technical report
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This document specifies requirements and provides guidance for the application, use and check of tamper verification features to the packaging of medicinal products.

  • Standard
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ISO 11418-4:2005 specifies the design, dimensions, material and requirements of tablet glass bottles. Tablet glass bottles are applicable to primary packs used in direct contact with a drug. ISO 11418-4:2005 is applicable to tablet glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations in solid and liquid dosage forms which are not intended for parenteral use.

  • Standard
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This International Standard applies to sterilized single use transfer sets that are used for pharmaceutical preparations.

  • Standard
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This International Standard specifies minimum requirements for concentrates used for haemodialysis and related therapies. For the purpose of this International Standard, “concentrates” are a mixture of chemicals and water, or chemicals in the form of dry powder or other highly concentrated media, that are delivered to the end user to make dialysis fluid used to perform haemodialysis and related therapies.
This International Standard is addressed to the manufacturer of such concentrates. In several instances in this International Standard, it became necessary to address the dialysis fluid, which is made by the end user, to help clarify the requirements for manufacturing concentrates. Because the manufacturer of the concentrate does not have control over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of the manufacturer.
This International Standard includes concentrates in both liquid and powder forms. Also included are additives, also called spikes, which are chemicals that may be added to the concentrate to increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid. This International Standard also gives requirements for equipment used to mix acid and bicarbonate
powders into concentrate at the user’s facility.
Concentrates prepared from prepackaged salts and water at a dialysis facility for use in that facility are excluded from the scope of this International Standard. Although references to dialysis fluid appear herein, this International Standard does not address dialysis fluid as made by the end user. Also excluded from the scope of this International Standard are requirements for the monitoring frequency of water purity used for the making of dialysis fluid by the dialysis facility. Recommendations from the technical committee responsible for this International Standard for monitoring water quality are contained in ISO 23500. This International Standard does not address bags of sterile dialysis fluid or sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid.

  • Standard
    37 pages
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This International Standard specifies minimum requirements for water to be used in haemodialysis and related therapies.
This International Standard includes water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.
The operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid are excluded from this International Standard. Those operations are the sole responsibility of dialysis professionals. This International Standard does not apply to dialysis fluid regenerating systems.

  • Standard
    25 pages
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This European Standard specifies requirements for 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 European 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.

  • Standard
    14 pages
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This European Standard specifies requirements for 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 European 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.

  • Standard
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This European Standard specifies requirements and provides guidance for the application of Braille to the labelling of medicinal products.
NOTE 1   The labelling of medicinal products placed on the market and incorporating Braille in accordance with this European Standard meets the requirements of European Directive 2001/83/EC, Article 56, (a) as amended by Directive 2004/27/EC [1].
NOTE 2   The principles in this European Standard can be applied in other sectors, as appropriate.

  • Standard
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ISO 22413:2010 applies to sterilized single use transfer sets that are used for pharmaceutical preparations.

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  • Draft
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ISO 22413:2010 applies to sterilized single use transfer sets that are used for pharmaceutical preparations.

  • Standard
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ISO 22413:2010 applies to sterilized single use transfer sets that are used for pharmaceutical preparations.

  • Standard
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  • Draft
    24 pages
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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.

  • Standard
    14 pages
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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.

  • Standard
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ISO 11418-1:2005 specifies the design, dimensions, material and requirements of drop-dispensing glass bottles. Drop-dispensing glass bottles are applicable to primary packs used in direct contact with a drug. ISO 11418-1:2005 is applicable to drop-dispensing glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.

  • Standard
    4 pages
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ISO 11418-3:2005 specifies the design, dimensions, material and requirements of screw-neck glass bottles (veral) for pharmaceutical preparations in solid and liquid dosage forms. Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug. ISO 11418-3:2005 is applicable to screw-neck glass bottles (veral) used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations in solid and liquid dosage forms which are not intended for parenteral use.

  • Standard
    4 pages
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ISO 11418-2:2005 specifies the design, dimensions, material and requirements of screw-neck glass bottles for pharmaceutical preparations in liquid form (syrups). Screw-neck glass bottles are applicable to primary packs used in direct contact with a drug. ISO 11418-2:2005 is applicable to screw-neck glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.

  • Standard
    4 pages
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  • Standard
    5 pages
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  • Standard
    5 pages
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  • Standard
    5 pages
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  • Standard
    5 pages
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  • Standard
    9 pages
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  • Standard
    9 pages
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Specifies the design, dimensions, materials and requirements of screw-neck bottles used for pharmaceutical preparations in liquid form (sirups). Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.

  • Standard
    4 pages
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  • Standard
    4 pages
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  • Standard
    4 pages
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Specifies the design, dimensions, materials and requirements of tablet bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of tablets which are not intended for parenteral use.

  • Standard
    4 pages
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  • Standard
    4 pages
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  • Standard
    4 pages
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Specifies the design, dimensions, materials and requirements of screw-neck bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of solid and liquid pharmaceutical preparations which are not intended for parenteral use.

  • Standard
    4 pages
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  • Standard
    4 pages
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  • Standard
    4 pages
    French language
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Specifies the design, dimensions, materials and requirements of drop-dispensing bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.

  • Standard
    4 pages
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  • Standard
    4 pages
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  • Standard
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