11.120.99 - Other standards related to pharmaceutics

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

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 regener...view more

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.

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 ...view more

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 ...view more

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 add...view more

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

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 fro...view more

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 ...view more

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.

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 inten...view more

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.

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.

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 ma...view more

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 d...view more

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

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

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