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The level of requirements presented in the EN 18000 series has been established as a priority for infectious diseases (bacterial, viral, fungal or parasitic) and associated animal species for which harmonization of practices in this area is necessary, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals.
The EN 18000 series is therefore not intended to be applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this standard cannot be validly evaluated in accordance with international requirements due, e.g. to the absence of a specific reference method and/or accessible and duly validated reference materials.
This first part describes the general and specific elements constituting the dossier for the submission of an animal health in vitro diagnostic reagent, in the above-described framework, to the control and approval by a control organization. Its purpose is to provide the applicant submitting an animal disease in vitro diagnostic reagent to control with the general input for the preparation of the control application file. It describes the optimal administrative and technical information regarding the applicant and the reagent required for the application file for initial control and for a batch-to-batch control respectively. It specifies, in particular, the validation parameters of the method using the reagent (objectives, methodology, criteria and results) according to international standards.
NOTE This document does not cover the step in which the user verifies a reagent (refer to section 3.1 for definition).

The level of requirements presented in the EN 18000 series has been established as a priority for infectious diseases (bacterial, viral, fungal or parasitic) and associated animal species for which harmonization of practices in this area is needed, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals.
The EN 18000 series is therefore not intended to be applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this standard cannot be validly evaluated in accordance with international requirements, due e.g. to the absence of a specific reference standard and/or accessible and duly validated reference materials.
This second part describes the control, in the above-described framework, of in vitro reagents for immunological analyses with a qualitative expression of results used in animal health. It involves control organizations (CO) and applicants (including their subcontractors, when relevant).

This document specifies fundamental requirements for uncut finished spectacle lenses. This document is not applicable to protective spectacle lenses.
This document takes precedence over the corresponding requirements of other standards, if differences exist.

This document provides clear methods for performance-testing for sharps-injury protection mechanisms, whether active or passive in design, for medical devices containing single-used ‘sharps’ for administration and/or extraction of body/blood fluids and/or medicinal substances. Testing will confirm usability and elimination of exposure to, and risk of accidental injury from, contaminated ‘sharps’ during the period of intended use, including the paths to final disposal.

This document specifies requirements for single use transfusion gravity sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment. Secondary aims of this document are to provide 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 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 requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures up to 200 kPa (2 bar). This International Standard ensures compatibility with containers for blood and blood components as well as intravenous equipment. Secondary aims of this document are to provide 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. Platelet components should not be transfused under pressure using these sets. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this document.

To propose test methods to evaluate the resistance of APTIs (assistive products for tissue integrity) against cleaning and disinfection with liquid chemical disinfectants.

To propose test methods to evaluate the resistance of APTIs (assistive products for tissue integrity) against cleaning and disinfection with liquid chemical disinfectants.

Describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure.

This document establishes a system for the designation of supernumerary teeth in humans using two alphanumeric characters.

ISO 11979-2:2014 specifies requirements and test methods for certain optical properties of intraocular lenses (IOLs) with any of spherical, aspheric, monofocal, toric, multifocal, and/or accommodative optics. The generic descriptor ?IOL' used throughout ISO 11979-2:2014 also includes phakic intraocular lenses (PIOL).