Yhteinen Toimialaliitto

 

This document specifies testing, inspection and marking for the type approval, initial inspection, periodic inspection, intermediate inspection and exceptional check of metallic tanks (shell and equipment) of fixed tanks (tank vehicles), demountable tanks, tank-wagons, portable tanks and tank containers for the transport of dangerous goods. This document is not applicable to battery-vehicles and battery-wagons comprising cylinders, tubes, pressure drums, bundles of cylinders, and multiple element gas containers (MEGCs), independent of whether the elements are receptacles or tanks.

 

This document specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408-1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408-7.

 

This document specifies the requirements for a terminally sterilized medical device to be designated ‘STERILE’. Part 2 of this European standard specifies the requirements for an aseptically processed medical device to be designated "STERILE". NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designation of a medical device as ‘STERILE’ is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN ISO 11135, EN ISO 11137, EN ISO 14160, EN ISO 14937, EN ISO 17665-1, EN ISO 20857, EN ISO 25424 and ISO 22441.

 

 

This document specifies the composition, tolerances and characteristics, i.e. mechanical, acoustic, optical, and thermal properties, of folio interlayers for the manufacturing of laminated glass and laminated safety glass for use in buildings and construction works and it defines their general quality criteria. This document does not apply to interlayers for laminated glass which are achieved by pouring the interlayer material in liquid state on or between the plies of glass or plastic glazing sheet material followed by drying or chemical or ultraviolet curing.

 

 

This European Standard defines the technical and safety requirements applicable to gangway systems used in all railway vehicles such as tram, tram trains, coaches, metro, suburban, main line and high speed trains that carry passengers. A gangway system gives comfortable passage from one vehicle to the other and consists of a flexible component which allows relative movement between vehicles. It also defines: - the requirements for the safety for passengers and/or staff in the gangway while the train is running; - the assessment methods as well as pass/fail criteria for gangways installed on vehicles.

 

Full revision of currently published 2014 version. Additionally, expand scope to include plume evacuation systems for endoscopic procedures (e.g. minimally invasive, laparoscopic). The scope is now the following: This Standard specifies requirements and guidelines for the design, manufacture, installation, function, performance, maintenance, servicing, documentation, testing, and commissioning of equipment for evacuation of plume generated by medical devices. It is applicable to: a) portable and mobile plume evacuation systems, b) local stationary plume evacuation systems, c) dedicated central pipeline systems for plume evacuation systems, and d) plume evacuation systems integrated into other equipment (e.g. laser equipment).

 

ISO 19979:2018 provides guidance to manufacturers for the development of information to be provided to eye care practitioners for the hygienic management of trial hydrogel, composite and rigid gas-permeable (RGP) contact lenses intended for multipatient use. ISO 19979:2018 does not apply to: - labelling of contact lenses; - the inactivation of prions and viruses since there are no standardised methods available for contact lenses. ISO 19979:2018 can be used as guidance for the development of a hygienic management procedure for multipatient use. NOTE ISO 14729 does not cover multipatient use.