Yleinen Teollisuusliitto

This part of EN 868 provides test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4 used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user. This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607-1.As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1.The materials specified in this part of EN 868 are intended for single use only.NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, may apply.

This part of EN 868 provides test methods and values for re-usable containers used as sterile barrier systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. These containers are intended to be used in steam sterilizers conforming to EN 285.NOTE 1 The need for a packaging material inside the container is determined by the manufactures and users.This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add nor modify the general requirements specified in EN ISO 11607-1.As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1.NOTE 2 When it is intended to use the containers in a steam sterilizer not conforming to EN 285 the sterilization performance of the container in the specific sterilization cycle to be used is validated by the user. Other attributes of the container are also reviewed for compatibility with the sterilizer cycle e.g. operating temperature.NOTE 3 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, may apply.

for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user.This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607-1.As such, the particular requirements in 4.2 to 4.3 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1.NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, may apply.The materials specified in this part of EN 868 are intended for single use only.

polyolefines, manufactured from nonwovens complying with EN 868-9 used for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user.This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add nor modify the general requirements specified in EN ISO 11607-1.As such, the particular requirements in 4.2 to 4.3 can be used to demonstrate compliance with one or more but not all of the requirements of EN ISO 11607-1.NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, container filter, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, may apply.The materials specified in this part of EN 868 are intended for single use only.

This International Standard defines terms in the field of sterilization of healthcare products used in the standards developed by ISO/TC 198 "Sterilization of healthcare products", CEN/TC 204 "Sterilization of medical devices", and CEN/TC 102 "Sterilizers and associated equipment for processing of medical devices".

This European Standard 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, rail tank wagons, portable tanks and tank containers for the transport of dangerous goods.This European Standard 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.It is essential that the requirements of the applicable regulations for the transport of dangerous goods prevail in all cases over those of this standard.

This European Standard specifies construction, design, performance requirements and test methods for medical face masks intended to limit the transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar requirements. A medical face mask with an appropriate microbial barrier can also be effective in reducing the emission of infective agents from the nose and mouth of an asymptomatic carrier or a patient with clinical symptoms.This European Standard is not applicable to masks intended exclusively for the personal protection of staff.NOTE 1 Standards for masks for use as respiratory personal protective equipment are available.NOTE 2 Annex A provides information for the users of medical face masks.

This European Standard specifies and classifies special basic products - borosilicate float glass, indicates their chemical composition, their main physical and mechanical characteristics, their dimensional and minimum quality requirements (in respect of optical and visual faults).This European Standard applies to special basic products - borosilicate float glass supplied in stock sizes, supplied sizes or in cut sizes for final end use.This European Standard does not apply to final cut sizes having a dimension less than 100 mm or a surface area less than 0,05 m².

This European standard covers the evaluation of conformity and the factory production control of basic borosilicate float glass for use in buildings.For glass products with electrical wiring or connections for, e.g. alarm or heating purposes, other directives, e.g. Low Voltage Directive, may apply.

This European Standard specifies and classifies special basic products - glass ceramics, indicates their chemical composition, their main physical and mechanical characteristics, their dimensional and minimum quality requirements (in respect of optical and visual faults).This European Standard applies to special basic products - glass ceramics supplied in stock sizes, supplied sizes or in cut sizes for final end use.This European Standard does not apply to final cut sizes having a dimension less than 100 mm or a surface area less than 0,05 m2.

This European standard covers the evaluation of conformity and the factory production control of basic glass ceramics for use in buildings.NOTE For glass products with electrical wiring or connections for, e.g. alarm or heating purposes, other directives, e.g. Low Voltage Directive, may apply.

This European Standard specifies product characteristics for demountable stands at permanent or temporary entertainment venues including sports stadiums, sport halls and indoor and outdoor facilities. This standard is not applicable to stands of a moveable type where last row of places for spectators is under 1 m height from the ground.NOTE Amusement parks are covered by EN 13814, Fairground and amusement park machinery and structures - Safety.