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This document provides terminology, concepts, requirements, and guidance for logging of AI systems.
It is primarily intended for organizations placing on the market or putting into service AI systems and is not specific to any particular sector.
This document specifies the technical conditions for inspection and delivery of wrought aluminium and wrought aluminium alloy sheet, strip and plate for general applications. It also includes provisions for ordering and testing.
It applies to products with a thickness over 0,20 mm up to and including 400 mm.
For many special applications of aluminium strip, sheet and plate, specific European Standards exist, where different or additional requirements are formulated and the appropriate alloys and tempers are selected: see Annex A. Most of these special European Standards refer to provisions of this document.
The selection of the relevant special European Standards is under the responsibility of the purchaser.
Specific European Standards are available for applications involving special properties, such as corrosion resistance, toughness, fatigue strength, surface appearance or welding properties.
This document specifies two test methods for the determination of the resistance of the edges of brittle ceramic materials to be damaged by chipping.
This document is applicable to homogeneous monolithic ceramics with flat surfaces and straight sharp or chamfered edges.
This document specifies minimum requirements for the design and performance of stretchers and other patient handling equipment used in road ambulances for the handling and carrying of patients. It aims to ensure patient safety and minimize the physical effort required by staff operating the equipment.
This document specifies minimum requirements for the design and performance of heavy duty stretchers used in road ambulances for the treatment and transportation of patients. It aims to ensure patient safety and minimize the physical effort required by staff operating the equipment.
This document specifies minimum requirements for the design and performance of foldable patient transfer chairs, which are used for the conveyance of patients to and/or from road ambulances. It aims to ensure patient safety and to minimize the physical effort required by staff operating the equipment.
This document contains guidelines for developing and establishing policies and procedures for deletion of personally identifiable information (PII) in organizations by specifying:
— a harmonized terminology for PII deletion;
— an approach for defining deletion rules in an efficient way;
— a description of required documentation;
— a broad definition of roles, responsibilities and processes.
This document is intended to be used by organizations where PII is stored or processed.
This document does not address:
— specific legal provision, as given by national law or specified in contracts;
— specific deletion rules for particular clusters of PII that are defined by PII controllers for processing PII;
— deletion mechanisms;
— reliability, security and suitability of deletion mechanisms;
— specific techniques for de-identification of data.
This document specifies functional requirements and specific safety requirements in addition to the general safety standard EN 913 for gymnastic and vaulting boxes for individual or multifunctional use. This document also specifies requirements when multifunctional boxes are used in combination with accessories.
This document specifies the technical delivery conditions for corrosion-resistant alloy seamless products for casing, tubing, coupling stock and accessory material (including coupling stock and accessory material from bar) for two product specification levels:
PSL-1, which is the basis of this document;
PSL-2, which provides additional requirements for a product that is intended to be both corrosion and cracking resistant for the environments and qualification method specified in Annex G and in the ISO 15156 series or NACE MR0175.
This document contains no provisions relating to the connection of individual lengths of pipe. Demonstration of conformance to ISO 15156-3:2020 or NACE MR0175-2021 of material affected by end sizing, connection manufacture or welding operations is outside the scope of this document.
This document contains provisions relating to marking of tubing and casing after threading.
This document is applicable to the following five groups of products:
a) group 1, which is composed of stainless alloys with a martensitic or martensitic/ferritic structure;
b) group 2, which is composed of stainless alloys with a ferritic-austenitic structure, such as duplex and super-duplex stainless alloy;
c) group 3, which is composed of stainless alloys with an austenitic structure (iron base);
d) group 4, which is composed of nickel-based alloys with an austenitic structure (nickel base);
e) group 5, which is composed of bar only (Annex F) in age-hardened (AH) nickel-based alloys with austenitic structure.
This document specifies the safety requirements and measures for manually loaded and unloaded vertical panel circular sawing machines (defined in 3.1) capable of continuous production use, with hand feed or integrated feed, hereinafter referred to also as “machines”.
This document deals with all significant hazards, hazardous situations and events, as listed in Annex A, relevant to the machines, when operated, adjusted and maintained as intended and under the conditions foreseen by the manufacturer, including reasonably foreseeable misuse. Transport, assembly, dismantling, disabling and scrapping phases are also taken into account.
This document is also applicable to machines fitted with one or more of the following devices/additional working units, whose hazards have been dealt with:
— an integrated feed device;
— a device for scoring;
— an angle cutting device;
— a middle support device;
— programmable end stops for parallel vertical cuts;
— a device for grooving with a milling tool with a cutting width not exceeding 27 mm;
— a panel pusher;
— a panel lowering device;
— stop devices for workpiece during horizontal cuts.
The machines are designed for cutting panels consisting of:
a) solid wood;
b) material with similar physical characteristics to wood (see ISO 19085-1:2021, 3.2);
c) composite materials with core consisting, for example, of polyurethane or mineral material laminated with light alloy;
d) polymer-matrix composite materials and reinforced thermoplastic/thermoset/elastomeric materials;
e) gypsum boards, gypsum bounded fibreboards;
f) honeycomb aluminium boards;
g) matrix engineered mineral boards, silicate boards;
h) aluminium light alloy plates;
i) composite boards made from the materials listed above.
This document does not apply to machines
— with pressure beam and saw unit mounted behind the workpiece support,
— where the guide rails on which the saw unit moves vertically are fixed on the machine frame and the horizontal cut can only be made by manually feeding the panel,
— designed to cut in vertical direction only,
— automatically performing two or more cutting cycles in sequence,
— intended for use in potentially explosive atmosphere, and
— manufactured prior to the publication of this document.
This document specifies the safety requirements and measures for wide belt sanding machines (defined in 3.1) and for surface treating machines (defined in 3.2) capable of continuous production use, altogether referred to as “machines”.
This document deals with all significant hazards, hazardous situations and events, as listed in Annex A, relevant to the machines, when operated, adjusted and maintained as intended and under the conditions foreseen by the manufacturer, including reasonably foreseeable misuse. Transport, assembly, dismantling, disabling and scrapping phases are also taken into account.
This document is also applicable to machines fitted with one or more of the following devices/additional working units, whose hazards have been dealt with:
— transversal sanding unit;
— cleaning brushing unit;
— satining roller unit;
— disk brushing unit;
— texturing brushing roller unit;
— texturing brushing belt unit;
— cutterblock unit;
— texturing band saw unit;
— spiked roller unit;
— multi blade unit;
— conveyor directly controlled by the machine;
— additional workpiece vacuum clamping device;
— antistatic bar unit.
NOTE 1 An antistatic bar is a device that eliminates electrostatic charges on the workpiece to ease its subsequent cleaning from dust by airflow.
This document is also applicable to machines fitted with a laser engraving unit, but the specific hazards of this unit have not been dealt with.
The machines are designed to process workpieces with flat surface and even thickness, in shape of panels or beams or frames, consisting of:
a) solid wood;
b) material with similar physical characteristics to wood (see ISO 19085-1:2021, 3.2);
c) gypsum boards, gypsum bounded fibreboards;
d) composite materials with core consisting of, e.g. polyurethane or mineral material;
e) composite boards made from the materials listed above;
f) all materials listed above, already lacquered.
This document does not deal with hazards related to:
— specific devices other than those listed above;
— access through in-feed and out-feed openings of machines with a work piece height capacity greater than 700 mm;
— systems for powered loading or unloading, or both, of the workpiece to or from a single machine;
NOTE 2 Loading the machine manually includes manually placing the workpiece onto a conveyor directly controlled by the machine. Unloading the machine manually includes manually removing the workpiece from a conveyor directly controlled by the machine.
— out-feed workpieces on machines with feed speed higher than 60 m/min;
— interfacing of the machine with any other machine.
This document is not applicable to machines intended for use in a potentially explosive atmosphere and to machines manufactured prior to the date of its publication.
This document specifies the requirements and test methods for sterilized absorbent points used in endodontic procedures. Absorbent points are marketed sterilized or non-sterilized. The requirements apply to absorbent points which have been sterilized once in a manner approved by the manufacturer. This document specifies numerical systems and a colour-coding system for designating the sizes of absorbent points.
Clause 7 specifies the labelling and packaging needed, including the instructions for use. A claim by the manufacturer that the contents of the unopened pack are sterile is the responsibility of the manufacturer (see Table 2). This document does not specify requirements or test methods for sterility.
NOTE 1 Reference to applicable national regulations can be made.
Reference is made to internationally accepted pharmacopoeia.
NOTE 2 National requirements can apply.
Standards on methods of validating sterilization processes are also available: ISO 11137-1, ISO 11137-2 and ISO 11137-3.