Ämnesområden

Ämnesområden: Muttrar
Kommittébeteckning: SIS/TK 103 (Fästelement)
Källa: CEN
Svarsdatum: den 19 jan 2025
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ISO 7042:2012 specifies the characteristics of prevailing torque type all-metal hexagon high nuts with threads from M5 up to and including M36, in product grade A for threads up to and including M16 and product grade B for threads above M16, and with property classes 5, 8, 10 and 12.

Ämnesområden: Muttrar
Kommittébeteckning: SIS/TK 103 (Fästelement)
Källa: CEN
Svarsdatum: den 19 jan 2025
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ISO 7040:2012 specifies the characteristics of prevailing torque type hexagon regular nuts (with non-metallic insert) with threads from M3 up to and including M36, in product grade A for threads up to and including M16 and product grade B for threads above M16, and with property classes 5, 8 and 10.

Kommittébeteckning: SIS/TK 116 (Oorganiska ytbeläggningar)
Källa: ISO
Svarsdatum: den 19 jan 2025
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This document gives guidelines for prevention of hydrogen assisted brittle fracture resulting from the manufacturing process (internal hydrogen embrittlement (IHE)). This document is applicable for parts or components made of high strength steels. It also advises on the relationship between material selection, manufacture including heat treatment, and coating.

Ämnesområden: Kullager
Kommittébeteckning: SIS/TK 105 (Rullningslager)
Källa: ISO
Svarsdatum: den 20 jan 2025
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 This document specifies the dimensional and geometrical characteristics, boundary dimensions and tolerances of insert bearings and eccentric locking collars and the radial internal clearances of insert bearings.

Ämnesområden: Bränslesystem
Kommittébeteckning: SIS/TK 287 (Utrustning för bensinstationer)
Källa: CEN
Svarsdatum: den 21 jan 2025
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This document specifies the minimum requirements for the contents of the user manual for Automotive LPG propulsion systems fitted in road vehicles. This document does not cover the user manual for forklift trucks or other industrial machinery.

Ämnesområden: Leksaker
Kommittébeteckning: SIS/TK 392/AG 05 (Kemikalier i leksaker)
Källa: CEN
Svarsdatum: den 21 jan 2025
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This part of EN 71 specifies requirements for the substances and materials used in finger paints and applies to finger paints only. Additional requirements are specified for markings, labelling and containers.

NOTE EN 71-3 and EN 71-12 specify requirements and test methods for finger paints for the migration of certain elements (see F.4) and N-nitrosamines (see F.9).

Ämnesområden: Slip- och polermaskiner
Kommittébeteckning: SIS/TK 275 (Verktygsmaskiner - Säkerhet)
Källa: CEN
Svarsdatum: den 21 jan 2025
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This International Standard specifies the requirements and/or measures to eliminate the hazards or reduce the risks in the following groups of stationary grinding machines which are designed primarily to shape metal by grinding: Group 1: Manually controlled grinding machines without power operated axes and without numerical control. Group 2: Manually controlled grinding machines with power operated axes and limited numerically controlled capability, if applicable. Group 3: Numerically controlled grinding machines. NOTE 1 For detailed information on the groups of grinding machines, see the definitions in 3.1 and 3.4. NOTE 2 Requirements in this International Standard are, in general, applicable to all groups of grinding machines. If requirements are applicable to some special group(s) of grinding machines only, then the special group(s) of grinding machine(s) is/are specified. This International Standard covers the significant hazards listed in Clause 4 and applies to ancillary devices (e.g. for workpieces, tools and workpiece clamping devices, handling devices), which are integral to the machine. This International Standard also applies to machines which are integrated into an automatic production line or grinding cell inasmuch as the hazards and risks arising are comparable to those of machines working separately. This International Standard also includes in Clause 7 a minimum list of safety-relevant information which the manufacturer has to provide to the user. See also ISO 12100:2010, Figure 2, which illustrates the interaction of manufacturer’s and user’s responsibility for the operational safety. The user's responsibility to identify specific hazards (e.g. fire and explosion) and reduce the associated risks can be critical (e.g. whether the central extraction system is working correctly). Where additional metalworking processes (e.g. milling, turning, laser processing) are involved, this International Standard can be taken as a basis for safety requirements. For specific information on hazards arising from other metalworking processes, which are covered by other International Standards, see the Bibliography. This International Standard applies to machines that are manufactured after the date of issue of this International Standard. This International Standard does not apply to stationary honing, polishing and belt grinding machines and not to transportable motor-operated electric tools in accordance with IEC 61029-2-2 and IEC 61029-2-10. 

Ämnesområden: Skyddsskor
Kommittébeteckning: SIS/TK 397/AG 01 (Skyddsskor)
Källa: CEN
Svarsdatum: den 21 jan 2025
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 This document specifies requirements and test methods for metallic toecaps, intended to function as components of PPE footwear (e.g. as described by ISO 20345 and ISO 20346).

Ämnesområden: Verktygsmaskiner: allmänt
Kommittébeteckning: SIS/TK 275 (Verktygsmaskiner - Säkerhet)
Källa: CEN
Svarsdatum: den 21 jan 2025
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This International Standard specifies the requirements and/or measures to eliminate the hazards or reduce the risks in the following groups of turning machines and turning centres, which are designed primarily to shape metal by cutting. — Group 1: Manually controlled turning machines without numerical control. — Group 2: Manually controlled turning machines with limited numerically controlled capability. — Group 3: Numerically controlled turning machines and turning centres. — Group 4: Single- or multi-spindle automatic turning machines. NOTE 1 For detailed information on the machine groups, see the definitions in 3.5, features and limitations in 5.1.1 and mandatory and optional modes of operation in 5.1.2.1. NOTE 2 Requirements in this International Standard are, in general, applicable to all groups of turning machines. If requirements are applicable to some special group(s) of turning machines only, then the special group(s) of turning machine(s) is/are specified. NOTE 3 The automatic exchange of clamping devices are excluded from this standard This international standard takes account of intended use, including reasonably foreseeable misuse, maintenance, cleaning, and setting operations. It specifies access conditions to operators positions and manual load/unload stations. It presumes accessibility to the machine from all directions. It describes means to reduce risks to operators and other exposed persons. This international standard also applies to workpiece transfer devices including transport devices for loading/unloading when they form an integral part of the machine. This international standard deals with significant hazards relevant to turning machines when they are used as intended and under the conditions foreseen by the manufacturer (see 4). Risk analysis of hazards arising from other metal working processes (e.g. grinding, milling, friction welding, forming, electro discharge, laser processing) are covered by other standards (see Bibliography). However, if additional milling and grinding operations are provided hazard arising from additional clamping condition and ejection of parts shall be considered. This International Standard also applies to machines which are integrated into an automatic production line or turning cell in as much as the hazards and risks arising are comparable to those of machines working separately. This International Standard also includes a minimum list of safety-relevant information which the manufacturer has to provide to the user. See also ISO 12100:2010, Figure 2, which illustrates the interaction of manufacturer's and user's responsibility for the operational safety. The user's responsibility is to identify specific hazards (e.g. fire and explosion) and reduce the associated risks can be critical (e.g. whether the central extraction system is working correctly). This International Standard applies to machines that are manufactured after the date of issue of this International Standard.

Ämnesområden: Termoplastmaterial
Kommittébeteckning: SIS/TK 156/AG 03 (Material)
Källa: CEN
Svarsdatum: den 22 jan 2025
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ISO 294-5:2017 specifies a mould (designated the type F ISO mould) for the injection moulding of plates with a preferred size of 80 mm × 120 mm and a minimum size of 80 mm × ≥90 mm and with a preferred thickness of 2 mm for single-point and multi-point data acquisition. It has been found to provide the maximum anisotropic properties, with only a slight sensitivity to the rate of injection. Whenever possible, a two cavity mould is intended to be used. For the design of plastic parts, this will provide upper and lower bounds for the tensile properties. Matching the plate thickness to a given part thickness is not a suitable criterion because of the effect of mould filling rate and part geometry on anisotropy. Investigation of the anisotropy of materials is a special procedure intended to provide guidance in the design of mouldings for end-use applications and is not intended as a quality control tool. In the injection moulding of thermoplastic materials, the flow of molten polymer can influence the orientation of fillers such as fibreglass or the orientation of polymer chains, resulting in anisotropic behaviour. For the purposes of ISO 294-5:2017, the flow direction is defined as the direction from the gate to the far end of the mould cavity and the cross direction as the direction perpendicular to the flow direction. The type F mould is not intended to replace the type D mould used to determine the moulding shrinkage of thermoplastics.

Ämnesområden: Dentala implantat
Kommittébeteckning: SIS/TK 327 (Tandvård)
Källa: CEN
Svarsdatum: den 24 jan 2025
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This document specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for an endosseous dental implant that may include:

— implant body,

— implant abutment,

— abutment screw,

— implant connecting part

— implant connecting part screw

— prosthetic screw,

— implant cover screw,

— transmucosal healing component.

 

This document includes requirements for intended use and performance, design attributes, components, biocompatibility, manufacturing, packaging, sterilization, shelf life, marking, labelling and information supplied by the manufacturer.

 

The following devices are not included within the scope of this document:

— Dental implant incorporating animal or human components or bioactive characteristics,

— Custom-made devices that have no pre-fabricated connection,

— Implantable materials for bone filling and augmentation in oral and maxillofacial surgery,

— Membrane materials for guided tissue regeneration in oral and maxillofacial surgery,

— Specific instruments indicated to be used as part of a dental implant system.

 

NOTE 1 ISO 22794 gives the necessary content of technical files for implantable materials for bone filling and augmentation in oral and maxillofacial surgery. ISO 22803 gives the necessary content of technical files for membrane materials for guided tissue regeneration in oral and maxillofacial surgery. These materials require a separate technical file.

 

NOTE 2 ISO 13504 gives the general requirements for specific instruments indicated to be used as part of a dental implant system. These instruments require a separate technical file.

 

NOTE 3 Custom made devices are defined in the following document IMDRF/PMD WG/N49 - Definitions for Personalized Medical Devices.

Kommittébeteckning: SIS/TK 623 (Biologisk mångfald)
Källa: CEN
Svarsdatum: den 29 jan 2025
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Building on the consolidated definitions of NBS, this document proposes a classification of NBS to support the development of an agreed terminology, the basis of the standardization process.

Ämnesområden: Tandvårdsmaterial
Kommittébeteckning: SIS/TK 327 (Tandvård)
Källa: CEN
Svarsdatum: den 6 feb 2025
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This document specifies the classification, requirements and test methods for endodontic sealing materials used in dentistry.

 

This document is applicable to materials used for conventional orthograde endodontic sealing (Type 1) and materials used for other endodontic sealing procedures including apexification, perforation filling, resorption, or retrograde root-end filling (Type 2).

 

The Type 2 endodontic sealing materials may be used for vital pulp therapy. However, this document does not address or include requirements for vital pulp therapy.

 

This document does not specify requirements or test methods for sterility.

 

NOTE 1 Reference to applicable national regulations and internationally accepted pharmacopoeias can be made.

NOTE 2 National requirements regarding sterilization processes, if available, can be used. Standards on methods of validating sterilization processes are also available: ISO 11737-1, ISO 11737-2 and ISO 11737-3.