Ämnesområden

Kommittébeteckning: SIS/TK 602 (Patientdelaktighet i personcentrerad vård)
Källa: CEN
Svarsdatum: den 15 nov 2025
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• Är standarden bra som den är och kan den därmed tillstyrkas (och gälla i ytterligare fem år)?
• Eller behöver den revideras, eller kanske till och med upphävas?
• Är någon av kommittédeltagarna beredd att delta i arbetet om beslut fattas om revidering?
• Hänvisas till standarden i svensk författningstext?
• Har Sverige beviljats en A-avvikelse (A-deviation) från denna standard, och i så fall, gäller den avvikelsen fortfarande? SIS/TK beslutar, genom konsensus, om vad SIS ska svara.

Vänligen bortse från texten i informationsrutan nedan.

 

Ämnesområden: Lyftkranar
Kommittébeteckning: SIS/TK 262 (Lyftkranar)
Källa: CEN
Svarsdatum: den 15 nov 2025
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This document applies to: — light crane systems, either suspended or free-standing systems, where the rated capacity of any single hoist mechanism is 4 t or less; — pillar- and wall-mounted jib cranes, without an operator's cabin, whose rated capacity is 10 t or less and whose overturning load moment is 500 kNm or less. NOTE 1 For illustration of crane types, see Annex C. This document is not applicable to cranes covered by another product specific crane standard, e.g. EN 15011:2020 or EN 14985:2012, see Annex E. This document is applicable to cranes and crane systems, whose structures are made of steel or aluminium, excluding aluminium structures containing welded joints. This document gives requirements for all significant hazards, hazardous situations and events relevant to cranes, when used as intended, foreseeable misuse and under foreseen conditions (see Annex A). NOTE 2 Automated operation can be subject to additional requirements. Guidance is given in Annex F. The specific hazards due to potentially explosive atmospheres, ionizing radiation, operation in electro-magnetic fields beyond the range of EN IEC 61000-6-2:2019 and operation in pharmacy or food industry are not covered by this document. This document does not cover hazards related to the lifting of persons. This document is not applicable to cranes manufactured before the date of its publication.

Kommittébeteckning: SIS/TK 410 (Vätgasteknik)
Källa: ISO
Svarsdatum: den 17 nov 2025
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This document specifies the requirements for rubber O-rings and their housing dimensions, which seal gaseous hydrogen, in high-pressure hydrogen devices for gaseous hydrogen fuelling stations, such as valves, filters, joints, breakaways and other such devices. This document is applicable to O-rings suitable for sealing hydrogen gas of up to 70 MPa nominal working pressure, in the operating temperature range of −40 °C to 65 °C.

This document contains safety requirements for the design of O-rings and their housing dimensions, compound design, and test methods for seal systems. This document applies to newly manufactured O-rings for hydrogen gas seal in high-pressure hydrogen devices used in hydrogen fuelling stations.

NOTE 1       This document was developed using the ISO 3601 series.

NOTE 2       This document was developed based on several temperature classes of rubber O-rings suitable for use with high-pressure hydrogen seals in devices for gaseous hydrogen stations.

NOTE 3       The operating temperature is not a temperature of the hydrogen gas to be sealed by the O-ring gas seal system. Regardless of the operating temperature, the hydrogen gas temperature to be sealed can rise up to 180 °C.

NOTE 4       The O-ring seal system for the high-pressure hydrogen devices are designed by the device manufacturers. The detailed specifications of the O-rings and design of static or non-static high-pressure hydrogen seal systems for the high-pressure hydrogen devices are determined as agreed upon between the interested parties by referring to this document.

Ämnesområden: Mjölk. Mjölkprodukter
Kommittébeteckning: SIS/TK 998 (Standardiseringsarbete utan svenskt deltagande)
Källa: CEN
Svarsdatum: den 17 nov 2025
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ISO 16958:2015 specifies a method for the quantification of individual and/or all fatty acids in the profile of milk, milk products, infant formula and adult nutritional formula, containing milk fat and/or vegetable oils, supplemented or not supplemented with oils rich in long chain polyunsaturated fatty acids (LC-PUFA). This also includes groups of fatty acids often labelled [i.e. trans fatty acids (TFA), saturated fatty acids (SFA), monounsaturated fatty acids (MUFA), polyunsaturated fatty acids (PUFA), omega-3, omega-6 and omega-9 fatty acids] and/or individual fatty acids [i.e. linoleic acid (LA), α-linolenic acid (ALA), arachidonic acid (ARA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)]. The determination is performed by direct transesterification in food matrices, without prior fat extraction, and consequently it is applicable to liquid samples or reconstituted powder samples with water having total fat ≥ 1,5 % m/m. The fat extracted from products containing less than 1,5 % m/m fat can be analysed with the same method after a preliminary fat extraction using methods referenced in Clause 2. Dairy products, like soft or hard cheeses with acidity level ≤ 1 mmol/100 g of fat, can be analysed after a preliminary fat extraction using methods referenced in Clause 2. For products supplemented or enriched with PUFA with fish oil or algae origins, the evaporation of solvents should be performed at the lowest possible temperature (e.g. max. 40 °C) to recover these sensitive fatty acids.

Ämnesområden: Textilfibrer: allmänt
Kommittébeteckning: SIS/TK 160/AG 12 (Kemi)
Källa: CEN
Svarsdatum: den 17 nov 2025
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This document specifies a common method for the quantitative chemical analysis of various mixtures of fibres. This method and the methods described in the other parts of ISO 1833 are applicable, in general, to fibres in any textile form. Where certain textile forms are excepted, these are listed in the scope of the appropriate part.

Ämnesområden: Textilfibrer: allmänt
Kommittébeteckning: SIS/TK 160 (Textil)
Källa: CEN
Svarsdatum: den 17 nov 2025
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This document specifies a qualitative procedure to qualifying leather animal species of (fibrous) protein from leather by MALDI-TOF mass spectrometer (MS). The composition of other fibres can be measured by methods described in the ISO 1833 series. Both results are then combined to determine the whole composition of fibres (see Annex C as an example of mixtures of (fibrous) protein from leather and polyester). The method is based on a preliminary identification, by light microscopy, of all fibres in a blend on the basis of their morphology, according to ISO/TR 11827.

Ämnesområden: Övrig medicinsk utrustning
Kommittébeteckning: SIS/TK 340/AG 02 (Biologisk säkerhet)
Källa: CEN
Svarsdatum: den 18 nov 2025
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This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of human origin. The materials are non-viable or have been rendered non-viable. The document specifies, in junction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing human tissues or derivatives such as: a) contamination by bacteria, moulds or yeasts; b) contamination by viruses; c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE); d) material responsible for undesired pyrogenic, immunological or toxicological reactions. For parasites and other unclassified pathogenic entities, similar principles can apply. This document does not stipulate levels of acceptability, because they are determined by a multiplicity of factors. This document does not specify a quality management system for the control of all stages of production of medical devices.

Kommittébeteckning: SIS/TK 643 (Rymdteknik)
Källa: CEN
Svarsdatum: den 18 nov 2025
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This document specifies the characteristics, test methods, qualification and acceptance conditions of single and multicore electric cables, without jackets, for general purpose with conductors in copper or copper alloy, intended for installation in aircraft circuits. The insulation of these cables is designed to withstand aircraft voltages at a frequency not exceeding 2 000 Hz. Unless specified by individual product standards the maximum demonstrated A.C. voltage of rating of these cables is 115 V RMS (phase to neutral) and 200 V RMS (phase to phase). They are divided into types, the characteristics of which are given in the product standards. Unless otherwise specified in the product standard, the tests defined in this document apply.

Ämnesområden: Bultar, skruvar
Kommittébeteckning: SIS/TK 643 (Rymdteknik)
Källa: CEN
Svarsdatum: den 18 nov 2025
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This document specifies the requirements for offset cruciform recess pan head screws with relieved shank and long thread in heat resisting steel FE-PA92HT, silver plated, tensile strength class 900 MPa at room temperature. The maximum test temperature of the material is 650 °C.

Ämnesområden: Bultar, skruvar
Kommittébeteckning: SIS/TK 643 (Rymdteknik)
Källa: CEN
Svarsdatum: den 18 nov 2025
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This document specifies the characteristics of bolts, normal hexagonal head, coarse tolerance normal shank, medium length thread, in heat resisting nickel base alloy, aluminium IVD coated. Classification: 1 250 MPa / 425 °C

Kommittébeteckning: SIS/TK 643 (Rymdteknik)
Källa: CEN
Svarsdatum: den 18 nov 2025
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The EN 4500 series specifies the rules for the drafting and presentation of metallic material standards for aerospace applications. This Part 001 specifies the “General rules” framework valid for all parts.

Ämnesområden: Lim
Kommittébeteckning: SIS/TK 643 (Rymdteknik)
Källa: CEN
Svarsdatum: den 18 nov 2025
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This document specifies the test method to determine the flow behaviour of structural adhesives supplied in the form of adhesive films. This document is applicable: — to check the flow behaviour of adhesives; — for determining the alteration in flow behaviour of adhesives depending on storage time; — for determining environmental influences on flow behaviour.

Kommittébeteckning: SIS/TK 643 (Rymdteknik)
Källa: CEN
Svarsdatum: den 18 nov 2025
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The EN 4500 series specifies the rules for the drafting and presentation of metallic material standards for aerospace applications. This Part 002 specifies the “Specific rules for aluminium, aluminium alloys and magnesium alloys”.

Kommittébeteckning: SIS/TK 643 (Rymdteknik)
Källa: CEN
Svarsdatum: den 18 nov 2025
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The EN 4500 series specifies the rules for the drafting and presentation of metallic material standards for aerospace applications. This Part 003 specifies the “Specific rules for heat resisting alloys”.

Kommittébeteckning: SIS/TK 643 (Rymdteknik)
Källa: CEN
Svarsdatum: den 18 nov 2025
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The EN 4500 series specifies the rules for the drafting and presentation of metallic material standards for aerospace applications. This Part 004 specifies the “Specific rules for titanium and titanium alloys”.

Ämnesområden: Stål
Kommittébeteckning: SIS/TK 643 (Rymdteknik)
Källa: CEN
Svarsdatum: den 18 nov 2025
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The EN 4500 series specifies the rules for the drafting and presentation of metallic material standards for aerospace applications. This Part 005 specifies the “Specific rules for steels”.

Kommittébeteckning: SIS/TK 643 (Rymdteknik)
Källa: CEN
Svarsdatum: den 18 nov 2025
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The EN 4500 series specifies the rules for the drafting and presentation of metallic material standards for aerospace applications. This Part 006 specifies the "Specific rules for filler metals for brazing".

Kommittébeteckning: SIS/TK 643 (Rymdteknik)
Källa: CEN
Svarsdatum: den 18 nov 2025
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This document specifies the general characteristics, the conditions for qualification, acceptance and quality assurance, as well as the test programs and groups for rectangular connectors with one or multiple removable modules, intended for use in a temperature range from −55 °C to 175 °C continuous. This family of connectors is particularly suitable for aeronautic use in zones of severe environmental conditions on board aircraft, applying EN 2282. The maximum in-service temperature can be limited by maximum temperature of contacts.