Toimialayhteisöt

 

This document is applicable to efficient particulate air filters (EPA), high efficiency particulate air filters (HEPA) and ultra-low penetration air filters (ULPA) used in the field of ventilation and air conditioning and for technical processes, e.g. for applications in clean room technology or pharmaceutical industry. This document establishes a procedure for the determination of the efficiency on the basis of a particle counting method using a liquid (or alternatively a solid) test aerosol and allows a standardized classification of these filters in terms of their efficiency, both local and integral efficiency. This document is based on particle counting methods which actually cover most needs of different applications.

 

1.1 This document specifies the safety requirements for lifting tables which fulfil the following characteristics: — serving no more than 2 fixed landings but able to pass a fixed landing and, — having a vertical travel speed of no more than 0,15 m/s, unless the lifting table is safe by position and, — raising or lowering goods (with or without operator(s) and/or authorized person(s)) with a fixed, movable or mobile lifting table or, — raising or lowering operator(s) and/or authorized person(s) with or without goods, to positions where they can carry out work from a fixed lifting table that is guided throughout its vertical travel only. 1.2 This document specifies the appropriate technical measures for eliminating and reducing the risks arising from the significant hazards listed in Annex B. 1.3 This document does not apply to the following equipment: — lifting tables with a vertical travel speed exceeding 0,15 m/s, unless the lifting table is safe by position; — lifting tables, serving more than 2 fixed landings of a construction, for lifting goods, with a vertical travel speed not exceeding 0,15 m/s (EN 1570 2:2016); — lifting tables, serving more than 2 fixed landings of a construction, for lifting operators, with a vertical travel speed not exceeding 0,15 m/s; — lifting tables carrying operators and installed in full enclosures with a vertical travel speed not exceeding 0,15 m/s; — lifting tables used on ships; — lifting tables designed for artists and stage set features during artistic performances (EN 17206:2020); — power operated lifting platforms for persons with impaired mobility (EN 81 41:2010); — mobile lifting tables for airport ground support equipment (EN 1915 2:2001+A1:2009 and EN 12312 1:2013); — mobile elevating work platforms (EN 280 1:2022); — vehicle servicing lifts (EN 1493:2022); — mobile lifting tables used for firefighting (EN 1777:2010); — mobile lifting tables with a horizontal travelling speed of more than 1,6 m/s; — rail dependent storage and retrieval equipment (EN 528:2021); — scissor lift pallet trucks (EN ISO 3691 5:2015); — lifting tables suspended from a ceiling. 1.4 This document does not consider the requirements for: — operation in severe conditions (e.g. extreme climates, freezer applications, strong magnetic fields); — operation subject to special rules (e.g. potentially explosive atmospheres, mines); — handling of loads, the nature of which could lead to dangerous situations (e.g. molten metal, acids, radiating materials, particularly brittle loads, loose loads (gravel, tubes)); — hazards occurring during construction, transportation, and disposal; — equipment installed on the load platform or the replacing or maintaining of it; — integration into broader systems or other machines, etc.; — cable-less controls, i.e. wireless; — lifting tables where the hydraulic pressure is derived directly from gas pressure; — lifting tables powered by internal combustion engines. This document is not applicable to lifting tables manufactured before the date of its publication.

 

1.1 This document specifies the constructional requirements for fans constructed to Group II G (of explosion groups IIA, IIB and hydrogen) categories 1, 2 and 3, and Group II D categories 2 and 3, intended for use in explosive atmospheres. NOTE 1 Operation conditions for the different categories of fans used in this document are defined in Clause 4. 1.3 This document specifies requirements for design, construction, testing and marking of complete fan units intended for use in potentially explosive atmospheres in air containing gas, vapour, mist and/or dusts. Such atmospheres can exist inside (the conveyed atmosphere (flammable or not)), outside, or inside and outside of the fan. This document covers mechanical equipment, in particular fans. The “type of protection” as specified in EN ISO 80079 37:2016 is constructional safety. 1.4 This document is applicable to fans working in ambient atmospheres and with normal atmospheric conditions at the inlet, having — absolute pressures ranging from 0,8 bar to 1,1 bar, — and temperatures ranging from -20 °C to +60 °C, — and maximum volume fraction of 21 % oxygen content, — and an aerodynamic energy increase of less than 25 kJ/kg. NOTE 1 25 kJ/kg is equivalent to 30 kPa at inlet density of 1,2 kg/m3. This document can also be helpful for the design, construction, testing and marking of fans intended for use in atmospheres outside the validity range stated above or in cases where other material pairings need to be used. In this case, the ignition risk assessment, ignition protection provided, additional testing (if necessary), manufacturer's marking, technical documentation and instructions to the user, clearly demonstrate and indicate the equipment's suitability for the conditions the fan can encounter. NOTE 2 Temperatures below -20 °C can be considered. Material suitability can require specific evaluation for these temperatures. With lower temperature the explosion pressure increases, which leads to increased test pressures (see A.3) and can require specific testing. Although the standard atmospheric conditions in EN ISO 80079 36:2016 give a temperature range for the atmosphere of -20 °C to +60 °C the normal ambient temperature range for the equipment is -20 °C to +40 °C unless otherwise specified and marked. 1.5 This document does not apply to: — group I fans (fans for mining); — explosion group IIC (other than hydrogen); — category 1D fans; — cooling fans or impellers on rotating electrical machines; — cooling fans or impellers on internal combustion engines, vehicles or electric motors. NOTE 3 Measures for category 1D fans are given in EN 1127 1:2019. NOTE 4 Measures for explosion group IIC (other than hydrogen) are given in EN 1127 1:2019. NOTE 5 Measures for explosion group I are given in EN ISO/IEC 80079 38:2016 and EN 1127 2:2014.

 

This document applies to hot rolled and cold rolled non-coated steel flat products made of multiphase steels for cold forming. It covers cold rolled products of thicknesses t < 3 mm and hot rolled products of thicknesses t = 6,5 mm. These products are delivered in sheet, hot rolled strip, slit hot rolled strip, cold strip, slit cold rolled strip or cut lengths obtained from slit wide strip. Flat products of multiphase steels for cold forming can be delivered with an electrolytic zinc coating according to EN 10152.

 

This document specifies the requirements of energy-based green ITS services on nomadic devices not only for encouraging eco-friendly driving to bus drivers but also for operating public transportation within the city in order to achieve efficient energy use and CO2 emissions reduction. This document defines the service framework for sustainable urban public transport operation and management which includes the following; — eco-friendly driving factors and indices applicable to drivers of urban public transport (i.e. buses) — indicators to monitor eco-friendly driving behaviours of urban public transport (i.e. buses) according to the guidelines provided to the drivers This document also defines the data, interfaces, and functions of the framework for urban public transport operations and management utilizing nomadic devices between users, service providers, data platform, and cloud server.

 

This document specifies a procedure for determining the loading level of a qualification test of a launch vehicle structure and takes into account all the minimum allowable strength characteristics necessary for these structures.

 

This document specifies requirements applicable to data and data quality of business transactions, events, measurements and sensor readings. These requirements apply to transaction data in most industrial contexts. The following are within the scope of this document: the different types of transaction data - events, certificates, measurements, sensor readings and business transactions; the nature of transaction data quality; changes to transaction data quality over time; managing transaction data quality. The following are out of scope of this document: the quality and effectiveness of the transaction itself; changes to master data arising from a transaction. NOTE 1 Where the word transaction is used in this standard it refers to "business transaction". NOTE 2 Quality of measurement data and sensor readings is described in more detail in ISO 8000-210:2024 [8], ISO 8000-220[9] and ISO 8000-230. NOTE 3 This standard relates to quality of data about transactions which contributes to the trustworthiness of a transaction, whereas cenelec:proj:82029EN 18235-1:2026 Trusted data transactions - Part 1: Terminology, concepts and mechanismsprEN 18235-2 (WI=JT025008) Trusted Data Transactions - Part 2: Trustworthiness requirements relate to transactions about data and does not conflict with or overlap but benefit from this standard. NOTE 4 ISO/IEC 15944-9:2023 [10] provides useful information about traceability.

 

Tätä standardia sovelletaan kohdan 1.2.6 mukaisten vaarattomien aineiden ja kohdan 1.2.7 mukaisten vaarallisten aineiden vaunusailiöiden ja säiliökonttien tyhjennysasemaan, jossa säiliö tyhjennetään johtamalla siihen paineilmaa tai paineenalaista inerttikaasua, josta seuraavassa käytetään nimitystä PAINEKAASU. Tämä standardi ei koske vaarallisten aineiden kuljetusmääräysten luokkien 1, 2 eikä 7 aineiden tyhjennysasemaa. Tähdellä (*) merkityt standardin kohdat koskevat ainoastaan sellaista tyhjennysasemaa, jossa käsitellään kohdassa 1.2.7 määriteltyä vaarallista ainetta. Ilman tähteä olevat standardin kohdat koskevat sekä vaarallisten että vaarattomien aineiden tyhjennysasemia. Kuljetusvälineeseen sijoitettuihin tyhjennyslaitteisiin, tilapäiseen tyhjennysasemaan sekä siirtokuormaukseen (vaunusäiliöstä tai säiliökontista toiseen) sovelletaan tätä standardia valvontaviranomaisten määräämässä laajuudessa. Lisäksi on kohdassa 6 paineella tyhjennettävän vaunusäiliön ja säiliökontin paineetonta täyttöä koskevia ohjeita.

 

Standardi esitetään kumottavaksi vanhentuneena

SFS:n tehtävänä on ylläpitää ajantasaista suomalaista SFS-standardikokoelmaa.

Tällä lausuntopyynnöllä pyritään selvittämään, tulisiko tämä SFS-standardi kumota vanhentuneena.

Vastaa kohdassa "Ota kantaa", tulisiko tämä SFS-standardi kumota.

(Hyväksyn = hyväksyn tämän standardin kumoamisen vanhentuneena.)

 

This document specifies requirements for the biobanking of human mesenchymal stromal cells derived from umbilical cord tissue (i.e. Wharton’s jelly), further referred to as hUC-MSCs, including the collection of umbilical cord tissue and associated data, isolation, culture characterization, quality control, cryopreservation, storage, thawing, disposal, distribution and transport..This document is applicable to all organizations performing biobanking of hUC-MSCs used for research and development. This document does not apply to hUC-MSCs for the purpose of in vivo application in humans, clinical applications or therapeutic use. NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.

 

This document specifies requirements for the biobanking of human mesenchymal stromal cells derived from bone marrow (hBM-MSCs), including the collection of bone marrow and associated data, isolation, culture, characterization, quality control, cryopreservation, storage, thawing, disposal, distribution and transport. This document is applicable to all organizations performing biobanking with hBM-MSCs used for research. This document does not apply to hBM-MSCs for the purpose of in vivo application in humans, cell therapy, clinical applications, tissue engineering or therapeutic use. NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.

 

This document specifies requirements for empty, sterile, single-use syringe, and needles attached or not to the syringe, intended solely for the withdrawal and injection of fluids of a drug or a substance into an eye or its tissues or into an ocular implantable device. It covers devices intended for single use only that comprises, but not limited to, configurations of co-packaged devices, device kits, syringe with fixed needle, transfer needle, and injection needle, with or without a filter membrane. The syringes are intended to be used immediately after filling and are not intended to store the drug or the substance. This document does not preclude the use of platform delivery systems validated for multiple ophthalmic clinical indications, provided that the device complies with all specific provisions of this standard for its intended intraocular use-case. This document does not specify materials to be used for the construction and lubrication of sterile syringes and needles intended for ophthalmic use because their selection will depend, to some extent, upon the manufacturer’s specific design, process of manufacture, and sterilization method. This document excludes any other application other than ophthalmic tissue injections and excludes syringes which are pre-filled, e.g. pre-filled syringes are covered within ISO 11040 series. Non-invasive route of administration and its drug delivery type of devices like eye droppers or contact lenses are not considered as an injection and therefore out of scope of this document.