Eurooppalaisen standardoinnin työohjelma vuodelle 2024 – YTL:n asioita
CEN on julkaissut työohjelman vuodelle 2024, tässä otteita YTL:n näkökulmasta
Yhteisen toimialaliiton standardointi jakaantuu 5 toimialaan – liikenne ja logistiikka, urheilu ja vapaa-aika, terveydenhuolto ja hyvinvointi, ympäristöhuolto sekä rakennuslasit.
CEN (European Committee for Standardization) työohjelman mukaan YTL:n standardointi jakaantuu monialaisesti:
- Kemikaalit (renkaiden kierrätys, sähkötupakat)
- Rakentaminen (lasirakenteet, eurokoodit, puhdastilat, katsomorakenteet, liikuntapaikkojen pintarakenteet)
- Kuluttaja (urheiluvälineet, kotitalouksien uima-altaat)
- Turvallisuus (alkometrit)
- Energia (jätehuolto, kierrätyspolttoaineet)
- Ruoka ja maatalous (ruokailuvälineet, kalastusvälineet (kierrätys))
- Terveydenhuolto (lääkinnälliset laitteet ja palvelut, hammaslääketiede, in vitro diagnostiikka, silmälääketiede, laitteiden sterilointi, pelastusjärjestelmät, anestesia, desinfiointiaineet, implantit, terveyspalvelujen laatu, vammaisten apuvälineet, vanhuspalvelut, potilaskeskeinen hoito, esteettinen kirurgia, eläintautidiagnostiikka, lääketieteellinen kuvantaminen)
- Koneet ja laitteet (laboratoriolaitteet, varastosäiliöt ja tankkausasemat)
- Palvelut (postipalvelut, kosmetologia, tatuointi, hautauspalvelut, opaskoirat)
- Liikenne (ajoneuvot, raideliikenne, älyliikenne, logistiikka, matkailuautot ja -vaunut, kuormansidonta, kontit, vaarallisten aineiden kuljetussäiliöt, hyperloopit)
- Saavutettavuus (vammaisten apuvälineet, logistiika, opaskoirat, katsomorakenteet)
- Kestävä kehitys (jätehuolto, kierrätyspolttoaineet, renkaiden kierrätys, kalastusvälineet (kierrätys))
- Älykäs yhteiskunta (älyliikenne)
Koko työohjelma on luettavissa täältä(avautuu uuteen ikkunaan, siirryt toiseen palveluun)
Tässä nostoja YTL:n standardointialueilta CENin 2024 – työohjelmasta:
The EN ISO 20957 series on Stationary training equipment is developed by CEN/TC 136 ‘Sports, playground and other recreational facilities and equipment’ (in parallel with ISO/TC 83 ‘Sports and other recreational facilities and equipment’) under M/506 in support of the General Product Safety legislation (2001/95/EC).
CEN/TC 204 ‘Sterilization of medical devices’(avautuu uuteen ikkunaan, siirryt toiseen palveluun) will continue to support the development of harmonized standards to support manufacturers aiming to build products compliant with the Medical Devices and In Vitro Diagnostic Regulations. The TC will also mirror ISO/TC 198 ‘Sterilization of health care products’ on key projects such as:
- EN ISO 17664-2 ‘Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices’;
- EN ISO 11135 ‘Sterilization of health care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices’;
- EN ISO 11137 series ‘Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices’.
- The EN 556 series ‘Sterilization of medical devices – Requirements for medical devices to be designated ”STERILE”’ will also be published in 2024.
Another TC active in this sector, CEN/TC 102 ’Sterilizers and associated equipment for processing of medical devices’(avautuu uuteen ikkunaan, siirryt toiseen palveluun), in 2024 will work on the following documents:
- The first edition of EN 17180 ’Sterilizers for medical purposes – Low temperature vaporized hydrogen peroxide sterilizers – Requirements and testing’;
- The revision of EN 14180 ‘Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – Requirements and testing’;
- The revision of EN 1422 ‘Sterilizers for medical purposes – Ethylene oxide sterilizers – Requirements and test methods’.
Three of TC 102’s Working Groups, WG 4 ‘Packaging’(avautuu uuteen ikkunaan, siirryt toiseen palveluun), WG 7 ‘Biological and chemical indicators’(avautuu uuteen ikkunaan, siirryt toiseen palveluun), and WG 8 ‘Washer-disinfectors’(avautuu uuteen ikkunaan, siirryt toiseen palveluun) will support the revision of:
- EN ISO 11607 series ‘Packaging for terminally sterilized medical devices’;
- EN ISO 11138 ‘Sterilization of health care products – Biological indicators’;
- The EN ISO 11140 ‘Sterilization of health care products – Chemical indicators’ and EN ISO 15883 ‘Washer-disinfectors’ series to meet the requirements of the MDR and develop the Annexes Z.
Moreover, CEN/TC 102 expects to finalize the below standards over the course of 2024:
- EN 14180 ’Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – Requirements and testing’;
- EN 17180 ’Sterilizers for medical purposes – Low temperature vaporized hydrogen peroxide sterilizers – Requirements and testing’;
- EN 13060 ’Small steam sterilizers’;
- EN ISO 15883-2 ‘Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices’;
- EN ISO 15883-3 ‘Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers’;
- EN ISO 11139 ‘Sterilization of health care products – Vocabulary of terms used in sterilization and related equipment and process standards – Amendment 1’.
CEN/TC 140 ‘In vitro diagnostic medical devices’(avautuu uuteen ikkunaan, siirryt toiseen palveluun) intends to complete the following standards by 2024:
- The EN ISO 18113-series ‘In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling)’;
- FprEN ISO 20916 ‘In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916:2019)’.
Finally, CEN/TC 206 ‘Biological and clinical evaluation of medical devices’(avautuu uuteen ikkunaan, siirryt toiseen palveluun) will continue with the revision of several standards of the EN ISO 10993 series. This series lays down the general principles governing the biological evaluation of medical devices within a risk management process.
CEN/TC 215 ‘Respiratory and anaesthetic equipment’(avautuu uuteen ikkunaan, siirryt toiseen palveluun) will develop some key standards. Among them, it expects to make headways on a new project, ISO 80601-2-93 ‘Medical electrical equipment – Part 2-93: Particular requirements for basic safety and essential performance of inhalational therapy nebulizer equipment’.
The Committee will also launch the development of harmonized standards to include in Annex Z specifically for:
- ISO EN 5359 ‘Anaesthetic and respiratory equipment – Low-pressure hose assemblies for use with medical gases’;
- and EN ISO 18562 series on ‘Biocompatibility evaluation of breathing gas pathways in healthcare applications’.
The aim is to support manufacturers to develop products in compliance with the Medical Device Regulations. Ongoing standardization activities within the portfolio of the TC will be further developed in 2024.
CEN/TC 216 ‘Chemical disinfectants and antiseptics’(avautuu uuteen ikkunaan, siirryt toiseen palveluun) works on the development of harmonized standards under the Medical Devices Regulation (EU)2017/745. Among them, in 2024 it expects to finalize and publish as a harmonized standard the general transversal standard EN 14885 ‘Chemical disinfectants and antiseptics – Application of European Standards for chemical disinfectants and antiseptics’.
In addition, the TC will start the revision of the following standards:
- EN 13624 ‘Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area – Test method and requirements (phase 2, step 1)’;
- EN 14348 ‘Chemical disinfectants and antiseptics -Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants – Test methods and requirements (phase 2, step 1)’;
- EN 14561 ‘Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area – Test method and requirements (phase 2, step 2)’.
CEN/TC 293 ‘Assistive products and accessibility’(avautuu uuteen ikkunaan, siirryt toiseen palveluun) will continue to develop standards in cooperation with ISO/TC 173 ‘Assistive products’ under the Vienna Agreement. One of the standards it will work on in 2024 is prEN ISO 15621 ‘Absorbent incontinence aids for urine and/or faeces – General guidelines on evaluation’.
Moreover, its Working Group 12 ‘Accessibility’(avautuu uuteen ikkunaan, siirryt toiseen palveluun) will continue working on prEN 17999 ‘Accessible systems for living independently — Requirements and recommendations’, which specifies requirements and provides guidance on aspects of accessible systems for living independently in relation to technical solutions, service design, provision, and information. This includes adapting the design and functionality of systems to allow ease of use by any user, regardless of their abilities. At the same time, Working Group 13 ‘Tactile lettering’(avautuu uuteen ikkunaan, siirryt toiseen palveluun) will start working on ‘Tactile lettering — Requirements on the presentation and application of Braille and raised lettering’.
CEN/TC 332 ’Laboratory Equipment’(avautuu uuteen ikkunaan, siirryt toiseen palveluun) closely collaborates with its international counterpart ISO/TC 48 to adopt European Standards (ENs) for laboratory equipment. These ENs closely align in structure and content with ISO standards, making the transformation between the two systems both reasonable and promising. Furthermore, in 2024, CEN/TC 332 will work on the following standards:
- EN 17242 ’Recirculatory Filtration Fume Cupboards’;
- EN 16589-2 ’Laboratory Local Exhaust Devices – Part 2: Commissioning and On-Site Testing of Articulated Extraction Arms’;
- Revision of EN 12469 ’Biotechnology – Performance Criteria for Microbiological Safety Cabinets’. The aim of this revision is to create a standard series that incorporates the latest developments and aligns with the current state of the art in biotechnology.
The standardization of postal services and the improvement of service quality are strategic priorities for the European Union: they are set out in Directive 97/67/EC on the development of the internal market of Community postal services. The development of appropriate standards is therefore indispensable to ensure interoperability between national networks and for the existence of an efficient universal service.
CEN/TC 331 ’Postal services’(avautuu uuteen ikkunaan, siirryt toiseen palveluun) is the technical committee responsible for fulfilling Standardization Request M/590 on postal services and the improvement of quality of service, in support of Directive 97/67/EC. This request was issued to CEN by the European Commission in 2023 and the work thereunder will be ongoing until 2027.
In 2024, CEN/TC 331 ’Postal services’ will work on the following two items, amongst others:
- a European standard on the safe, secure, and contactless delivery of postal items;
- a European standard on the harmonization of track and trace events, which will consist of at least two parts, with the first one dedicated to forward flow.
CEN/TC 278 ‘Intelligent Transport Systems’(avautuu uuteen ikkunaan, siirryt toiseen palveluun), and in particular its Working Group 3 (Public Transport), is revising a series of standard related to Transmodel and NeTex series, aiming to enhance data exchange interoperability among diverse stakeholders in public transport. These activities seek to address the existing challenges associated with the need for interoperability between various data models employed by different participants in the public transport ecosystem. The new deliverables will include the development of a glossary for public transport, which aims to assign a consistent term to each concept used in the field.
To strategically support data exchange coordination activities, a back-office group involving all major public transport stakeholders will address the challenges due to the revision of a Technical Specification for Interoperability, explicitly focusing on ticketing and passenger-related information. In particular, this group will gather feedback from businesses on specifications for implementing and exchanging timetable and tariff data.
Finally, following the approval of the Standardization Request on automatic number plate recognition in support of Directive (EU) 2019/520, CEN/TC 278’s Working Group 1 (Electronic Fee Collection) will start the standardization work on the revision of three standards.
CEN/CLC/JTC 20 ‘Hyperloop systems’(avautuu uuteen ikkunaan, siirryt toiseen palveluun) will finalize prEN 17930 ‘Hyperloop Systems Aspects – Reference Architecture’. This standard specifies the reference architecture for a hyperloop system and, more precisely, the functions of each (sub)system, to define the purpose of each block and its different possible implementations, and highlight how the (sub)systems support each other. Transportation system interfaces will be listed, whether internal or external. This characterization will consider the technical as well as operational features of the transport service.
CEN/TC 256 ‘Railway applications’(avautuu uuteen ikkunaan, siirryt toiseen palveluun) will work on an important revision of the set of standards dedicated to axleboxes. Standards revised will include EN 12080 on rolling bearings, EN 12081 on lubricating greases, and EN 12082 on performance testing.
These standards are fundamental for railways manufacturers and operators: in particular, EN 12080 specifies the quality parameters of axlebox rolling bearings supporting the load of the vehicle; EN 12081 specifies the quality requirements of greases intended for the lubrication of axlebox rolling bearings according to prEN 12080; and EN 12081 specifies the principles and methods for a rig performance test of the system of axlebox rolling bearing(s), housing, seal(s) and grease.
This set of standards allows for the safe circulation of freight and passengers trains on the European network. It also supports the application of Directive 2016/797 on railways interoperability, in the framework of the Standardization request M/591 ‘Rail interoperability II’.
CEN/TC 301 ‘Road vehicles’(avautuu uuteen ikkunaan, siirryt toiseen palveluun) will work on the development of several standards on the conditions and protocols for the safe repair and re-use of modules and batteries of road vehicles, in the framework of Standardization Request M/581 ‘Batteries’ in support of Regulation (EU) 2023/1542.
CEN/TC 466 ‘Circularity and recyclability of fishing gear and aquaculture equipment’(avautuu uuteen ikkunaan, siirryt toiseen palveluun) will continue in 2024 the work addressing the requirements of Standardization Request M/574 in support of Directive (EU) 2019/904’ on the reduction of the impact of certain plastic products on the environment, in order to encourage preparing for re-use and facilitate recyclability at end of life.
The standard(s) for circular design of fishing gear (such as the series prEN 17988) should provide a level playing field for the industry to develop a higher quality and environmentally friendly fishing gear that can be easily reused or recycled at the end of life. It will also provide the industry the opportunity to act sustainably for a healthier planet. These standards will be finalized by the end of 2024.
The deliverables of CEN/TC 183 ‘Waste management’(avautuu uuteen ikkunaan, siirryt toiseen palveluun) specify technical requirements to, on the one hand, minimize significant hazards and hazardous situations which may occur during the collection and transportation of waste, and, on the other, increase the efficiency of waste disposal processes.
In 2024, the Committee will start the revision of the EN 1501 series ‘Refuse collection vehicles – General requirements and safety requirements’ to incorporate and cover the new and updated Essential Health and Safety Requirements of the Machinery Regulation (EU) 2023/1230.
CEN/TC 183 also expects to adopt ISO 24162 on environmental efficiency of refuse collection vehicles as its first EN ISO standard. This standard will specify a uniform, reproducible testing process for various drive units, chassis, constructions and lifting devices for refuse collection vehicles, with which a comparison of energy consumption can be performed.
Furthermore, the TC will finalize a work item on ‘Waste management — Mobile IT systems – Requirements for the XML interface Office-Mobile’. This new standard will define the digital data exchange between the dispatching stationary unit (office) and the mobile units of the refuse collection vehicles. With the standardization of this interface, it will be possible to combine the management software with different subsystems of the mobile vehicle equipment without having to make one-time and recurring interface agreements.
Kimmo Konkarikoski
kimmo.konkarikoski@ytl.fi