Palvelualojen työnantajat PALTA

 

 

This document establishes a vocabulary for high-pressure pipes and end-connections in fuel injection systems for diesel (compression-ignition) engines. The terms defined in this document are required precisely for high-pressure pipes and end-connections in fuel injection systems. Terms and definitions relating to other fuel injection equipment are found in the other parts of the ISO 7876 series. NOTE When the word “fuel” is used in the terms listed it can be omitted providing there can be no misunderstanding.

 

This document specifies the requirements and corresponding test methods for a biocompatible and bio-inert ceramic bone-substitute material based on yttriastabilized tetragonal zirconia (yttria tetragonal zirconia polycrystal, Y-TZP) for use as a material for surgical implants.

 

Tässä asiakirjassa määritellään tapahtumien vastuullisuuden hallintajärjestelmän vaatimukset kaiken tyyppisille tapahtumille ja tapahtumiin liittyville toiminnoille ja annetaan ohjeita näiden vaatimusten täyttämiseen. Tätä asiakirjaa voidaan soveltaa mihin tahansa organisaatioon, joka haluaa: a) perustaa, toteuttaa, ylläpitää ja parantaa tapahtumien vastuullisuuden hallintajärjestelmää b) varmistaa, että hallintajärjestelmä on organisaatiolle määritellyn vastuullisuuspolitiikan mukainen c) saavuttaa tapahtumien vastuullisuuden hallintajärjestelmälle asetetut tavoitteet d) osoittaa vapaaehtoisesti vaatimustenmukaisuuden tämän asiakirjan kanssa seuraavin tavoin: — ensimmäinen osapuoli (itsearviointi ja itseilmoitus) — toinen osapuoli (vaatimustenmukaisuuden vahvistaminen organisaation sidosryhmien, kuten asiakkaiden, toimesta tai muiden toimijoiden toimesta heidän puolestaan) — riippumaton kolmas osapuoli (esimerkiksi sertifiointielin).

Tämä standardiehdotus sisältää kansainvälisen standardin ISO 20121:2024 "Event sustainability management systems — Requirements with guidance for use" englanninkielisen tekstin ja suomenkielisen käännöksen.
Tällä lausuntokierroksella on tarkoitus selvittää, tulisiko tämä standardi hyväksyä kansalliseksi SFS-standardiksi. Vastaa lausuntopyyntöpalvelun kohdassa ’Ota kantaa’ tulisiko tämä ISO-standardi vahvistaa kansalliseksi SFS-ISO-standardiksi.
SFS:n tehtävänä on ylläpitää suomalaista SFS-standardikokoelmaa. Maailmanlaajuisten standardien kohdalla ISO vahvistaa standardin ensin, ja Suomi päättää sen jälkeen, vahvistaako se standardin vai ei.
Vahvistamispäätökseen vaikuttaa alan suomalainen näkemys ja  kiinnostus vahvistettavaan standardiin.

 

This document specifies the requirements on rail gas pressure welding, including the requirements for approval process, laboratory tests, production test, approval of contractor/welder, as well as the acceptance criteria of gas pressure welds in track. This document concerns the welding of 43 kg/m – 75 kg/m new vignole rails of the same profiles and the same grades. This document is restricted to butt welding for connecting rail ends. NOTE Conformity with the requirements of this standard does not ensure the suitability of a welding process for specific conditions of track and traffic. This document does not cover welds made between different rail sections, differently worn rails or different rail grades.

 

This document is a product specification, giving performance requirements for plumbed-in multiple nozzle emergency safety body showers which are permanently connected to a water supply and installed on industrial and logistic sites. Emergency safety body showers using fluid other than water are not considered in this document. This document also specifies requirements in respect of installation, adjustment and marking of the showers as well as operation and maintenance instructions to be given by the manufacturer. NOTE 1 Plumbed-in emergency safety body showers designed for laboratory facilities are dealt with in EN 15154-1. NOTE 2 Water overhead body showers for sites other than laboratories are dealt with in FprEN 15154-5. NOTE 3 Attention is drawn to national regulations which can apply in respect of the installation and use of emergency safety showers.

 

This document specifies the conformance test plan for the CAN data link layer and the physical coding sublayer standardized in ISO 11898-1:2024. This includes the implementation options in accordance with ISO 11898-1:2024, C1. CAN FD light as defined in the Annex A of 11898-1 is not covered by this document.

 

This document specifies the test method and performance metrics to evaluate the behaviour of a vehicle equipped with door open warning system during several accidental scenarios. These potential accidents occur when a door is about to be opened and there is a risk of collision due to the vehicle door opening. This document applies to category M1 and N1 vehicles equipped with a door open warning system. NOTE Depending on accidentology, only a part of the scenarios can be used for an evaluation of performance.

 

This document specifies a method for the simultaneous determination of the fluorine, chlorine, bromine, and sulphur content in solid recovered fuels by oxidative pyrohydrolytic combustion at (1 050 ± 50) °C, followed by ion chromatography. The method is applicable for the determination of mass fractions = 10 mg/kg of each element based on dry matter. The upper limit and exact concentration range covered depends on the blank levels of the instrumentation and the capacity of the chromatographic separation column used for determination. NOTE 1 Simultaneous determination of iodine content is possible but currently not validated. NOTE 2 Other detection methods can be applied if validated.

 

This document defines terms relating to the classification of road vehicle collisions, concentrating on configuration aspects. This document focuses on terminology for classification of vehicle-vehicle collisions and vehicle-obstacle collisions and does not include collisions with vulnerable road users. NOTE Additional terms and definitions on road vehicle accidents are given in ISO 12353-1.

 

This document specifies requirements and gives recommendations for next generation sequencing (NGS) workflows for in vitro diagnostics and biomedical research. This document covers the pre-examination processes including human DNA (somatic and germline) isolation, sequencing library preparation, sequencing, sequence analysis and reporting of the examined sequences for diagnostic purposes from isolated DNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates (FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles, circulating cell free DNA from plasma, and DNA from saliva. NOTE 1 Typical applications include, but are not limited to, NGS for oncology, pharmacogenomics and clinical genetics; approaches include panels (e.g. disease panels, exome panels, target gene panels and in silico panels), exome and whole genome sequencing, as well as certain epigenetic and certain single-cell analyses. This document addresses in vitro diagnostic examinations including laboratory developed examinations and is applicable to medical laboratories, molecular pathology laboratories and molecular genetic laboratories, in vitro diagnostic developers and manufacturers, biobanks and institutions and organizations performing biomedical research or sequencing services. This document is not applicable for in situ sequencing, DNA-mediated protein sequencing, forensic sequencing, sequencing of pathogens or microorganisms and microbiome analysis. NOTE 2 International, national or regional regulations or requirements or multiples of them can also apply to specific topics covered in this document.

 

This document specifies requirements and gives recommendations for next generation sequencing (NGS) workflows for in vitro diagnostics and biomedical research. This document covers the pre-examination processes including human RNA isolation, sequencing library preparation, sequencing, sequence analysis and reporting of the examined sequences for diagnostic purposes from isolated RNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates (FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles, and circulating cell free RNA from plasma. NOTE 1 Typical applications include, but are not limited to, NGS for oncology and clinical genetics, certain single-cell analyses. This document addresses in vitro diagnostic examinations including laboratory developed examinations and is applicable to medical laboratories, molecular pathology laboratories and molecular genetic laboratories, in vitro diagnostic developers and manufacturers, biobanks as well as institutions and organizations performing biomedical research or sequencing services. This document is not applicable for in situ sequencing, forensic sequencing, sequencing of pathogens or microorganisms and microbiome analysis. NOTE 2 International, national or regional regulations or requirements or multiples of them can also apply to specific topics covered in this document.

 

This document specifies requirements and gives recommendations for next generation sequencing (NGS) workflows. This document covers the pre-examination processes, human RNA isolation, sequencing library preparation, sequencing, sequence analysis and reporting of the examination of sequences for diagnostic purposes from isolated RNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates (FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles, and circulating cell free RNA from plasma. NOTE 1 Typical applications include, but are not limited to, NGS for oncology and clinical genetics, certain single-cell analyses. This document is addressing in vitro diagnostic examinations including laboratory developed tests and is applicable to medical laboratories, molecular pathology laboratories and molecular genetic laboratories, in vitro diagnostic developers and manufacturers, biobanks as well as institutions and organizations performing biomedical research or sequencing services. This document is not applicable for in situ sequencing, forensic sequencing, sequencing of pathogens or microorganisms and microbiome analysis. NOTE 2 International, national or regional regulations or requirements or multiples of them can also apply to specific topics covered in this document.

 

This document specifies requirements and gives recommendations for next generation sequencing (NGS) workflows. This document covers the pre-examination processes, human DNA (somatic and germline) isolation, sequencing library preparation, sequencing, sequence analysis and reporting of the examination of sequences for diagnostic purposes from isolated DNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates (FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles, circulating cell free DNA from plasma, and DNA from saliva. NOTE 1 Typical applications include, but are not limited to, NGS for oncology, pharmacogenomics and clinical genetics; approaches include panels (e.g. disease panels, exome panels, target gene panels and in silico panels), exome and whole genome sequencing, as well as certain epigenetics and certain single-cell analyses. This document is addressing in vitro diagnostic examinations including laboratory developed tests and is applicable to medical laboratories, molecular pathology laboratories and molecular genetic laboratories, in vitro diagnostic developers and manufacturers, biobanks as well as institutions and organizations performing biomedical research or sequencing services. This document is not applicable for in situ sequencing, DNA-mediated protein sequencing, forensic sequencing, sequencing of pathogens or microorganisms and microbiome analysis. NOTE 2 International, national or regional regulations or requirements or multiples of them can also apply to specific topics covered in this document.

 

This document defines technical considerations needed for monitoring unmanned store operations. Technical considerations include the platform, data elements, and interface needed to collect and analyse information from logistics bases, facilities, devices, and other components of unmanned stores. Here, the platform may be designed on a cloud -based system. The Scope Clause 1 is a mandatory element of the text.For rules on the drafting of the Scope, refer to the ISO/IEC Directives, Part 2:2021, Clause 14.

 

This document specifies the particular requirements, including performance criteria for washer-disinfectors (WD) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes. This document also specifies the performance requirements for the cleaning and disinfection of the WD and its components and accessories which can be required to achieve the necessary performance criteria. The methods, instrumentation and instructions required for type testing, works testing, validation (installation, operational and performance qualification on first installation), routine control and monitoring, and requalification of WD periodically and after essential repairs, are also specified. NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of activities covered by this document. NOTE 2 WD conforming with this document can also be used for cleaning and chemical disinfection of other thermolabile re-usable medical devices for which the device manufacturer has recommended and validated this method of disinfection. WD conforming with the requirements of this document are not intended for cleaning and disinfection of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or sterilized by thermal methods (see ISO 15883-1:2024, 4.1.5). NOTE 3 The specified performance requirements of this document cannot ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. NOTE 4 If it is considered that prion protein might be present, particular care is needed in the choice of cleaning agents and disinfectants to ensure that the chemicals used do not react with the prion protein or other protein in a manner that can inhibit its removal or inactivation from the load or WD. NOTE 5 This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of the WD, manufacturers of endoscopes, cleaning products, and disinfecting products.

 

This document defines technical concepts for unmanned stores and classifies them according to the degree of autonomy in their operations and/or services. It includes a definition, relevant actors, and a classification of unmanned stores. It also outlines the detailed operations and services by autonomy level, including those at unmanned stores.

 

 

ISO 5359:2014 specifies requirements for low-pressure hose assemblies intended for use with the following medical gases: oxygen, nitrous oxide, medical air, helium, carbon dioxide, xenon, specified mixtures of the gases listed above, oxygen-enriched air, air for driving surgical tools, nitrogen for driving surgical tools, and for use with vacuum. It applies to hose assemblies operating at pressures up to 1 400 kPa and for vacuum systems at pressures not greater than 60 kPa absolute. It does not specify the dimensions and allocation of the gas-specific inlet and outlet connectors for the hose assemblies.It does not specify requirements for coaxial hoses used for the supply and removal of air for driving surgical tools.Nor does it specify the intended uses of hose assemblies.

 

ISO 18082:2014 specifies the dimensions, the allocation and marking of non-interchangeable screw-threaded (NIST) connectors intended to be used at operating pressures up to 1 400 kPa, and for vacuum systems at pressures not greater than 60 kPa absolute. ISO 18082:2014 specifies NIST connectors intended for use with the following medical gases: oxygen; nitrous oxide; medical air; helium; carbon dioxide; xenon; specified mixtures of the gases listed above; oxygen-enriched air; air for driving surgical tools; nitrogen for driving surgical tools; use with vacuum.