Palvelualojen työnantajat PALTA

 

This document specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of a specified sterilization dose to achieve an SAL of 10-6. This document also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. This document defines product families for sterilization dose establishment and sterilization dose audit.

 

This document specifies the fire resistance requirements and testing methods for fire barriers for railway vehicles. Use of a Fire Containment and Control System, where permitted as an alternative to a fire barrier, is not in the scope of this document. It is not within the scope of this document to describe measures that ensure the preservation of the railway vehicles in the event of a fire.

 

 

 

 

 

This document specifies the common requirements for heat and moisture exchangers (HME), breathing system filters (BSF) and combined devices (HMEF) intended for anaesthetic and respiratory use. It addresses materials, design, performance, requirements for devices supplied sterile, marking, and information to be provided by the manufacturer. NOTE 1 Wherever the term “device” is used in this document, it refers to an HME or, HMEF or BSF. This document also applies to HMEs or HMEFs that do not have a machine port for connecting to a ventilator. Requirements for active HMEs are located in ISO 80601-2-74 [1]. This document is not applicable to other types of filters: those designed to protect vacuum sources or gas sample lines; to filter compressed gases; to protect test equipment for physiological respiratory measurements; on inlet of resuscitation bags; port of nebulisers. NOTE 2 A method for assessing moisture loss from an HME/HMEF is given in ISO 9360-2: 202X. NOTE 3 A method for assessing filtration performance of BSF/HMEF is given in ISO 9360-3:202X. Filters used for filtering anaesthetic gases from the respiratory gas are not within scope of this document. NOTE 4 Requirements for Active HMEs are included in ISO 80601-2-74 [1].

 

Additional requirements for connectors for accessory access connection port

 

This document specifies requirements for the measurement of moisture loss from heat and moisture exchangers (HMEs), including those incorporating breathing system filters (HMEFs), intended for the humidification of respired gases for use primarily with patients with a tidal volume equal to or greater than 250 ml. Breathing system filters (BSF) are also included in scope, as these devices do some amount of moisture to inspired gases. This document also includes requirements for the measurement of moisture loss from HMEs for use with tracheostomized patients that do not have a machine port and having minimum tidal volumes of 250 mL. Active HMEs are excluded from this document, the requirements for active HMEs are included in ISO 80601-2-74:2026 [1]. NOTE 1 Wherever the term “device” is used in this document, it may either refer to HME, HMEF or BSF. *** Add rationale why 250ml lower limit*** NOTE 2 HMEs, HMEFs that do not have a machine port for connection to a breathing tube are intended for patients who are spontaneously breathing via a tracheostomy and do not require mechanical ventilation.

 

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.