Palvelualojen työnantajat PALTA

 

This document specifies minimum requirements for instruments and systems that fall into the class of corneal topographers (CTs). It also specifies tests and procedures to verify that a system or instrument complies with this document and thus qualifies as a CT according to this document. It also specifies tests and procedures that allow the verification of capabilities of systems that are beyond the minimum requirements for CTs. This document defines terms that are specific to the characterization of the corneal shape so that they may be standardized throughout the field of vision care. This document is applicable to instruments, systems and methods that are intended to measure the surface shape of the cornea of the human eye. NOTE The measurements can be of the curvature of the surface in local areas, three-dimensional topographical measurements of the surface or other more global parameters used to characterize the surface. This document is not applicable to ophthalmic instruments classified as ophthalmometers.

 

 

The primary objective of this document is to define standard methods to measure three-dimensional relationships between road vehicle foot controls and the enclosing structures such as the floor, sidewalls and lower instrument panel. This standard provides methods for the design or the competitive assessment of the layout, spacing, and clearances between foot controls and their surrounding components. It will include terms and definitions encountered in the design, development and evaluation of foot controls, in both static and dynamic use. This standard also provides guidelines to create requirements for the three-dimensional space between, above, below, and to the side of a foot control system, including use-cases and factors that influence the design of foot controls, such as foot position and foot size based on vehicle type, environmental considerations, and differences between Heavy Trucks and Buses, and Passenger Cars, Sports Utility Vehicles and Light Trucks. This document will include but not be limited to lateral spacing of foot controls (ISO 3409), and will address several deficiencies in ISO 3409, including a modern format with definitions and external references. An addendum will also outline dynamic usability considerations both for manual and semi-autonomous driving, such as the differences between dynamic and static heel points, heel-toe, misapplication, simultaneous push A-B pedals, the effect of driver anthropometry, driver positioning geometry, and design considerations for entry / exit as a function of vehicle type. This standard assumes foot controls of different types for controlling different functions, corresponding both to what exists and will come.

 

This document specifies minimum requirements for instruments and systems that fall into the class of corneal topographers (CTs). It also specifies tests and procedures to verify that a system or instrument complies with this document and thus qualifies as a CT according to this document. It also specifies tests and procedures that allow the verification of capabilities of systems that are beyond the minimum requirements for CTs. This document defines terms that are specific to the characterization of the corneal shape so that they may be standardized throughout the field of vision care. This document is applicable to instruments, systems and methods that are intended to measure the surface shape of the cornea of the human eye. NOTE      The measurements can be of the curvature of the surface in local areas, three-dimensional topographical measurements of the surface or other more global parameters used to characterize the surface. This document is not applicable to ophthalmic instruments classified as ophthalmometers.

 

ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10-6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.

 

 

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.

 

 

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 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].

 

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.