SFS-EN 14180:en

Soveltamisala

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This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only.
These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities.
This European Standard specifies minimum requirements:
- for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices;
- for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.

Tämän julkaisun valmistelusta Suomessa vastaa Palvelualojen työnantajat PALTA ry, puh. 040 579 4393.

Tuoteryhmä(t)

11.080.10 Sterilointivälineet »

Sidokset

Velvoittavat viittaukset

EN 14222:2003 Stainless steel shell boilers
EN 60584-1:2013 Thermocouples - Part 1: EMF specifications and tolerances
EN 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors

Näytä julkaisuun liittyvät velvoittavat viittaukset

EN 14222:2003 Stainless steel shell boilers
EN 60584-1:2013 Thermocouples - Part 1: EMF specifications and tolerances
EN 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors
EN 61010-1:2010 Mittaukseen, säätöön ja laboratoriokäyttöön tarkoitettujen sähköisten laitteiden turvallisuusvaatimukset. Osa 1: Yleiset vaatimukset
EN 61010-2-040:2005 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
EN 61326-1:2013 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
EN 764-7:2002 Pressure equipment - Part 7: Safety systems for unfired pressure equipment
EN 867-5:2001 Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
EN 868-5:2018 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
EN ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006)
EN ISO 11138-5:2017 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017)
EN ISO 11140-6:2022 Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers (ISO 11140-6:2022)
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
EN ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
EN ISO 15223-1:2021 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
EN ISO 16396-1:2015 Plastics - Polyamide (PA) moulding and extrusion materials - Part 1: Designation system, marking of products and basis for specifications (ISO 16396-1:2015)
EN ISO 16396-1:2022 Plastics - Polyamide (PA) moulding and extrusion materials - Part 1: Designation system and basis for specifications (ISO 16396-1:2022)
EN ISO 228-1:2003 Pipe threads where pressure-tight joints are not made on the threads - Part 1: Dimensions, tolerances and designation (ISO 228-1:2000)
EN ISO 3746:2010 Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746:2010)

Piiloita näkyvistä julkaisuun liittyvät velvoittavat viittaukset

Tekninen komitea

CEN/TC 102 Sterilizers and associated equipment for processing of medical devices »

Direktiivi

93/42/EEC Lääkinnälliset laitteet

http://ec.europa.eu »

Vahvistuspäivä

16.06.2014

Kumouspäivä

11.04.2025

Painos

2

Sivumäärä

62

Julkaisun kieli

englanti

SFS-EN 14180:en Kumottu