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EVS-EN 285:2015

Steriliseerimine. Aursterilisaatorid. Suured sterilisaatorid

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Kehtiv alates 05.01.2016
Alusdokumendid
EN 285:2015
Tegevusala (ICS grupid)
11.080.10 Steriliseerimisvahendid
Direktiivid või määrused
puuduvad
Standardi ajalugu
Staatus
Kuupäev
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Nimetus
Muudatus
EN 285:2015/prA1:2018
05.01.2016
Põhitekst
07.07.2009
Põhitekst + muudatus
This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e. g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads. This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l. Large steam sterilizers can also be used during the commercial production of medical devices. This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues. This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer. NOTE 1 Attention is drawn to the standards for quality management systems e. g. EN ISO 13485. NOTE 2 Environmental aspects are addressed in Annex A.
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CEN ISO/TS 17665-2:2009

Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
Uusim versioon Kehtiv alates 07.05.2009
Põhitekst

EVS-EN ISO 11140-1:2009

Tervishoiutoodete steriliseerimine. Keemilised näitajad. Osa 1: Üldised nõuded
Kehtetu alates 09.12.2014
Muudatus

ISO 2859-1:1999/Amd 1:2011

ISO 2859-1:1999 - Amendment
Uusim versioon Kehtiv alates 17.06.2011
Põhitekst

EVS-EN ISO 11140-1:2014

Tervishoiutoodete steriliseerimine. Keemilised näitajad. Osa 1: Üldised nõuded
Uusim versioon Kehtiv alates 09.12.2014