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EVS-EN 285:2015+A1:2021

Steriliseerimine. Aursterilisaatorid. Suured sterilisaatorid

Üldinfo
Kehtiv alates 15.10.2021
Alusdokumendid
EN 285:2015+A1:2021
Tegevusala (ICS grupid)
11.080.10 Steriliseerimisvahendid
Direktiivid või määrused
2017/745 Meditsiiniseadmed
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
15.10.2021
Põhitekst + muudatus
05.01.2016
Põhitekst
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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Muudatus

EVS-EN ISO 14971:2019/A11:2021

Meditsiiniseadmed. Riskihalduse rakendamine meditsiiniseadmetele
Kehtiv alates 15.12.2021
Põhitekst + muudatus

EVS-EN ISO 14971:2019+A11:2021

Meditsiiniseadmed. Riskihalduse rakendamine meditsiiniseadmetele
Uusim versioon Kehtiv alates 15.12.2021
Põhitekst + muudatus

EVS-EN ISO 11737-1:2018+A1:2021

Tervishoiutoodete steriliseerimine. Mikrobioloogilised meetodid. Osa 1: Mikroobse populatsiooni määramine toodetel
Uusim versioon Kehtiv alates 01.07.2021
Põhitekst

EVS-EN ISO 20417:2021

Meditsiiniseadmed. Tootja esitatav teave
Uusim versioon Kehtiv alates 17.05.2021