ČSN EN 285 (847108) Zrušená norma

Sterilizace - Parní sterilizátory - Velké sterilizátory

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Anotace obsahu normy

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 large steam sterilizers 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.

Označení ČSN EN 285 (847108)
Katalogové číslo 99797
Cena 770 Kč770
Datum schválení 1. 7. 2016
Datum účinnosti 1. 8. 2016
Jazyk angličtina (obsahuje pouze anglický originál)
Počet stran 106 stran formátu A4
EAN kód 8590963997971
Norma byla zrušena k 1. 7. 2017
a nahrazena ČSN EN 285 (847108)
Dostupnost skladem (tisk na počkání)