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SSH EN 285:2015

Sterilization - Steam sterilizers - Large sterilizers

Oct 13, 2016
95.99 Withdrawal of Standard   Oct 29, 2021

General information

95.99     Oct 29, 2021

DPS

DPS/KT 206

European Norm

11.080.10  

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Scope

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.

Related directives

Directives related to this standards.

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN 285:2006+A2:2009

PUBLISHED
SSH EN 285:2015+A1:2021

NOW

WITHDRAWN
SSH EN 285:2015
95.99 Withdrawal of Standard
Oct 29, 2021

Related project

Adopted from EN 285:2015