SR EN 285:2016

Sterilization - Steam sterilizers - Large sterilizers

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 equipmen

62.13

Status : Withdrawn
Approval date : 5/31/2016
Withdrawal date : 11/29/2021
Number of pages : 98
ICS : 11.080.10 Sterilizing equipment
Technical Committee : 377 - Medical devices

Relations with other standards: