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  • BSI
    BS EN 285:2015+A1:2021 Sterilization. Steam sterilizers. Large sterilizers
    Edition: 2021
    $569.57
    / user per year

Description of BS EN 285:2015+A1:2021 2021

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.

Standard NumberBS EN 285:2015+A1:2021
TitleSterilization. Steam sterilizers. Large sterilizers
StatusDefinitive
Publication Date2021-11-09
ReplacesBS EN 285:2006+A2:2009
Identical National Standard OfEN 285:2015/A1
AmendsBS EN 285:2015
DescriptorsAir, Quality, Safety devices, Dimensional tolerances, Air permeability, Medical equipment, Marking, Pressure gauges, Type testing, Equipment safety, Control systems, Noise (environmental), Performance testing, Pressure testing, Leak tests, Steam, Steam sterilizers, Contaminants, Recording instruments (measurement), Design, Temperature-measuring instruments, Performance, Large, Instructions for use, Signal devices, Sterilization (hygiene), Safety measures, Sterilizers, Microbiological analysis
ICS11.080.10 Sterilizing equipment
CommitteeCH/198
ISBN978 0 539 01380 1
PublisherBSI
Pages144

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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