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DIN EN 285:2016-05

Sterilization - Steam sterilizers - Large sterilizers; German version EN 285:2015

Edition date: 2021-12-01
Cancelled
Available languages: English, German
Summary: 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.
Keywords: Amount of inspection|Bowie and Dick test|Closures|Compatibility|Connections|Definitions|Design|Dimensions|Drainability tests|Efficiency|Indicating devices|Inspection|Inspection specification|Leakage|Limits (mathematics)|Marking|Materials|Measuring instruments|Medical devices|Medical equipment|Medical products|Medical sciences|Microbiological analysis|Microbiology|Performance requirements|Pressure vessels|Public health|Sound power|Specification (approval)|Steam sterilizers|Sterilization (hygiene)|Sterilized goods|Sterilizers|Test equipment|Testing|Thermoelectric
ICS: 11.080.10-Sterilizing equipment
CTN:

International Equivalence

Identic EN 285:2015+A1:2021

Reemplazo Normas

Reemplaza a DIN EN 285:2009-08

Reemplaza a DIN EN 285:2014-09

Es reemplazada por DIN EN 285:2021-12

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