DIN EN 285:2008 PDF

Standard No.: DIN EN 285:2008
Release Date: 2008
Published By: German Institute for Standardization
Status: Withdraw 2009-08
Replace By: DIN EN 285:2009
Latest: DIN EN 285/A1:2018; DIN EN 285:2016; DIN EN 285:2021-12; DIN EN 285 E:2013-05; DIN EN 285:2009

Scope: 1.1 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 sterilizer 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. Large steam sterilizers can also be used during the commercial production of medical devices. 1.2 This European Standard is not applicable to steam sterilizers designed to process a size of load less than one sterilization module or having a chamber volume less than 60 I. 1.3 This European Standard does not describe a quality assurance system for the control of all stages of the manufacture of the sterilizer. NOTE Attention is drawn to the standards for quality management systems e.g. EN ISO 13485. 1.4 Planning and design of products applying to this European Standard should consider the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex A. NOTE Additional aspects of environmental impact are addressed in EN ISO 14971.

DIN EN 285:2008 history

2021 DIN EN 285:2021 Sterilization - Steam sterilizers - Large sterilizers; German version EN 285:2015+A1:2021
2018 DIN EN 285/A1:2018 Sterilization - Steam sterilizers - Large sterilizers; German and English version EN 285:2015/prA1:2018
2016 DIN EN 285:2016 Sterilization - Steam sterilizers - Large sterilizers; German version EN 285:2015
2009 DIN EN 285:2009 Sterilization - Steam sterilizers - Large sterilizers (includes Amendment A2:2009); English version of DIN EN 285:2009-08
2008 DIN EN 285:2008 Sterilization - Steam sterilizers - Large sterilizers; German version EN 285:2006+A1:2008
1970 DIN EN 285:1997 Sterilization - Steam sterilizers - Large sterilizers