Standard Swedish standard · SS-EN 285:2006+A1:2008

Sterilization - Steam sterilizers - Large sterilizers

Status: Withdrawn

· Replaced by: SS-EN 285:2006+A2:2009
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Standard Swedish standard · SS-EN 285:2006+A1:2008

Sterilization - Steam sterilizers - Large sterilizers
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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 l.
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.

Subjects

Sterilizing equipment (11.080.10)


Buy this standard

Standard Swedish standard · SS-EN 285:2006+A1:2008

Sterilization - Steam sterilizers - Large sterilizers
Subscribe on standards - Read more Dölj
Price: 1 731 SEK
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Price: 1 731 SEK
standard ikon

Paper

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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-65563

Edition: 1

Approved: 3/17/2008

No of pages: 92

Replaces: SS-EN 285:2006

Replaced by: SS-EN 285:2006+A2:2009