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Standard

NS-EN 285:2006

Withdrawn

Note: This standard has a new edition: NS-EN 285:2015+A1:2021

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Abstract

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.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 2006-05
  • Version: 1
  • Document type: NAT
  • Pages
  • ICS 11.080
  • ICS 11.080.10
  • National Committee SN/K 108

Legal references

EU law:
Law referenceRestrictions
93/42/EEC

Product Relations

Product life cycle