CEN/TC 102/WG 3 - Requirements

This amendment specifies a test method to demonstrate that at the levels at which the controls are set, air dilution from within the test piece is sufficient to permit even steam penetration into it.

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.

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.

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.