EN 285:2015 pdf download.STERILIZATION – STEAM STERILIZERS – LARGE STERILIZERS.
EN 285 specifies test procedures and acceptance criteria to confirm whether the sterilizer is safe and can deliver an operating cycle for sterilizing the range of medical devices and loading configurations used in healthcare. It can also be used in other manufacturing sectors and industries. In addition, national regulations can necessitate consideration of the impact the sterilizer could have on the environment.
A steam sterilization process uses water in its liquid and vaporous state to penetrate as steam into the load and to condense on the surfaces of a device. The distribution of moisture and temperature throughout the sterilization load and the process of sterilization itself cannot be measured directly for each routine sterilization process. This is done by comparison of measurement results with cycle parameters shown previously by validation to deliver an efficient sterilization process to the exposed medical devices.
An instruction manual supplied with the sterilizer is required to have comprehensive information on the sterilizer, programmed operating cycles and safe operation. Requirements for the validation and routine control of sterilization are not addressed as they are specified EN ISO 17665-1.
Medical devices used in health care can differ in properties such as materials, mass, shape, volume and packaging. Each sterilizer load can comprise a variable number of packages each containing different types of variably distributed medical devices.
The state “sterile” is specified in EN 5 56-1. For the steam sterilization in health care national regulations and the European Pharmacopoeia require or recommend combinations of minimum process parameters to produce a substantial overkill. This European Standard identifies combinations of sterilization temperatures and holding times, with tolerances, recommended by the “Working Party on Pressure-steam Sterilisers”). The use of these values is justified when also considering the variable characteristics of sterilizer loads in healthcare.
Process variables and process parameters as defined in EN ISO 17665-1 characterize the microbicidal effectiveness of the sterilization process. Cycle parameters are associated with the control of the operating cycle and have implications on the attainment of process parameters, the uniformity of steam penetration, the removal of air, drying and deterioration of medical devices and their packaging.
This European Standard refers to sections in the all risks safety standard EN 610 10-1 and specific safety standard for sterilizers EN 61010-2-040 and offers as alternatives EN ISO 12100 and other harmonized safety standards listed in the Official Journal of the European Union under the Medical Devices Directive or Machinery Directive. Information on the relationship of this European Standard and the Essential Requirements of the Directives on medical devices and machinery is provided in the Tables ZA.1 and
ZA.2.
The European Directive on pressure equipment applies to sterilizers and this is addressed by reference to harmonized standards on pressure equipment. Outside the EU other pressure equipment specifications can apply.
This European Standard contains no specific requirements for the sterilization of liquids or test methods to assess the heat transfer into a liquid. The sterilization of a liquid or the sterilization of contained product requires specific means for monitoring the temperature profile in the liquid or by reference to a challenge device.
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 1.
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.
EN 285 does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.