Name: DIN EN 1422:2014-08
Brand: DIN
Price: 152.8 EUR
Availability: InStock

Fecha edición:	2014-08-01 En Vigor
Idiomas disponibles:	Inglés, Alemán
Resumen:	This European Standard specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories. This European Standard specifies requirements for ethylene oxide sterilizers (EO-sterilizers) working at super or sub-atmospheric pressure for: <(Liste) the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices;> <(Liste) the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.> The test loads described in this European Standard are selected to represent a number of loads for the evaluation of the performance of EO sterilizers for medical devices. However, specific loads may require the use of other test loads. This European Standard does not specify those tests which are necessary to determine the probability of a processed product being sterile, nor the routine quality control tests required prior to release of sterile product. These topics are addressed in prEN ISO 11135:2012. This European Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities. NOTE 1 For further information on safety, see examples in the Bibliography. National or regional regulations can exist. This European Standard does not cover sterilizers which employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber. NOTE 2 See EN ISO 14937. This European Standard is not intended as a checklist for suitability of an existing EO sterilizer when assessing compliance with prEN ISO 11135:2012. This standard is not intended to be applied retrospectively. This European Standard does not cover analytical methods for determining levels of residual EO and/or its reaction products. NOTE 3 For further information see ISO 10993-7.
Keywords:	Aeration\|Biological hazards\|Capability of sterilization\|Chambers\|Charge\|Chokes\|Closures\|Components\|Condensates\|Conditioning\|Connections\|Construction requirements\|Containers\|Control\|Control devices\|Control functions\|Coordination\|Cycle\|Definitions\|Density\|Dimensions\|Doors\|Double doors\|Dryness\|Electrical installations\|Electrically-operated devices\|Electromagnetism\|Environmental effect\|Equipment\|Equipment safety\|Ethylene oxide\|Feed-waters\|Filters\|Flushing\|Gas cylinders\|Gas sterilizers\|Gases\|Gaskets\|Hand operated\|Heat\|Heat-sensitized materials\|Humidity\|Impurities\|Indicating devices\|Inert gases\|Information\|Instructions for use\|Instruments\|Interference suppression\|Interferences\|Marking\|Materials\|Maximum values\|Measurement\|Measuring techniques\|Medical devices\|Medical equipment\|Medical sciences\|Operating instructions\|Operation\|Overheating\|Performance\|Performance testing\|Phases\|Pipelines\|Power-operated\|Pressure\|Pressure vessels\|Public health\|Recording instruments\|Reliability\|Safety engineering\|Safety of products\|Safety requirements\|Sampling methods\|Screwings\|Sensors\|Sequence of operations\|Sound\|Specification\|Specification (approval)\|Sterilization (birth control)\|Sterilization (hygiene)\|Sterilizers\|Sterilizing gases\|Supply\|Tanks (containers)\|Temperature\|Testing\|Thermal insulation\|Thermoelectric\|Time\|Vacuum\|Vapours\|Ventilation\|Water
ICS:	11.080.10 - Material de esterilización
CTN:
Equivalencia Internacional	Idéntica EN 1422:2014
Reemplazo Normas	Reemplaza a DIN EN 1422:2009-08 Reemplaza a DIN EN 1422:2013-01

DIN EN 1422:2014-08

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