European EN and International ISO standards Essay

The abbreviations “EN” refers to European Norm while “ISO” refer to International Standards Organization. Endoscopy literally means “looking inside” and it is normally refers to look inside the organic structure normally in relation to medical grounds utilizing an instrument called an endoscope. It is used to analyze the interior parts of a hollow organ or pit of the organic structure. and they are inserted straight into the organ.

The endoscopes. particularly flexible endoscopes are normally complex but can be reused but require really alone conditions for reuse in regard to their decontamination. It is non merely their outer surfaces that are exposed. but besides their air channels. H2O channels and even their accoutrements that enable them to work in the right mode. Their exposure to organic structure fluids and other contaminations means that their reuse has to be really carefully looked into so as to avoid spread of diseases. It is besides of import to recognize that most endoscopes are heat labile and can non be autoclaved intending they change under different heat conditions.

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European ( EN ) and International ( ISO ) criterions that would be applicable to an endoscope decontamination unit ( EDU ) in the UK

As abstracted from EN ISO 15883. information from the makers should be given prior to buying the endoscope. This implies that the maker provides information such the best germicides to utilize with that peculiar endoscope and what is expected when cleansing. for illustration the bacteriums expected to be found at that place and besides if the germicide in inquiry is compatible with the automatic reprocessor in which it is being used. ( Gurusamy Manivannan. 2008 )

As per BS EN ISO 15883-1. a temperature recording equipment holding no fewer than 10 detectors should be used. and the specifications are good indicated in the ISO criterion. This is because the endoscopes are heat labile. and temperature may impact the chemical composings of the accoutrements or other chemicals involved.

The maker should besides set up the worst conditions under of the devices constellation. Such conditions encompass temperature. detersive concentration and foster device constellation. This besides includes H2O flow force per unit area for usage during proving. This may besides be categorized in a similar mode as biocompatibility proving where bounds such as residuary bounds are stipulated as per ISO 10993. ( Denise Sheard. 20120

The standardizations should be checked in conformity with ISO 10012-1 for uniformity intents. These are normally dictated by makers utilizing a validated method of using a reasonable mention. Each instrument should besides be labeled with a alone mention figure. This is of import when mensurating transition of fluids or drugs so as to acquire accurate and true consequences.

The standard prEN ISO 15883-1-2004 has a clause that indicates that the industry shall all add-on information associated with the usage and decontamination of the peculiar endoscope. Information such as maximal flow and force per unit area of fluids within each channel in the device and the maximal possible allowable limitation of flow within each channel is deemed of import and must be provided. ( James Walker. 2014 )

There is besides a standard similar to both that the makers may be requested to give information refering the device at any phase. and act as advisers. This is stipulated in prEN ISO 15883-1-2004. This is of import when complications arise that forces involved were non anticipating


Gurusamy Manivannan. Disinfection and decontamination: rules. applications and related issues. Boca Raton: CRC Press/Taylor & A ; Francis Group. 2008

Denise Sheard. A practical usher to decontamination in health care. Hoboken: John Wiley & A ; Sons. 2012.

James Walker. Decontamination in infirmaries and health care. Oxford: Woodhead Publishing. 2014

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