European EN and International ISO standards Essay Example for Free

European EN and International ISO standards EssayThe abbreviations EN refers to European Norm while ISO refer to International Standards Organization. Endoscopy literally means aromaing inside and it is usually refers to look inside the personate usually in relation to medical reasons using an instrument called an endoscope. It is used to attempt the interior parts of a hollow organ or cavity of the body, and they are inserted directly into the organ.The endoscopes, peculiarly flexible endoscopes are usually complex but can be reused but require very(prenominal) preposterous conditions for reuse in respect to their decontamination. It is not only their outer surfaces that are exposed, but in like manner their air channels, wet channels and even their accessories that enable them to function in the right manner. Their exposure to body fluids and other contaminants means that their reuse has to be very carefully looked into so as to avoid spreading of diseases. It is also important to realize that most endoscopes are heat labile and cannot be autoclaved meaning they swop under different heat conditions.European (EN) and International (ISO) standards that would be applicable to an endoscope decontamination unit (EDU) in the UKAs abstracted from EN ISO 15883, information from the manufacturers should be given prior to purchasing the endoscope. This implies that the manufacturer provides information such the best disinfectants to use with that particular endoscope and what is expected when cleaning, for example the bacteria expected to be found in that respect and also if the disinfectant in question is compatible with the automatic reprocessor in which it is being used. (Gurusamy Manivannan, 2008)As per BS EN ISO 15883-1, a temperature recorder having no fewer than ten sensors should be used, and the specifications are well indicated in the ISO standard. This is because the endoscopes are heat labile, and temperature may affect the chemical composi tions of the accessories or other chemicals involved.The manufacturer should also make believe the worst conditions under of the whatsiss configuration. Such conditions encompass temperature, detergent concentration and surrogate device configuration. This also includes water flow pressure for use during testing. This may also be categorized in a standardized manner as biocompatibility testing where limits such as residual limits are stipulated as per ISO 10993. (Denise Sheard, 20120The calibrations should be check into in accordance with ISO 10012-1 for uniformity purposes. These are usually dictated by manufacturers using a pass method of applying a sensible reference. Each instrument should also be labeled with a unique reference number. This is important when measuring passage of fluids or drugs so as to get accurate and square(a) results.The standard prEN ISO 15883-1-2004 has a clause that indicates that the manufacture shall all addition information associated with the us e and decontamination of the particular endoscope. knowledge such as maximum flow and pressure of fluids within each channel in the device and the maximum possible permissible restriction of flow within each channel is deemed important and essential be provided. (James Walker, 2014)There is also a standard similar to both that the manufacturers may be pass to give information concerning the device at any stage, and act as consultants. This is stipulated in prEN ISO 15883-1-2004. This is important when complications get hold that personnel involved were not expectingReferencesGurusamy Manivannan, Disinfection and decontamination principles, applications and related issues. Boca Raton CRC Press/Taylor Francis Group, 2008Denise Sheard , A practical guide to decontamination in health care . Hoboken John Wiley Sons, 2012.James Walker, Decontamination in hospitals and healthcare. Oxford Woodhead Publishing, 2014Source document