ISO Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices. Summary: Specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device. STANDARD. ISO. First edition. Sterilization of medical devices —. Information to be provided by the manufacturer for the processing of.
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Medical devices containing carcinogenic, mutagenic or reproductive toxicants must meet higher requirements. The reprocessing of medical devices requires every responsible preparer and user. Only then you as a manufacturer may recommend it. The two following documents can be interpreted as a clear indication that authorities intend to step up surveillance. We want to offer you the best possible service. Proof sent to secretariat or FDIS ballot initiated: The harmonized standard EN ISO for the sterilization of medical devices has been 1764 the new title “Preparing healthcare products – Information to be provided by the medical device manufacturer for the reprocessing of medical devices” since Preparers of medical devices are also subject to legal obligations.
Software hardly falls into class I.
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Immediately after receipt of the goods, we will initiate the testing of the specified reprocessing procedure for your medical device. The testing laboratory ensures that the medical device can be effectively processed using the ios instructions. This standard has been revised by ISO Sie erreichen uns unter folgender Telefonnummer: These instructions must contain validated reprocessing processes for the respective medical device.
Our scientific director classifies the results of the test report for you in this assessment.
Please tell us for this, which medical device and application area it is. In addition, MDR specifies specific requirements:. In doing so, we check all available reprocessing processes. Each manufacturer names a responsible person who has qualified specialist knowledge of the respective medical device.
To “special notified bodies”. As part of the MDR, “special notified bodies” are used for high-risk products.
Notice d’utilisation et de traitement EN ISO
This ensures that the medical device is free from any viable microorganisms when reused. This means that the products must not be microbially contaminated or functionally impaired. The classification includes an overall assessment and, if applicable, a rating in accordance with EN ISO as well as other standards and acceptance criteria.
Official documents are now confirming the international hygiene drive in the healthcare sector, where the focus of interest is increasingly turning to instructions for use IFU for the reprocessing of medical devices. Avoid unnecessary risks and costs!
EN ISO Manufacturer information for medical device | Hygcen®
You will receive a test report incl.
For example, the following guidelines: If the reprocessing instruction is defective, the purchaser must ask the manufacturer for an EN ISO compliant user manual. Method of detection As a manufacturer, izo must ensure a valid reprocessing process by demonstrating the cleaning an disinfection efficacy.
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Check instructions for use. Furthermore, the reprocessing is subject to the recognized rules of technology and the occupational safety and accident prevention regulations. Involve HygCen at an early stage in 17646 review of your healthcare reprocessing process.