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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Our scientific director classifies the results of the test report for you in this assessment. To the labeling of medical devices.
What are the consequences of the new MDR for manufacturers? To “special notified bodies”. These have increased significantly.
IFUs for reprocessing | TÜV SÜD
Duration of use HygCen checks how often your medical device can be processed without damage. It is likely that some processing procedures will be generic and well known and will use equipment and consumables conforming to recognized standards.
These are regulated in more detail in Annex 2 of the MDR. Immediately after receipt of the goods, we will initiate the testing of the specified reprocessing procedure for your medical device. Check instructions for use. For the content of the technical documentation. Only then you as a manufacturer may recommend it. We will establish an individual validation plan for the reprocessing process of your instructions for use!
Furthermore, the reprocessing is subject to the recognized rules of technology and the occupational safety and accident prevention regulations.
Association for the Advancement of Medical Instrumentation
The European database for medical isi will be greatly expanded. Be qualified for the reprocessing of medical devices. There are 1 million hospital infections annually in Germany.
For this, the testing laboratory has to create an individual validation plan. For example, the manual reprocessing by cleaning and disinfection, the mechanical reprocessing thermal and various sterilization processes steam, H2O2, ethylene oxide EOformaldehyde, etc.
However, in cases where there is no third-party surveillance, the parties involved tend to 1664 somewhat liberal about implementing the requirements of the EN ISOwhich defines the information that manufacturers need to provide. The reprocessing of medical devices requires every responsible preparer and user. Request a quote from us – by phone or via online request. Clinical evaluations need to be updated using post-market data of the post-market surveillance.
The two following documents can be interpreted as a clear indication that authorities intend to step up surveillance. Currently, a significantly higher documentation effort for manufacturers is emerging. Sie finden uns hier: To the 176664 responsible person. The testing laboratory ensures that the medical device can be effectively processed using the manufacturer’s instructions.
EN ISO 17664
The harmonized standard EN ISO for the sterilization of medical devices has been isso the new title “Preparing healthcare products – Information to be provided by the medical device manufacturer for the reprocessing of medical devices” since Method of detection As a manufacturer, you must ensure a valid reprocessing process 17646 demonstrating the cleaning an disinfection efficacy. Pre-treatment at the site of use before processing Preparation before cleaning Cleaning Disinfection Drying.
The identifiability of medical devices. Both documents are landmarks in terms of implementation of the requirements regarding manufacturer surveillance. To products with hazardous substances. You will receive a test report incl. This standard has been revised by ISO This particularly applies to Class I medical devices which must be sterilized before use and which have not yet been subject to inspection by a Notified Body prior to 17646 approval.