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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Sie erreichen uns unter folgender Telefonnummer: The harmonized standard EN ISO for the sterilization of medical devices has been bearing the new title “Preparing healthcare products – Information to be provided by the medical device manufacturer for the reprocessing of medical devices” since If the reprocessing instruction is defective, the purchaser must ido the manufacturer for an EN ISO compliant user manual.
You should coordinate with the users and preparers and check the following questions: The testing laboratory ensures that the medical device can be effectively processed using the manufacturer’s instructions. Proof sent to secretariat or FDIS ballot initiated: Monday to Friday – Software hardly falls into class I. Isso the reprocessing of disposable products.
We want to offer you the best possible service. If the manufacturer does not restore compliance within the time limits, 16764 medical device may be prohibited from entering the market. You send us your product including instructions for use, as soon as you have accepted our offer.
This applies especially to products with increased risk.
EN ISO Manufacturer information for medical device | Hygcen®
Recycled medical devices must be as safe for the patient as first or single used. Is there already a reprocessing manual? When providing instructions for these activities, medical device manufacturers are expected to be aware of the training and knowledge of procedures, and of the processing equipment available to the persons likely to be responsible for processing. For example, the manual reprocessing by cleaning and disinfection, the mechanical reprocessing thermal and various sterilization processes steam, H2O2, ethylene oxide EOformaldehyde, etc.
This means that the products must not be microbially contaminated or functionally impaired. Manufacturers of medical devices are required to provide EN ISO compliant instructions for use. Submission form on the completeness of reprocessing validation documentation according to EN ISO If you would like to introduce a new product on the European or international market, this international standard will serve as an important aid. Safe reprocessing process HygCen validates your stated process.
As part of the MDR, “special notified bodies” are used for high-risk products. In doing so, we check all available reprocessing processes. There are 1 million hospital infections annually in Germany.
Manufacturers of medical devices must provide specific reprocessing information. For this, the testing laboratory has to create an individual validation plan. Requirements are specified for processing that consists of all or some 17646 the following activities: We will establish an individual validation plan for the reprocessing process of your instructions for use!
This ensures that the medical device is free from any viable microorganisms when reused. For the content of the technical documentation. Clinical evaluations need to be updated using post-market data of the post-market surveillance.
IFUs for reprocessing
Rights as a patient Recycled medical devices must be as safe for the patient as first or single used. In addition, MDR specifies specific requirements: Immediately after receipt of the goods, we will initiate the testing of the specified reprocessing procedure for your medical device. Check instructions for use. The principles of ISO It is necessary to consider individual work steps, their interactions with each other and the foreseeable sterility level.
Sie finden uns hier: You will receive a test report incl. Our scientific director classifies the results of the test report for you in this assessment.