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.
|Published (Last):||10 February 2004|
|PDF File Size:||3.8 Mb|
|ePub File Size:||19.68 Mb|
|Price:||Free* [*Free Regsitration Required]|
These instructions must contain validated reprocessing processes for the respective medical device. Take the next step How can we help you?
State a reprocessing process As a manufacturer, you must state one reprocessing process. You should coordinate with the users and preparers and check the following questions: Involve HygCen at an early stage in the review of your healthcare reprocessing process.
Can the prescribed reprocessing process be technically and personally implemented by the operator? Does the instructions for use meet the legal requirements? Ich habe die Informationen zur Verwendung meiner Daten gelesen und bin damit einverstanden. Be qualified for the reprocessing of medical devices.
If the manufacturer does not deliver then, it may violate the medical device law.
For this, the testing laboratory has to create an individual validation plan. Follow the manufacturer’s instructions for reprocessing. The European database for medical devices will be greatly expanded. Criteria for efficacy As an manufacturer, you must specify how and often your medical device can be effectively processed by the user. Market surveillance authorities can determine, according to MDR, whether products are ios compliant.
So you can hedge uso as a manufacturer. Duration of use HygCen checks how often your medical device can be processed without damage. To the new responsible person. Clinical evaluations need to be updated using post-market data of the post-market surveillance.
HygCen also checks your product for FDA compliance. The reprocessing of medical devices requires every responsible preparer and user.
To clinical reviews and exams through post-market data. In this case, a reference in the instructions is all that is required.
If the manufacturer does not restore compliance within the time limits, the medical device may be prohibited from entering the market. In addition, MDR specifies specific requirements: Immediately after receipt of the goods, we ieo initiate the testing of the specified reprocessing procedure for your medical device.
Association for the Advancement of Medical Instrumentation
Sie erreichen uns unter folgender Telefonnummer: Requirements isoo specified for processing that consists of all or ieo of the following activities:. The identifiability of medical devices.
In the future, only these specially designated bodies will be able to carry out conformity assessments for high-risk products. To “special notified bodies”. In general, the validation of the reprocessing process becomes more important. As a manufacturer, you are required to provide all necessary information for reprocessing.
Depending on the reprocessing process, we are bound by other standards.