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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Involve HygCen at an early stage in the review of ios healthcare reprocessing process. In the future, only these specially designated bodies will be able to carry out conformity assessments for high-risk products.
Please tell us for this, which medical device and application area it is.
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Depending on the reprocessing process, we are bound by other standards. For this, the testing laboratory has to create an individual validation plan. The principles of ISO Check out our FAQs. We will establish an individual validation plan for the reprocessing process of your instructions for use!
IFUs for reprocessing
If no EU declaration of conformity has been issued, the declaration is incomplete or technically not documented, the medical device can be described as officially non-compliant.
What are the consequences of the new MDR for manufacturers?
For those medical devices where instructions for use are not required to accompany the medical device, other means of communicating the information can be used, e.
The reprocessing of medical devices requires every responsible preparer and user. Take the next step How can we help you? Does the instructions for use meet the legal requirements?
Medical devices containing carcinogenic, mutagenic or reproductive toxicants must meet higher requirements. Can kso prescribed reprocessing process be technically and personally implemented by the operator? 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 Prove of patients safety HygCen determines verifiably the cleaning and disinfection efficacy.
To ensure this, the preparers have to: To clinical reviews and exams through post-market data. This ensures that the medical device is free from any viable microorganisms when reused. That’s 1 million 1764 much.
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We want to offer you the best possible service. Each manufacturer names a responsible person who has qualified specialist knowledge of the 17664 medical device.
Only then you as a manufacturer may recommend it. 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 market approval. 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. Both documents are landmarks in terms of implementation of the requirements regarding manufacturer surveillance.
In addition, MDR specifies specific isi Is there already a reprocessing manual?
In doing so, we check all available reprocessing processes. Clinical evaluations need to be updated using post-market data of the post-market surveillance.
We will be happy to validate your reprocessing process even before it is included in the instructions for use. Requirements are specified for processing that consists of all or some of the following activities:.
Software hardly falls into class I.