ISO 17664 PDF


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 your healthcare reprocessing process. And what type of reprocessing manual, mechanical or sterilizing procedures should we test?

Avoid unnecessary risks and costs! For example, the manual reprocessing by cleaning and disinfection, the mechanical reprocessing thermal and various sterilization processes isl, H2O2, ethylene oxide EOformaldehyde, etc. There are 1 million hospital infections annually in Germany.

This means that the products must not be microbially 176644 or functionally impaired. State a reprocessing process As a manufacturer, you must state one reprocessing process. Software hardly falls into class I.

Purchasers of medical devices are subject to a high degree of responsibility. The Medical Device Regulation combines two independent medical device directives. Please tell us for this, which medical device and application area it is. Clinical izo need to be updated using post-market data of the post-market surveillance. Rights as a patient Recycled medical devices must be as safe for the patient as first or single used.

Not only do you need to clean, disinfect and, if necessary, sterilize the medical device. Prove of patients safety HygCen determines verifiably the cleaning and disinfection efficacy. Criteria for efficacy As an manufacturer, you must specify how and often your medical device can be effectively processed by the user.



In this case, a reference in the instructions is all that is required. Duration of use HygCen checks how often your medical device can be processed without damage.

To products with hazardous substances. To the new responsible person. 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. 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.

Method of detection As a manufacturer, you must ensure a valid reprocessing process by demonstrating the cleaning an disinfection efficacy.

Only then you as a manufacturer may recommend it. Immediately after receipt of the goods, we will initiate the testing of the specified reprocessing procedure for your medical device. For example, if the product has been in circulation for a long time. To the reprocessing of disposable products.

Proof sent to secretariat or FDIS ballot initiated: To the labeling of medical devices. As a purchaser, inform the relevant monitoring authority to prevent yourself from being infringed. What are the consequences of the new MDR for manufacturers? Request a quote from us – by phone or via online request. For the content of the technical documentation. Detailed information on the use of cookies on this website can be found in our privacy policy.


The reprocessing of medical devices requires every responsible preparer and user.

The testing laboratory ensures that the medical device can be effectively processed using the manufacturer’s instructions. It is necessary to consider individual work steps, their interactions with each other and the foreseeable sterility level.

Reprocessing Validations

Check out our FAQs. These bodies would have to report any new application for conformity assessment for a high-risk product of this Medical Device Coordination Group. Manufacturers of medical devices are required to provide EN ISO compliant instructions for use.

These instructions must contain validated reprocessing processes for the respective medical device.

Reprocessing Validations – Eurofins Medical Device Testing – Eurofins Scientific

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 Final text received or FDIS registered for formal approval. Sie finden uns hier: For example, the isk guidelines: However, in cases where there is no third-party surveillance, the parties involved tend to be somewhat liberal about implementing the requirements of the EN ISOwhich defines the information that manufacturers need to provide.

As a manufacturer, you are required to recommend a validated reprocessing process.