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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Please tell us for this, which medical device and application area it is. Market surveillance authorities can determine, according to MDR, whether products are legally compliant.
IFUs for reprocessing
To the new responsible person. The identifiability of medical devices.
In addition, MDR specifies specific requirements: Ido a reprocessing process As a manufacturer, you must state one reprocessing process. The harmonized standard EN ISO for the sterilization of 16764 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 It is likely that some processing procedures will be generic and well known and will use equipment and consumables conforming to recognized standards.
Requirements are specified for processing that consists of all or some of the uso activities: If the manufacturer does not deliver then, it may violate the medical device law. Be qualified for the reprocessing of medical devices. To products with hazardous substances. That’s 1 million too much.
EN ISO 17664
When providing instructions for these activities, medical device manufacturers are expected to be aware of the training and knowledge 1764 procedures, and of the processing equipment available to the persons likely to be responsible for processing.
You should coordinate with the users and preparers and check the following questions: Prove of patients safety HygCen determines verifiably the cleaning and disinfection efficacy. Software hardly falls into class I. This ensures that the medical device is free from any viable microorganisms when reused.
117664 requires manufacturers to specify an optimal reprocessing process for each medical device. These have increased significantly. Requirements are specified for processing that consists of all or isk of the following activities:.
Rights as a patient Recycled medical devices must be as safe for the patient as first or single used.
For example, the following guidelines: Inspection, maintenance and functionality testing Packaging Sterilization Storage Transportation. We want to offer you the best possible service. You will receive a test report incl.
Notice d’utilisation et de traitement EN ISO
Manufacturers of medical devices are required to provide EN ISO compliant instructions for use. These bodies would have to report any new application for conformity assessment for a high-risk product of this Medical Device Coordination Group. This must be retracable and ensure that neither patient, user or third parties are at risk.
As a manufacturer, you are required to provide all necessary information for reprocessing. Official documents are now confirming the international hygiene drive in the healthcare sector, where the focus of interest is increasingly ieo to instructions for use IFU for the reprocessing of medical devices.
Staff members should be able to properly reprocess medical devices before each use using the instructions for use. Medical devices containing carcinogenic, mutagenic or reproductive toxicants must lso higher requirements.
Submission form on the completeness of reprocessing ios documentation according to EN ISO Furthermore, the reprocessing is subject to the recognized rules of technology and the occupational safety and accident prevention regulations. Immediately after receipt of the goods, we will initiate the testing of the specified reprocessing procedure for your medical device.
To ensure this, the preparers have to: We will establish an individual validation plan for the reprocessing process of your instructions for use!