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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We will be happy to validate your reprocessing process even before it is included in the instructions for use. The renaming implies additional obligations for manufacturerspurchasers and preparers.
The 1764 standard 176664 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 For example, the manual reprocessing by cleaning and disinfection, the mechanical reprocessing thermal and various sterilization processes steam, H2O2, ethylene oxide EOformaldehyde, etc. Medical devices containing carcinogenic, mutagenic or reproductive toxicants must meet higher requirements.
Furthermore, the reprocessing is subject to the recognized rules of technology and the occupational safety and accident prevention regulations. Monday to Friday – You will receive a test report incl. To clinical reviews and exams through post-market data.
In addition, MDR specifies specific requirements: We want to offer you the best possible service. If the reprocessing instruction is defective, the purchaser must ask the manufacturer for an EN ISO compliant user manual.
You should coordinate with the users and preparers and check the following questions: Manufacturers of medical devices must provide specific reprocessing information. The two following documents can be interpreted as a clear indication that authorities intend to step up surveillance.
The principles of ISO Our scientific director classifies the results of the test jso for you in this assessment. Rights as a isi Recycled medical devices must be as safe for the patient as first or single used. For example, the following guidelines: To the new responsible person. Please tell us for this, which medical 176664 and application area it is. Is there already a reprocessing manual?
EN ISO 17664
The classification includes an overall assessment and, if applicable, a rating in accordance with EN ISO as well as other standards and acceptance criteria. State a reprocessing 176644 As a manufacturer, you must state one reprocessing process. These instructions must contain validated reprocessing processes for the respective medical device.
Recycled medical devices must be as safe for the patient as is or single used. 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.
To ensure this, the preparers have to: To the classification of some products. Be qualified for the reprocessing of medical devices.
Reprocessing Validations – Eurofins Medical Device Testing – Eurofins Scientific
The preparer also checks the technical-functional safety or restores ios. If the manufacturer does not deliver then, it may violate the medical device law. These are regulated in more detail in Annex 2 of the MDR.
As part of the MDR, “special notified bodies” are used for high-risk products.
And what type of reprocessing manual, mechanical or sterilizing procedures should we test? Ich habe die Informationen zur Verwendung meiner Daten gelesen und bin damit einverstanden.
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 1766 approval.
This must be retracable and ensure that neither patient, user or third parties are at risk. Manufacturers of medical devices are required to provide EN ISO compliant instructions for use.
EN ISO Manufacturer information for medical device | Hygcen®
We will establish an individual validation plan for the reprocessing process of your instructions for use! Proof sent to secretariat or FDIS ballot initiated: If the manufacturer does not restore compliance within the time limits, the medical device may be prohibited from entering the market.