reusable devices (general)

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    UDI labeling MDR requirement for reusable medical device accessories

    I have a question regarding UDI label for reusable accessories... According to PART C, Annex VI of MDR there is a requirement Does it mean that there are two possibilities - to place UDI on device itself or on its packaging even if it is possible to (for example) engrave the qr code on the...
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    Sterilizing Reusable Medical Devices: Gravity vs. Vacuum Displacement

    We are considering revalidating our sterilization parameters in our IFU. The products are orthopedic instrument/implant cases that are double-wrapped and sterilized by the hospital. We currently use a non-standard cycle. Draft FDA guidance, AAMI TIR 12 and AAMI ST79 all list some "standard"...
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    Reusable Surgical Instruments - Definition per Annex IX of Directive 93/42/EEC

    Dear all, Can anyone help me with the interpretation of the definition for “Reusable surgical Instrument" as per section 1.3 of Annex IX of Directive 93/42/EEC? “Instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar...
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    Reusable Instrument Sterilization Method Validations

    I was hoping someone might be able to help. We are looking at doing some reusable instrument sterilization validations and have some conflicting requirements: Our US team wants to validate to 4 mins at 132 celsius using the partial cycle BI approach in ISO17665 Our UK team wants to validate...
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