为您的骨科器械选择合适的包装系统.pdf

1、Sponsored byWendy Mach,Canyon LabsPick the Right Packaging System for Your Orthopedic DeviceAgenda Design Input Design Output Design Review Design Verification Design Validation Packaging Failures Packaging its all about DesignFDA CFR 21.8.820Design controls are in place to require manufacturers of

2、medical devices to maintain procedures to control the design of the device to ensure that specified design requirements are met.Design Input820.3(f)“Design input means the physical and performance requirements of a device that are used as a basis for device design.”Understand your user needs-voice o

3、f the customer Package designs must be easy to open and intuitive.Systems should be transparent,allowing for quick recognition.Visual cues and good thermoformed designs that will both protect and display items in a manner that supports the surgical team.Shippers must ensure outer package integrity a

4、nd durability.Listen for competitor complaintsDesign Input-Device protectionConsider implant geometry,weight,sharp edges,coatings,surface protectionDesign Input-Device ProtectionPackaging-protects the device and maintains the sterile barrier to the point of use.Packaging also enables medical staff t

5、o clearly identify parts and confirm no punctures or abrasion damage occurred during transport.Some configurations must support multiple cycles without degradation.Sustainability interest in recyclable materials,bulk packaging,environmental concernsDesign Input-Sterilization Modality Understand how

6、the mode of sterilization affects both product and packaging will drive material selection Not all materials are compatible with all forms of sterilization Ethylene oxide Radiation Steam Novel AAMI TIR17:2017(R)2020 Compatibility of materials subject to sterilization Design Input-Sterilization Modal