orthopedics (general topics)

  1. M

    Real-time-aging Validation - ISO / ASTM Standard - Class 111 Orthopedic Implant

    Hi, Can someone please advise on the standard ISO / ASTM to be followed for Real Time Aging Validation for a class 111 orthopedic implant . Thanks Michelle
  2. M

    Electropolishing Validation of Orthopedic Parts - What OQ parameter range

    We’re a contract manufacturer and now we're doing a EP validation for different type of materials. We have 440A, 420B, 17-4, 455, 304, 316. We never get formal input from our customers. So my intension is to define two validation purpose, one is the surface roughness is reduced, and the...
  3. N

    GMDN codes for orthopedic implants

    As the membership fee for GMDN agency is too high for me to afford, can any one help me provide the gmdn code for orthopedic implants orthopedic instruments orthopedic external fixators any link or list or details would be of great help. regards
  4. M

    Declaration of conformity for "orthopedic soft goods"

    Hello it's the unfortunate textile engineer again, I have a new question. I am drafting our Class I Medical Devices, Declaration of Conformity and I am stumped as to what standards to include in the declaration apart from the "typical ones" like EN ISO 13485:2012, EN 1041:2008+A1:2013, EN ISO...
  5. D

    Off-Label Medical Device Use

    Along these lines, i'm wondering if anyone knows the fda regulations/guidance that support the following excerpt from an FAQ section of the American Association of orthopaedics surgeons website: "Can company representatives be present in the operating or procedure room when the procedure or...
  6. M

    Content Requirements for a Declaration of Conformity (CE Marking)

    In a declaration of Conformity ( CE Marking ) is it mandatory to give reference to standards of materials used for orthopaedic device viz screws , plates hip and knee joints etc Michelle
  7. M

    Orthopedic IFU ( Instruction For Use )

    we are orthopaedic device manufacturers we manufacture various types of plates screws , nails ,joints etc . Regarding IFU is it diffrenet for each type of plate or screw or nail or one common one covering all ? should IFU of say a DHS plate be different from IFU of Nail ? is it depending on...
  8. O

    Clavicle Pin Classification Number: UMDNS Code

    Dear All, Does anyone know the UMDNS Code for Clavicle Pin (Intramedullary Pin)? Is it the same with the UMDNS Code for Wire, Bone? Please advice. I would highly appreciate your advice. Thank you. Regards, Stephy
  9. E

    Ultrasonic Cleaning of Orthopedic Implants - Detergents and Frequency - How?

    Hi all, We are a small startup company, producing patient-specific implants. Since every implant is unique, and the volumes are still low, we clean the implant before sterilization using ultrasonic cleaning (in a desktop bath positioned in a flow cabinet). Regulations on custom implants are...
  10. M

    Biomechanical Testing of Orthopaedic Implants

    please let me know the biomechanical standards applicable for testing orthopaedic implants viz plates, screws ,nails, hip and knee joints if any for ISO 13485 and CE marking of the above what are the mandatory biomechanical tests required Thanks michelle
  11. O

    US FDA Consultants in Mumbai - Orthopaedic Devices 510K Submission help

    Does anyone know of any US -FDA consultants in Mumbai? I am looking for orthopaedic devices help. Someone to help in the 510K submission. If not in Mumbai, I am open for someone elsewhere in India. Thanks!
  12. M

    Cleaning of Orthopaedic Implants before Sterilization

    Is anyone aware of standards to be followed for cleanliness of an orthopaedic implant before gamma sterilization? How "clean" should the implant be before gamma? And what is the best way to achieve this? Thanks. Michelle.
  13. M

    Demineralized (DM) Water Specifications - Cleaning Orthopaedic Implants

    we manufacture medical devices viz orthopaedic implants , to clean the same we have installed a DM water plant ,the manufacturer of the DM plant says that we have to specify the specs of output water from the plant , my question is ,are there no standard specs for dm water ? if u r aware please...
  14. P

    Control of "manufacturing material" that has adverse effect on the medical device?

    Dear Sir, FDA part 820 talk has the requirement on the control of "manufacturing material" that has adverse effect on the medical devices. May i know what are the minimum controls that normally practice by orthopedics medical device manufacturers that can still comply to regulation? Below are...
  15. somashekar

    Advice on Device classification under MDD Annex IX.

    MDD experts... please help me to classify these medical devices. Orthopedic implantable devices : Is it class 2b or 3 in Rule 8 ? Wound suction drainage system : Is it class 2a or 2b in Rule 11 ? Also let me know if I am looking at the correct rules ~~~ :thanx:
  16. J

    IFU inside or outside Ortho Implant Sterile Device

    Can anyone provide specific standard on requires for where IFU must be placed in packaging. Currently IFU is inside sterile pacakge pre-sterilization. But discussion about putting IFU post sterilzation against package under shrink wrap. I think this is issue with sterile feild in OR if IFU...
  17. C

    BS EN ISO 12952-1 thru 4 - Test methods for burning behaviour of bedding items

    :confused: I need some help with the BS EN ISO 12952-1 thru 4 regarding general and specific test methods for burning behaviour of bedding items. We currently have the standard from 1999 and I understand that there is a new revision from 2010. I believe we will need to purchase the new version...
  18. M

    Trichloroethlene and REACH - Any less harmful substitute available?

    We manufacture medical devices mainly orthopaedic implants , we sometimes use very small amouints of trichloroethylene to clean some implants do we need to register with Reach ? is there any substitute material avaialable which is not harmful? what is the harm in using trichloroethylene is...
  19. M

    Use of Trichloroethylene and Spirit to Clean SS Parts used in Orthopedic Surgery

    do u know if in EU u are allowed to use trichloroethylene and spirit to clean ss parts used in orthopedic surgery like screws , nails, joints etc which go into humna body? is there any alternative to these ie trichloroethylene and spirit and which is allowed for use . if the above two are...
  20. L

    OQ (Operational Qualification) for Electropolish - Orthopedic Cutting Tools

    My company is a orthopedics cutting tool manufacturer. Now we are required by one of customer to do process validation on electropolish and other special process. For OQ protocol of electropolish, does anybody have any suggestion on what should be the output of electropolish. My question is what...
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