SBS - The best value in QMS software

Knee Implant (Femoral -Cobalt chrome)-Sub chronic toxicity test (ISO 10993-11)choice of root

S

srinu

Registered
#1
#1
Dear All,
We would like to do the Biocompatibility test for our Knee implant system (Femoral component-Cobalt chrome),so I would like to know the Sub chronic toxicity test(ISO 10993-11) choice of root ..
We have 1.Dermal 2.Implantation 3.Inhalation 3.Intradermal 4.Intramuscular 5.Intraperitoneal 6.Intravenous 7.Oral 8. Subcutaneous roots
which root is suitable for the device femoral component for Sub chronic toxicity test?

Please have a look and give us your valuable suggestions and any evidence data.

Thanks in advance.
 
12 questions to ask before buying a QMS
Elsmar Forum Sponsor
planB

planB

Trusted Information Resource
#2
#2
srinu,

ISO 10993-11:2006 says in section 4.3 "The test route of exposure shall be the most clinically relevant to the use of the device, where possible. If an alternative route of exposure is necessary, it shall be justified." and in Annex A.1: "Expert consultation is suggested when designing appropriate studies." So "implantation" would be an obvious clinically relevant route, but you may also chose another clinically relevant route - and you may talk back to your test house to design the most appropriate study.

Hope this helps,
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S Orthopedic Implants (Knee system) Sterilization Indicators Manufacturing and Related Processes 6
B Required Knee Prosthesis Class III Tests and Design Dossier EU Medical Device Regulations 2
K Material Selection for Orthopedic Knee Implants Other Medical Device and Orthopedic Related Topics 2
V Cpk Measurement for Knee Implants on CMM Machine Capability, Accuracy and Stability - Processes, Machines, etc. 5
E 510k Submission Samples - Class II Medical Device - Knee Joint Prosthesis 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q How do you overcome knee jerk reactions from upper management on CA? Quality Manager and Management Related Issues 18
C QM wants 1-2-3 blocks calibrated and on a schedule - Knee-jerk reaction to ISO13485? General Measurement Device and Calibration Topics 10
C Nerve stimulation Implant cleaning services ISO 13485:2016 - Medical Device Quality Management Systems 3
S Special 510(k) for orthopedic implant 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
J Cochlear Implant Testing 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
K Article 18: Implant Card and information to be communicated. EU Medical Device Regulations 5
T Implant Card - Article 18.1(a) and MDCG 2019-8 clarification EU Medical Device Regulations 3
K Article 18 in the Implant Card - Expected lifetime of the device EU Medical Device Regulations 3
S Retained samples from each batch of spinal implant medical screws that we make ISO 13485:2016 - Medical Device Quality Management Systems 7
M Informational TGA – Current status of breast implant products in Australia Medical Device and FDA Regulations and Standards News 0
K Implant Card - Full Manufacturer's Address - Space issues EU Medical Device Regulations 4
M Informational TGA – Medical device patient information leaflets and implant cards Medical Device and FDA Regulations and Standards News 0
M Informational EU – Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council o Medical Device and FDA Regulations and Standards News 2
E Sampling plan for orthopedic implant - Process Validation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
M Informational From the Implant Files – French commission calls for massive medtech regulation overhaul Medical Device and FDA Regulations and Standards News 1
M Informational From the Implant Files – Rare immune-system cancer linked for first time to buttock implant Medical Device and FDA Regulations and Standards News 0
M Informational RIVM – Summary International Expert Meeting on breast implant-associated lymphoma Medical Device and FDA Regulations and Standards News 0
M FDA News USFDA – Breast Implant Associated- Anaplastic Large Cell Lymphoma (BIA-ALCL) – Letter to Health Care Providers Medical Device and FDA Regulations and Standards News 0
M Medical Device News MedTech Europe Statement on the Implant Files Medical Device and FDA Regulations and Standards News 0
T Clarification on MDR - Article 18(d) - Implant Card EU Medical Device Regulations 14
M Medical Device News FDA news - 17-09-18 - Agency's commitment to studying breast implant safety Other US Medical Device Regulations 0
M Real-time-aging Validation - ISO / ASTM Standard - Class 111 Orthopedic Implant Other Medical Device and Orthopedic Related Topics 1
J Studies conducted on the amount of autoclave sterilization of a PEEK implant Other Medical Device and Orthopedic Related Topics 1
W "New" MDR implant card for absorbable substances EU Medical Device Regulations 6
S Do subjects pay for a medical implant in PMCF study? Quality Manager and Management Related Issues 3
M Lux Level for Orthopaedic Implant Factory Other Medical Device and Orthopedic Related Topics 4
E Class II Implant Steam Sterilizer Validation Other Medical Device and Orthopedic Related Topics 3
M Biocompatibility Test requirements for 510k - Orthopaedic Implant Screws US Food and Drug Administration (FDA) 2
M Jail Terms for Poly Implant Prothese Executives EU Medical Device Regulations 2
H ISO Standard for Titanium & Stainless Steel finishing for Implant Other Medical Device Regulations World-Wide 3
I Implant Raw Material Supplied from Customer to Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 1
D Are implant rods (made of Titanium) passivated? Other Medical Device and Orthopedic Related Topics 7
S Medical Implant Sterile Packaging Design EU Medical Device Regulations 6
D Device that makes another Device (Active Implant Medical Device) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
D Medical Device Implant Registration Cards required by SOR/98-282 Canada Medical Device Regulations 2
O Classification of Instrumentation Used to Place Implant 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Ronen E European Commission calls for action following PIP's Breast Implant Saga EU Medical Device Regulations 1
G Breast Implant Scandal in France - Industrial Silicone Used in Implants ISO 13485:2016 - Medical Device Quality Management Systems 46
D Declaration of Conformity for a Class III Medical Device Implant EU Medical Device Regulations 5
D Implantable Medical Device (Silicone Implant) Regulations for Thailand & Mexico Other Medical Device Regulations World-Wide 13
J IFU inside or outside Ortho Implant Sterile Device EU Medical Device Regulations 3
D Orthopaedic Implant & Biocompatibity Other Medical Device Related Standards 3
F Marketing Prototype Devices - Waiting for 510K approval on implant (mesh) device ISO 13485:2016 - Medical Device Quality Management Systems 1
M Spinal Implant Testing Requirements - Bioburden, TGA & Ion Chromatography 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Is a Test or Prototype Implant a Medical Device per ISO 13485 definition? ISO 13485:2016 - Medical Device Quality Management Systems 4

Similar threads

Top Bottom