Orthopedic Devices and Implants Manufacturing Cleanliness Requirements

Elsmar Forum Sponsor
Y

yana prus

#3
probably you mean ISO 11737-1:2006 
Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products. It can also be
ISO 11137-1:2006(en) Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
 
Thread starter Similar threads Forum Replies Date
J Cleanliness of Manufacturing Area for Orthopedic Devices and Implants ISO 13485:2016 - Medical Device Quality Management Systems 13
M Informational US FDA final guidance Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices Medical Device and FDA Regulations and Standards News 0
M Seeking Consultant for Orthopedic Start Up company Other Medical Device and Orthopedic Related Topics 1
S Orthopedic implant sterility testing Medical Device and FDA Regulations and Standards News 1
S Orthopedic Implants (Knee system) Sterilization Indicators Manufacturing and Related Processes 6
S Special 510(k) for orthopedic implant 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Accelerated Ageing Test for Orthopedic Implants -- ASTM F 1980 or ISO 11607 or both are applicable ? Other Medical Device and Orthopedic Related Topics 2
E Sampling plan for orthopedic implant - Process Validation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
M Real-time-aging Validation - ISO / ASTM Standard - Class 111 Orthopedic Implant Other Medical Device and Orthopedic Related Topics 1
M Defining the lifetime of orthopedic implants joints Other Medical Device and Orthopedic Related Topics 2
M Electropolishing Validation of Orthopedic Parts - What OQ parameter range Manufacturing and Related Processes 1
N GMDN codes for orthopedic implants Other Medical Device and Orthopedic Related Topics 2
M Declaration of conformity for "orthopedic soft goods" EU Medical Device Regulations 5
K Material Selection for Orthopedic Knee Implants Other Medical Device and Orthopedic Related Topics 2
M Orthopedic IFU ( Instruction For Use ) EU Medical Device Regulations 3
E Ultrasonic Cleaning of Orthopedic Implants - Detergents and Frequency - How? Other Medical Device and Orthopedic Related Topics 3
M Use of Trichloroethylene and Spirit to Clean SS Parts used in Orthopedic Surgery Miscellaneous Environmental Standards and EMS Related Discussions 4
L OQ (Operational Qualification) for Electropolish - Orthopedic Cutting Tools Other Medical Device Related Standards 3
M Orthopaedic (Orthopedic) Implants - SS 316L or ISO 5832 EU Medical Device Regulations 8
I Consignment Sets & Traceability - Orthopedic surgery - Small plates and screws ISO 13485:2016 - Medical Device Quality Management Systems 10
M Procedure for Validating Laser Marking & Electropolishing of Orthopedic Implants Other Medical Device and Orthopedic Related Topics 13
M Calibration - Class I medical device manufacturer (Manual orthopedic instruments) General Measurement Device and Calibration Topics 4
M Medical Devices - DFM Medical Device and FDA Regulations and Standards News 3
B Transport Validation For Non-sterile Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
B Recent 510(k) Clearances for Devices Imported from China Medical Device and FDA Regulations and Standards News 1
S Post Market Surveillance Report (PMSR) for Medical Devices EU Medical Device Regulations 6
R Labeling requirements for single use devices Manufacturing and Related Processes 4
A Mandatory Languages Requirements for Medical Devices CE Marking (Conformité Européene) / CB Scheme 1
N Shelf life guidance EU MDR, class 1 and class 2 Medical Devices EU Medical Device Regulations 2
E 510k reference devices US Food and Drug Administration (FDA) 4
B Do I need a Cleanroom to manufacture Medical Devices? ISO 13485:2016 - Medical Device Quality Management Systems 2
K Not keeping CE mark for some devices CE Marking (Conformité Européene) / CB Scheme 1
E PMS record retention time for legacy devices EU Medical Device Regulations 1
G Updating MDD devices after MDR transitional period EU Medical Device Regulations 0
T Incomplete / For further manufacture devices EU Medical Device Regulations 0
P Servicing of Class IIb devices under MDD EU Medical Device Regulations 2
Derrick Yang 各国医疗器械上市流程的区别 (Differences in the listing process of medical devices in various countries) Service Industry Specific Topics 3
G Significant changes on MDD devices/Old Devices after MDR transitional period EU Medical Device Regulations 1
T Assessing risk where harm is indirect - Generic devices / accessories / intermediates ISO 14971 - Medical Device Risk Management 8
JoCam Acquisitions - Legacy Devices UK Medical Device Regulations 0
P UDI on devices exclusively intended for retail point of sale EU Medical Device Regulations 3
D Regulatory Affairs Certification (RAC) Devices Exam - Autumn 2022 study Professional Certifications and Degrees 2
Judy Abbott Guideline as for devices utilizing plants and their derivatives in medical device US Food and Drug Administration (FDA) 6
Q Finding Independent License Holder (Medical devices) in Philippines Other Medical Device Regulations World-Wide 1
M Custom made class 1 Medical devices EU Medical Device Regulations 3
G Need Help with Run @ Rate for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 0
T Intended purpose for devices that might not fit the IP criteria EU Medical Device Regulations 0
M MDR transfer for legacy devices EU Medical Device Regulations 1
S ISO 14644 Cleanrooms: Industry-Specific Requirements for Medical Devices Other Medical Device Related Standards 0
E IVD devices helping labs meet CLIA/CAP QC requirements? Hospitals, Clinics & other Health Care Providers 0

Similar threads

Top Bottom