Orthopedic Implants (Knee system) Sterilization Indicators

srinu

Registered
#1
Dear All,
I have a one question regarding the Sterilization Indicators for our knee implant system.
Which one is good among BI (Biological Indicators) or CI(Chemical indicators)?
Which is the recent trend/most companies used among BI or CI?
Any one has info about this please share or give your openions.

Thanks in advance.
 
Elsmar Forum Sponsor

planB

Super Moderator
#2
Srinu,

As long as the BI is certified according to
- ISO 11138-1, Sterilization of health care products – Biological indicators – Part 1: General requirements, and the applicable sub-part depending on your chosen sterilisation modality
- USP <55> Biological Indicators – Resistance Performance Tests

and the CI is certified to ISO 11140-1, Sterilization of health care products - Chemical indicators - Part 1: General requirements

you may chose from any commercially available brand.

You may want to conservatively make sure that you do not mix different indicator lots / brands in one run. You may also consider that, regulatory-wise, employing BIs for validation and in-process monitoring of sterilisation may be more accepted than CI for certain sterilisation modalities..

Hope this helps,
 

mpfizer

Involved In Discussions
#4
Srinu,

As long as the BI is certified according to
- ISO 11138-1, Sterilization of health care products – Biological indicators – Part 1: General requirements, and the applicable sub-part depending on your chosen sterilisation modality
- USP <55> Biological Indicators – Resistance Performance Tests

and the CI is certified to ISO 11140-1, Sterilization of health care products - Chemical indicators - Part 1: General requirements

you may chose from any commercially available brand.

You may want to conservatively make sure that you do not mix different indicator lots / brands in one run. You may also consider that, regulatory-wise, employing BIs for validation and in-process monitoring of sterilisation may be more accepted than CI for certain sterilisation modalities..

Hope this helps,

How long can a BI used in gamma sterilization process be kept before testing it for sterility ?
Is it mentioned in any standard or is it to be determined by the BI manufacturer

Thanks

Michelle
 

planB

Super Moderator
#7
mpfizer,

as a good practice, BIs exposed to a sterilisation process should be tested for sterility without undue delay. To my knowledge, there is no restriction or defined limit for the time frame between BI cycle-exposure and BI sterility test. However, if you want to retain them for (5) years, you will surely exceed the BIs shelf life and thus, may invalidate such a delayed sterility test, e.g. encounter growth due to a compromised BI packaging.

Hope this helps,
 
Thread starter Similar threads Forum Replies Date
K Material Selection for Orthopedic Knee Implants Other Medical Device and Orthopedic Related Topics 2
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
M Defining the lifetime of orthopedic implants joints Other Medical Device and Orthopedic Related Topics 2
N GMDN codes for orthopedic implants Other Medical Device and Orthopedic Related Topics 2
M Orthopedic Devices and Implants Manufacturing Cleanliness Requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
E Ultrasonic Cleaning of Orthopedic Implants - Detergents and Frequency - How? Other Medical Device and Orthopedic Related Topics 3
M Orthopaedic (Orthopedic) Implants - SS 316L or ISO 5832 EU Medical Device Regulations 8
M Procedure for Validating Laser Marking & Electropolishing of Orthopedic Implants Other Medical Device and Orthopedic Related Topics 13
J Cleanliness of Manufacturing Area for Orthopedic Devices and Implants ISO 13485:2016 - Medical Device Quality Management Systems 13
S Orthopedic implant sterility testing Medical Device and FDA Regulations and Standards News 1
S Special 510(k) for orthopedic implant 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
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
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 Electropolishing Validation of Orthopedic Parts - What OQ parameter range Manufacturing and Related Processes 1
M Declaration of conformity for "orthopedic soft goods" EU Medical Device Regulations 5
M Orthopedic IFU ( Instruction For Use ) EU Medical Device Regulations 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
I Consignment Sets & Traceability - Orthopedic surgery - Small plates and screws ISO 13485:2016 - Medical Device Quality Management Systems 10
M Calibration - Class I medical device manufacturer (Manual orthopedic instruments) General Measurement Device and Calibration Topics 4
M Implants made by Additive Manufacturing process approved by USFDA Other Medical Device and Orthopedic Related Topics 1
M Covid Free Statements for Implants and sales reps. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Definition of "servicing activities" - Spinal Implants ISO 13485:2016 - Medical Device Quality Management Systems 4
M Informational US FDA Draft Guidance – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Medical Device and FDA Regulations and Standards News 0
M Informational EU – Minutes of the 24 July 2019 SCHEER Working Group on safety of breast implants in relation to anaplastic large cell lymphoma (BIA-ALCL) meeting Medical Device and FDA Regulations and Standards News 0
M Informational US FDA paper – Biological Responses to Metal Implants Medical Device and FDA Regulations and Standards News 0
M Informational DSVG 04 – Breast Implants – Guidance on the vigilance system for CE-marked medical devices Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Australian regulatory action on breast implants and breast tissue expanders Medical Device and FDA Regulations and Standards News 0
M Informational The FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants; Requests Allergan Voluntarily Recall Certain Breast Implants a Medical Device and FDA Regulations and Standards News 0
J Custom-made implants (Class IIb) and pre-commercialization clinical trials in Spain EU Medical Device Regulations 4
M Cleaning Process after laser marking on orthopaedic implants Other Medical Device and Orthopedic Related Topics 3
M Informational Technology and innovation of human implants | Panel for the Future of Science and Technology (STOA) | European Parliament Medical Device and FDA Regulations and Standards News 0
M Informational The ANSM decides, as a precautionary measure, to withdraw from the market macrotextured breast implants and breast implants with polyurethane-coated s Medical Device and FDA Regulations and Standards News 0
M Informational Health Canada advises Allergan of its intent to suspend its licences for Biocell breast implants as a precautionary measure Medical Device and FDA Regulations and Standards News 0
M Informational FDA Panel Recommends New Postmarket Requirements for Breast Implants Medical Device and FDA Regulations and Standards News 1
M Informational FDA Panel: Too early to pull textured breast implants over cancer risk, need more data Medical Device and FDA Regulations and Standards News 0
M Medical Device News EC – Commission reply to a Petition “For a Compensation Fund for PIP Breast Implants and CE” from the website change.org Medical Device and FDA Regulations and Standards News 0
E Cleaning Validation Process of Non-Sterile Implants and Instruments Other Medical Device Related Standards 2
Q Use of parts in gamma sterilization validation - Reprocessing implants EU Medical Device Regulations 1
T Orthopaedic Registries - Bone fracture implants (e.g. screws. plates,etc) ISO 13485:2016 - Medical Device Quality Management Systems 0
B Reclassification of Spinal Implants via Rule 8 (EU 2017/745) EU Medical Device Regulations 0
M SOP or template for a study to Define Storage Conditions of Orthopaedic Implants EU Medical Device Regulations 3
C PMCF (Post Market Clinical Followup) Enrollment Sizes (Spinal Implants) EU Medical Device Regulations 5
P Medical Device changes - Active implants EU Medical Device Regulations 2
A Post-market Clinical Studies of Orthopaedic (Revision) Implants EU Medical Device Regulations 1
J Maximal limit of Aluminum in Polymer Medical Device Implants (EU) Other Medical Device and Orthopedic Related Topics 1
E Types of nonactive Medical Device implants - What is the origin of this codification? EU Medical Device Regulations 6
M Mechanical Testing for Orthopaedic Implants for CE Marking EU Medical Device Regulations 2
F Notification Procedure for Reimbursement Implants and Invasive Devices in Belgium EU Medical Device Regulations 4

Similar threads

Top Bottom