ISO 10993-14:2001 - Gel implants stored in glass syringes

#1
Hello everyone,

Could you, please, help me with questions regarding the degradation study?

In the case of gel implants stored in glass syringes do this medical device falls under the scope of ISO 10993-14:2001 (for ceramic and glass) as well as ISO 10993-13:2010 considering polymeric stopper of the syringe? Or degradation issue supposed to be relevant for the gel itself?

Thank you in advance,
Yuliia.
 
Elsmar Forum Sponsor

planB

Super Moderator
#2
Yuliia,

ISO 10993-1:2018, section 6.1 provides some general guidance - quote:
Where the potential for degradation exists under the conditions of manufacture, sterilization, transport, storage, and use of the medical device, the presence and nature of degradation products shall be characterized [...]
So you might want to risk-assess two aspects:
1) Is there a potential that your syringe (including its stopper) interacts with the contained gel that it contributes it may contribute to a potential gel degradation over the labelled shelf life?
2) Is there potential that the gel degrades during shelf life?


ISO 10993-1:2018, section 6.3.2.13 then more specifically provides guidance for your gel onyl - quote:
Degradation information shall be provided for any medical devices, medical device components or materials remaining within the tissue, that have the potential for degradation within the human body.
Degradation tests shall be considered if
a) the medical device is designed to be absorbable, or
b) an informed consideration of the finished medical device composition indicates that toxic degradation products might be released during body contact.
Would you gel fall under above quoted section (a) and/or (b)?

HTH,
 
Thread starter Similar threads Forum Replies Date
C Biologic Evaluation based on ISO 10993-1 EU Medical Device Regulations 2
S Knee Implant (Femoral -Cobalt chrome)-Sub chronic toxicity test (ISO 10993-11)choice of root Medical Device and FDA Regulations and Standards News 2
R ISO 10993-18 Medical Device and FDA Regulations and Standards News 1
M ISO 10993-17 - Ancillary Medicinal substance leachables Medical Device and FDA Regulations and Standards News 3
M Medical Devices - Ancillary - ISO 10993-17 Medical Device and FDA Regulations and Standards News 6
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
L Biological Assessment (ISO 10993-1) Other Medical Device Related Standards 1
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
S ECG Cable Banana to Snap or Tab electrode Adapters -- ISO 10993 Requirement Other Medical Device Related Standards 0
K Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1 Manufacturing and Related Processes 7
A ISO 10993-7:2008/ Amd.1:2019 - Classification of special populations Other Medical Device Related Standards 8
P European versions of standards - ISO 10993-1 and ISO 11607-1 EU Medical Device Regulations 6
S ISO 10993 Biocompatibility Evaluation - Electronic thermometer Other Medical Device Related Standards 3
P ISO 10993-1:2018 - When will the European equivalent become a Harmonized Standard? Other Medical Device Related Standards 13
I ISO 10993 Biocompatibility Requirements - manufacturing process chemicals Other Medical Device Related Standards 8
N Technical File Reviewer has requested more testing to ISO 10993 Other Medical Device Related Standards 10
T ISO 10993-7 - Ethylene oxide sterilization residues Other Medical Device Related Standards 1
planB ISO 10993-1:2018 has just been published Other Medical Device Related Standards 2
M Does ISO 10993 Apply to Packaging? (e.g. Travel Case) Other Medical Device Related Standards 4
K ISO 10993 Requirements For 510k - Substantial Equivalence Other US Medical Device Regulations 11
T Using Risk Management in ISO 10993 - Medical Device Accessory 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P ISO 10993 - Sterile (Irradiation) Polypropylene Syringe Question Other Medical Device Related Standards 6
D Actual Definition of Non-Contact for ISO 10993 Other Medical Device Related Standards 1
R Biocompatibility - ISO 10993 and SVHC Requirements Other Medical Device Related Standards 4
S ISO 10993-1: External Communicating Device biocompatibility test requirements Other ISO and International Standards and European Regulations 4
S Selecting materials for implants to comply with ISO 10993 biocompatibility Other Medical Device Related Standards 4
T Plastic of an infusion pump enclosure and ISO 10993 ISO 13485:2016 - Medical Device Quality Management Systems 2
E Upcoming changes for ISO 10993 and IEC 60601 in South Korea Other Medical Device Regulations World-Wide 2
M FDA issues draft guidance to replace G95-1 (Application of ISO 10993) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B Verify GB/T 16886 is the same as ISO 10993 US Food and Drug Administration (FDA) 5
B New ISO 10993-12 - Consistency of Extraction Conditions through different Assays Other ISO and International Standards and European Regulations 1
S Suppliers of ISO 10993 compliant Material for Skin Contact Other ISO and International Standards and European Regulations 3
M ISO 10993 - Repeat tests necessary if colour changes slightly? Other Medical Device Related Standards 11
M Pre-Selecting Materials for ISO 10993-1 Biocompatibility Compliance Other ISO and International Standards and European Regulations 5
F ISO 10993-10 - Removed from List of Harmonized Standards Other Medical Device Related Standards 4
S ISO 10993 Cytotox Testing - Direct Contact rather than Extractables Other Medical Device Related Standards 4
E Meeting ISO 10993-1 2009 Material Risk Assessment Requirements Other Medical Device Related Standards 13
M ISO 10993 Labs which can test Cytotoxicity, Sensitizaton and Irritation Other Medical Device Related Standards 10
M ISO 10993 for Fabric based Electrode - Finding already FDA Approved Materials Other Medical Device Related Standards 11
J Biological Evaluation requirements per ISO 10993 - Medical Device Testing ISO 13485:2016 - Medical Device Quality Management Systems 2
A Claiming Biocompatibility without ISO 10993-1 Other Medical Device Related Standards 19
J ISO 10993 (Biological Compatibility) Approved Materials US Food and Drug Administration (FDA) 23
T ISO 10993-10: 2002 vs 2010 version - What are the Major Changes? ISO 13485:2016 - Medical Device Quality Management Systems 2
W ISO 10993 (Biological Evaluation of Medical Devices) for Suppliers Other ISO and International Standards and European Regulations 8
I EO (Ethylene Oxide) Residuals - EN ISO 10993-7:2008 EU Medical Device Regulations 5
D Does anyone know of a biocompatible ABS tested & certified to ISO 10993-1 Other Medical Device Related Standards 5
W ISO 10993 - Replacing Sensitization Test with Systemic Toxicity Test? Other Medical Device Related Standards 4
I ISO 10993-10:2010 Guidance Document for Irritation and Sensitization Test - Changes ISO 13485:2016 - Medical Device Quality Management Systems 3
M EO (Ethylene Oxide) and ECH (Ethylene Chlorohydrin) Residual as per ISO 10993-7:2008 ISO 13485:2016 - Medical Device Quality Management Systems 15
I ISO 10993-1:2009 Sensitization (Initial Evaluation Test) vs. USP Other Medical Device Related Standards 3

Similar threads

Top Bottom