ISO 10993 Cytotox Testing - Direct Contact rather than Extractables

S

Sarah_B

#1
Hi, just wondering, does anyone know when doing cytotox testing why you would do direct contact rather than extractables?

Thanks
S
 
Elsmar Forum Sponsor
M

MIREGMGR

#3
Sometimes it's argued that they excite different receptor mechanisms, and therefore that a test of both gives greater assurance of results-validity than a test of just one.
 
S

Sarah_B

#4
Thanks for your help, so the type of material would not necessarily dictate the type of testing needed?
 
M

MIREGMGR

#5
No, you shouldn't conclude that.

As a general rule and from basic scientific principles, whenever a biocompatibility test process provides alternate techniques and only a single technique will be utilized, a person with relevant expertise should select the technique that most realistically simulates the expected exposure and the rationale for that selection should be documented.
 
Thread starter Similar threads Forum Replies Date
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
Kuldeep Singh 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 1
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
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
B What ISO 10993 considers Non-Invasive vs. Invasive MDD 93/42/EEC EU Medical Device Regulations 3
C Differences between the biocompatibility standards ISO 7405 and ISO 10993 Other Medical Device Related Standards 2
R What the difference in ISO 10993-11:2006 and 2009? Other Medical Device Related Standards 17
R Extent of Recognition of ISO 10993-1 US Food and Drug Administration (FDA) 5
M Biocompatibility of Medical Devices (ISO 10993 vs Japan requirement) Japan Medical Device Regulations 1
J ISO 10993: Biocompatibility and Use of Textile Materials for Skin Contact Devices Other Medical Device Related Standards 1
D Cytotoxicity testing to ISO 10993-5 results - Is 1/ mild a pass or fail? Other Medical Device Related Standards 7
B Implementation Schedule in EU for ISO 10993-7:2008 - Transition period? EU Medical Device Regulations 9

Similar threads

Top Bottom