ISO 10993-18 vs ISO 18562-4

L

lahol

Registered
#1
#1
Hi all,

Our anaesthetic filter range requires leachables in condensate testing for MDR requirements.

Finding a lab to do testing as per ISO 18562-4 has proven challenging and is otherwise very costly. One of the labs I requested a quote from said that regulatory bodies accept either ISO 10993-18 or ISO 18562-4 in regards to leachables.

Does anyone know if this is the case? I'm currently awaiting an answer on the topic from our notified body but in the meantime thought I would ask here.

Thanks
 
SQCpack - Communicate Quality Metrics
Elsmar Forum Sponsor
planB

planB

Super Moderator
#2
#2
The vertical ISO 18562 series has been developed in order to account for the special situation of breathing gas pathways in healthcare application, that have been recognised to not be adequately and fully covered by the horizontal ISO 10993 series. Thus, ISO 18562-4 would be your preferred primary source to seek guidance for testing gas-pathway devices, unless you have a scientifically valid rationale why you would expect an equally representative leaching profile when resorting to ISO 10993-18. Cross-checking and agreeing with your NB is definitely a good idea.

HTH,
 
L

lahol

Registered
#3
#3
planB said:
The vertical ISO 18562 series has been developed in order to account for the special situation of breathing gas pathways in healthcare application, that have been recognised to not be adequately and fully covered by the horizontal ISO 10993 series. Thus, ISO 18562-4 would be your preferred primary source to seek guidance for testing gas-pathway devices, unless you have a scientifically valid rationale why you would expect an equally representative leaching profile when resorting to ISO 10993-18. Cross-checking and agreeing with your NB is definitely a good idea.

HTH,
Click to expand...
I figured this was the case which is why the lab saying either standard was acceptable for NB didn't really make sense to me.

Nevertheless, I'll wait to receive confirmation from my NB.

Thank you for your reply.
 
Ronen E

Ronen E

Problem Solver
Moderator
#4
#4
Technically speaking, both standards are not yet harmonized under the MDR, so from a formal perspective they are equally "relevant". If the lab provides a written rationale why 10993-18 is relevant in this case (subject matter wise), and the lab itself if accredited for these standards under 17025, I think there should be no material reason for the NB to object.
 
L

lahol

Registered
#5
#5
Ronen E said:
Technically speaking, both standards are not yet harmonized under the MDR, so from a formal perspective they are equally "relevant". If the lab provides a written rationale why 10993-18 is relevant in this case (subject matter wise), and the lab itself if accredited for these standards under 17025, I think there should be no material reason for the NB to object.
Click to expand...
Just as an update - our NB was happy for us to skip 18562-4 testing provided we consider Leachables in condensate within our risk analysis as well as sufficient material characterisation and justification with PMS data.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
P Biocompatibility testing ISO-10993 for FDA submission Other Medical Device Related Standards 7
M Is complete testing required as per ISO 10993 for materials used in orthopedic implants or is literature review route possible Other Medical Device Related Standards 3
J ISO 10993-1:2018 Format to Perform Risk Management Process US Food and Drug Administration (FDA) 1
M In Vitro irritation testing according to ISO 10993-23 ISO 13485:2016 - Medical Device Quality Management Systems 2
M Extractables testing replicates - Chemical Characterization ISO 10993-18 EU Medical Device Regulations 2
O ISO 10993 or ISO 18562? Other Medical Device Related Standards 1
Judy Abbott ISO 10993-18: 2020 extractables screening Other ISO and International Standards and European Regulations 2
V EN ISO 10993-1, Category of surface device by nature of body contact Other Medical Device Related Standards 2
Y ISO 10993-14:2001 - Gel implants stored in glass syringes Other Medical Device Related Standards 1
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

Similar threads

Top Bottom