Brass in medical equipment

EMengineer

Involved In Discussions
#1
Hi everyone,

We are developing surgical equipment (device which holds cardiovascular guidewire) and planning to use brass material as holder. The main question is brass a suitable material for such use? I find it antibacterial but not biocompatible. The contact with patient would be indirect contact with blood (according ISO 10993-1). This part is single use, thus we do not want to use expensive materials (titanium, cobal alloys, etc.), maybe there are alternatives? The main requirement is metal should be soft which allows easy processing. Maybe there is medical grade brass?
 
Elsmar Forum Sponsor

EMengineer

Involved In Discussions
#4
After some research what I have found is that brass should not be used where biocompatibility is required. Maybe some manufacturers used "ECO-BRASS" or similar lead free alloys and somehow managed to pass biocompatibility requirements. I found that guidewire used in vascular surgeries sometimes is gripped with grabber made from brass. I was surprised how it complied biocompatibility requirements (should be indirect blood contact which means more requirements to comply) as well as brass hubs used in needles.
 

planB

Super Moderator
#5
Some food for thought:
  1. "medical grade" is a marketing term that does not relate to any legal or standard requirement
  2. There is no restriction to materials, as long as you can demonstrate biological safety of the _final_ medical device within a risk management process when applied according to ist intended use (and foreseeable misuse).
  3. Apart from the (indirect) contact you are claiming based on your device's intended use, the (maximum expected) contact duration is key for you biological risk assessment. Moreover, indirect contact means that adverse biological effect can only be caused by inacceptable quantities of leachables, including particulate matter, released to the patient during use. In case you can address the related biologcal effects with either existing data, or data to be generated, you may be a in a position to substantiate the biocompatibility of you device even when made out of materials not commonly used for this purpose.
HTH,
 

EMengineer

Involved In Discussions
#6
Some food for thought:
  1. "medical grade" is a marketing term that does not relate to any legal or standard requirement
  2. There is no restriction to materials, as long as you can demonstrate biological safety of the _final_ medical device within a risk management process when applied according to ist intended use (and foreseeable misuse).
  3. Apart from the (indirect) contact you are claiming based on your device's intended use, the (maximum expected) contact duration is key for you biological risk assessment. Moreover, indirect contact means that adverse biological effect can only be caused by inacceptable quantities of leachables, including particulate matter, released to the patient during use. In case you can address the related biologcal effects with either existing data, or data to be generated, you may be a in a position to substantiate the biocompatibility of you device even when made out of materials not commonly used for this purpose.
HTH,
Finally we decided to go with stainless steal 316L (easier to avoid risks related with misuse as you suggested in #2). You gave me some good thoughts in #3. Thank you!
 
Thread starter Similar threads Forum Replies Date
K BS 1400 1961 standard for Brass material Other ISO and International Standards and European Regulations 2
T Bright Dipping Process of Lead Free Brass Balls Gr200. Manufacturing and Related Processes 3
P ASTM B687 Brass Pipe Nipple Standard Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
H Normalising of Dezincification Resistant (DZR) Brass Manufacturing and Related Processes 3
V Cladding on Brass - Seeking companies that clad on parts such as brass pieces Manufacturing and Related Processes 1
ScottK Brass bar stored in green wood boxes tarnished Manufacturing and Related Processes 5
ScottK Surface Finish on machined brass (or other metals)- Attribute or Variable inspection? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
M Brass, Bronze & Copper. Will their chips or powder be harmful to CNC Machines? Manufacturing and Related Processes 4
H Tapping Brass Inserts - Taps breaking too frequently Manufacturing and Related Processes 12
ScottK Detecting non-visible defects in machined brass - Where to start? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 19
M Casting defect in brass gravity die casting - Manufacturer of taps, faucets Manufacturing and Related Processes 5
A Chrome burning and yellowness in chrome bath - Electroplating of brass Manufacturing and Related Processes 3
F Who knows DIN 1755 standard tolerance for brass tubes? Various Other Specifications, Standards, and related Requirements 0
B Are Brass weights obsolete? Should they be replaced by Steel weights? General Measurement Device and Calibration Topics 7
E Tablet integrated into medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Ed Panek Is this a medical device? US Medical Device Regulations 2
S Local (country) registration of medical devices - Who does it in best case? Other Medical Device Regulations World-Wide 2
P Medical device testing lab/service standard Other Medical Device Related Standards 1
G Labeling requirements for REFURBISHED medical devices EU Medical Device Regulations 0
L Selling medical devices from USA in EU markets CE Marking (Conformité Européene) / CB Scheme 1
K Medical Device file and "Component" Manufacturers? Other Medical Device and Orthopedic Related Topics 6
rob3027 ISO 13485 justification for design and development exclusion for medical packaging ISO 13485:2016 - Medical Device Quality Management Systems 18
A Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745) CE Marking (Conformité Européene) / CB Scheme 2
H Active Implantable Medical Devices - ISO 14708 and EN 45502 Other Medical Device Related Standards 0
C Statistics/sampling plan for medical device Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
A Non-medical device testing in the medical system IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
J Regulatory path to enter EU market for non medical 60601 component Other Medical Device Regulations World-Wide 2
S Training in D&D for engineers with no medical device experience Design and Development of Products and Processes 8
M Software as Medical Device import activities for Chile and Mexico Other Medical Device Regulations World-Wide 0
M Medical Device Indications for Use Health Canada Canada Medical Device Regulations 6
dgrainger Informational Draft for comment - "reclassification of products without an intended medical purpose" EU Medical Device Regulations 6
J Average number of Nonconformances during internal quality audit for Medical Device Manufacturers Internal Auditing 3
D Exclusion 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 5
M Lifetime of medical device EU Medical Device Regulations 16
M UDI IVD Medical Device Class III US Food and Drug Administration (FDA) 1
E How to risk assess tooling? For a medical device and is it needed??? Manufacturing and Related Processes 2
P Definition of "Standalone" medical device Other Medical Device Regulations World-Wide 5
B Spare parts of medical device need CE mark? EU Medical Device Regulations 0
R EU MDR Article 22 applicability of medical device with components. EU Medical Device Regulations 4
M Medical Device AE Reporting SOP Medical Device and FDA Regulations and Standards News 0
M Class Exempt Medical Device Recall Question US Food and Drug Administration (FDA) 3
P Requirements for Exporting Medical Devices to Libya Other Medical Device Regulations World-Wide 2
B Technical Documentation for a medical device accessory Medical Device and FDA Regulations and Standards News 6
T Peru Veterinary Medical Devices Other Medical Device Regulations World-Wide 0
S Assembling technical file for a medical device ISO 13485:2016 - Medical Device Quality Management Systems 1
I Request for information regarding remote medical monitoring software (its technical documentation and the IUD system) IEC 62304 - Medical Device Software Life Cycle Processes 2
H Medical Devices Regulatory Intelligence for International Markets ISO 13485:2016 - Medical Device Quality Management Systems 1
K Class I Medical Device Registration EU Medical Device Regulations 11
V Retrospective validation medical devices Qualification and Validation (including 21 CFR Part 11) 7
K 2021/2226 on Electronic Instructions for Use (IFU) for medical devices Article 22 Packs EU Medical Device Regulations 1

Similar threads

Top Bottom