Does anyone know of a biocompatible ABS tested & certified to ISO 10993-1

D

DangerousDave

#1
Hi All,

Does anyone know of a biocompatible ABS tested / certified to ISO 10993-1 (biological evaluation of medical devices) for short term surface contact?

Thanks

D
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Re: Biocompatible ABS

Hi All,

Does anyone know of a biocompatible ABS tested / certified to ISO 10993-1 for short term surface contact?

Thanks

D
Hi Dave.
Biocompatibility is the domine of the medical device manufacturer and the ABS as an engineering plastic raw material could be used in the medical device, however the ABS manufacturer will have no idea how and where his ABS would be put to use.
So you may get ABS which is claimed good to use generally in medical device but this does not mean biocompatibility per the ISO 10993-1 for short term surface contact or other type of contacts.
As your medical device, you have to subject it with the ABS part for biocompatibility tests to any qualified lab and claim same once the report confirms meeting to ISO 10993-1 for short term surface contact.
 
D

DangerousDave

#3
Re: Biocompatible ABS

Thanks for your reply.

I am aware that testing is an option. With some other materials (polycarbonate springs to mind) we have sourced biocompatible materials that were tested by the manufacturer of the material which has satisfied out need.

I was hoping someone would be aware of one that has been tested by the manufacturer.

D
 

somashekar

Staff member
Super Moderator
#4
Re: Biocompatible ABS

As far as I know, even if the stated material (polycarbonate springs to mind) is having a biocompatibility tested in an application, it cannot be grandfathered to an other device, unless again that new application device is tested per the standard by the necessary extraction of specimen sample and biocompatibility tested.
It will do good to check this with your certification and approval agency.
Biocompatibility is to a specific device based on type of body contact during use. Any other biocompatibility details of material could at best give you assurance that you will have a pass result in your device biocompatibility when tested per standard.
 
M

MattSmith

#6
Cycolac is an ABS from Sabic that we use in medical devices. Cycoloy is another Sabic product, a PC/ABS alloy that we use for medical device casings.
If you are on the hunt for biocompatible materials, USP grade VI would be the most readily published piece of information that indicates some degree of confidence in its potential as a biocompatible material. Manufacturer claims of ISO 10993 passes for irritation, sensitization, and cytotoxicity should also be pursued. Manufacturer data is only likely to apply to the natural material, even if you are using a manufacturer supplied pigmented material.
The latest edition of ISO 10993 for medical devices requires chemical characterisation of the material prior to biocompatibility testing to assess potential toxicity and eliminate uneccessary animal testing. USP testing is the first basic part of this process, follow by FTIR, GC/MS, defining scanning calorimetry (DSC) to define the material for future purity tesing, Inductively Coupled Plasma Spectroscopy (ICP) to check upon pigment stability. The resulting data can be assessed on-line through TOXNET.
Dependant upon your application, different testing may be required, but regulatory submssion of a medical device to the FDA now requires some degree of toxicological risk assessment as part of a biocompatiblity evaluation.
Its not quite as bad as it sounds, but if you're trying to do everything from scratch it can be expensive to perform the full round of testing. Best of luck.
 
Thread starter Similar threads Forum Replies Date
A Does anyone have a checklist of API Spec 650 13th Edition? Oil and Gas Industry Standards and Regulations 0
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1
GreatNate Metrotom - Does anyone have any exposure to the Zeiss Metrotom 800 or 1500? Manufacturing and Related Processes 0
M Honda Audits - Does anyone have any experience with the QAV audit? General Auditing Discussions 4
Q Does anyone have experience implementing a QMS without ISO certification? Quality Manager and Management Related Issues 2
J Does anyone here use ISOXpress/IMSXpress QMS software? Software Quality Assurance 11
K Does anyone have a copy of a GM 5 Phase Problem solving form Problem Solving, Root Cause Fault and Failure Analysis 1
M Does anyone has a good verification and validation plan template? ISO 13485:2016 - Medical Device Quality Management Systems 3
B Does anyone charge for annual layouts? APQP and PPAP 8
N Does anyone know a registrar that offers both ISO 9001 and ISO 17020? Registrars and Notified Bodies 6
W Does anyone have any experience with the Easy Metric System? General Measurement Device and Calibration Topics 2
J Does anyone have a good APQP template that meets IATF requirements? APQP and PPAP 3
D IATF 16949 - 8.5.2.1 Traceability Plan - Does anyone have an example? IATF 16949 - Automotive Quality Systems Standard 4
C Does anyone have an AS9100:2015 audit schedule template? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
R Does anyone have example test report of defibrillator IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
G Definition Parallel Loop - Does anyone know what the term Parallel loop means? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
B Does Anyone utilize MS Outlook Read Receipts ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
L Does anyone know what is going on in DQS? Registrars and Notified Bodies 1
P Scope Document - Does anyone happen to have an Example Scope Document (4.3)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Does anyone have a comparison between ISO 9001:2015 and ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
D Does anyone have a list of the IATF "Shalls" they would be willing to share? IATF 16949 - Automotive Quality Systems Standard 4
S Plant within a Plant - Does anyone currently manage their facility this way? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
E Does anyone have experience implementing a Tiered QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
J Does anyone have an example Authority Listing SOP example? Misc. Quality Assurance and Business Systems Related Topics 3
SteveK Does anyone know what a healthcare GDSN data pool actually looks like? Hospitals, Clinics & other Health Care Providers 2
R Does anyone have any experience on change control? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
ScottK Does anyone have experience with how MDD unanounced audits of suppliers are going? EU Medical Device Regulations 21
A Does anyone have experience providing a summary of Pre-IDE discussions in the 510k US Food and Drug Administration (FDA) 1
S Does anyone use the Boeing STP0565 and STP0637 specs? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Does anyone have a breakup of Establishments based on Device Classes ? Other US Medical Device Regulations 1
R Legal Register - Does anyone have an example of a legal register? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A MDS software - Does anyone have experience with iPoint? RoHS, REACH, ELV, IMDS and Restricted Substances 8
P Does anyone have a DFMEA process Interface Matrix .xls template FMEA and Control Plans 7
S Does anyone know about FIAT Normation N.9.91320/02 ? Customer and Company Specific Requirements 2
M Does anyone here have experience implementing PCI DSS (Data Security Standard) IEC 27001 - Information Security Management Systems (ISMS) 10
R Does anyone know why the TC 176 website has been hijacked by CSA? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 1
S Does anyone have procedure on "Regulatory Compliance"? US Food and Drug Administration (FDA) 18
K Q1-Ford - Does anyone have any Q1 templates? Document Control Systems, Procedures, Forms and Templates 2
G Does anyone have a ISO 13485 Gap Analysis form they'd be willing to share? Quality Manager and Management Related Issues 3
C List of QMS Documents - Does anyone have a template? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
A Does anyone go Mushroom Hunting Coffee Break and Water Cooler Discussions 18
J Does anyone have experience in submitting TSE Dossiers to EDQM? EU Medical Device Regulations 1
J Does anyone have an example of Risk-Benefit Analysis per ISO 14971? Other ISO and International Standards and European Regulations 2
S Does anyone have any pointers on TS 16949 Internal Auditor Training IATF 16949 - Automotive Quality Systems Standard 4
C Does anyone know anything about the Mitutoyo MACH V CMM? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
A Does anyone have a SW (LIMS) Vendor Audit Checklist? Other ISO and International Standards and European Regulations 5

Similar threads

Top Bottom