FDM Technology, 3D Printing Materials, 3D Printing, Medical

FDM Material Biocompatibility

By Kelly Judson on September 11, 2018

3D printing has come a long way from where it started. It has made so many advances that it can even help save people's lives. Currently, Stratasys offers (3) different materials that have either been tested by the raw material manufacturer, or by Stratasys, and have some level of compliance.

Biocompatibility

Biocompatibility is the ever-changing status of knowledge and testing into how biomaterials, in our case 3D printed FDM materials, interact with the body and how those interactions help determine the clinical success of a medical device or accessory to medical process. Or in a more simple term, testing to make sure the 3D printed materials are safe to use in conjunction with the human body and medical procedures. Biocompatibility is the material's lack of interaction with living tissue or living system by not being toxic, injurious or physiologically reactive. The goal is to not cause an immune response by a person.

International Standard Organization (ISO)

The International Standards Organization (ISO) developed ISO 10993 trying to standardize biocompatibility testing. ISO 10993 is a 20-part standard that evaluates the effects of medical device materials on the body. It uses matrices to break medical devices down into three categories: Surface, External Communicating and Implant. These are further broken down into subcategories based on exposure time (limited, prolonged and permanent) as seen in Table 1. ISO 10993 is not a checklist, but more of a guide used to provide the information to get you pointed in the right direction and design a testing program. Luckily for us, most material manufacturers, or printing companies have done a decent amount of this testing. 

ISO 10993-1 Biocompatibility Testing Selection Criteria

FDM materials can be used inside of ISO 10993 to test what options are available to meet the standard. 

ULTEM 1010

ULTEM 1010 is a high-performance FDM thermoplastic and has the highest tensile strength and chemical and heat resistance of any FDM thermoplastic. It has NSF 51 food contact certification and is biocompatible per ISO 10993 and USP Class VI certification. It can be sterilized using autoclave and other methods, making it appropriate for medical tools such as surgical guides. It has the lowest coefficient of thermal expansion of any FDM material, making it suitable for many industrial tooling applications and other parts that require ULTEM 1010the unique combination of strength and thermal stability.

ULTEM manufacturer tests for the following regarding ISO 10993:

  • Systemic toxicity
  • Intracutaneous toxicity
  • Cytotoxicity
  • Hemolysis test
  • Pyrogenicity test
  • Sensitization test
  • Physico-chemical test

ABS-M30i

ABS-M30i blends strength with biocompatibility and sterilization capability. It complies with ISO 10993 and USP Class VI for biocompatible testing and can be sterilized using gamma radiation, hydrogen peroxide gas plasma or EtO methods. Parts made with ABS-M30i have excellent mechanical properties and are well-suited for conceptual modeling, functional ABS-M30iprototyping, manufacturing tools, and end-use parts.

Stratasys tests for the following regarding ISO 10993:

  • Cytotoxicity – ISO 10993-5
  • Irritation and delayed-type hypersensitivity – ISO 10993-10
  • Systemic toxicity – ISO 10993-11

 

PC-ISO

PC-ISO is a polycarbonate with biocompatibility per ISO 10993 and USP Class VI. The material can be sterilized using EtO and gamma radiation. PC-ISO has high tensile and flexural strength and a high heat deflection temperature. In these categories, its values are 33 percent to 59 percent higher than those of ABS-M30i. Applications include medical PC-ISOdevices and food and drug packaging.

Stratasys tests:

  • Cytotoxicity – ISO 10993-5
  • Irritation and delayed-type hypersensitivity – ISO 10993-10
  • Systemic toxicity – ISO 10993-11
Serializability ULTEM 1010 PC-ISO

ABS-M30i

EtO Yes Yes Yes
Hydrogen Peroxide Gas Plasma Yes No Yes
Gamma Radiation Yes  Yes Yes
Autoclave (Steam) Yes No No
Flas Autoclave Yes No No

The three materials listed are all printable on the Fortus 400, 450 and 900. The Fortus 380 is not able to print in the ULTEM 1010 material but is still able to print in the ABS M30i and the PC-ISO material. The support material used for ABS-M30i is soluble and the support material for the both the PC-ISO and ULTEM 1010 is breakaway.

Interested to learn more about how 3D printing coincides with the medical industry? Download our guide, Advancing Health Care With 3D Printing. 

Download Our Guide