Biocompatibility update in response to COVID-related inquiries.

In response to customer inquiries: 

Stratasys engaged a third-party laboratory that conducted a MED610 material evaluation and found minimal biocompatibility risk in use for gas pathway components in respiratory and ventilator equipment. The evaluation was performed by experts in the field who based their conclusion on a set of biocompatibility tests for which the material was already approved and assessed the residual risk to meet ISO 18562-1 (Biocompatibility evaluation of breathing gas pathways in healthcare applications).

The risk assessment is specific for COVID-19 emergency scenarios when the material is used to print minority components in a dry or humidified gas pathway, where the part is not expected to be submerged in liquids.

MED610 material usage.

MED610 is available for use on Stratasys Polyjet systems: Objet30 Prime™, Objet30 Dental Prime™, Objet260 Dental™, Objet Eden260VS™, Objet Eden260VS Dental Advantage™, Objet260/500™ Connex1, Objet260/500 Dental Selection™, Objet260/350/500™ Connex3, and J750. The official report is available upon request and will soon be available on the Stratasys website.

 

Click here for more information: https://www.stratasys.com/materials/search/biocompatible

 

Stratasys is responding to the current global COVID-19 (coronavirus) pandemic in many ways.  One way we are responding is to provide additional information about our products.  Stratasys has obtained a report, titled “Biocompatibility of MED610 as a Component in Gas Path Devices”, dated 30 March 2020, published by Nelson Labs A Sotera Health company and is sharing this information with you.  Note, this is for informational purposes only.  While the information is deemed accurate, you may not rely on this information, but must complete your own analysis or obtain your own advice.  Stratasys does not warrant product selection and you are solely responsible for the same.  You are responsible for determining the appropriateness and use of materials, whether there are any governmental rules, regulations, laws or requirements for use of materials or the products derived from materials, and informing others of these requirements.  Medical devices, including those manufactured from MED610, may be subject to additional rules and regulations.  Stratasys is not responsible for the biocompatibility assessment of any part or medical device printed with MED610 or use of a printing option.  Final product classifications are not discussed in this document.  Stratasys retains no and disclaims all liability for any claims of any kind made by any person, either as a result of use of or as related to this information and the relevant materials.  STRATASYS, FOR ITSELF AND ON BEHALF OF ITS AFFILIATES, OFFICERS, DIRECTORS AND EMPLOYEES, DISCLAIMS ALL WARRANTIES RELATED TO THIS INFORMATION OF ANY KIND, EXPRESS AND IMPLIED, INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR USE OR A PARTICULAR PURPOSE; NON-INFRINGEMENT; COMPLIANCE WITH ANY REGULATORY STANDARDS; AND COMPLIANCE WITH ANY OTHER LAWS.