Meeting ISO 10993-1 2009 Material Risk Assessment Requirements

E

ElmerF

#1
Hello, I'm new to the forum. Just wanted to say how much I appreciate the exchange of information and thank all the contributers.

With regard to the update to 10993-1 2009, conducting a material risk assessment is now compulsory. My background in QA/RA and the standard calls for "The biological evaluation shall be planned, carried out, and documented by knowledgeable and experienced professionals.....The risk management plan should identify aspects of the biological evaluation requiring specific technical competencies and shall identify the person(s) responsible for the biological safety evaluation. " Just wondering what companies are doing here. Is it acceptable for companies to conduct these assessments themselves or hire material and toxicology experts or perhaps just include expert opinions on higher risk materials, implant.

Also anyone know where I might find a general template to get an idea of what is required?

Thanks for your suggestions.
 
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Marcelo

Inactive Registered Visitor
#2
Re: ISO 10993-1 2009, Material Risk Assessment

Hi

Just moved this thread to the right forum.

Related to the new version of ISO 10993-1. The idea is that you use 10993 to deal, inside a risk management process of ISO 14971 (not only risk assement), with the hazards and hazardous situations related to biocompatibility.

The general idea is given in Figure 1 and Annex B. Any template would need to be based on ISO 14971 and follow these additinal guidelines (and some more guidelines are being generated on the use of process standards such as ISO 10993 in conjunction with the risk manage process of ISo 14971 - this will be published in the new ISO TR 24971 - Guidance on the application of ISO 14971).

You as a company is responsible for the risk management process. This does not mean that you have to perform it or parts of it - you can delegate activities to other individuals. This is usually needed in the case of particular aspects such as biocompatibility that comapanies might not have experts related to the subject.
 
Last edited:

Highground

Involved In Discussions
#3
Re: ISO 10993-1 2009, Material Risk Assessment

Hi, Marcelo. I have been given the privilege :/ of writing a biocompatibility document based on supplier material certifications on a device that monitors the gas flow of O2 and CO2 and anesthesia. Do I review all material on the device or only the materials in the gas pathway? What type of documentation should I ask for from the suppliers?
 

Marcelo

Inactive Registered Visitor
#4
Hi, Marcelo. I have been given the privilege :/ of writing a biocompatibility document based on supplier material certifications on a device that monitors the gas flow of O2 and CO2 and anesthesia. Do I review all material on the device or only the materials in the gas pathway? What type of documentation should I ask for from the suppliers?
Please remember the you have to evaluate the device as a whole, not only the materials. Anyway, what is more important are the arts the touch the patient/tissue/organs/etc.

What you need to ask from the suppliers really depende on the risk analysis and the plan you define tho show the the risk is acceptable. There's no straight pathway.

For example, one of the things you need to do is review das (including literature) about materials, you could find these in a literature review or get data from the manufacturer if he has such data. But them again you may conclude that those data do net enable to draw conclusions, so you would need to perform certain tests.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Re: ISO 10993-1 2009, Material Risk Assessment

Hi, Marcelo. I have been given the privilege :/ of writing a biocompatibility document based on supplier material certifications on a device that monitors the gas flow of O2 and CO2 and anesthesia. Do I review all material on the device or only the materials in the gas pathway? What type of documentation should I ask for from the suppliers?
Hi,

As there seems to be only indirect (gas) patient contact, this standard is probably applicable. Do you have it?

Cheers,
Ronen.
 
#7
Hi Guys:bigwave:

Wanted to quickly check if Polyurethane considered biocompatible for skin surface and not subjected to special regulatory testing?

Thanks
 

Ronen E

Problem Solver
Staff member
Moderator
#8
Hi Guys:bigwave:

Wanted to quickly check if Polyurethane considered biocompatible for skin surface and not subjected to special regulatory testing?

Thanks
Hi,

1. "Polyurethane" is way to general - there are countless types and grades.
2. Generally speaking, all materials are subject to the same testing regime. There is no "special regulatory testing" for any specific material.
 
#10
Thanks Ronen,

Just wanted to check here, if we review our contract vendor spec for PU (used in our sub-parts), would that suffice? Or, being the medical device manufacturer ( we do the final assembly at our unit), do we need to perform the biocompatibility tests nevertheless?

Also, if I understand right, if the vendor specs are of medical grade PU with the applicable biocompatibility tests performed, we as the manufacturer, need not submit the device for the tests?

Thanking once again, for your guidance.
 
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