Hi,

What is the status of a "Material Safety Data Sheet" - says "May be used to comply with OSHA´s Hazard Communications Standard, 29 CFR 1910.1200" ?

Background: We are distributing a Sterile Ultrasound Gel together with our ultrasound equipment. However, the manufacturer of the Sterile Ultrasound Gel does not want to give us any certificate of biocompatibility apart from this "Material Safety Sheet".
What status does this "material data sheet" have in comparison with a 10993 certificate?

How far can I go to request info on this?

best regards
t.

Hi,

What is the status of a "Material Safety Data Sheet" - says "May be used to comply with OSHA´s Hazard Communications Standard, 29 CFR 1910.1200" ?

Background: We are distributing a Sterile Ultrasound Gel together with our ultrasound equipment. However, the manufacturer of the Sterile Ultrasound Gel does not want to give us any certificate of biocompatibility apart from this "Material Safety Sheet".
What status does this "material data sheet" have in comparison with a 10993 certificate?

How far can I go to request info on this?

best regards
t.

Hi t,

Sorry, I have no answers for you - lets wait for responses. :)

Hello t,

The MSDS is not meant to satisfy the requirements of ISO 10993, the requirement chapters for which I reviewed at this site (http://en.wikipedia.org/wiki/ISO_10993). The MSDS is meant to provide specific information on a substance's toxicity, reactivity and flammability for the sake of safe transport, storage and handling in the workplace and at home. Its contents are based on the requirements of the "Right To Know" law, include cancer-causing carcinogen information and toxicity as compared to medically established threshold limit values (TLV) for a normal workday's period of 8 hours' exposure.

In contrast, ISO 10993 deals with test methods, among other things. If your supplier does not wish to supply you with such methods in spite of your specifically worded request and reason, I would consider a different supplier. But the test methods to make the MSDS may not even be known; the testing could have been done years ago, by a contracted laboratory.

So, in short they are not the same things at all and the MSDS will not likely give you the information you need.

Anyone else feel free to correct me. I'm not in my specialty here.

I agree with what Jennifer said.
An MSDS likely will not get you what you need as OSHA doesn't require biocompatibility studies.

Thanks, thats what I thought...

Though I do not understand that a product that is both CE marked and sold in the USA have not been tested for biocompatibility.

At least that´s my impression of the manufacturer...and they won´t even give me the intended use / indications for use for the product.


regards
t.

Thanks, thats what I thought...

Though I do not understand that a product that is both CE marked and sold in the USA have not been tested for biocompatibility.

At least that´s my impression of the manufacturer...and they won´t even give me the intended use / indications for use for the product.


regards
t.

sounds odd to me... maybe you should kick up your requests a level to the manager of the person you've been talking to.
You are a customer, after all.