Medical Grade Equipment Manufacturers? 2

[Helepolis]

Hi all,

Need suggestions for companies (preferably international) that manufacture components with medical grade standards (for Bio.Med-Engineering), components such as:
[ul]
[li]Electro-mechanical valves (solenoid and pinch valves)[/li]
[li]Pneumatic Cylinders[/li]
[li]Linear Actuators[/li]
etc...
[/ul]

Thanks!

 

[hendersdc]

What do you mean by "medical grade"? Any particular standard you want these components to meet?

I have designed many medical devices that have included the components on your list and have not needed to restrict myself to certain suppliers that are medical grade.

Are you just looking to limit failure rate or make sure the components will last the life of your product? You can look for components that already have life testing data from the suppliers.

The only medical grade components I am familiar with are power supplies, for those the distinction is around safety and product line longevity. By that I mean that the power supply will be available for sale from the supplier for a long time and will not be discontinued. This is needed because additional regression testing would need to be performed on the product if the power supply was discontinued and a new one was selected. I have also seen this with LCDs but I don't think they used the term medical grade.

 

[danw2]

For a valve mfg familiar with parentarel applications and USP, ASME BPE and ISP compliance, check out Steriflow, a division of Jordan Valve

 

[Helepolis]

What do you mean by "medical grade"? Any particular standard you want these components to meet?

I understand that "medical grade" is a very general term, but from the search i have done there are some standards that classify a device if it is suitable for medical use (e.g. ISO 10993, Premarket approval (PMA)).
Unfortenatly i couldn't find anything that (at least) specifies which general material families/classes/types are used in regards for medical devices.

I have designed many medical devices that have included the components on your list and have not needed to restrict myself to certain suppliers that are medical grade.

While designing, you weren't restricted by certain types and grades of metals and polymers?
For (a simple) example, it just seems logical to me that SS-316 will be acceptable while 4130 alloy may be rejected as incompatible material for medical use.
Or in case of cylinders and actuators, I'm sure that there are restrictions on the types of lubricants, sealants and glues that can be used.
Those restrictions must be backed by some type of broad standard/s.

Are you just looking to limit failure rate or make sure the components will last the life of your product? You can look for components that already have life testing data from the suppliers.

I guess that minimal failure rates go hand in hand with devices that are designed for medical use.

The only medical grade components I am familiar with are power supplies, for those the distinction is around safety and product line longevity. By that I mean that the power supply will be available for sale from the supplier for a long time and will not be discontinued. This is needed because additional regression testing would need to be performed on the product if the power supply was discontinued and a new one was selected. I have also seen this with LCDs but I don't think they used the term medical grade.

Thanks for the info!

Besides that, do you remember, and can suggest, any of the suppliers/manufacturers/companies that you worked with.

For a valve mfg familiar with parentarel applications and USP, ASME BPE and ISP compliance, check out Steriflow, a division of Jordan Valve

Thanks, i'll check them out.

 

[hendersdc]

While designing, you weren't restricted by certain types and grades of metals and polymers?
For (a simple) example, it just seems logical to me that SS-316 will be acceptable while 4130 alloy may be rejected as incompatible material for medical use.
Or in case of cylinders and actuators, I'm sure that there are restrictions on the types of lubricants, sealants and glues that can be used.
Those restrictions must be backed by some type of broad standard/s.

I think you are talking about biocompaitiblility. This is something that is dealt with but not on every device, only ones that are implanted, swallowed, or come in contact with mucus membranes or tissue such as in surgery, ISO 10993-1 is a good reference for that. Many medical devices do not enter the body and do not have these restrictions.

With the types of components you are talking about, I assume these aren't being implanted. Even for devices that do need to adhere to 10993-1, it is only the outer materials that need to comply, you can have a OTS linear actuator covered by a 10993-1 compliant shell or bag and be fine as long as it is sealed or otherwise kept from coming in contact.

To give you a point of reference, think of a implanted pace maker. The battery itself and circuit board contain materials that could never be made biocompatible but it doesn't matter since they are inside a sealed enclosure.

As far as suggesting components, can you give us an idea of what requirements you have for the components so we can make good suggestions?

- Volumes?
- Size/stroke/force?
- Cost target?
- Fluids involved?
- etc

 

[Sparweb]

Depending on the equipment that interests you, this will also include electromagnetic compatibility.
For the same reason that people are forbidden from using their cell phones in hospital rooms, medical monitors and PID controls need to be hardened against noise in the environment. They also need assurance that each device does not emit noisy EM that messes up everything else.

I'm not familiar with the guidelines myself, but the subject did come up while investigating the compatibility of medical equipment in helicopters, which you should know are used as medivac ships and also need a mutual assurance of non-interference. The standards in the USA are (of course) published by the FDA.

STF

 

[Helepolis]

Depending on the equipment that interests you, this will also include electromagnetic compatibility.
For the same reason that people are forbidden from using their cell phones in hospital rooms, medical monitors and PID controls need to be hardened against noise in the environment. They also need assurance that each device does not emit noisy EM that messes up everything else.

I'm not familiar with the guidelines myself, but the subject did come up while investigating the compatibility of medical equipment in helicopters, which you should know are used as medivac ships and also need a mutual assurance of non-interference. The standards in the USA are (of course) published by the FDA.

Seemingly this should be a straight forward matter, or at least i thought it to be, but the more i delve in to it the more complicated it gets.
I thought that, at least, there will be a general (macro) guideline for that stuff and from there to be redirected to more specific (micro) standards (electromagnetism, longevity, contamination, toxicity etc.)
Contacted the FDA with the hope that they would direct me to a standard or two so i can get some "traction" on that matter.

As far as suggesting components, can you give us an idea of what requirements you have for the components so we can make good suggestions?

I'll focus on a specific component, an Air Cylinder.
Is there an air cylinder that can be used to push clean air in to the respiratory system? (assuming that there is an air filter on the intake and outlet)