Read the whole text of that requirement and see if the answer is there:
Do you know how the product will be used? If yes, you should validate that it will work for that application. If not, you already have an "exclusion" built into the standard.
By the way, you should also look at what you're allowed to exclude:
The short story is if you design product and you know how it's used, you have to validate. You'd have a really tough time justifying an exclusion. My take is that if you design product and you don't validate it, and it doesn't meet requirements, then you're still on the hook. If it can only be validated in a higher assembly by the customer, then you should specify that in your agreement with them.
Howste - the standard is somewhat confusing to me, maybe I'm just having an off day, but here's an example. As I said above, we make application heaters. So, a customer calls and they need a heater to warm a table to keep a dog at the right temperature while they operate. So, we know the application.
How do we validate this application, simply show that the heater will get to the specified temperature they need? Or, do we have to build a table, apply a heater to it, perform surgery on a dog and see whether or not the dog was kept at the right temperature the whole time?
This is what I'm struggling with. Because we have thousands and thousands of customers, all with different applications, we can't re-create every single customer's application that we know to validate that the heater will meet the application requirements.
If they tell us the heater needs to maintain the table to 98.6 degrees F, we can validate this in house very easily.
If they tell us it needs to maintain the normal body temperature of a dog while under anesthesia for 6 hours continuously in a room that maintains 71 degrees F with a 50% humidity, we cannot validate this for several reasons. If this were to happen, we would tell them we need specific temperatures to work with but we would now know exactly how the heater is going to be used, are we still expected to validate all of these requirements?