Quote: (Originally Posted by
divetheworld)
Thats cool, good luck with that. The certification process is difficult enough, try not to put too many barriers between you and realisation of the product.
Obviously you could bring your product to the market place very quickly if you wanted to, and the fundamental principle of the product precludes that.
I guess I am suggesting not to do too much if you dont have to.
Brent
Following on from your earlier point, I just raised this question of whether or not the scrubber is within the EN61508 scope in an eCCR with Audrey Canning of Verkonnen. Audrey was involved in setting up CASS, a Director of CASS Scheme Ltd until recently, works with BSI on 61508 implementation and on the International Committee for 61508. More definitive is hard to find. Audrey's view was the scrubber is certainly included in the scope of EN61508 if it is fitted to an eCCR.
CASS is the official interpretation of 61508. If a product meets 61508 it can be CASS registered.
The reason the scrubber falls into 61508 in an eCCR, is throughout 61508 there is an end to end requirement: one is not allowed to say, "our electronics ends here, so the fact that it is connected to a stick of dynamite with a burning fuse is not our concern, so the whole thing must have a SIL 4 safety level as that is what our electronics has". Does not wash. If the electronics is controlling the mechanics, then the mechanics and electronics together form the system. If the electronics is just injecting O2 but the system must remove CO2 for the user to stay alive, then the CO2 control falls into 61508. Just like on aircraft: you cannot say the wings are excluded from the safety case.
You appreciate the issues of bringing equipment to market fast, but without cover. This is fully accepted. I know it is very tempting when one is diving a product but we cannot sell anything until the independent safety certificates are in the safe. This is embedded in our formal Quality Processes.
How this works is interesting: our clients are either they are in countries where the Objective Responsibility law applies, or they are in the USA and big enough that if it is not done to the letter of the book then lawyers feast on them as soon as something goes wrong. What I am saying, is that after deciding to do it properly, we took on a client base that has the same objectives and would not sway from this noble goal. A mutually comfortable situation.
On both ethical and commercial grounds, we will apply the regulations exactly as they are written. EN14143 is easy - almost any decent design can meet it if the EN61508 compliance is ignored. EN61508 involves much more work. HSE are just really starting to pick up on this. Soon it will be just like trying to sell product that does not meet EN14143, if it does not meet EN61508 it has neither certification, so cannot have the CE mark. I think that will be good for diving generally, making it more accessible and with fewer personal tragedies.
Cheers,
Alex