Searching for any information regarding ISO 10079-1 - Vacuum Collection Canisters

K

kbunz

#1
I am searching for any information regarding ISO 10079-1. I'm not looking for a free copy. Just info. We manufacture and resell medical devices (filters, tubing, CPAP filters, etc.). One thing we resell is vacumm collection canisters. A possible new customer is asking if this canister is tested and approved to ISO 10079-1. I'm willing to buy a copy but just not sure what this covers or even if it is appropriate to this product. I've already contacted the manufacturer and they don't even seem to know what ISO 10079 is. Can anyone recommend a place to have these devices tested? Thanks in advance. kb
 
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K

kbunz

#3
Re: Iso 10079-1

Thanks. This is one of the first things I saw. I'm looking for more detailed info and especially anyone who has a test source. kb
 

rob73

looking for answers
#4
Kbunz
The tests on the collection containers in 10079 deal with implosion, leak and overflow testing. These are tests that the manufacturer should have done during the validation of the product, if the product is CE marked this should be a given as the ISO 10079 series are all harmonised standards.
I would pester your supplier until he can come up with a reasonable explanation.
Rob

EDIT -just remembered having a check-list for part 3 - see attached - it will give you an idea of what checks and test where required, part 1 is slightly different as it deals with electrically powered equipment, part 3 is from pressure or vacuum source.
Rob
 

Attachments

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S

SteveK

#5
To continue from Rob's input this is what I have in my Receiver Jar Product Dossier (Design Verification) see attachment. I hope this helps.

Steve
 

Attachments

K

kbunz

#6
rob & SteveK...

Thanks. Great info. This is what sort of info I am searching for. Especially appreciate the checklist and test summary. I'm going to go back to the manufacturer again to, as rob suggested "pester" them for more data.

Do companies typically perform these tests themselves or do they use a 3rd party lab? Could anyone recommend a lab that has the ability to test to this standard? I've explored a couple of local labs (I'm near St. Louis Missouri) but with no success.

Thanks again,

kbunz
 
S

SteveK

#7
Hi again kbunz,

I our case we did the tests ourselves. If the jar is intended for repeated use and needs to be sterilized (e.g. 121 Degrees C) by autocalve - you obviously need an autoclave since the standard requires cycling before testing for resistance to implosion etc. Other than that the kit required by the standard is fairly basic and mainly relates to the suction controller used with the jar. The jar tests cover overfill protection, leakage, spillage etc as already indicated.

Steve
 
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