BS 7320 Sharps Containers - Seeking Information

[Karichan]

Dear all

Can anybody send me some information regarding the standard BS 7320?

How can our products conform to this specification?

Thanks in advance

Kari

 

[Jim Wynne]

Dear all

Can anybody send me some information regarding the standard BS 7320?

How can our products conform to this specification?

Thanks in advance

Kari

You seem to already know that BS 7320 addresses requirements for sharps containers, so I'm not sure what information you're looking for. Do you have a copy of the standard? If not, it's available from https://www.bsi-global.com/Global/BuyStandards.xalter.

 

[Karichan]

Hi

I would like to know the general process for conforming the BS 7320 of our containers. Before i purchase the standard, I'm considering the value to manufacture our products according to BS 7320.

e.g. % of testing samples required? Do we need to have a system audit like ISO 9001? Technical File required? Product labelling requirement?..

Kari

 

[Al Rosen]

Hi

I would like to know the general process for conforming the BS 7320 of our containers. Before i purchase the standard, I'm considering the value to manufacture our products according to BS 7320.

e.g. % of testing samples required? Do we need to have a system audit like ISO 9001? Technical File required? Product labelling requirement?..

Kari

I believe it is considered a medical device and you will need ISO 13485 registration and have a technical file. If you plan to martket in the US, you will need to meet the FDA QSR, register and file a 510(k) Premarket Notification.

 

[Medevice]

I believe it is considered a medical device ....

Can you tell me please how you formed this belief? I cant find a clear link between the classification criteria in the MDD and sharps containers.

 

[Al Rosen]

I based it on the US regulation. It's a class 2 device.

 

[Medevice]

Yes, they are clearly Class 2 510(k) required in the US. The original question regarding BS 7320 and the answer reference to ISO 13485 and technical file caused me to think you meant they are a medical device in the EU context. Sorry for the misunderstanding.

 

[Al Rosen]

Yes, they are clearly Class 2 510(k) required in the US. The original question regarding BS 7320 and the answer reference to ISO 13485 and technical file caused me to think you meant they are a medical device in the EU context. Sorry for the misunderstanding.

I should appologize. It has been a while since that post and I don't know why I made a leap to the EU based on the FDA requirements. I usually research things like that. I checked again and can't find a link. So, I must have been mistaken.

 

[brandwood]

I had cause to seek advice on this very issue from the MHRA just a week ago. These are Class II devices in the US, borderline in the EU. But in practice these devices are generally not CE marked under the MDD and not followed up by regulators, but instead regulated by in-facility controls usually requiring compliance with the BS 7320. If you are going to supply these things - why not invest in a copy of the standard and make sure you can meet it?

Arthur

 

[Medevice]

Also, the Therapeutic Goods Administration have determined that sharps disposal collectors/containers are not medical devices in Australia.