Here are 2 more images.
In the USP (US Pharmacopeia) there are 2 monographs I am aware of related to water - one for Purified Water (PW) and one for Water for Injection...
Wow! Well reasoned response Peter! Thank you. Somewhat unfortunately for my client the directly applicable standard (which does not mandate...
Thank you lama01. That link brought me to a draft of the European MDR dated 2012-09-26. Through other resources I found a draft from 2015-09....
Spot on Pads38. There are some interesting YouTube videos showing a 1 hand sterile / 1 hand non-sterile technique, by a nurse who is not garbed...
Hi Ronen, Do the instructions for use require the end-user to sterilise or disinfect that catheter before use? No, and I agree the risk is...
Estonian standards body just published EN ISO 13485:2016. Got 20 Euros?
Does any one have a link to the latest draft of the new European medical device regulation? What does it say about reducing risk? Still AFAPing?...
Notified Body Technical File Review Question: The device is provided non-sterile. On the bright side, it does have established requirements for...
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