Oxygen mask and nebilzer mask Applied standards

S

shwagdy

#1
We are starting producing Non Sterile Oxygen Mask , Venturi Mask , nasal cannula , Nebulizer oxygen oxygen mask .

I need support to know the applied standards used for these products
 
Elsmar Forum Sponsor
G

Guillaume Prom

#2
Here are standards I used for nasal cannula & oxygen mask:

EN 13544-2: Respiratory therapy equipment. Tubing and connectors
EN ISO 15001 : Anaesthetic and respiratory equipment — Compatibility with oxygen
EN 15986 (if using phtalates)
 

SteveK

Trusted Information Resource
#3
You might also wish to consider (assuming not too obvious):

EN 980 or EN ISO 15223-1 ? Symbols
EN 1041 ? IFU guidance
ISO 9001 and/or ISO 13485 ? Quality Systems
ISO 14971 ? Risk Management

Steve
 
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