S shwagdy Sep 18, 2014 #1 Sep 18, 2014 #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
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
G Guillaume Prom Sep 18, 2014 #2 Sep 18, 2014 #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)
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)
S SteveK Sep 18, 2014 #3 Sep 18, 2014 #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
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