Oxygen mask and nebilzer mask Applied standards

S

shwagdy

#1
#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
#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

SteveK

Trusted Information Resource
#3
#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 must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
A An Example of a Risk Analysis Report for a Class II Medical Device (Oxygen Mask) ISO 14971 - Medical Device Risk Management 29
S Do we need to submit our memory foam oxygen mask gasket for FDA approval? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C How about the classification under 93/42/EEC? Sterile oxygen mask ISO 13485:2016 - Medical Device Quality Management Systems 7
N Medical Devices in oxygen rich environment IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A IEC 60601 11.2.2.1 Risk of Fire in an Oxygen Rich Environment, Source of Ignition IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
K What is mean by Oxygen Rich Environment as per the IEC 60601-1 clause no 11.2.2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
P IEC 60601 11.2.2 - Oxygen Rich Environment sources of ignition IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M Oxygen enriched environment applicability - Operating table used in general surgeries in hospital IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
C Requirements for dissolved oxygen and/or head space oxygen in Pharmaceuticals Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
M Regulations for oxygen/air-tubing and connectors inside of ME equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
F Heat and Moisture Oxygen Port Changes Classification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T CFDA issues notice for Small Oxygen Respirators (9/16/2013) China Medical Device Regulations 0
B Defining Expected Oxygen Leakage for Safety Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Ronen E Nidek Medical Class I recall: Medical Mark5 Nuvo Lite Oxygen Concentrators Other US Medical Device Regulations 0
N Chemical Oxygen Demand (COD) Determination in Industrial Waste Water General Measurement Device and Calibration Topics 5
R Testing Medical Equipment used in conjunction with Oxygen Rich Environments IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
M Oxygen Data Logger that we can place with each shipment via aircraft ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
T Is Oxygen a Drug per FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
A Recreational Oxygen Concentrator - FDA or other requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
H Oxygen Purity Requirements - Oxygen to use in electrical arc furnace ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
F Risk of fire in an Oxygen rich environment - Fire Prevention - IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
sonflowerinwales Oxygen gauge on Nitrogen supply ISO 13485:2016 - Medical Device Quality Management Systems 16
F Oxygen Concentrator Hazards ISO 13485:2016 - Medical Device Quality Management Systems 9
ScottK Oxygen Cleaning and Surfactants used for leak detection Various Other Specifications, Standards, and related Requirements 1
G Process monitoring of portable & stationary oxygen units: Can we use Cpk, Ppk, SPC ? Capability, Accuracy and Stability - Processes, Machines, etc. 3
G Process monitoring - Stationary and portable oxygen units ISO 13485:2016 - Medical Device Quality Management Systems 1
C Surgical mask stability testing (CE mark) EU Medical Device Regulations 1
M Risk managment report of Surgical Mask Example ISO 14971 - Medical Device Risk Management 14
S Technical File for Surgical Mask in Class 1 MDD Elsmar Cove Forum ToS and Forum Policies 1
M CE self-certification for Class I device (face mask) EU Medical Device Regulations 9
I Selling medical gown and mask in China China Medical Device Regulations 0
J Antiviral Mask or Mask to Mitigate or Control Corona Virus Manufacturing and Related Processes 30
J EU Regulations - Food (beverage used to mask the flavor of contrast agent) EU Medical Device Regulations 6
D Need help on correct material composition of solder resist or solder mask in PCB for APQP and PPAP 1
M Employee Wears Respiratory Mask, but a Respiratory Mask is not required Various Other Specifications, Standards, and related Requirements 41
P CE technical file - Buying Surgical Mask from China ISO 13485:2016 - Medical Device Quality Management Systems 16
Marc GM tried to mask its billion-dollar third-quarter loss with bright news World News 15

Similar threads

Top Bottom