Dr. Patrick Druggan That's your job. You need to start with the Essential Requirements (93/42/EC) or Essential Principles and work from there. https://www.tga.gov.au/form/european-medical-device-directive-essential-requirements-checklist

Vin Cohan Thanks Patrick

Dr. Patrick Druggan Vin Kumar you'll find it a really useful document

Jim Ball Vin, this is helpful, but barely gets you started.
A mask must be designed
- to seal well
- at pressures up to 25 cm of H2O
- without threatening any damage to the eyes
- no matter how a patient turns their head
- or their body
- whether they are on their side, stomach, back
- with various kinds of headgear
(in various states of stretchiness)
- on various shapes of heads
- and various shapes of faces
- with various nose sizes
- with or without head hair
- or facial hair
- with or without humidification
- and not interfere with use of any oral appliances
(to move jaw forward, prevent teeth grinding, etc)
- and should have a quick release from tubing
(so you don't have to remove the mask and then readjust
during middle of night bathroom trips)

Jim Ball Vin,
These days, it should also be.....
- durable
- comfortable to wear in all temps & humidities
- not so cumbersome that it affects sleep
- hypoallergenic
- microbe & fungus resistant, at least
- antimicrobial & antifungal, if possible
- not prone to absorbing sweat, saliva, cleaning solutions, etc
- easy to REALLY clean - no hard-to-reach nooks/recesses
that only get "kind of" clean, allowing things to grow.
- easy to take apart, if needed
- easy to put back together while still having a great seal
- easy for older people, too - people w/ imperfect eyesight
& hands that don't work as well as they used to
- with replaceable parts
(so you can replace a cushion w/out buying a whole new mask)
- easy to put on & take off, even if the user is groggy
(think about the total darkness & confusion of suddenly waking
up from a dream during a middle-of-the-night power outage)

Beluh Mabasa Ginting I hope this document could help you too, http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n68-2012-safety-performance-medical-devices-121102.pdf
The availability of the Conformity Assessment Body (CAB) such as accredited laboratory is also priority too to make sure that you product will be accepted on the market.

Low Dead space is always a factor as well as Skin break down. Creating a seal on a face can be challenging as no one person has the same face geometry as another person. It is also important to remember that individuals will need to clean/disinfect /sterilized these masks every so often. Your everyday end user at home may not be comfortable with using High Level Disinfectants (HLD) such as Cidex OPA . While soap and water may be adequate it has been proven that most end users feel machine washing (Dish Washer) is preferable. If you can use a material that can withstand steam autoclave it would be a plus.

Miquel Sisteré Manonelles
Add to the comments of Dr. Druggan, the facility for use in any model of cpap

Miquel Sisteré Manonelles I think that the 3d printers can manufacture an individual mask for each patient and then we will have the personalized medicine

Anthony Dwyer this is not my field but as a user I would suggest careful attention needs to be paid too the exhaust. This needs to be diffused so it dose not blow air on to yourself or a partner. one brand had a really good diffuser but a lousy strap that wasn't adjustable. and it stretched very quickly

Vin Cohan Hi Everyone, I have been through everyone's information that has been posted(Much appreciated). It was quite useful. I now have a better understanding of the sleep apnea mask. However, I am still struggling on the material for the sleep apnea mask and its face seal. I know many companies are using Polycarbonate but polycarbonate is not a BPA free plastic. Any suggestions for an alternate material?

Hello team, one of the most commonly used materials for face masks is silicone. Easy to clean, permeable, wide varieties of hardness and used in many long term skin contact medical applications. It is expensive compared to other low durometer materials but there are a number of compounds that clear ISO 10993. Look at Wacker and Nusil.

Nana Ryu Hi Vin Kumar The sleep apnea mask can also be made of silicone and rubber. Silicone is low toxicity.

Vin Cohan Hi Nana Ryu and Aron Yngve, MBA Thanks for your response, Yes you guys are right liner is made from Silicone and from last few days I am looking for alternate material for liner and harness as well. Currently for harness, many companies are using neoprene.

It is important to have a latexfree material.
Silicon will do but Silicone Rubber Thermoplast will be a good alternative.

Dr. Patrick Druggan Vin, look up Cochrane Reviews for more information

Nana Ryu Vin Kumar Some people are allergic to neoprene. When using neoprene to make a harness, this should be highlighted and stand out to ensure users read it and don’t miss it.

Vin Cohan Nana Ryu Thanks for your kind information. I am looking for alternate material for neoprene.

Miquel Sisteré Manonelles We are testing the world's smallest and portable cpap in the Dakar Rally (Albert Llovera - trucks). On January 12, we will present our Airmony so that investors can collaborate on the project.
We could associate the best mask designers with Airmony and launch an innovative product.
https://www.eventbrite.es/e/entradas-presentacion-para-inversores-de-las-oportunidades-de-negocio-de-tbiom-30872200583?aff=efbnreg

Miquel Sisteré Manonelles Masks aren't our priority. There are many and good masks