
Here are the key differences between the two rules for medical face masks. The new rule is called ASTM F2100-23. The old rule was ASTM F2100-19. The new rule adds two important changes for better safety e quality.
A New Rule for Shelf Life
The biggest of the updates is about labeling. The latest version of the padrão has a new requirement. Fabricantes must now print the shelf life on the mask packaging.
- What is shelf life? O shelf life tells users how long a mask can be stored before it is used. After that date, the mask’s material e construction might not work as well. Its performance could go down.
- Why is this important? This change is very important for the healthcare industry. It gives clear informação e guidance. This helps with compliance e adherence to best practices. It makes sure every individually wrapped disposable surgical face masks offers the right protection. This is key for patient safety e worker protection.
- How does it help? People who buy masks, like procurement professionals, can now see this date. They know they are buying masks that meet all specifications. This new rule helps make sure the masks will pass all performance criteria. The testing methods check for many things. These include bacterial filtration efficiency (BFE) e sub-micron particulate filtration efficiency (PFE). They also check fluid resistance e flame spread. A mask that is too old might not meet these requirements. This new labeling rule applies to all classification levels of masks, like level 1, level 2e level 3.
A New Rule About Using Masks Again
Another of the key differences in ASTM F2100-23 is a clear rule about reprocessing.
- What is reprocessing? Reprocessing means to clean and reuse a mask. The new padrão says that disposable medical face mask are for one use only. They should not be used again.
- Why is this important? This update gives clear guidance. The old ASTM F2100-19 did not talk about this. The new rule makes it clear that the design of these masks is for one person for one time. Using a mask again can be unsafe. It can lower its protection e performance. Things like biocompatibility e differential pressure, or breathability, are tested for one use.
- How does it help? This part of the guide helps everyone understand how to use masks safely. Following these regulations is important for safety. It helps keep both patients and workers safe. It makes sure every disposable doctor face mask in hospital is clean and works right.