Posts Tagged ‘#NIOSH’
Surgical Mask Guidance
Surgical Mask EUA During the COVID-19 pandemic, the FDA issued Emergency Use Authorizations (EUA) for certain Personal Protective Equipment (PPE), including Surgical Masks. Normally a FDA 510K Premarket Notification is required prior to marketing a mask as a Surgical Mask. This is still a long term requirement. However, due to the issuance of the Umbrella…
Read MorePain is Weakness Leaving the Body!
Pain is Weakness Leaving the Body! I love this old military mantra! Or then there’s “No pain no gain!” Sometimes a little bit of pain goes a long way for ultimate success! We accept this mantra at Quality Audit Consulting (QAC)! We can help you get through your growing pains with a gap assessment for…
Read MoreN95 Mask Sampling Requirements
NIOSH 42 CFR Part 84 provides the standards for the approval of N95 respiratory protective devices. The approval of N95 respiratory protective devices requires that there be a Quality Control Plan in place. Part 84.41 describes the Quality Control Plan. One of the parts of the Quality Control Plan which must be in place in…
Read MoreN95 Respirator Test Requirements for NIOSH Submission
N95 Respirator Test Requirements for NIOSH Submission NIOSH requires that N95 manufacturers follow the guidelines in the Code of Federal Regulations (CFR), 42 CFR Part 84. 42 CFR Part 84 provides the test procedures, requirements, and documentation needed to file an application with NIOSH Before respirators can be submitted to NIOSH for certification, manufacturer’s must…
Read MoreNIOSH and N95 Respirator Certification Steps
The FDA defines N95 Respirator as a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles. The edges of the respirator should be designed to form a seal around the nose and mouth. Surgical N95 Respirators are commonly used in healthcare settings and are a subset…
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