本文主要讲的是事实与标准，标准:根据联邦法规电子代码868.5620小节，截至2016年2月22日，呼吸吹口是第一类设备。因此，必须满足这些标准。此外,21 CFR 801部分部分A, B, D,和E-Labeling 21 CFR 812 -临床实验的设备部分豁免,21 CFR 868 -麻醉学部分设备和设计控制(直流04 01特区04 04特区04 12,DC 20 04,直流04 16日直流04 28日直流04 24日直流04 40)也会实现。本篇美国传播学论文代写文章由美国论文通AssignmentPass辅导网整理，供大家参考阅读。
Standards: Under subsection 868.5620 of the Electronic Code of Federal Regulations, as of Feb 22, 2016, breathing mouthpieces are Class I devices. Hence these standards have to be met. In addition, 21 CFR Part 801 Subparts A, B, D, and E-Labeling, 21 CFR Part 812-Investigational Device Exemptions, 21 CFR Part 868-Anesthesiology Devices and the Design control (DC 04 01, DC 04 04, DC 04 12, DC 04 20, DC 04 16, DC 04 28, DC 04 24, DC 04 40) are to be met as well.
There are voluntary standards to be met such as ISO 13485-Requirements for regulatory processes, ISO 14971-Risk Management, ISO 11712:2009-Supralaryngeal Airways and Connectors, ISO/DIS 18190-general requirements for airways and related equipment not followed
Specific Risk Assessments: As per standards, risk assessments have to be conducted as well. Risks assessment must have been done even before the study was initiated. In subsequent years of the study, risks assessment must have been done to ensure the treatment considered all set of newer options and treatments possible.
User needs: User needs must be given high priority here. Some of the user requirements identified for the device are that it should be usable by holding the mandible forward and must be attachable to a ventilation tube if necessary. It should be of easy use techniques in that it can be inserted and removed within a 30 second period and must be sterile and at the same time should also be economical as currently available cheaper versions of mouth guards. Similar to the risks assessment, the user requirements must also be checked over years to see if they have changed.