AAMI Standards

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The AAMI standard is created by over 100 technical committees working together to produce standards, forms of practice (good practices) for the use of medical devices.
These standardized practices are part of the national consensus approved by the American
National Standards Institute (ANSI) as American National Standards. In addition to the
American approval end, the AAMI standards are adopted and approved by several other organizations such as the International Organization for Standardization (ISO) and the
International Electrotechnical Commission (IEC) (Curfman et al. 1550). The purpose of this report is to present the AAMI standards and their importance in the context of advancing safety in medical technology.
The AAMI standards help medical …show more content…
Standards that are developed need to have a clear objective and need to be validated by the risk assessment. These must address the essential requirement. The utilization of the resources needs to be limited and must be used wisely. As an ancillary to this statement, these serve as important reference to the decision-making. These must not replace the decision making by the medical devise creators and users.
7. The governments must take an active role in the participation of the stakeholders.
These are used in the setting of the priorities for the standards. The governments must not utilize the voluntary standards in regulatory processes. The government must not be the exclusive agent in the development standards. Except in cases of exceptional conditions where the needs of the people need to be understood as well.
8. In many cases, the governments do not have the resources to effectively handle the standards. They need the resources of the private sectors to meet the needs of the industry.
It is imperative to have a voluntary consensus from all the relevant stakeholders who are involved in the process. The government needs to have clearly mandated regulations that would ensure that the consumer needs are understood
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