Protective masks, health vision in relation to ISO 13485:2016

Because of what has been happening lately, the respiratory mask is one of those items that we cannot, and should not, leave home without. Moreover, masks tend to become a symbol associated with the COVID-19 pandemic, and an aid to reduce the risk of contracting the virus that lingers unseen among us.

We are aware of the danger of infection; therefore information on the effectiveness of protective masks is paramount in maintaining the health of the population and especially in protecting the most vulnerable among us. The incidence of illness in recent months shows that failure to follow even simple rules costs money.

In the same way, failure to comply with health care standards increases the risk of infection with COVID-19.

Take, for example, the ISO 13485:2016 standard for the quality management system for medical devices, adapted from the quality management system standard ISO 9001:2015. It ensures that medical device manufacturers continue to design, develop, manufacture and deliver these devices safely and in accordance with regulatory requirements relevant to their intended purpose, without harming the user.

It is important to note that a supplier cannot claim that the mask complies with ISO 13485:2016, as this standard is a certification of the company’s management practices, not a certification of the quality of the mask itself.

Why does the protective mask make us safer?

Because wearing a protective mask properly helps prevent the spread of infection and prevents the caller from contracting infectious airborne germs. When someone coughs, talks, sneezes, they could release germs capable of infecting those around them, which we want to stay away from as much as possible.

Systema encourages healthy habits and the involvement of each of us to get well again.