ISO 15001:2010

The ISO 15001:2010 , The Anaesthetic and respiratory equipment – Compatibility with Oxygen provides intensive recommendations for selection of materials and cleaning of components made from them for use in high-oxygen atmospheres.

Apply For ISO Registration



What is ISO 5001?

Oxygen gas whether pure or mixed with medical gases is used widely in Medical applications. Clincal personell as well high-risk patients are often in close proximity of such oxygen rich environements.

Through a variety of sources, a risk of injury increases significantly in the case of a fire breaking out in such oxygen-heavy environments. /h3>

The ISO 15001:2010 , The Anaesthetic and respiratory equipment – Compatibility with Oxygen provides intensive recommendations for selection of materials and cleaning of components made from them for use in high-oxygen atmospheres.

Normative References:

The ISO 14791, – Application of Risk Mangement to Medical Devices , is indispensable for an application for ISO 15001:2010.

Specifications:

The documentation for the ISO 15001: 2010 also gives a comprehensive list of scientific terms and conditions to avoid endangering situations like a fire
for eg.

Adiabtatic pressure –compression process that occurs without the transfer of heat in and out of a system.

Apart from that, Cleaniness measures and hydrocarbon specifications have been specified for the proper cleaning of equipments. Resistance to ignition , Risk Management are the other provisions included in the certification . These will help in effective and swift decision making for crisis situations while minimizing the occurence of such events to a bare minimum.