A ventilator is a breathing machine which is also be known as respirator, may be used to help people have conditions or illnesses that make breathing on their own very difficult. Ventilator is attached to a tube that goes through one’s mouth and into his/ her’s windpipe. When one is on the ventilator, he/she can’t speak or swallow. A ventilator is used for life support in emergency situations. It can be used for a short time, like during surgery or after a sudden illness or injury. During short-term ventilator use, a person in an intensive care unit (ICU) in a hospital. There are different types of ventilators, and each provides varying levels of support. The one which doctor uses, depend upon a person’s condition, like: Ventilators for emergency care, Ventilators for critical care, Transportable ventilators etc.
We all know that, these devices will be used on the patients so, the product must deliver the intended output. To make the quality product the manufacturer should have manufacturing and testing guidance. BIS which is the national standard body provides the related standards which contains the details of manufacturing and testing methods.
Today we will discuss about standard of the critical care ventilator.
Designation of the standard is
IS 13450 (Part 2/Sec12): 2023 / ISO 80601-2-12: 2020 and the title is The Medical Electrical Equipment Part 2 Particular Requirements for Basic Safety and Essential Performance
Section 12 Critical Care Ventilators
The scope of the standard covers the basic safety and essential performance of a ventilator in combination with its accessories.
1. Intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;
2. Intended to be operated by a healthcare professional operator; and
3. Intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.
The object of this document is to establish basic safety and essential performance requirements for a ventilator and its accessories.
The standard consists of various sections, General requirements, General requirement for testing the equipment, classification of the equipment, equipment identification, marking and identification, protection against electrical hazards, radiation hazards, construction of the equipment, Biocompatibility of the equipment, alarm conditions, which are discussed in detail. The standard is the complete guide for the manufacturer to make the efficient and safe product.
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