What is ISO 80601‑2‑12 about?
ISO 80601 discusses medical electrical equipment. ISO 80601‑2‑12 outlines the basic safety and essential performance of a ventilator in combination with its accessory’s hereafter referred to as ME equipment. Critical care ventilators are intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening, require comprehensive care and constant monitoring in a professional healthcare facility.
Critical care ventilators are intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.
Note 1: A critical care ventilator is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings.
Note 2: ISO 80601‑2‑12 does not apply to ME equipment or an ME system operating in a ventilator operational mode solely intended for patients who are not dependent on artificial ventilation.
Note 3: ISO 80601‑2‑12 does not apply to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility.
Note 4: ISO 80601-2-12 does not specify the requirements for ventilators or accessories intended for anaesthetic applications, ventilators or accessories intended for the emergency medical services environment, ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, ventilators or accessories intended for home-care ventilatory support devices, obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70, continuous positive airway pressure (CPAP) ME equipment, high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs).
Who is ISO 80601‑2‑12 for?
ISO 80601‑2‑12 on critical care ventilators is useful for:
- Manufacturers of ventilators for medical use
- Test centers for critical care ventilators
- Hospitals
- Operators of critical care ventilators
- Regulatory authorities
Why should you use ISO 80601‑2‑12?
Critical care ventilators are intended for use in an environment that provides specialized care for patients who cannot breathe on their own or who require assistance to main adequate ventilation.
ISO 80601‑2‑12 provides an acceptable degree of basic safety, essential performance, and protection against electrical hazards, mechanical hazards, unwanted and excessive radiation hazards, and excessive temperatures and other hazards for critical care ventilators. This minimizes chances of injury to the patient and operator when using critical care ventilators.
What’s changed since the last update?
BS EN ISO 80601‑2‑12:2020 supersedes ISO 80601‑2‑12:2011, which has been withdrawn. BS EN ISO 80601‑2‑12:2020 has some technical changes with respect to ISO 80601‑2‑12:2011.
These include:
- Alignment with IEC 60601-1:2005+AMD1:2012, IEC 60601-1-8:2006+AMD1:2012, IEC 60601-1-2:2014 and IEC 60601-1-6:2010+AMD1:2013
- Determination of the probability of component failure during the expected service life
- Delivered gas maximum enthalpy requirement
- New test protocol for internal electrical power source operation time
- Performance test and disclosure requirements for other inflation-types
