What is ISO 80601‑2‑70 about?
ISO 80601 discusses medical electrical equipment. ISO 80601-2-70 outlines the basic safety and essential performance of sleep apnoea breathing therapy equipment hereafter referred to as medical electrical (ME) equipment.
Sleep apnoea breathing therapy equipment is intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.
ISO 80601‑2‑70 applies to ME equipment or an ME system intended for those patients who are not dependent on mechanical ventilation.
Note 1: ISO 80601‑2‑70 excludes sleep apnoea breathing therapy equipment intended for use with neonates.
Note 2: ISO 80601‑2‑70 does not apply to high‐frequency jet ventilators (HFJVs) or high‐frequency oscillatory ventilators (HFOVs).
Note 3: ISO 80601‑2‑70 does not specify the requirements for ventilators or accessories intended for anaesthetic applications, ventilators or accessories intended for home care ventilators for ventilator‐dependent patients, and ventilators or accessories intended for homecare ventilatory support.
Who is ISO 80601‑2‑70 for?
ISO 80601‑2‑70 on sleep apnoea breathing therapy equipment is useful for:
- Manufacturers of sleep apnoea breathing therapy equipment
- Test centers for breathing therapy equipment
- Hospital and non-hospital environment where sleep apnoea breathing therapy equipment is used
- Operators and end-users of sleep apnoea breathing therapy equipment
- Regulatory authorities
Why should you use ISO 80601‑2‑70?
Sleep apnoea is a chronic medical condition where the patient repeatedly stops breathing during sleep. Awareness of the risks associated with obstructive sleep apnoea has grown significantly. As a result, the use of sleep apnoea breathing therapy equipment to treat obstructive sleep apnoea has become common.
ISO 80601‑2‑70 provides information on 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 sleep apnoea breathing therapy equipment. This minimizes risks to the patient and operator when using sleep apnoea breathing therapy equipment.
What’s changed since the last update?
BS EN ISO 80601‑2‑70:2020 supersedes ISO 80601‑2‑70:2015, which has been withdrawn. BS EN ISO 80601‑2‑70:2020 has some technical changes with respect to ISO 80601‑2‑70:2015.
These include:
- Modification of the bi‐level positive airway pressure mode stability test method
- Modification of the biocompatibility requirements
- Reformatting to provide a unique identifier for each requirement
- Harmonization with the ‘A2 project’ of the general standard
