What is BS EN 60601‑1-2 about?
BS EN 60601‑1-2 is the first part of a series of documents on medical electrical (ME) equipment that is applicable to the basic safety and essential performance of ME equipment and ME systems.
BS EN 60601‑1-2 addresses the safety and performance of ME equipment and systems in the presence of electromagnetic disturbances. BS EN 60601‑1-2 also discusses electromagnetic disturbances emitted by ME equipment and systems.
Who is BS EN 60601‑1-2 for?
BS EN 60601‑1-2 on ME equipment and systems (safety and performance) is applicable to:
- Manufacturers of ME equipment and systems
- Hospitals
- Engineers / designers of ME equipment and systems
- Quality control personnel
Why should you use BS EN 60601‑1-2?
To protect users and operators, ME equipment and systems are expected to ensure safety during performance in an electromagnetic environment for the intended use, throughout their expected service life.
BS EN 60601‑1-2 specifies immunity test levels for safety for ME equipment and systems intended for use in the professional healthcare facility environment or the home healthcare environment. BS EN 60601‑1-2 recognizes that RF wireless communications equipment can no longer be prohibited from most patient environments, because in many cases it has become essential to the efficient provision of healthcare. So the safety tests described in EN 60601‑1-2 are designed protect workers and patients during use of the ME equipment and systems.