What is BS EN IEC 80601‑2‑71 - Medical electrical equipment about?
BS EN IEC 80601 is an international standard that focuses on particular requirements of medical electrical equipment for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment. Medical electrical equipment is any device intended to be used for medical purposes. BS EN IEC 80601‑2‑71 applies to the basic safety and essential performance of functional NIRS equipment intended to be used by themselves, or as a part of a medical equipment system, for the production of functional NIRS equipment output for adjunctive diagnostic purposes, hereinafter referred to as medical equipment.
Who is BS EN IEC 80601‑2‑71 - Medical electrical equipment for?
BS EN IEC 80601‑2‑71 on particular requirements of medical electrical equipment for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment is useful for:
- Manufacturing unit of medical electrical equipment
- The professional technicians who can maintain the basic needs and service of electric equipment
- The doctors
Why should you use BS EN IEC 80601‑2‑71 - Medical electrical equipment?
A global definition for a medical device is difficult to establish because there are numerous regulatory bodies worldwide overseeing the marketing of medical devices. The minimum safety requirements specified in BS EN IEC 80601‑2‑71 is considered to provide for a practical degree of safety in the operation of functional NIIRS equipment. A "Particular guidance and rationale" text giving some explanatory notes, where appropriate, about the more important requirements, is included in BS EN IEC 80601‑2‑71. It is considered that knowledge of the reasons for these requirements will not only facilitate the proper application of the standard but will, in due course, expedite any revision necessitated by changes in clinical practice or because of developments in technology.
The purpose of BS EN IEC 80601‑2‑71 functional NIIRS equipment is considered not to have essential performance. Notwithstanding this fact, when BS EN IEC 80601‑2‑71 refers to essential performance as an acceptance criterion, the average optical power shall be evaluated. Using BS EN IEC 80601‑2‑71 you can understand the basic safety and essential performance of functional NIRS equipment intended to be used by themselves, or as a part of a medical equipment system.
