What is BS EN IEC 60601‑2‑76-Low energy ionized gas haemostasis equipment about?
BS EN IEC 60601‑2‑76 is part 2-76 of the multi-series standard that discusses medical electrical equipment. BS EN IEC 60601‑2‑76 outlines the basic safety and essential performance of low energy ionized gas haemostasis equipment hereafter referred to as ME equipment.
BS EN IEC 60601‑2‑76 provides guidance on establishing requirements for basic safety and essential performance of low energy ionized gas haemostasis equipment as defined in 201.3.207.
Note: hazards inherent in the intended physiological function of ME equipment or me systems within the scope of BS EN IEC 60601‑2‑76 are not covered by specific requirements in BS EN IEC 60601‑2‑76 except in 7.2.13 and 8.4.1 of the general standards.
Who is BS EN IEC 60601‑2‑76 for-Low energy ionized gas haemostasis equipment?
BS EN IEC 60601‑2‑76 on low energy ionized gas haemostasis equipment is useful for:
- Manufacturers of low energy ionized gas haemostasis equipment
- Test centres for haemostasis ME equipment
- Medical laboratories
- Regulatory authorities
Why should you use BS EN IEC 60601‑2‑76-Low energy ionized gas haemostasis equipment?
Haemostasis is the control or prevention of bleeding from capillaries and similar small blood vessels in biological tissues using ionized gas. Low energy ionized gas haemostasis equipment is an ionized gas accessory and any other associated accessories. Which uses ionized gas for the purpose of haemostasis in biological tissue and limits the Ionization frequency leakage current to 20 ma or less.
BS EN IEC 60601‑2‑76 guidelines help you with essential performance requirements and protection against electrical hazards, mechanical hazards, unwanted and excessive radiation hazards, excessive temperatures, and other hazards for low energy ionized gas haemostasis equipment.
BS EN IEC 60601‑2‑76 improves the performance and safety of low energy ionized gas haemostasis equipment. In addition, this minimizes hazards to the patient and operator.