BS EN 60601-2-40:2019

What is BS EN 60601‑2‑40-Requirements for electromyographs and evoked response equipment about? 

BS EN 60601 is a European standard on medical electrical equipment. BS EN 60601‑2‑40 outlines requirements for the basic safety and essential performance of electromyography and evoked response equipment to ensure the safety of equipment to prevent a hazardous situation.  

BS EN 60601‑2‑40 is the fortieth subpart of the second part of a multi-part series that applies to the basic safety and essential performance of electromyography and evoked response equipment are hereafter referred to as medical electrical equipment. 

BS EN 60601‑2‑40 assists you with the basic safety and essential performance of electromyography and evoked response equipment and ensures safety throughout the product’s lifecycle. 

Note 1:  ME EQUIPMENT intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators are outside the scope of BS EN 60601‑2‑40. 

Note 2: Under BS EN 60601‑2‑40 If a clause or subclause is specifically intended to apply to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, relevant. 

Who is BS EN 60601‑2‑40-Requirements for electromyographs and evoked response equipment for? 

BS EN 60601‑2‑40 on the requirements for electromyographs and evoked response equipment is relevant to- 

• Biomedical laboratories 
• Manufacturers of electromyographs  
• Hospitals 
• Regulatory authorities 

Why should you use BS EN 60601‑2‑40-Requirements for electromyographs and evoked response equipment? 

Electromyograph equipment is used for the detection or recording of biopotentials accompanying nerve and muscle action, either spontaneously, intentionally, or evoked by electrical or other stimulation. Evoked response equipment is used for the detection or recording of biopotentials resulting from an evoking stimulus. 

Under BS EN 60601‑2‑40, when used electromyograph properly detects and records the electrical potential generated by muscle cells when are activated and results will be reproducible in any other laboratories.  

Electromyograph recording despite its low specificity- continuous to be valuable tool included in multimodal monitoring set during neurosurgical and orthopedic procedures. 

BS EN 60601‑2‑40 assists you to standardize the requirements of electromyography and evoked response equipment to ensure basic safety. 

In addition, with compliance and obedience of BS EN 60601‑2‑40, you can enhance the efficacy of electromyography and evoked response equipment and build a standardized product that has global acceptance in the market. 

What’s changed since the last update? 

BS EN 60601‑2‑40:2019 supersedes IEC 60601‑2‑40:1998, which is withdrawn. BS EN 60601‑2‑40:2019 has made some technical changes compared to IEC 60601‑2‑40:1998. These include: 

• No special test phantom was used for EMC testing 
• Test method for continuous masking sound pressure level and visual stimulators 
• Allows the use of equipment not intended for continuous operation 
• Clarification that audible and visible indicators are not to be considered ALARM SYSTEMS as per IEC 60601-1-8