Choosing a Standard: Choosing the appropriate product safety standard for a product begins by verifying what standard or standards are applicable based on the intended use and purpose of the product. In some cases, there may be alternative standards to choose from. If you have options, you must determine which standard best meets the intended use of the product.
Medical Electrical Equipment Definition: In accordance with the 60601 standard series, “ME Equipment” is defined as electrical equipment having an applied part or, transferring energy to or from the patient or, detecting such energy transfer to or from the patient, and which is intended by the manufacturer to be used:
1) In the diagnosis, treatment, or monitoring of a PATIENT; or
2) For compensation or alleviation of disease, injury or disability
Is it a Medical Product? For electrical products that clearly meet the definition for ME Equipment, the decision on the applicable standard is easy = 60601 (AAMI-ES60601, CSA60601, EN60601, etc.). However, for medical products, there are many more requirements that apply including the need for a Risk Assessment, a Risk Management File, and a Usability report. Consequently, choosing the electrical medical product path is usually out of necessity. But there are some products that fall into a “grey area” where the medical path is not obvious. For these product manufacturers, there can be a significant benefit avoiding the medical compliance path. This whitepaper will discuss the situations that create a “grey area” and the associated standards for those products.
The “Grey Area”: There are products that provide similar functionality that are intended for non-medical applications = this includes many devices that display EKG or provide other data about the human body for “wellness” purposes. There are also products that are used in and around a medical facility that fall into question because of their location.
What Does the Manual Say? The product manual is always the first consideration. The product manual should clearly indicate the product’s intended purpose. If the product is not intended for medical purposes (see definition above), the manual should clearly indicate such. The manual should not suggest that the product is certified for medical use if it is not. In no circumstance should the manual present misleading information.
Massage & Exercise Equipment: Many of the products that fall in the “grey area” use the massage & exercise standards (UL1647, CSA68, EN60335) instead of the medical standards. Another alternative is Personal Hygiene & Healthcare” (UL1431, CSA68, EN60335). Wellness products fall into these categories. Of course the manual for such products must indicate that they are not intended for medical purposes.
Product Use Location: In many cases, where the product is to be used creates an incorrect assumption that the electrical medical standards must be used. However, location of use is not mentioned in the definition for ME Equipment. For example:
a) Products used in a Hospital are not automatically evaluated to 60601. Certainly products used directly on the patient are medical products. However, products used in the “patient vicinity” come into question. Non-medical products used in the patient vicinity are often required to meet some aspects of medical compliance (i.e. leakage current). However, that does not make the product a medical device subject to the full medical compliance process.
b) Products used outside of patient areas are evaluated to the appropriate standard based on the product function and purpose. Products used in the hospital laboratory are typically evaluated to the 61010 series of standards (laboratory equipment). This includes a special provision for IVD equipment – see below.
c) Physical Therapy practices are popping up in a variety of buildings and locations, not just healthcare facilities. Although physical therapy would appear to meet the definition for ME Equipment (compensation for injury or disability), physical therapy offices tend to be comprised of exercise equipment rather than medical equipment. Note that when a physical therapy office is located in a medical facility, there can be a concern for products not certified as medical equipment.
In-Vitro Diagnostic Equipment: As stated in the scope of the ME Equipment standard 60601, products identified as in-vitro diagnostic equipment (IVD) are to be evaluated for compliance using the 61010 series (61010-1, 61010-2-101).
FDA Consideration: Is the product required to be approved by the FDA? If so, what standard does the FDA require for the product? There is no point in obtaining a product certification that is not consistent with an FDA decision. The FDA will be expecting a copy of the certification report to the standard defined by the FDA. If the FDA decides a product is a medical device, they will require a 60601 report.
Conclusions: Selecting the best standard for your product should be a well thought out process. For products that are obviously “medical”, the 60601 series is applicable. However, for products that fall into the “grey area”, a non-medical standard may be a better option – especially if the objective is to avoid being categorized as a medical product and being forced to apply the 60601 standards.
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