Helps Determine the Test Program to 60601-1, 2nd Ed. Based Standards
An important step to help determine the test program for your product is to identify the classification of your product per the standard you will be testing and/or certifying to. Also, classification of a product will help you determine certain marking, labeling, and physical construction requirements.
For electro-medical device based standards IEC60601-1, EN60601-1, UL60601-1, CSA C22.2 No 60601.1, etc., the following are important issues to consider while classifying your product. This article was written based on the second edition of IEC 60601-1 and the national standards based on IEC 60601-1, 2nd edition. The classification requirements in the 3rd edition of IEC 60601-1 are similar. If you need assistance with comparing these or a full analysis of your product to 3rd ed. we offer gap analysis services for 60601-1, 3rd edition.
- Protection Against Electrical Shock: If your product is powered from an external electrical source you have the option of classifying your product Class I or II.
Class I product: A product that is provided with a reliable protective earth such that all accessible metal parts can’t become live in the event of a failure of Basic Insulation (future articles will explains the different types of insulation terms) and therefore will provide protection against electric shock in the case of the failure of Basic Insulation.
Class II product: A product without a protective earth and where Double or Reinforced Insulation (typically a plastic enclosure) is relied upon to provide the protection against electric shock. The Class II symbol is which indicates double insulation.
For internally powered source, such as a battery, there is no additional classification.
- Installation & Use of Product (Equipment): There are seven classifications of how equipment may be used. These terms are fixed, hand-held, mobile, permanently installed, portable, stationary, and transportable equipment. Even though some of them seem like they are identical by terminology they have different meanings.
- Ingress of Liquids: If the standards require or you have a portion of your product tested for water ingress then you need to mark the product with appropriate symbol. The symbols are based on IEC 60529 – Degree of protection provided by enclosures (IP code). So, in the case of a footswitch used in operating rooms the requirements state the need to meet IPX8 per clause 56.11 d) of the standards. There are a variety of IPX codes from IPX0 (ordinary use – no water ingress tested) to IPX8 (where the part or product is submersed under water). Note if you classify your product IPX0 you do not need to have the product marked, whereas with all other classifications you must put the IPX rating on the product.
Equipment Mode of Operation: There are five different modes of operation defined in the standard. They are continuous, short-time, intermittent, continuous operation with short-time loading, and continuous operation with intermittent loading. The most typical classification of operation is continuous and if used does not have to be identified on the product. The other modes limit the range in which the product is used and this tends to be a disadvantage unless the product was designed for less than continuous usage.
Use with Flammable Anesthetics: There are three classifications for this issue. Very few products now days have a rating other than of ordinary or not for use in the presence of flammable anesthetics. Therefore, it is rare to see a classification of category AP or APG equipment.
Degree of Protection Against Electric Shock: This classification deals with the definition of Applied Parts (parts or circuits that are connected to the patient). There are three types of Applied Parts: B, BF, & CF. Since amendment 2 of the standard this definition has changed from a system type of designation to the specific applied part in question. Note that if you have multiple applied parts there may need to be different classifications of the different applied parts. Also, note defibrillation-proof applied parts are an additional item to consider if your product may be used in a situation where the product is connected to the patient while defibrillation may be applied.
To find out more about classification and other requirements or to get assistance for your product or product line, please contact us at Leo@EisnerSafety.com