Helps Determine the Test Program to
60601-1, Edition 3.0 or 3.1 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, AAMI ES60601-1, 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 third edition of IEC 60601-1 and the national standards based on IEC 60601-1, 3rd edition.
- Protection Against Electrical Shock (Power Source): If your product is powered from an external electrical source you have the option of classifying your product Class I or II. If some type of internal power source then you classify the product Internally powered ME Equipment.
Class I product: A product that is provided with a reliable protective earth such that all accessible and internal metal parts can’t become live in the event of a failure of Basic Insulation 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 looks like two squares one inside the other, which indicates double insulation.
For internally powered source, such as a battery, it is classified as an internally ME Equipment (which means Medical Electrical Equipment)
- Protection Against Electrical Shock (Applied Parts): 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. This is not a system designation but for 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.
- 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 or Particulate Matter: 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.
Particulate Matter is similar to Liquid Ingress but the IP codes are IP0X to IP6X (not protected to dust tight protection).
- Equipment Mode of Operation: There are two different modes of operation defined in the standard. They are continuous operation or non-continuous operation . The most typical classification of operation is continuous and if used does not have to be identified on the product. The other mode limits 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.
The US version of the standard AAMI ES 60601-1 has a national deviation which adds for X-ray systems shall be classified as long time operation (> 5 min) or momentary operation (<5 sec).
- Methods of Sterilization: New to 3rd ed. (wasn’t specifically in 2nd edition): The product or it’s accessories intended to be sterilized shall be classified according to the method(s) of sterilization as indicated in the instructions for use. The example list in the standard mentions EtO, Gamma, steam, and other method validated & described by the manufacturer.
- Suitability for use in an Oxygen Rich Environment: Products intended for use in an Oxygen Rich Environment shall be classified for such use per the requirements of clause 11.2.2. Very few products now days have a rating other than for regular atmospheric conditions.
To find out more about classification and other requirements or to get assistance for your product or product line, please contact us at Leo at EisnerSafety dot com