Navigating The Safety Agency Certification Maze
This is for everyone who manufacturers and markets electrical products (not specifically medical products) and who wants to learn the process of Safety Certification Agency Approval (referred to as “Agency”). This includes how to deal with National and International Certification Agencies.
The following steps will help you get through the process:
1) Determine if it is of value to go through the process to get your product safety certified or accepted into certain markets. Once you decide to proceed you must determine which regulations you need to meet in order to sell your product in regional world markets.
Some of the reasons you may choose to get your product tested to safety standards include, meeting National Electrical Codes, gaining a marketing advantage, liability, as a passport into certain regions/countries (i.e. Europe), and meeting local, regional, and federal regulations.
2) Now that you have determined your markets and the regulations you need to meet, you or a consultant need to contact the Agencies. Request a quote for testing which includes the number and type of samples required and additional information to provide.
What do you do if you need to go to multiple Agencies for different regions of the world? There are several options: you could test at each one separately, you could have them all come together and witness test at one of the Agencies, or you can have them come to your site (if you have the appropriate equipment). If your product falls under the Information Technology Equipment (ITE), Laboratory and Test Equipment, or Electrical Medical Equipment Categories you can get a CB scheme report issued which is accepted in many countries, etc. Note that most medical device manufacturers don’t end up obtaining the CB scheme certificate as they tend to obtain a US & Canadian Agency Certification, obtain an EU test report (very similar to a CB scheme report), and then submit their products thru each national health regulatory body for approval to market their product in that region of the world.
Since there are so many different ways to go about testing how do you know which is best for you? One way is to get quotes and ask the engineer you deal with at each Agency which option has worked best for them and why. The other option is to ask a consultant that has expertise in your product category to work with the agencies and offer you several options so you can make an informed decision.
Remember not all consultants are alike and they all have strong and weak points. Ask them what their expertise and experience is before you have them work for you.
3) The next step is to prepare the project to submit to the Agency you have chosen to work with. To be successful you want to have the appropriate information so the project will not be stopped because of missing information or because the construction does not meet the standard.
If you have prior experience with using the appropriate safety standard(s) and have worked with one or more Agencies, you may not need or want to use a consultant. On the other hand, if you have no experience, you may want the advantage of the experience of the appropriate consultant. Consultants can help you prepare the product by doing a construction review against the standard(s), review your markings (product, manual, shipping carton, etc.), and conduct testing. The construction, marking reviews and pre-tests can help your product get through testing faster and be for sale more quickly.
A construction review can be a big task especially for those that have never looked at a safety standard before. A construction review entails going through the standard(s), identifying deficiencies and fixing them before submitting to the Agency.
A) The first step for the person evaluating the product is to understand the usage of the product. In addition an isolation diagram showing the required spacings and Dielectric Voltage requirements is essential in the construction of the product.
B) Once the person evaluating the product knows the operation of the product he or she should draft a test program that fits the product. If possible the tests should be conducted or at a minimum discussed with the technical staff to confirm that the product will meet these tests.
C) Another item that is critical in the pre-evaluation is the review of all the safety critical components in the product, because if the components do not meet the appropriate safety requirements there is a good likelihood that your product will not meet the requirements of your standard(s). So, the selection of the appropriate safety critical components is extremely important in getting the product approved via a quicker route.
What are some of these safety critical components? Power supplies, transformers, pumps, fuses, protective devices such as positive temperature coefficient devices (PTC’s), PWB’s, plastics, power cords, wiring, wire ties, ring lugs, terminal blocks, and fans.
In addition to selecting the appropriate safety critical components, you need to prove to the Agency that the components meet the appropriate standards and they are used in the appropriate application (i.e. not higher than their rated voltage values, etc.).
To do this you must provide proof of certification which can be done several ways; copies of Agencies certificates, with a copy of an Agency test report (this can be very hard to get), or by getting a portion of the Underwriters Labs (UL) report called the C of A’s (Conditions of Acceptability).
Now that you have finished a portion of the preparatory work what else do you need to do before submitting to the Agency? Four additional things: collect appropriate samples; the marking information; provide any additional documentation and have the money to start the project(s).
4) Typically the Agency can work with one sample but if the product does not work after a certain test you may be dead in the water and unable to continue. I usually recommend having at least one sample more than the Agency requires to provide a backup in case of failure.
This may not be possible because you may have only a few prototypes or the product is expensive to make and keep on hand. This is an area that can cause a lot of grief but should be considered carefully.
Some other samples you may have to or want to provide are additional protective devices (i.e. fuses and other non-resetable devices) used in your product so if the protective device opens you can replace it with another and continue testing. If the transformer(s) and/or motor(s) you have in your product has not been evaluated by an Agency previously, you may need to submit an unvarnished one for a construction review to make sure it meets the spacings and dielectric requirements.
Also, you may need to submit several units of each transformer or motor for testing as well as the unvarnished samples. Included with these samples, you will need to describe the material used for the construction of the devices, provide a diagram showing how these devices are built and show the temperature/electrical ratings of each material, etc.
In addition to the above, you may need to submit bare PWB’s, plastic enclosure(s), parts that require testing to IP ratings (European Standard) or NEMA ratings (enclosures, footswtiches, etc.), and of course various other things that depend on the standard(s), Agencies, and engineers you are working with.
5) What are some of the things the Agency may ask for in regard to markings? You should include some type of user manuals and sometimes service manuals. There may be some warnings in these manuals, requiring international symbols defined, and of course the electrical ratings need to be in these type of manuals. Another type of marking may be required directly on your product such as electrical ratings, replaceable fuse ratings, cautions, etc.
6) The additional information you may need to supply to the Agency depends on how they work and also the standard(s) you are working with. You typically want to provide them with a list of safety critical components (most European Agencies call this a Construction Data Form), where UL and CSA would put this information into a written descriptive report. Either way you will need to provide this information to the Agency.
You need to fill out application forms to the Agency you are submitting to so they have the protection if the product is damaged during testing that the liability does not fall on their shoulders. Also, most agencies consider your product proprietary information and will not disclose any information about your product to anyone else without your permission. If you read a contract and the proprietary clause is not included you may want to go to another Agency to prevent disclosure to your competitors that your device is being tested and anything about the construction.
Also, there are usually agreements giving the Agency the right to inspect your production facility once you are certified. This is so they can follow-up on the product when under production to make sure it is being built the way you presented it to them originally.
Technical information to be supplied can include schematics; voltage maps; block diagrams; Isolation diagrams; parts lists; safety critical component lists; copies of certifications of components; construction diagrams of transformers, motors, power supplies; etc.
7) Depending on the Agency you go to and your past history with that Agency, you may need to pay anywhere from 0% to 150% of the project fees up-front. One of the reasons an Agency may want more than 100% up-front is if there are travel expenses that are above and beyond the quoted amount. In addition to the up-front money, most Agencies want a purchase order to bill against for the project. Also, it is important to realize not all services are typically considered part of a quote such as travel expense, travel time, copying, photos, shipping, etc.
Now that you’ve done your preparatory work, given the Agency your fist born (prototypes and money), how long will it take before you know you are successful? This question is a loaded one because there are so many factors. If you designed the product completely correct per the standard, provided all the correct info, money, forms, etc, depending on the category and amount of test time, a project could take as little as 4 weeks or over a year for approval. Usually if everything is in order, it should take from 1-1/2 to 3 months.
The key to a successful project is to do all the preparatory work before starting the project to avoid costly re-designs. There is no substitute for experience in leading to a safe, affordable, and speedy product approval.
To find out more about navigating the regulatory maze and the product safety requirements for your products please contact us at Leo at EisnerSafety dot com