When is product certification required (or not!) - Page 1
Forum section: electronics / general

author: steaky1212
author_rank: Regular Contributor
timestamp: June 08, 2022, 05:50:19 pm
content: Hi,I have been having a discussion with a colleague regarding the testing and certification requirements of a particular product.Assume the product is battery powered, voltage under LVD, no pressure requirements, no ATEX requirements, intentional radiator (2.4GHz). Crucially, the device is not to be sold. Instead, it is to be issued to specific customers. This may be for a fixed term, or indefinitely.His argument is that as the device is not sold, that it isn't subject to any specific certification. My argument is that it is put into service, at least outside of our premises, so the requirements apply.Obviously different regions have different rules, so any experience/advice on UK, EU, and USA would be appreciated.Many thanks,steaky

author: Benta
author_rank: Super Contributor
timestamp: June 08, 2022, 06:37:42 pm
content: i can only speak for the EU. The term used is "putting on the market", which says nothing about selling, lending, leasing, for free etc.It's out of your hands and it needs to be certified. If someone gets killed or injured because of a bad design, the designer/producer is responsible, free or not.I've no idea what BoJo plans on this point, but AFAIK CE rules still apply in the UK.

author: jonpaul
author_rank: Super Contributor
timestamp: June 08, 2022, 07:31:37 pm
content: Any electronic devices shipped internationally may be inspected by import or export authorities.Lack of compliance with emissions and safety can result in stopping the freight shipping, return to sender or seizures.The intention to sell, give away or donation has no impact.Jon

author: floobydust
author_rank: Super Contributor
timestamp: June 08, 2022, 07:57:40 pm
content: Is this safety or RF/EMC/communications certifications you wish to dodge?A customer's insurance policy is invalidated if they use/install a product not conforming to safety standards.You think your product is harmless but the battery can still be a source of fire/ignition. Is there a fuse, thick enough wiring, non-flammable plastics etc. these common-sense things are looked at during an evaluation/certification, which is one reason they are done.It's too bad certification agencies are outrageously expensive and formal, as well as the access to safety standards-preventing entrepreneurs from making products, yet the chinese can export unsafe garbage to our countries unimpeded.I would do the basic assessment of the product's possible hazards and if there are some... certification or at least special inspection would be needed.

author: janoc
author_rank: Super Contributor
timestamp: June 08, 2022, 09:08:41 pm
content: Quote from: floobydust on June 08, 2022, 07:57:40 pmFor the EU CE you can self-certify, no formal lab visit is required. Now whether that's a good idea depends ...A battery powered flashlight is likely safe to self-certify, something that could cause interference, major fire or was dealing with mains - there it would be another story. One could still self-certify but should anything go wrong, you better have the paperwork ready showing your device isn't exceeding the applicable standards because if it does, false conformity declaration would bring you a lot of pain.

author: Benta
author_rank: Super Contributor
timestamp: June 08, 2022, 09:20:35 pm
content: Quote from: floobydust on June 08, 2022, 07:57:40 pmI dunno what's "outrageously expensive" is to you, but working for a company I didn't find it so. For a private person or single-owner company it could be.The certifications we needed were LVD, EMC, RED plus a couple of general ones to get CE. We're talking MCU or DSP boards/systems, in some cases with WLAN or BT as well.It cost around 5k...10k Euro. In a single complicated case 15k.

author: tszaboo
author_rank: Super Contributor
timestamp: June 08, 2022, 09:43:41 pm
content: Quote from: Benta on June 08, 2022, 09:20:35 pmYeah, honestly as an employee, if a company that you work for cannot afford the money for necessary certification, run. You as an engineer are probably seriously underplayed, and they clearly don't care about laws. There are people in management positions with serious psychological issues, ignoring public health and safety requirements is puts them into that category. You don't want to be anywhere near those people.

author: SiliconWizard
author_rank: Super Contributor
timestamp: June 08, 2022, 10:00:56 pm
content: Yes. The cost is almost marginal. Actually, the salary costs of the employees dealing with certification one way or another are usually higher than the cost of any regulatory body.For CE marking, unless the product falls into a number of categories requiring going through a notified body, you can self-certify. Which doesn't mean the cost of certification will be zero. Actually, if you do things properly, it will only shave off a few thousand bucks.

author: floobydust
author_rank: Super Contributor
timestamp: June 08, 2022, 10:02:07 pm
content: In North America, lab time/consults ~$375/hour, Certifier is ~$500/hour, on par with expensive lawyers and BTW you have to purchase the standard for another $500-$1,000.Some agencies have their certifiers under pressure to make money, increase month-end, meet quotas- instead of customer success being the priority.They do give quotations but any findings or issues and you'll go past that figure, they are very crude estimates. I find it's $10,000-$100,000 for approvals depending on the standard. A corporation can afford it- but not an entrepreneur or small business unfortunately.You can budget $15,000 and surprise we're at $25,000 now. There is always a huge element of the unknown - as far as the design being good. If you're coming in with a design having solid engineering expertise, assessment goes quickly. One issue, a component change and it's a new PC board build plus resubmitting that for evaluation again, which takes weeks.In Asia it's treated differently, certifications are basic business and done quickly, albeit the quality is not top notch but the price is very good and they work fast.Germany appears to have standards for everything, I'm not sure what the rates are like there for certification. How does it work for entrepreneurs or does it lock out the small guy?

author: SiliconWizard
author_rank: Super Contributor
timestamp: June 08, 2022, 10:21:43 pm
content: Quote from: floobydust on June 08, 2022, 10:02:07 pmWell, I dunno for the whole Asia, but in China, we once had to submit a product to a chinese lab to potentially sell it in China, and we were surprised by how thorough and meticulous they were. Maybe they do this for foreign products more so that for their own, I don't know for sure, but compared to european labs and the CE marking, it was definitely no picnic.

author: Benta
author_rank: Super Contributor
timestamp: June 08, 2022, 10:25:22 pm
content: @floobydust, I'm sorry to hear about your experiences.It's seems that the NA market for this kind of thing is completely skewed (this could be a business opportunity for someone!).Here in the EU, I've only had great experiences with the testing/certification consultants.The first certification was difficult (you have to learn), but the subsequent ones went through like a dream.The secret is getting the CE consultants on board already in the design phase. They provide so many tips and tricks, that the final certification is just whoosh! and it's done.If you need CE at some point, PM me and I'll name you a couple of companies over here (don't worry, they speak English).

author: thm_w
author_rank: Super Contributor
timestamp: June 09, 2022, 01:53:04 am
content: I use many products given or sold by major companies that are not certified: programmers and development kits. However, they are obviously intended to only be used by professionals and not end users.The containing batteries and wireless functionality does make it a lot riskier.Is there no way to achieve the same operation with an off the shelf product, eg cell phone, battery bank, etc?

author: floobydust
author_rank: Super Contributor
timestamp: June 09, 2022, 02:49:47 am
content: Number one mistake is rationalizing that no product certification or approvals are even necessary.One CEO demanded I prove that a product for sale in the USA needed safety approvals "where is it written?". The USA doesn't have Federal law about it, it's the jurisdictions -town/village/municipality that has the laws, as if it's the Wild West. Example NFPA-70 for electrical code, some statesuse bits and pieces or do not even require it.Other safety standards are not law until there's a fire or explosion, then the jurisdiction figure it's good to adopt it.Point is, do your homework to see what the applicable safety standards are or ask an agency for a consult about it- although they don't like telling you that, they are liable for any mistake there.Number two mistake is getting certification or approvals at the END of a product development project, considered as a formality.Right when the product is "finished" and you're almost ready to sell it, there's this little formality amidst a ton of pressure to start selling it and make money.But certification will always have findings requiring design changes, unless you've got senior engineers that know the standards and are well experienced.Some managers try to outsmart the safety standards by coming up with some cockamamie idea, others get furious and hate the certification people (as if they don't notice the disrespect), others find a certification body that is dodgy, there are some out there.I worked a lot on product development in oil and gas, where combustion, electrical and hazardous location safety standards are to be met.I've had a CEO, engineering manager push to get it through approvals, regardless if it's actually safe or not. Many noob engineers/techs pleasing the boss and going along with the sneaky moves. One product a mosfet shorted due to ESD leaving a gas solenoid turned on. Well, two explosions occurred and that did nothing to change the ethics at that company. I tell them that product should not even be on the market, I will not sign off on anything about it, and let's shoot that engineer messenger lol.CE means nothing in North America, china has thoroughly bastardized the CE label with their unsafe exports of mains-powered goods, and fake certificates if any.I've never heard of the EU actually asking someone to provide CE proof, ever. That they allow this to happen, means nobody is actually doing any policing or enforcement it seems, and china exploits this. Even in Canada there is nothing preventing unsafe china products from being imported, we allow it.

author: janoc
author_rank: Super Contributor
timestamp: June 09, 2022, 02:41:17 pm
content: Quote from: thm_w on June 09, 2022, 01:53:04 amThat is irrelevant. There is no difference between "professionals" and "end users" in this regard.What matters is that kits generally don't need to be certified - only final products do.If something is a component intended to be assembled into something else (a module, part, even a kit), you don't need to certify. But it is often advantageous to do so for business reasons (e.g. wireless pre-certified modules are easier to get through the EMC testing than having to do it from scratch).Re programmers - I am pretty sure if that thing is a "boxed" product (i.e. not a bare PCB with a USB connector sticking out of it), it will have an FCC/CE certification markings at least.

author: janoc
author_rank: Super Contributor
timestamp: June 09, 2022, 02:50:46 pm
content: Quote from: floobydust on June 09, 2022, 02:49:47 amThat's not true. However, the regime is different from North America. There you must do the paperwork and lab visitsbeforeyou are allowed to bring anything to the market.In the EU you need to do the paperwork - but you are allowed to self certify. All you need to produce is a paper ("declaration of conformity") that your product conforms to the relevant regulations and standards, stick CE marking on it and you are good to sell it.Enforcement happens only if there is a complaint or the gadget is found unsafe. Either because of some incident caused by it or by a random inspection/testing. If you have declared that the device is conforming and it is found to not be the case, that's when you will be in trouble, either as the manufacturer or importer (importers are the ones responsible for the conformity declarations on imported goods if the manufacturer doesn't provide it). As a minimum the product will get recalled and the manufacturer/importer may get fined.There is no systematic testing and certification of everything being brought to the market in Europe, that would be completely unfeasible (and not only because of China). However, that covers only the CE marking, many products require additional things that CE may not cover and will be subjected to systematic testing (e.g. medical, safety critical stuff, etc.)See here for details (including link to the RAPEX website listing the various alerts and notifications about dangerous products):https://www.cemarkingassociation.co.uk/how-is-the-ce-mark-enforced/

author: mjs
author_rank: Regular Contributor
timestamp: June 09, 2022, 04:30:30 pm
content: A related question Anybody know good and reasonable cost test labs in EU for sub-giga CE accredited certifications (RED, i.e. LVD, EMC and EN300220 for RF) ? We've done our precompliance and DoC, but to go outside domestic markets I'd like to have stamped papers.Would be especially interesting with rough price experience!