Regulatory Requirements for Supplying a Complete Kit / Prebuilt

Any summaries available for the regulatory requirements that have to be met to supply a printer as either a complete kit or prebuilt printer?

Found a good discussion here with directives listed.

[groups.google.com]

I will now go looking for the certificate of incorporation for the duet boards.

Edited 1 time(s). Last edit at 02/17/2019 09:01AM by WesBrooks.

Ok, for the pre-built machines the most complete set of regulations that I have found is from Stratsys (Brochure on: [www.stratasys.com] - [www.stratasys.com]) and is as follows (copied word for word - including repeat of FCC):

CE (low-voltage and EMC directive), FCC, EAC, cTUVus, FCC, KC, RoHs, WEEE, Reach

Of those for a UK machine I think the following are most relevant:

CE (low-voltage and EMC directive), RoHs, WEEE, Reach.

With regards to the RoHs, WEEE, and Reach I think you would end up needing to collect evidence that all the components received from suppliers are compliant with these regulations. I think that would rule out using sites like Aliexpress for imported parts as you - as the importer - then become responsible for the CE information. CE marking documentation can't be done out side of Europe.

This is a large undertaking and I suspect some of our communities favorite UK suppliers would struggle to supply the certification to state the components they supply comply with the required regulations.

Scrub that, MakebotsCE certificates on this page are more thorough:

[www.makerbot.com]

The main safety one appears to be:

Quote
BSIGroup
BS EN 60950-1:2006+A2:2013 Information technology equipment. SafetyGeneral requirements specifies requirements intended to reduce risks of fire, electric shock or injury for the OPERATOR and layman who may come into contact with the equipment and, where specifically stated, for a SERVICE PERSON.

This standard is intended to reduce such risks with respect to installed equipment, whether it consists of a system of interconnected units or independent units, subject to installing, operating and maintaining the equipment in the manner prescribed by the manufacturer.

This standard is applicable to mains-powered or battery-powered information technology equipment, including electrical business equipment and associated equipment, with a RATED VOLTAGE not exceeding 600 V.

Edited 2 time(s). Last edit at 02/18/2019 04:58AM by WesBrooks.

Ultimaker's CE Certificate (https://ultimaker.com/download/72576/Sum-prt-00117111315451.pdf) is interesting as it mentions the machinery directive and also has a certificate authorising unattended operation.

CE Certificate: [ultimaker.com]
Unattended Operation: [ultimaker.com]

The unattended operation certificate is interesting as it doesn't seem to list anything formal that the CE certificate doesn't list other than "NL40196" after UL60950-1. The risk assessment and failure mode analysis seem to be internal documents. In other words Ultimaker must just have a mighty meaty insurance policy!

Edited 1 time(s). Last edit at 02/18/2019 06:01AM by WesBrooks.

Good discussion and something I did not think about when contemplating making a kit.

Looks like the power supplies are the usual critical item certified.

But we could use a few more power safeties, and probably a EMI shield for the RAMPs/meta combo.

Tipping or fallover would be easy to detect.

Overcurrent sensing might address the other issues.

I think if you supply a complete kit then you are on dubious ground not having a CE certificate. The thing I find most frustrating is the framework is there to allow us to make and trade safe goods (or at least to demonstrate we have paid due diligence) but each one of these standards is hundreds of pounds. They're (or the knowledge they contain is) needed before you take the product to market. It effectively creates a must have money to pass barrier. Not to mention the amount of time needed. A full user manual is compulsory.

The person who signs the documents is the person who is pulled over the coals in the courts if there is an accident.

Quote
WesBrooks
I think if you supply a complete kit then you are on dubious ground not having a CE certificate. The thing I find most frustrating is the framework is there to allow us to make and trade safe goods (or at least to demonstrate we have paid due diligence) but each one of these standards is hundreds of pounds. They're (or the knowledge they contain is) needed before you take the product to market. It effectively creates a must have money to pass barrier. Not to mention the amount of time needed. A full user manual is compulsory.

The person who signs the documents is the person who is pulled over the coals in the courts if there is an accident.

Do you believe the Chinese go through all this ?
For them CE is China Export !

And you supply a kit. So just limit the parts in it that don't require any. The rest, certified UL, CA, CE .... chinese parts.

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"A comical prototype doesn't mean a dumb idea is possible" (Thunderf00t)

The Chinese don't need to. The person responsible in these cases is the importer. Buy from Aliexpress and that is yourself so it is buy at your own risk.

When you sell a complete kit within the UK and EU market it needs the CE documentation.

I'm not discussing it here in order to find loop holes, I'm gathering information on the bare minimum to do it properly.

It also effectively prevents you from using cheap Aliexpress/ebay import parts as life is made much easier if you can get certification to say the sub component complies with regulations limiting hazardous chamicals and heavy metals. This won't come with imported parts as the documentation needs to be within the UK/EU.