Safety Components and the Machinery Directive 2006/42/EC

From time to time we are presented with a device that seemingly “fits” into the Low Voltage Directive 2014/35/EU because it only has electric function and no moving components. This would lead most to apply the Low Voltage Directive instead of the Machinery Directive 2006/42/EC in order to satisfy requirements.

That approach can be incorrect.

See the Machinery Directive 2006/42/EC, Article 1 (1.):

Article 1, Scope

  1. This Directive applies to the following products:

(a) machinery;

(b) interchangeable equipment;

(c) safety components;

(d) lifting accessories;

(e) chains, ropes and webbing;

(f) removable mechanical transmission devices;

(g) partly completed machinery.

Next, see the definition of “safety component” indicated in Article 2 (c):

(c) ‘safety component’ means a component:

— which serves to fulfil a safety function,

— which is independently placed on the market,

— the failure and/or malfunction of which endangers the safety of persons, and

— which is not necessary in order for the machinery to function, or for which normal  components may be substituted in order for the machinery to function. An indicative list of safety components is set out in

Annex V, which may be updated in accordance with Article 8(1)(a); 

Now, we look at Annex V, in particular (4.), (8.), and (10.):

ANNEX V,  Indicative list of the safety components referred to in Article 2(c)

  1. Guards for removable mechanical transmission devices.
  2. Protective devices designed to detect the presence of persons.
  3. Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in items 9, 10 and 11 of Annex IV.
  4. Logic units to ensure safety functions.
  5. Valves with additional means for failure detection intended for the control of dangerous movements on machinery.
  6. Extraction systems for machinery emissions.
  7. Guards and protective devices designed to protect persons against moving parts involved in the process on the machinery.
  8. Monitoring devices for loading and movement control in lifting machinery.
  9. Restraint systems to keep persons on their seats.
  10. Emergency stop devices.
  11. Discharging systems to prevent the build-up of potentially dangerous electrostatic charges.
  12. Energy limiters and relief devices referred to in sections 1.5.7, 3.4.7 and 4.1.2.6 of Annex I.
  13. Systems and devices to reduce the emission of noise and vibrations.
  14. Roll-over protective structures (ROPS).
  15. Falling-object protective structures (FOPS).
  16. Two-hand control devices.
  17. Components for machinery designed for lifting and/or lowering persons between different landings and included in the following list:

(a) devices for locking landing doors;

(b) devices to prevent the load-carrying unit from falling or unchecked upwards movement;

(c) overspeed limitation devices;

(d) energy-accumulating shock absorbers,

— non-linear, or

— with damping of the return movement;

(e) energy-dissipating shock absorbers;

(f) safety devices fitted to jacks of hydraulic power circuits where these are used as devices to prevent falls;

(g) electric safety devices in the form of safety switches containing electronic components.

The purpose of this article is to show that even though a device may look like an electrical product, in the scope of the Low Voltage Directive 2014/35/EU and matching the scope of EN 61010-1:2010, it may not be legally correct to use either to show safety compliance for CE marking.

The Machinery Directive 2006/42/EC will be applicable instead of the Low Voltage Directive 2014/30/EU, even with no moving parts, if the application or description matches the above. And in that case you will not be able to apply EN 61010-1:2010 as the applicable standard because EN 61010-1:2010 is harmonized to the Low Voltage Directive and not the Machinery Directive.

If you have a product like the above, or any question regarding applicability of CE marking requirements to your product: call us. We will sort it out.

F2 Labs is here to help. Have a question or a comment? We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you.

 

Posted in CE marking, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC | Tagged , , , , , , , , , , , , | Leave a comment

CE marking and the ATEX Directive 2014/34/EU

Many times, we receive a request for assistance from a customer for a project that involves, “CE marking and ATEX.” While there is nothing wrong with calling ATEX out separately from other CE marking requirements, we note that the ATEX Directive is a CE marking Directive.

What does this mean?

Good question. What it means is that ATEX is just another CE marking requirement, as important but no more important than any other CE marking Directive like the Machinery Directive 2006/42/EC, Low Voltage Directive 2014/35/EU, or the EMC Directive 2014/30/EU.

The ATEX Directive has many complicating factors, for instance, there are three category classifications and those are cross-referenced with two sets of risk zones: three for dust and three for gas. Next, the compliance path requires categorization by the designation of Group I (underground mine equipment) or Group II (all other equipment).

Once the above is settled, Annex I of the ATEX Directive must be reviewed to determine the available compliance module (i.e., the allowable path to compliance in the ATEX Directive for your product).

There are seven compliance modules:

* Annex III – MODULE B: EU-TYPE EXAMINATION

* Annex IV – MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS

* Annex V – MODULE F: CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION

* Annex VI – MODULE C1: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT TESTING

* Annex VII – MODULE E: CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE

* Annex VIII – MODULE A: INTERNAL PRODUCTION CONTROL

* Annex IX – MODULE A: INTERNAL PRODUCTION CONTROL

Yes, ATEX will complicate your project somewhat… but it is just a CE marking Directive and companies like F2 Labs have experience navigating through it and helping manufacturers comply with it.

To illustrate this, see Annex X, the EU declaration of conformity. Just like all the other CE marking Directives:

F2 Labs is here to help. Have a question or a comment? We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you.

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The EU declaration of conformity

A frequent source of confusion for exporters of products to the EU is the EU declaration of conformity. Many customers that we assist are vaguely familiar with the concept and the role of the “DoC”.

The EU declaration of conformity is a one-page (usually) document that indicates the following information:

  • Manufacturer name and address.
  • Product name, type, model, and serial number (or other traceable information such as batch number).
  • CE markings to which the manufacturer is claiming compliance for the subject equipment.
  • Harmonized EN standards which the manufacturer used to design and evaluate the equipment.
  • Declarative statement that the equipment is in compliance with the indicated Directive(s).
  • Signature by a company officer.

Additional items which may be indicated but are not required are:

  • Test report numbers.
  • The 3rd party lab engaged for technical intervention by the manufacturer (i.e., a lab hired by the manufacturer to identify applicable Directives and EN standards and then test).
  • Other standards which are not harmonized EN standards, for instance, IEC standards.

Some of the items we commonly see on declarations of conformity which are not correct are:

Prior to 2016 the role of a regulatory affairs professional was made slightly more complex by the differing requirements and formats of DoC’s in the myriad of different Directives. However, the recasting of many Directives as a part of the New Legislative Framework of 2008 (aka NLF) simplified the process. Many Directives were rewritten, primarily to clarify definitions and responsibilities but also to streamline some of the requirements, like the EU declaration of conformity.

This means that if you have a product that is in the scope of the Low Voltage Directive 2014/35/EU and the EMC Directive 2014/30/EU you will not have to look at two vastly different declaration of conformity templates in both Directives and hope that you covered everything indicated in both Directives. We note that the Machinery Directive 2006/42/EC was not recast as a part of the NLF and there are slightly different, but important, requirements for it.

See below the model structure as indicated in Annex IV of the Low Voltage Directive 2014/35/EU:

Next, see the model structure as indicated in Annex IV of the EMC Directive 2014/30/EU:

Note there is an additional item in the EU declaration of conformity under the EMC Directive. This is for the inclusion of information regarding the technical intervention of a Notified Body, for example if an EU-type Examination Certificate was issued. Since there is no role for a Notified Body in the Low Voltage Directive 2014/35/EU that is not included in Annex IV of 2014/35/EU.

Once the format for the EU declaration of conformity is understood, the equipment is compliant, and the document is drafted and signed… what next?

We advise all clients to translate the document and include it with every product sent to the EU. The best place for this is printed in the product documentation: the manual.

“How do we print a serial number for each one in its own unique manual?”

That is a common question. The answer to that is to print a range of serial numbers for the product and reserve them for that product. The idea is that an inspector or quality manager in the EU must be able to pick up your product, look at the nameplate, and match it definitively to the serial number or batch number indicated on the declaration of conformity. It is advisable to make this correct and as transparent as possible. The main issues we hear from customers who have their products stopped, questioned, or seized by market surveillance authorities in the EU is due to a sloppy, incorrect EU declaration of conformity.

Finally, we note that technically, for many Directives it is not required that you send the declaration of conformity with the product. The requirement is that you keep it together with the technical file for ten years so that you can hand it over to the authorities if questioned.

Our strong advice is this: You did everything right. You designed the product safely and engaged an A2LA accredited laboratory like F2 Labs to evaluate and test the product so that you could legally export it to the EU. Why not provide the declaration of conformity with the product so that any questions about the compliance of it are answered before a formal inquiry can be made?

As a younger man, I trained at Parris Island during which I witnessed… many things. I will tell a story of one of those things that I remember to this day. I was a recruit and standing at attention in the 2nd Battalion barracks. A hard rule in the Marines, and it starts on day one is this: ALWAYS LOCK UP YOUR VALUABLES. On that day, a drill instructor walked by us as we stood at attention and noticed that the end of a string was hanging from underneath the lid of the footlocker belonging to the guy across the squad bay from me.

The next thing we all saw was this Marine Corps Drill Instructor on his knees pulling and tugging on this string until he pulled out the guy’s USMC-issued money valuables bag from a still-locked footlocker. Then he dumped it out all over the deck and started going through it, including love letters from the guy’s girlfriend, which he read to all of us.

Don’t give an EU market surveillance authority a string to pull on.

Make sure your EU declaration of conformity is correct.

F2 Labs is here to help. Have a question or a comment? We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you.

Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, EN 60601-1, General Product Safety Directive 2001/95/EC, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Directive 93/42/EEC, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Product Testing, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU | Tagged , , , , , , , , , , , , , , , | Comments Off on The EU declaration of conformity

CE marking and the Technical File

Manufacturers who send equipment into the EU are required to send a CE compliant product in most cases. This means that if you are making an electromechanical device, chances are that you will need to comply with at least one, maybe a few, CE marking Directives. These could include the EMC Directive 2014/30/EU, the Machinery Directive 2006/42/EC, or the Low Voltage Directive 2014/35/EU.

These Directives (and the other CE marking Directives) allow the manufacturer to prove compliance on his or her own without the involvement of a regulatory authority (like OSHA through the NRTL program). The flipside of this, which is referred to as ‘self-certification’, is that you must retain proof that your product was in compliance when you placed it on the market in the EU. This ‘proof’ is compiled in the Technical File and you must be able to produce it for the authorities for ten years after you ship. This means that if you make an electric toothpick dispensing machine, and you sell many to the EU, you are required to be able to produce a Technical File for the authorities for ten years after you ship the last one to the EU.

The contents of the Technical File include the Technical Reports (test reports from an accredited laboratory) bill of materials, declarations of conformity or declarations of incorporation for equipment (and sub-assemblies) incorporated into your build, general layout drawings, schematics, and anything else required to prove that your equipment complies with the applicable CE marking Directives (EU laws) that you claim to comply with.

We are working with a customer who makes an electrical product and is selling this product into Europe. The distributor for this product sent our customer’s technical information (i.e., his Technical File) to a 3rd party lab for review of the compliance of the equipment to applicable CE marking Directives, in this case: the EMC Directive 2011/65/EU and the RoHS Directive 2011/65/EU.

The third party indicated that our customer did not comply with the Technical File requirements stated in the EMC Directive, specifically the requirements in Annex II (b) & (c):

(b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;

(c) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the apparatus;

I assisted this customer by providing the below response. After I finished I thought that this could be useful information for other manufacturers. The name of the customer has been changed.

John,

The EMC Directive 2014/30/EU makes the requirement for a Technical File in Annex II (3.).

You asked directly about 2014/30/EU, Annex II (3.) (b):

(b) conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc.;

…and 2014/30/EU, Annex II (3.) (c):

(c) descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the apparatus;

First – keep in mind: this is a request made by a 3rd party lab (same as if someone asked me to audit your technical file).

This is not a request by market surveillance authorities: there is no legal weight to what they are asking.

In regards to what they are asking for my opinion is that all you are required to supply to satisfy Annex II (3) (b) & (c) in the technical file (you aren’t required to send this information to Europe unless a formal request is made) is the following:

  • General layout drawing
  • Electrical schematic
  • A key if the drawing is in another language
  • Operations and maintenance manual

Supplying that information will satisfy this requirement.

If you really get into this, you do not have to hand over the TF to anyone but the authorities and then only by request.

I have attached the EMC Directive 2014/30/EU.

Your obligations as the manufacturer are indicated in Article 7. See Article 7 (2), (3), and (9) regarding the TF.

Your importer or distributor can make a case to ask you for the TF. I suggest you defend against that.

The way to do it (in my opinion) is to reference this:

Importers – Article 9 (8)

  1. Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form, necessary to demonstrate the conformity of apparatus in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by apparatus which they have placed on the market.

Distributors – Article 10 (5)

  1. Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation in paper or electronic form, necessary to demonstrate the conformity of the apparatus. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by apparatus which they have made available on the market.

 Draft an agreement to hand over the TF to the authorities (or to the distributor or importer) only in a case where a written request by the authorities has been made.

Other than that, all you are required to supply is the product, declaration of conformity, and the manual(s)…. That’s it.

I hope this helps.

F2 Labs provides many CE marking services, including compilation of the Technical File so that instead of a large administrative headache at the end of your project you have everything organized on this:

 

F2 Labs is here to help. Have a question or a comment? We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you.

Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, General Product Safety Directive 2001/95/EC, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Medical Devices Directive 93/42/EEC, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Product Testing, R&TTE Directive 1999/5/EC, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU | Tagged , , , , , , , , , , , , | Comments Off on CE marking and the Technical File

Repeal of the Affordable Care Act and the Medical Device Tax

Yesterday afternoon, March 6th, the House Republicans released the bill to repeal (most of) the Affordable Care Act, also known as Obamacare.

Since F2 Labs is a safety compliance laboratory, helping many companies comply with regulatory issues when bringing their medical devices to market, we are most interested in the fate of the medical device tax levied on manufacturers through the Affordable Care Act.

As I understand it from reading the article titled, GOP hits the gas on Obamacare repeal, published last night, the bill is in two parts – one part written by the Energy and Commerce Committee (here) and the second part by the Ways and Means Committee.

This morning I reviewed the half of the bill written by the House Ways and Means Committee and published here: Ways and Means Committee repeal bill.

In the Ways and Means Committee bill, see page 17, section 11, Repeal of Medical Device Excise Tax below.

 

We will follow this developing story closely.

F2 Labs is here to help. Have a question or a comment? We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you.

Posted in EN 60601-1, Medical Devices Directive 93/42/EEC, Product Testing | Tagged , , , , , , | Comments Off on Repeal of the Affordable Care Act and the Medical Device Tax

Lasers, IEC/EN 60825-1, the Low Voltage Directive 2014/35/EU, and the General Product Safety Directive 2001/95/EC

Laser devices sent to Europe are subject to specific safety requirements. Some of these requirements are applicable even if the rest of the device is seemingly innocuous.

To start with, we will present a case where a device appears to be completely harmless and therefore out of the scope of any applicable safety legislation. We often see small pen-sized laser-pointers that are powered by off-the-shelf batteries. Since these batteries are below the scope threshhold (75 VDC to 1,500 VDC) of the Low Voltage Directive 2014/35/EU it appears that the manufacturer would not need to submit the laser pointer to a lab for safety testing.

The Low Voltage Directive 2014/35/EU (aka the LVD) is associated with a few harmonized EN standards dealing with lasers. The first LVD laser standard that must be considered is EN 60825-1:2014. See below from the European Commission’s page for the LVD:

This standard is challenging to comply with, namely because so few lab’s in the United States provide support for compliance to EN 60825-1 or the IEC version: IEC 60825-1. Keep in mind that if your laser pointer had a way to connect to AC mains power (say, for instance to an AC/DC adapter) then it would be considered as an AC-powered product, likely over the AC power threshhold of 50 VAC for inclusion in the scope of the LVD, and therefore you would have to comply with EN 60825-1 in order to place a CE marking on the laser.

But, what about a low-power, battery-powered, laser pointer? What do you do about that in order to properly ensure its safe use?

Europe has another safety Directive, besides the Low Voltage Directive 2014/35/EU. It is the General Product Safety Directive 2001/95/EC, also called the GPSD. Unlike the LVD, the GPSD is not a CE marking Directive. This means that the CE marking for the product will not refer to the GPSD and the declaration of conformity will not contain any reference to the GPSD either.

However, just like a CE marking Directive, in order to claim conformity, usually the fastest route is via the presumption of conformity by complying with harmonized EN standards. In this case, the GPSD and a laser device, there is no harmonized EN standard for laser product safety compliance indicated in the official list published in the Official Journal of the EU. However the EU published Commission Decision 2014/59/EU in 2014 regarding laser products and the GPSD.

See recital (4):

2014/59/EU continues to explain that harmonized standards must be developed for the safety of consumer laser devices. Additionally, a notification from the European Commission was published in June 2014. Most notable is section 2.4:

The most recent reference to consumer laser protection available after a web search is the same notification published in May 2016, here. See below the reference to laser products and the GPSD.

The number in the last column, December 31, 2017, refers to the date the deliverable is due. It appears there will be a specific safety standard for consumer lasers, soon. This means that laser products out of the scope of another safety Directive (like the LVD) will need to comply with a specific laser safety standard in order to be compliant with the GPSD.

F2 Labs is here to help. Have a question or a comment? We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you.

Posted in CE marking, General Product Safety Directive 2001/95/EC, Lasers, Product Testing | Tagged , , , , , , , | Comments Off on Lasers, IEC/EN 60825-1, the Low Voltage Directive 2014/35/EU, and the General Product Safety Directive 2001/95/EC

UL 94 testing

UL 94 is a standard that measures, in a laboratory setting, the burn characteristics of plastic materials. The title of the standard itself is pretty descriptive: UL Standard for Safety for Tests for Flammability of Plastic Materials for Parts in Devices and Appliances.

This standard is for testing plastic materials to ensure they meet the required resistance to burning for a specific application: typically for enclosures made out of plastic. Using this standard in a laboratory setting we are able to see and record the burning characteristics of a plastic to ensure it is suitable for its intended use. The tests tell us how quickly they self-extinguish because the amount of time that the plastic stays on fire is recorded and that is part of the criteria to determine the UL 94 rating applied to the material following the testing.

There are six tests that are outlined and defined in UL 94:

  • Horizontal Burning Test: HB
  • 50W (20 mm) Vertical Burning Test; V-0, V-1, or V-2
  • 500 W (125 mm) Vertical Burning Test; 5VA or 5VB
  • Thin Material Vertical Burning Test; VTM-0, VTM-1, or VTM-2
  • Horizontal Burning Foamed Material Test; HBF, HF-1, or HF-2

F2 Labs hold ISO accreditation for all of UL 94 but by far the test we conduct the most is the 50W (20 mm) Vertical Burning Test (VB Test). We will discuss this testing in this article.

 

The VB Test is outlined in clause 8 of Ul 94 and instructions regarding the specifications of the test samples are detailed. Clause 8.3.1 identifies that the test samples, “…are to be cut from sheet material, or are to be cast or injection, compression, transfer molded to the necessary form.” Test samples need to be deburred and the edges smooth.

The VB Test samples must be 125 mm (plus or minus 5 mm) long by 13.0 mm (plus or minus 5 mm) wide. The sample can be no thinner than 0.025 mm – unless they distort while in the clamp during the test set-up. In that case the sample must be thicker. 13 mm is the maximum thickness. Additionally, intermediate thicknesses in 3.2 mm increments are also required in cases where the test results are inconsistent.

Pigmentation in plastic means that different materials or chemicals have been added to the plastic to change the color. This may mean that the burn characteristics are different. Therefore, each color of plastic used in your product, for which you want to claim a UL 94 rating, must be tested fully, according to the standard.

For the Vertical Burning Test, you will be required to submit twenty samples for testing. Ten of those samples will be placed in an environmental chamber for seven days prior to the testing and ten will be placed in a different chamber two days prior to the testing.

The VB Test then requires the burning of ten of the samples at a specific distance over a ball of cotton.  The amount of time that the plastic remains on fire after the flame is removed from the plastic is measured. Whether the dripping particles are in flames and catch the cotton beneath on fire is also recorded. This data is then compared against Table 8.1 in UL 94, see below.

The classification of your material is made based upon these measurements.

Why 20 samples if we only burn ten? Good question. The standard requires 20 samples so that there are two batches of ten each. This is done in case there are wild differences in burning rates with the first batch of ten samples. If that happens there is a second batch with which to conduct testing.

Many times you can alleviate the need for UL 94 testing for the plastic in your product by specifying suitably approved plastic from your plastic vendor. To understand what you will need (which VB rating) you will need to evaluate the design of your product against the relevant safety standard applicable to your product.

F2 Labs is here to help. Have a question or a comment? We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you.

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The Machinery Directive 2006/42/EC and lifting accessories

The Machinery Directive 2006/42/EC, broadly, is applicable to machinery, defined in Article 2 (a) as an assembly fitted or intended to be fitted with a drive assembly to perform a function. The power, unless used for lifting purposes, must come from other than human power (electrical, hydraulic, pneumatic, etc.).

‘Lifting accessories’ which, among some other products (which will be the subject of later articles), are not ‘machinery’ as defined in Article 2 (a) and can be as simple as a C-hook or a purpose-built piece of metal used to prop open and hold a cowling on an aircraft during maintenance. Lifting accessories that are permanently attached to lifting machinery are not considered as lifting accessories, the definition is meant to encompass the device between the lifting machinery and the load itself.

Lifting accessories are defined in Article 2 (d):

Another example is an engineered hook used to attach to something to lift it up: such as an engine or an engine part. An engineered piece of metal used in this way, though with no moving parts or electrical components, would require a full evaluation against the requirements of the Machinery Directive 2006/42/EC, Annex I, plus a CE marking, declaration of conformity, and a Technical File.

This means that in order to claim compliance and put a CE marking on your lifting accessory you will need to contact a laboratory experienced with EN ISO 12100:2010 and probably at least one other standard, possibly falling on the C-type standards list as published by the European Commission. For the example immediately above, this is likely the harmonized C-type Machinery Directive EN standard:

EN 13155:2003+A2:2009 Cranes – Safety – Non-fixed load lifting attachments

The EU Commission has published some information for your review if you are unsure regarding where your equipment fits, as pertains to Article 2 (d). See some helpful links below.

F2 Labs is here to help. Have a question or a comment? We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you.

 

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New RoHS restrictions, substances added to Annex II

shutterstock_370043891

There is a change on the horizon for manufacturers used to complying with RoHS based on the restriction of the six substances indicated in RoHS 2011/65/EU (Annex II):

  • Lead (0.1%)
  • Mercury (0.1%)
  • Cadmium (0.01%)
  • Hexavalent chromium (0.1%)
  • Polybrominated biphenyls (PBB) (0.1%)
  • Polybrominated diphenyl ethers (PBDE) (0.1%)

The change is Commission Delegated Directive (EU) 2015/863 published in the Official Journal of the European Union on March 31, 2015.

This new Directive makes the following change to the above list of restricted substances by adding four new substances:

  • Bis(2-ethylhexyl) phthalate (DEHP) (0.1%)
  • Butyl benzyl phthalate (BBP) (0.1%)
  • Dibutyl Phthalate (DBP) (0.1%)
  • Diisobutyl phthalate (DIBP) (0.1%)

The Directive is very short, only three pages, and below are three notable sections.

  • Article 2 – 2015/863 is applicable to all RoHS products effective July 22, 2019
  • Annex II – medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments are exempted from these new restrictions until July 22, 20121
  • Annex II – some of the substance restrictions indicated in 2015/863 are current substance restrictions applicable to toys per the REACH Regulation 1907/2006.

Finally, note that Article 2 of the new Directive requires that all EU Member States adopt this Directive and publish “…laws, regulations and administrative provisions necessary to comply with this Directive.”

F2 Labs is here to help. Have a question or a comment? We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you.

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Compliance with the Low Voltage Directive 2014/35/EU, Annex I

F2 Labs is constantly working to help customers better understand their responsibilities in complying with CE marking Directives that may or may not apply to their equipment. Previously we published an article about the relationship between the Low Voltage Directive 2014/35/EU and the Machinery Directive 2006/42/EC. Besides the LVD’s relationship with the MD, a question that comes up over and over is the need to comply with the Low Voltage Directive 2014/35/EU for some products that are seemingly not in the scope of this law at all.

The Low Voltage Directive 2014/35/EU scope of applicability is indicated in Annex I, paragraph 2, and is:

This Directive shall apply to electrical equipment designed for use with a voltage rating of between 50 and 1 000 V for alternating current and between 75 and 1 500 V for direct current, other than the equipment and phenomena listed in Annex II.

This means that electrical equipment with an input power of from 50 to 1,000 volts AC and from 75 to 1,500 volts DC are within the scope of the law. Battery powered devices that operate with an input power of 12 volts DC are therefore excluded from the law.

Unfortunately, it is not that simple. For example, if you have a product that operates on 12 volts DC power but you supply an AC/DC adapter with your product when you ship to the EU then your product is operating with an input power of 230 volts AC and it is within the scope of the Low Voltage Directive. Similarly, if you do not supply the power supply with the product but you specify that an AC/DC power supply must be used with your product then it is considered an AC powered product and therefore will operate at 230 volts AC power and is within the scope of the LVD.

Also note that both the Radio and Telecommunications Terminal Equipment Directive 1999/5/EC and the Radio Equipment Directive 2014/53/EU require compliance with Annex I of the LVD no matter the voltage.

See below Article 3 (1.) (a) from the R&TTE Directive 1999/5/EC:

  1. The following essential requirements are applicable to all apparatus: (a) the protection of the health and the safety of the user and any other person, including the objectives with respect to safety requirements contained in Directive 73/23/EEC, but with no voltage limit applying;

 Note that Directive 73/23/EEC was the Low Voltage Directive in effect when 1999/5/EC was written. By law that refers to, now, the Low Voltage Directive 2014/35/EU.

See below Article 3 (1.) (a) from the Radio Equipment Directive 2014/53/EU (also called the “RED”):

  1. Radio equipment shall be constructed so as to ensure: (a) the protection of health and safety of persons and of domestic animals and the protection of property, including the objectives with respect to safety requirements set out in Directive 2014/35/EU, but with no voltage limit applying;

 It is informative at this point to also point out that both the R&TTE 1999/5/EC and the RED 2014/53/EU exclude the Low Voltage Directive from being applicable to the equipment if either R&TTE or RED are applicable.

See below an excerpt from recital (46) from the R&TTE Directive 1999/5/EC:

…whereas Directives 73/23/EEC and 89/336/EEC will no longer apply to apparatus within the scope of this Directive, with the exception of protection and safety requirements and certain conformity assessment procedures,

And also see below recital (7) from the RED 2014/53/EU:

(7) The objectives with respect to safety requirements laid down in Directive 2014/35/EU are sufficient to cover radio equipment, and should therefore be the reference and made applicable by virtue of this Directive. In order to avoid unnecessary duplications of provisions other than those concerning such requirements, Directive 2014/35/EU should not apply to radio equipment.

 This can be confusing unless you read it a few times. What it means, in the cases of both the R&TTE Directive 1999/5/EC and the RED 2014/53/EU, is this:

  1. Annex I from the Low Voltage Directive is applicable to equipment within the scope of either “radio” Directives regardless of the power input. Therefore if your device has a tiny coin cell battery and a wireless module and no connection to AC mains power you must comply with Annex I of the LVD.
  1. In these cases only Annex I from the LVD is applicable and nothing else from the LVD.
  1. The LVD will not be referenced on the EU declaration of conformity for the product because compliance with Annex I of the LVD is presumed when compliance to either R&TTE or RED are claimed. Therefore the LVD itself is excluded, only Annex I is applicable and that is through Article 3 (1.) (a) of both the R&TTE Directive 1999/5/EC and the RED 2014/53/EU.

So, the next question is, “What is Annex I of the LVD?” See below:

lvd_annexi

Compliance with Annex I of the LVD will require, in most cases, testing using an applicable harmonized EN standard from the official list published in the Official Journal of the European Union. The latest available list was published on July 8, 2016 and is published here: LVD standards OJ List.

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