RoHS 2011/65/EU and Machinery

F2 Labs assists many manufacturers, internationally, with CE marking requirements. Regarding CE marking, primarily we test and evaluate electro-mechanical equipment for compliance with electrical safety, machinery safety, EMC and radio, medical device, and hazardous location requirements.

However, when a manufacturer completes a compliance project for Europe and places a CE marking on the equipment, that CE marking is an overt claim of compliance with the RoHS Directive 2011/65/EU: intentional or not. This is because the CE marking on a product is a claim of compliance to any CE marking Directive that is applicable.

In other words: if your product is in the scope of RoHS then putting a CE marking on the product is a claim that it complies with the RoHS substance restrictions… for every component in and on your equipment. Including the paint and labels.

It is very common for our customers to assume that RoHS does not apply to their equipment because it is machinery. This is not a legal reason to ignore RoHS. This article will explain why.

RoHS 2011/65/EU defines equipment within its scope as per below –

Article 2, Scope

  1. This Directive shall, subject to paragraph 2, apply to EEE falling within the categories set out in Annex I.

See definition of ‘EEE’ in Article 3 (1)

Article 3, Definitions

For the purposes of this Directive, the following definitions shall apply:

(1) ‘electrical and electronic equipment’ or ‘EEE’ means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields and designed for use with a voltage rating not exceeding 1 000 volts for alternating current and 1 500 volts for direct current;

See Annex I (6.) and (9.)

ANNEX I, Categories of EEE covered by this Directive

  1. Large household appliances.
  2. Small household appliances.
  3. IT and telecommunications equipment.
  4. Consumer equipment.
  5. Lighting equipment.
  6. Electrical and electronic tools.
  7. Toys, leisure and sports equipment.
  8. Medical devices.
  9. Monitoring and control instruments including industrial monitoring and control instruments.
  10. Automatic dispensers.
  11. Other EEE not covered by any of the categories above.

Next, we look to the WEEE Directive 2012/19/EU to see the indicative list of equipment matched to Annex I in RoHS 2011/65/EU. Keep in mind that these lists are indicative, not complete. And, we also highlight that WEEE and RoHS were written as complimentary Directives and refer to each other. (link: RoHS/WEEE).

See WEEE 2012/19/EU, Annex II (6.) and (9.)

  1. ELECTRICAL AND ELECTRONIC TOOLS (WITH THE EXCEPTION OF LARGE-SCALE STATIONARY INDUSTRIAL TOOLS)
  • Drills
  • Saws
  • Sewing machines
  • Equipment for turning, milling, sanding, grinding, sawing, cutting, shearing, drilling, making holes, punching, folding, bending or similar processing of wood, metal and other materials
  • Tools for riveting, nailing or screwing or removing rivets, nails, screws or similar uses
  • Tools for welding, soldering or similar use
  • Equipment for spraying, spreading, dispersing or other treatment of liquid or gaseous substances by other means
  • Tools for mowing or other gardening activities
  1. MONITORING AND CONTROL INSTRUMENTS
  • Smoke detector
  • Heating regulators
  • Thermostats
  • Measuring, weighing or adjusting appliances for household or as laboratory equipment
  • Other monitoring and control instruments used in industrial installations (e.g. in control panels)

Next we refer to two possible exclusions in RoHS 2011/65/EU.

See RoHS 2011/65/EU, Article 2 (4.) (d) and (e):

Article 2, Scope

  1. This Directive does not apply to:

(d) large-scale stationary industrial tools;

(e) large-scale fixed installations;

Next, see the definitions of each in RoHS 2011/65/EU, Article 3 (3) and (4):

(3) ‘large-scale stationary industrial tools’ means a large-scale assembly of machines, equipment, and/or components, functioning together for a specific application, permanently installed and de-installed by professionals at a given place, and used and maintained by professionals in an industrial manufacturing facility or research and development facility;

(4) ‘large-scale fixed installation’ means a large-scale combination of several types of apparatus and, where applicable, other devices, which are assembled and installed by professionals, intended to be used permanently in a pre-defined and dedicated location, and de-installed by professionals;

Referring next to the EU Commission published RoHS 2 FAQ, if you can not categorize your machinery as meeting ALL of the criteria below then your equipment is not excluded from RoHS.

See Q3.1 –

 Q3.1 What are “large-scale stationary industrial tools” and “large-scale fixed installations”? (Articles 2(4)(d) and 2(4)(e)).

Unlike RoHS 1, RoHS 2 has an open scope. However, several product groups are excluded from the RoHS 2 scope.

Two of the exclusions listed in Article 2(4) refer to combinations of EEE in a professional context, i.e. “large-scale stationary industrial tools” (Article 2(4)(d)) and “large-scale fixed installations” (Article 2(4)(e)).

 Both terms are explained in the definitions (Articles 3(3) and 3(4)), however it is not explained what “large-scale” means. Both categories are combinations of various types of items, such as machinery, components etc. for permanent use at a specific place, installed and de-installed by professionals. Therefore the two categories may overlap. However, it is important to consider that the meaning of “large-scale” in absolute terms may be a different one for tools and installations, as there are differences between tools and installations.

Tools are essentially machines, stand-alone or assemblies, often with moving parts, and used for example for the treatment or manufacturing of materials and work pieces. The Machinery Directive11 can be used as guidance.

Typical machine tools can also be part of fixed installations.

 In order to benefit from either exclusion, the tool or installation must meet all the respective requirements. As stated below, it has to be:

 (Tool)

  • an assembly of machines, equipment and/or components, functioning together for a specific application;
  • permanently installed and de-installed by professionals at a given place;
  • used and maintained by professionals in an industrial manufacturing facility or R&D facility;
  • and it has to be large-scale;

 (Installation) – a combination of several types of apparatus and, where applicable, other devices;

  • assembled, installed and de-installed by professionals;
  • with the intention to be used permanently in a pre-defined and dedicated location;
  • and it has to be large-scale.

“Large-scale” is part of both sets of requirements. Evidently, this draws a line between “larger” tools and installations benefiting from an exclusion, and otherwise similar, “smaller” equipment.

“Large-scale” refers to dimensional or similar criteria as explained below, although this criterion is not specified in the RoHS 2.

The important take-away is this sentence from Q3.1:  In order to benefit from either exclusion the tool or installation must meet all the respective requirements.

This means that your equipment must all of the above criteria in order to be excluded from RoHS. With that interpretation (provided by the EU) it is clear that most machinery is in the scope of RoHS, presently.

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, Consulting, 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, Product Testing, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU | Tagged , , , , , , , , , , | Leave a comment

FCC – New Labeling and Manual Requirements

The FCC released new guidance and procedures for manufacturers to show compliance with FCC regulations in June 2017. Some of the changes are in the labeling requirements and, notably, the allowance for the use of a Suppliers Declaration of Conformity, or SDOC. The National Institute of Standards and Technology published some basic information to understand this, here.

Internally at F2 Labs, our Director of EMC and Wireless Operations sent guidance to staff to assist in helping our customers comply with these new FCC procedures. Copied below and in italics is the text from that company correspondence, most of which is taken directly from the published FCC rules and regulations –

Labeling of Equipment

It will be the responsibility of the manufacturer or importer to permanently affix the appropriate label when marketing the equipment.

 The label shall bear the following statement per FCC 15.19(a)(1)-(5):

  • Receivers associated with the operation of a licensed radio service, g.,FM broadcast under part 73 of this chapter, land mobile operation under part 90 of this chapter, etc., shall bear the following statement in a conspicuous location on the device:

This device complies with part 15 of the FCC Rules. Operation is subject to the condition that this device does not cause harmful interference.

  • A stand-alone cable input selector switch, shall bear the following statement in a conspicuous location on the device:

This device complies with part 15 of the FCC Rules for use with cable television service.

(3)     All other devices shall bear the following statement in a conspicuous location on the device:

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

(4)     Where a device is constructed in two or more sections connected by wires and marketed together, the statement specified under paragraph (a) of this section is required to be affixed only to the main control unit.

(5)     When the device is so small or for such use that it is impracticable to label it with the statement specified under paragraph (a) of this section in a font that is four-point or larger, and the device does not have a display that can show electronic labeling, then the information required by this paragraph shall be placed in the user manual and must also either be placed on the device packaging or on a removable label attached to the device.

Note:  If the product contains a pre-approved wireless module, a label is also required to show the product contains an approved wireless module.  The following is an example of what the label should state:

Contains FCC ID: XXXXXXX

  • 2.1074 Identification.

Devices subject to authorization under Supplier’s Declaration of Conformity may be labeled with the following logo on a voluntary basis as a visual indication that the product complies with the applicable FCC requirements. The use of the logo on the device does not alleviate the requirement to provide the compliance information required by §2.1077.

  • 2.1077 Compliance information.

(a) If a product must be tested and authorized under Supplier’s Declaration of Conformity, a compliance information statement shall be supplied with the product at the time of marketing or importation, containing the following information:

(1) Identification of the product, e.g., name and model number;

(2) A compliance statement as applicable, e.g., for devices subject to part 15 of this chapter as specified in §15.19(a)(3) of this chapter, that the product complies with the rules; and

(3) The identification, by name, address and telephone number or Internet contact information, of the responsible party, as defined in §2.909. The responsible party for Supplier’s Declaration of Conformity must be located within the United States.

 Exhibit VIII

 Manual Requirements

FCC Manual Statement: §15.21 Information to user.

Note:  This requirement applies to all devices unless exempted by 15.103:

The user’s manual or instruction manual for an intentional or unintentional radiator shall caution the user that changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

FCC Manual Statement: §15.105 Digital Devices Statement

For all Class A Digital Devices, the following statement must be included in the manual:

Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.

For all Class B Digital Devices, the following statement must be included in the manual:

Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

—Reorient or relocate the receiving antenna.

—Increase the separation between the equipment and receiver.

—Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.

—Consult the dealer or an experienced radio/TV technician for help.

Finally, F2 Labs offers additional guidance as pertains FCC requirements and testing on our website, links are 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.

Posted in Consulting, FCC | Tagged , , , , , , , , , , , | Leave a comment

EU’s Rapid Alert System for dangerous non-food products

The EU has a direct conduit for market surveillance authorities to communicate information about non-compliant products directly between 31 EU member nations and the European Commission.

This system is called the Rapid Alert System, or RAPEX.

This is not where you want your products to show up after a web search, see below.

This site, published and continuously updated by the EU Commission, highlights and posts non-compliant products. These are products that were stopped in customs, started a fire, broke and proved unsafe, or were questioned and subsequently found to be non-compliant after further review.

Below is an example of a product that was stopped in Germany and then submitted to RAPEX.

Below is another.

The way to avoid this is by determining which EU laws apply to your equipment and then making sure that the product complies.

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, Consulting, EMC Directive 2014/30/EU, EN 60601-1, General Product Safety Directive 2001/95/EC, IP Testing, Lasers, 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, Radio Equipment Directive 2014/53/EU, RoHS Directive 2011/65/EU | Tagged , , , , , , , , | Leave a comment

IP69 vs. IP69K

We are presented with a request for quote for IP69K testing on a regular basis at F2 Labs. Usually my first reply to the customer is this, “Do you mean IP69 or IP69K?” Believe it or not, there is a difference and it is an important distinction. This article will explain.

Before we get into the details, the most general distinction is that IP69 testing is for equipment, like control panels or electrical equipment that is installed in areas that get washed (pharmaceutical manufacturing, industrial food packaging), and IP69K is for equipment installed on road vehicles. And the IP69K testing is meant to validate that the equipment installed in road vehicles can withstand very severe wash-downs with pressure washers.

IP69 is the IP (ingress protection) code for a very high level of protection as indicated in IEC 60529 – Degrees of protection provided by enclosures (IP code).

IP69K is the IP code for a very high level of protection as indicated in ISO 20653 – Road vehicles – Degress of protection (IP code) – Protection of electrical equipment against foreign objects, water and access.

First, I want to share the full chart from IEC 60529, clause 4.2 below –

4.2 Elements of the IP Code and their meanings
A brief description of the IP Code elements is given in the following chart. Full details are
specified in the clauses indicated in the last column.

Notice there is no reference to any “K” test or designation anywhere in the chart. It does not exist in IEC 60529.

The IP69 testing consists of a dust test (IP6X) and a water test (IPX9). See this previous article for more information regarding IEC 60529 testing.

Link – IEC 60529 testing article

As pertains this article, we want to investigate the differences between the IPX9 testing from IEC 60529 and the IPX9K testing from ISO 20653.

The IPX9 test from IEC 60529 is indicated in clause 14.2.9 and is below –

14.2.9 Test for second characteristic numeral 9 by high pressure and temperature water jetting The test is made by spraying the enclosure with a stream of water from a standard test nozzle as shown in Figures 7, 8 and 9.

The set-up for measuring the impact force of the water jet is given in Figure 10.

The distribution force shall be verified at upper and lower limits of distance tolerance range (see Figure 11).

a) For small enclosures (largest dimension less than 250 mm), the enclosure shall be mounted on the test device shown in Figure 12.
– turntable speed: 5 r/min ± 1 r/min
– spray positions: 0°, 30°, 60°, 90°
The test duration is 30 s per position.

b) For large enclosures (largest dimension greater than or equal to 250 mm), the enclosure shall be mounted as per intended use. The entire exposed surface area of the enclosure shall be subjected to the spray at some point during the test procedure.
– spray positions: the enclosure shall be sprayed from all practical directions covering the entire surface area and the spray shall be, as far as possible, perpendicular to the sprayed surface.
– distance between nozzle and sample under test shall be 175 ± 25 mm.

The test duration is 1 min/m2 of the calculated surface area of the enclosure (excluding any mounting surface), with a minimum duration of 3 min.

Next, we will review the correlating chart in ISO 20653. See Table 1 in clause 4.2 below –

4.2 Meaning of IP code
Table 1 contains an overview of the IP code elements.

We notice right away that there are several “K” designations in the above table – IP5KX, IP6KX, IPX4K, IPX6K, and IPX9K. (Note that the inserted “X” means the correlating water or dust test from the string is not considered. For example, IP5KX means that there is 5K dust test but no water test is indicated.)

There are no “K” designations in the table from clause 4.2 of IEC 60529.

Since most requests we receive with a “K” at F2 Labs are for IP69K, we will investigate the IPX9K test from ISO 20653 and compare it to the IPX9 test from clause 14.2.9 of IEC 60529.

We will review Table 7 in clause 9.2 of ISO 20653 to understand the test conditions/ protocol for IPX9K –

Let’s get a close-up of the 9K test –

Since we have laid out both test procedures (IEC 60529 IPX9 and ISO 20653 IPX9K) next we will make a direct comparison, see below –

Some notable differences are:

  1. The distance for the test nozzle for the IPX6 test is 175 mm, plus or minus 25 mm and the ISO IPX9K test is 100 to 150 mm.
  2. The impact of the water is measured in terms of force for the IP6X test while it is measured in terms of pressure for the IP6K test.

The tests are different.

Adding to the confusion, there appears to be a typo in IEC 60529 standard that has caused some headaches (and probably not only here in our lab!). IEC 60529 was written in French and the standard, when purchased, typically comes in French and English in the same document.

See clause 14.2.9 in the English part of IEC 60529 –

Now see clause 14.2.9 in the French part of IEC 60529 –

Since we are all busy and this article has become long enough, I will show you what the discrepancy is. There is a sentence about temperature in the French section that is not in the English section. See below –

I do not speak French, but Google tells me that the sentence translates as follows:

So, this validates that the temperature requirement is the same for IPX9 and IPX9K testing.

Continuing, I have been asked on a few occasions to quote an IP69K test for a product based on the German standard, DIN 40050-9 – Road vehicles; degrees of protection (IP-code): protection against foreign objects; water and contact; electrical equipment. DIN is the German Institute for Standardization.

Please see below the WITHDRAWN status of DIN 40050-9, as indicated on the DIN site –

Summarizing all of the above, please see below –

  1. IP69 is testing from an IEC standard and is for electrical equipment while IP69K is testing from an ISO standard and is for electrical equipment mounted on road vehicles.
  2. IP69 testing requires that the FORCE of a water jet is measured during the water test while IP69K testing requires that the PRESSURE of the water jet is measured during the water test.
  3. The distance of the water jet nozzle can be 25 mm further away for the IP69 water test (175 mm) as compared to the IP69K water test (150 mm).
  4. Frequently DIN 40050-9 is indicated as a rationale for requiring IP69K testing. DIN 40050-9 is not an active standard.

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 IP Testing, Product Testing | Tagged , , , , , | Leave a comment

Aerosol Dispensers Directive 75/324/EEC

The Aerosol Dispensers Directive 75/324/EEC, also called the ADD 75/324/EEC is one of Europe’s oldest Directives. Although it has never been replaced like, for instance, the Low Voltage Directive 73/23/EEC (replaced by the LVD 2006/95/EC and then the LVD 2014/35/EU) it has been revised / amended many times. Fortunately, the EU publishes the amended version here, and you will not need to refer to the separate amendments.

The ADD 75/324/EEC applies to aerosol dispensers as defined in Article 2 – any non-reusable glass, metal, or plastic container that contains gas under pressure with a release device so that the contents (liquid, powder, paste, or gas) can be ejected.

One caveat is that the container, to be within the scope of the ADD 75/324/EEC, must have a maximum capacity of equal to or greater than 50 ml. That means the ADD 75/324/EEC does not apply if the container is 49.9 ml or less.

Some requirements in the Directive apply to all aerosol dispensers in scope. For example: labeling specifications, storage considerations, inhalation risks, and construction requirements (for the valve). Next, it starts to get tricky. The ADD 75/324/ECC next lays out the requirements based on the nature of what is in the dispenser. They differ based on the below factors:

  1. Glass (differentiating between protected and non-protected glass), metal, plastic
  2. Non-flammable, flammable, extremely flammable

The material which the dispenser is made from is self-explanatory. The flammability, as pertains the ADD 75/324/EEC, is defined in the Annex (1.9):

For the purpose of this Directive, an aerosol is considered as ‘nonflammable’, ‘flammable’ or ‘extremely flammable’ according to its chemical heat of combustion and mass content of flammable components, as follows:

(a) The aerosol is classified as ‘extremely flammable’ if it contains 85 % or more flammable components and the chemical heat of combustion exceeds or is equal to 30 kJ/g;

(b) The aerosol is classified as ‘non-flammable’ if it contains 1 % or less flammable components and the chemical heat of combustion is less than 20 kJ/g;

(c) All other aerosols will be submitted to the following flammability classification procedures or shall be classified as ‘extremely flammable’. The ignition distance test, the enclosed space test and the foam flammability test shall comply with point 6.3.

Aerosol dispensers which contain flammable mixtures must then be subjected to testing, as indicated in the Directive, to determine if it is flammable or extremely flammable. Flammable and extremely flammable aerosol dispensers are not barred from the market on that basis, they are subject to more extreme labeling requirements than non-flammable products.

Lastly, I want to point out the Annex (6.1.4) Final inspection of filled aerosol dispensers tests indicated in the Annex (6.1.4.1.) (a), (b), and (c). See below –

6.1.4.1. Aerosol dispensers shall be subject to one of the following final test methods.

(a) Hot water bath test

Each filled aerosol dispenser shall be immersed in a hot water bath.

(i) The temperature of the water bath and the duration of the test shall be such that the internal pressure reaches that which would be exerted by its contents at a uniform temperature of 50 °C.

(ii) Any aerosol dispenser showing visible permanent distortion or a leak must be rejected.

(b) Hot final test methods

Other methods for heating the contents of aerosol dispensers may be used if they guarantee that the pressure and temperature in each filled aerosol dispenser reach the values required for the hot water bath test and distortions and leaks are detected with same precision as in the case of the hot water bath test.

(c) Cold final test methods

An alternative cold final test method may be used if it is in accordance with the provisions of an alternative method to the hot water bath test for aerosol dispensers specified in point 6.2.4.3.2.2 of Annex A to Directive 94/55/EC.

 OK, “great!,” right…? Maybe. Next see the Annex 6.1.4.3 –

6.1.4.3. In case of test methods according to points 6.1.4.1(b) and 6.1.4.1(c):

The test method must be approved by a competent authority.

(b) The person responsible for the marketing of aerosol dispensers must submit an application for approval to a competent authority. The application must be accompanied by the technical file describing the method.

(c) The person responsible for the marketing of aerosol dispensers must, for surveillance purposes, keep the approval of the competent authority, the technical file describing the method and, if applicable, control reports readily available at the address specified on the label in accordance with point (a) of Article 8(1).

(d) The technical file must be established in an official Community language or a certified copy thereof must be available.

(e) ‘competent authority’ means the authority designated in each Member State under Directive 94/55/EC.

 This means that if the final testing of the dispensers is not performed according to 6.1.4.1. (a) then a competent authority must be involved. That means two things for the manufacturer:

  1. More time
  2. More cost

This can be problematic if the manufacturer, for whatever reason, cannot raise the temperature to 50°C.

F2 Labs is here to help with your ADD 75/324/EEC project. 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 | Tagged , , , | Leave a comment

RoHS 2011/65/EU, EN 50581:2012, and clause 4.3.3.

Manufacturers that send equipment to the EU with a CE marking must understand that a CE marking is a blanket claim by the manufacturer. The claim is that the equipment complies with any applicable CE marking Directive. This article is meant to explain the documentation required for the assembly of a report to back up that claim of compliance.

In many cases that means the Restriction of Hazardous Substances Directive 2011/65/EU, also called “RoHS” or “RoHS2”. RoHS applies to almost everything that can be defined as ‘electrical and electronic equipment’ (aka ‘EEE’) per Article 3 (1) and fitting into any of the categories listed in Annex I:

ANNEX I

Categories of EEE covered by this Directive

  1. Large household appliances.
  2. Small household appliances.
  3. IT and telecommunications equipment.
  4. Consumer equipment.
  5. Lighting equipment.
  6. Electrical and electronic tools.
  7. Toys, leisure and sports equipment.
  8. Medical devices.
  9. Monitoring and control instruments including industrial monitoring and control instruments.
  10. Automatic dispensers.
  11. Other EEE not covered by any of the categories above.

Proving compliance to RoHS means compiling a report using the sole harmonized standard for RoHS compliance: EN 50581:2012 Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances.

EN 50581:2012 details the process for collecting, evaluating, and organizing the information needed to prove that a product which is in the scope of RoHS 2011/65/EU is compliant. Manufacturers will need to collect supporting information for every component in the subject equipment, including labels, paint, glue… everything.

Clause 4.3.3 indicates the information required, see below.

4.3.3 (a) indicates that a supplier declaration or a contractual agreement can be used. The first indent defines a ‘supplier declaration’. Simply put, this should be a document, on company letterhead, that identifies the part by part number and affirmatively claims compliance for that part to the RoHS 2011/65/EU restriction levels. It should be signed and dated as well. The second indent states that a contract can be used for this purpose as well. This could be a purchase order from the buyer (in this case, the manufacturer of the EEE that is in the scope of RoHS) stating that the parts must be compliant, and signed by the manufacturer of the part.

4.3.3 (b) lists the requirements for a material declaration. A material declaration is a much more formal document and it lists the specific content of each of the restricted substances in the part. Additionally, it refers to another standard, EN 62474:2012 Material declaration for products of and for the electrotechnical industry (IEC 624 7 4:2012 (EQV)). A review of EN 62474 directs the reader to clause 4, and then multiple instructions and requirements in clause 4.2 and 4.3. See below the descriptors for these clauses in the contents section of EN 62474:

The immediate takeaway from a comparison of EN 50581:20102, clause 4.3.3 (a) vs (b) is that a supplier declaration (or a properly formatted and signed purchase order) can be compiled more quickly and expediently than a material declaration.

Next, clause 4.3.3 (c) from EN 50581:2012 is explained. That section indicates that a manufacturer of a part can supply a test report, showing that the component was taken apart, chemically, in a laboratory and evaluated for its composition. These reports are common and, as a side-note, I have compiled EN 50581:2012 reports for F2 Labs customers based on laboratory reports for almost every component in the product.

F2 Labs can help your company get a handle on RoHS 2011/65/EU and most other EU requirements. 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, RoHS Directive 2011/65/EU | Tagged , , , , , , , | Leave a comment

Safety Fences and the Machinery Directive 2006/42/EC

While reading the new Guide to application of the Machinery Directive 2006/42/EC, Edition 2.1, I was interested to see that the last sentence in section 42, dealing with Safety Components and their status under the Machinery Directive, is this:

Specific guidance on safety fences as a safety component is given in §411.

I found this interesting for two reasons:

  1. There is no mention of the term “Safety Fences” in Edition 2.0. (see above picture).
  2. Section 411 is an addition to Edition 2.1, it is not revised.

Section 411 describes that safety fences are safety components per 2006/42/EC, Article 1 (1) (c). Additionally, three common scenarios that are faced by machinery manufacturers are detailed. Below, I have summarized the scenarios and what the Machinery Working Group says about them in section 411.

Scenario 1 – the safety fence is not considered a Safety Component per Article 1 (1) (c).

  • The machinery manufacturer either designs and builds a proprietary safety fence for a specific machine or completely designs the safety fence and hires a fence manufacturer to make the safety fence from the manufacturer’s design.

Scenario 2 – the safety fence is considered a Safety Component per Article 1 (1) (c).

  • The fence manufacturer performs the design and build function for a safety fence for a third party’s machine. That is to say, the machinery manufacturer hires a fence manufacturer to look at the machine, design the safety fence, and deliver the safety fence to the machinery manufacturer. In scenario 2 the machinery manufacturer must require a CE marking on the delivered safety fence and a declaration of conformity (and everything else required by the Machinery Directive 2006/42/EC per Article 5 (1)).

Scenario 3 – the safety fence is not considered a Safety Component per Article 1 (1) (c).

  • A supplier or manufacturer supplies a safety fence component to a machine builder or as a replacement part for an existing fence in service on EU soil. In scenario 3 it is defined that safety fence components are not to be considered as safety components under the Machinery Directive. However, section 411 does clarify that an individual component of a safety fence that has a direct safety function, such as a gate, could be considered as a safety component on its own.

If you are sending a machine to the EU, or preparing a bid to build one for a European customer: please call us. We will sort out the requirements beforehand and will give you an accurate price for the CE marking evaluation and testing services that you will need. Many of our projects start this way, a year or more before we start any compliance work.

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, Machinery Directive 2006/42/EC | Tagged , , , , , , , , , | Leave a comment

Guide to application of the Machinery Directive 2006/42/EC, Edition 2.1 – published in July 2017 and EN 61010-1 equipment

The Guide to application of the Machinery Directive 2006/42/EC, Edition 2.1, was published by the EC Commission in July. The link to the document is here. Be advised that is a direct download link.

The “guideline” is extremely useful and we refer to it often. We have read through the changes and want to highlight what we consider to be pretty significant: the addition of the Low Voltage Directive 2014/35/EU to the Article 3 exclusion in the Machinery Directive 2006/42/EC.

2006/42/EC, Article 3 is below.

Article 3 is interesting because it offers the ability to exclude the Machinery Directive 2006/42/EC if all of the safety risks can be covered in a different Directive: for instance, the Medical Device Directive 93/42/EEC. It has always been a gray area to exclude certain products from the Machinery Directive in favor of the Low Voltage Directive if those products did not meet the criteria established in 2006/42/EC, Article 1 (2) (k).

2006/42/EC, Article 1 (2) (k) is below.

This has caused some confusion because of the inclusion of a main electrical safety standard on the list of harmonized standards for the Low Voltage Directive 2014/35/EU and not the Machinery Directive 2006/42/EC list. That standard is EN 61010-1.

See EN 61010-1 as it is displayed on the EC Commission’s page for the LVD, linked here.

EN 61010-1 is a very thorough and comprehensive safety standard, covering most (0r all) risks presented by a lot of types of machines, but in some cases it could not be applied if the equipment did not meet the exclusion requirements indicated in Article 1 (2) (k).

That brings us to the important change in the guidelines. The previously referenced guideline document is a thorough publication which clearly explains nearly everything required by the Machinery Directive. Since it is published by the EC Commission the text in the document is seen as the official word.

Section 90 of the guidelines indicates the EU Directives that are available for consideration instead of the Machinery Directive, per Article 3.

The EU Directives listed in section 90 of Edition 2.0 are listed below.

  • Toys Directive 2009/48/EC
  • Personal Protective Equipment Directive 89/686/EEC
  • Medical Devices Directive 93/42/EEC
  • Lifts Directive 95/16/EC
  • Cableways Directive 2009/9/EC

And now, in Edition 2.1, the list in section 90 has been revised as indicated below.

  • Low Voltage Directive 2014/35/EU
  • Toys Directive 2009/48/EC
  • Personal Protective Equipment Directive 89/686/EEC
  • Medical Devices Directive 93/42/EEC
  • Lifts Directive 2014/33/EU
  • Cableways Directive 2009/9/EC
  • Regulation (EU) No 167/2013 (this is a new regulation, dealing with agricultural and forestry tractors separately from the Machinery Directive)

This addition of the Low Voltage Directive 2014/35/EU to the list in section 90 of the Edition 2.1 Guideline to application of the Machinery Directive 2006/42/EC makes it clear that the Machinery Working Group considers that some particular equipment can legally satisfy CE marking requirements through the Low Voltage Directive instead of the Machinery Directive. Laboratory and testing equipment with moving parts, within the scope of EN 61010-1, are the best example.

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, Machinery Directive 2006/42/EC | Tagged , , , , , , | Leave a comment

ATEX Directive 2014/34/EU and the ATEX Directive 99/92/EC

The ATEX Directive 2014/34/EU applies to equipment used in mines and potentially explosive atmospheres. It is very common for the sales staff at F2 Labs to receive a request for technical assistance to comply with ATEX but it is not that simple.

ATEX 2014/34/EU is a Directive that has many compliance paths which are dependent upon a few factors which must be defined prior to an evaluation or even a proposal.

Per Annex I of 2014/34/EU, equipment is first separated between Equipment-group I (mining applications) and Equipment-group II (non-mining but used in areas where mixtures of gas, vapor, mist, or dust can cause explosion). After the equipment group is defined, the subject equipment must be evaluated according to the category designated below:

Mining

  • Equipment-group I, category M1
  • Equipment-group I, category M2

Non-mining

  • Equipment-group II, category 1
  • Equipment-group II, category 2
  • Equipment-group II, category 3

The complicating factor is that in order to determine the category (and therefore the compliance path) the end-user must indicate to the manufacturer the ATEX zone in which the equipment will operate, for it is the ATEX zone which directs the manufacturer to the category of risk that must be complied with.

The ATEX zones are defined in a different ATEX Directive: ATEX 99/92/EC. See Annex I of 99/92/EC below.

The correlation for the categories for Equipment-group II are as follows:

  • Zone 0 (gas)/ 20 (dust) – Category 1 – highest risk, requires Notified Body involvement
  • Zone 1 / 2 – Category 2 – Notified body involvement required if the equipment contains energized parts
  • Zone 2/ 22 – Category 3 – does not require Notified Body involvement

All three categories of equipment require a CE marking and third party test lab involvement, usually to test and evaluate against a set of IEC/EN 60079 standards.

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, Machinery Directive 2006/42/EC, Medical Devices Directive 93/42/EEC | Tagged , , , , , , , , , , , , , , | Leave a comment

Net Neutrality, what is it?

I have been hearing a lot about “net neutrality” lately but I did not really know what it means, probably the same as most people, so I decided to find out. Read on.

Basically, net neutrality means that no place on the internet can be accessed faster than any other place. That means that your internet service provider cannot arrange for one business’s web site to load faster than another. For example – if you perform a web search for motorcycles and come across www.harley-davidson.com and also www.indianmotorcycle.com they will both load, theoretically, at the same speed. Unless one or both of these companies pay for special placement using a “pay-per-click” ad program through Google they will be placed according to site rankings, determined mathematically using Googles algorithm. Neither company can pay Comcast, for example, to load their sites on your screen faster than the other (or other motorcycle manufacturer websites).

To understand why people are so involved in this issue, consider that a company like Comcast sells internet service and streaming cable TV service. You may be a customer of Comcast who is considering only using them as an internet service provider but buying your cable TV entertainment from Netflix. Without net neutrality it could be possible for Comcast to charge sites like Netflix (or Amazon Prime or Hulu) more to stream across their internet service — causing those companies to raise their rates. This could be considered unfair since Comcast competes directly with those companies through its Xfinity cable service.

You don’t watch Netflix, so… “so what?”. OK, what if you listen to a lot of music and you pay for Apple’s service, Apple Music, and your cable ISP decides to offer faster speed to either Apple Music or Sirius XM for whoever pays more? That will mean you will either pay more (because the cost will be passed right back to the customers) or your music downloads will be slower, deliberately.

Since the FCC is in charge of the “the internet” as a public utility it is within its jurisdiction. Net neutrality rules were passed in 2015 and presently they are under consideration for revision and or elimination.

The FCC is taking comments regarding this issue until August 3o, 2017.

The link to the comment page on the FCC site is here: FCC comment page link.

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 FCC | Tagged , , | Leave a comment