Staying Connected - August 2013

RoHS and REACH Considerations for Medical Cable Assemblies

The majority of medical device makers for which Affinity manufactures cable assemblies, operate globally and ship products into European Union member countries.  Because of this, most of the products that Affinity manufactures are, or will be, required to comply with RoHS and REACH directives.



There is no standard logo
to show RoHS compliance

RoHS – Restriction of Hazardous
Substances Directive

Adopted in February 2003 by the European Union, Directive 2002/95/EC (Restriction of Hazardous Substances Directive) took effect on July 1st, 2006.  The directive restricts the use of six hazardous materials in the manufacture of electronic and electrical equipment.  Medical devices were excluded from the original RoHS directive.  In 2011, the European Union adopted “RoHS Recast” which eliminates the exemption for most medical devices in July 2014.

RoHS Restricted Substances

Compared to REACH, which is discussed later, the RoHS directive is relatively simple and only restricts the use of six specific substances:

  • Lead (Pb)
  • Mercury (Hg)
  • Cadmium (Cd)
  • Hexavalent chromium (Cr6+)
  • Polybrominated biphenyls (PBB)
  • Polybrominated diphenyl ether (PBDE)

PBB and PBDE are often referred to as brominated flame retardants (BFR).  These substances are commonly used as flame retardants for plastic materials.

Maximum Concentrations

For RoHS compliance, the maximum permitted concentration of listed substances is 0.1% or 1,000 parts per million for all but cadmium.  For cadmium, the maximum permitted concentration is 0.01% or 100 parts per million.  The restriction is for any “homogeneous material,” meaning any substance that can even theoretically be separated.

RoHS requires that every component that can be identified as a homogeneous material must be below the maximum concentration.  As an example, if a device includes a solder connection and the solder contains more than 0.1% of lead, the entire device would be considered non-compliant under the RoHS directive.

Lead

The first restriction often thought of in relation to RoHS is the restriction on the use of lead.  Lead has been a common substance used in the manufacture of electronic and electrical devices, both in electronic components and in solder.


A typical symbol that designates
a product as lead-free


Except where customers specify
leaded solder, Affinity transitioned to
lead-free solder in 2008

Excluding products where the customer continues to specify leaded solder, Affinity transitioned to lead-free solder in early 2008.  “Except for a much higher cost, we don’t see a difference in manufacturing with lead-free solder,” said Affinity Manager of Manufacturing, Kevin Kom.  “Ongoing solder training to IPC 610 and 620 for all of our manufacturing associates has been done with lead-free solder for the past five years.”

Cadmium

Copper alloy conductors are often used for cable applications where greater flex life or tensile strength is required.  To increase performance a small amount of cadmium has been commonly used with copper and other substances. While the amount of cadmium in these alloys was typically about 1%, that is far in excess of the .01% permitted to be RoHS compliant.

RoHS compliant copper alloys have become available with various combinations of beryllium, tin, phosphorus, chromium, and iron which offer nearly the same performance as non-compliant alloys that contained cadmium.

Brominated Flame Retardants (BFR)

Brominated flame retardants are prohibited by RoHS and are typically not a concern for medical cables.  The addition of flame retardants typically causes the cable jacket to fail biocompatibility and cytotoxicity requirements.  Because of this, the resins used by Affinity for medical cable jackets and for over molding do not typically include flame retardants.

REACH - Registration, Evaluation, Authorization and Restriction of Chemicals


REACH - was approved by the European Parliament on December 13 2006 and was formally adopted shortly thereafter.  It became effective June 1, 2007 with implementation scheduled to be phased in over eleven years.

One of the major elements of REACH is the requirement to communicate information on chemicals up and down the supply chain. This helps ensure that manufacturers, importers and also their customers have access to information relating to health and safety of the products supplied.  Using potentially toxic substances (such as phthalates or brominated flame retardants) is deemed undesirable and REACH will force the use of certain of these substances to be phased out.



The flag of the European Union

Headquartered in Helsinki, Finland, the European Chemicals Agency (ECHA) was founded in 2007.   The Agency manages the technical, scientific and administrative aspects of REACH.  It manages the databases necessary to operate the system, co-ordinates the evaluation of chemicals and offers a searchable public database of chemical substances.

The Agency has set three major deadlines for the registration of chemicals. In general the registration deadline is determined by the amount of the substance manufactured or imported by a company or individual.

Quantity Registration Deadline
1,000 tons or more per year December 1, 2010
100 tons or more per year June 1, 2013
1 ton or more per year June 1, 2018

Because of the potential negative impact on human health or the environment, REACH also addresses the use of “substances of very high concern” (SVHC).  Beginning June 1, 2011, the European Chemicals Agency must be notified of the presence of SVHC substances in articles if the total quantity used or imported is more than one ton per year and the amount of the substance is greater than 0.1% of the weight of the article.

Bis(2-ethylhexyl) phthalate - DEHP

Un-plasticized polyvinyl chloride (PVC) is hard and brittle at room temperature.  DEHP is the most commonly used plasticizer added to increase the flexibility PVC.  It is also referred to as a phthalate.  Medical devices that may contain DEHP-plasticized PVC include: bags, tubing, catheters, and, some medical cables.

PVC is one of the materials commonly used as a jacket for lower cost medical cables and leadwires.  PVC is not as durable as thermoplastic rubbers or urethanes and is often used for limited use cables or disposable leadwires.

Medical grade PVC resins are available that do not contain DEHP and that meet both RoHS and REACH requirements.  As our OEM partners update their specifications, Affinity is transitioning components that previously contained DEHP to RoHS and REACH compliant materials.


The European Chemicals Agency
advances the safe use of chemicals


Substances of Very High Concern – SVHC

As of June, 2013, the list of SVHCs contained 144 “candidate” substances.  Manufacturers or importers of articles containing more than 0.1% by weight of any listed item must provide their customers adequate information on the safe use and disposal of the substance or article which contains the substance.  Beginning June 1, 2011, manufacturers and importers also had to notify the European Chemicals Agency of the quantities of SVHCs used in their articles.

The list is referred to as the "candidate" list because all substances placed on it are candidates for inclusion in Annex XIV of REACH. If a substance is added to Annex XIV, it is given a "latest application date" and a "sunset date".  The sunset date is the date after which the substance cannot be used or imported into the EU without specific authorization from the ECHA.



As a global company, the Molex website
provides environmental compliance
information and guidance

The cable assemblies, connectors and interfaces produced by Affinity are designed and manufactured to the specifications of our OEM customers.  Because of this, Affinity does not share RoHS or REACH compliance information regarding those products except with the OEMs that products are manufactured for.

Affinity’s parent, Molex, offers products for sale worldwide.  To obtain product-specific environmental compliance information concerning Molex products visit www.molex.com or contact ProductCompliance@molex.com.  To view the Molex REACH position statement, please visit: http://www.molex.com/images/about/MolexREACH.pdf.

Summary

For device manufactures operating globally, complying with RoHS and REACH is a necessity.  If your current cables to not meet these requirements, the Affinity engineering team would be happy to offer a compliant alternative.  For additional information, please contact us at +1 949-477-9495 or via email to customercare2@affinitymedical.com.

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Meet Araceli Soto – Material Handler


Araceli Soto, Material Handler


Araceli joined the Affinity team about 3 ½ years ago starting in production.  Her uncle, who did contract work for Affinity, heard that the company was hiring and suggested that Araceli apply.  Not only did Araceli apply, but here sister Susana did too and they both were hired.

Starting in work cell seven, Araceli worked in production for about a year before moving into the warehouse as a material handler.  “I am good at multi-tasking so I like the pace of working in the warehouse,” said Araceli.  “I am also detail oriented which is really important for labeling.  Because we manufacture medical products, we cannot have even a single labeling mistake.”

Asked what she likes about her job and working at Affinity Araceli commented, “I really like the people that I work with.  The company really cares about the employees and I feel that I have the opportunity to learn new things and grow.”



Araceli (right) discussing materials
issue with her supervisor, Sue Alessi

Araceli lives with her family in Riverside County, more than 50 miles away.  “We have a small ranch with horses and chickens.  It takes about 45 minutes to get to work in the morning and often an hour and a half to get home.  I like it that we start work at 5:00 A.M. Traffic would be much worse if we started later.  My mother started working at Affinity about two years ago so the three of us – my mother, sister and me – drive together.  We have someone to talk with during the ride and we take turns driving which makes our long commute easier.”

Talking about her job, Araceli said, “The main thing that I do is labeling and kitting orders.  I pull the raw materials and components to kit more than 15 orders a day.  This is a job that has to be done accurately or the work cell won’t be able to build our products.  Often while I am kitting one order I get interrupted because a work cell has damaged a component and needs a replacement in order to continue manufacturing.  I not only have to pull the additional component, but also make sure that all of our paperwork is accurate and in order.”

Asked about what she would like to do in the future, Araceli said, “I like my job and want to stay with Affinity.  I would like to move into purchasing someday.”

When not working, Araceli like so shop and watch documentaries.  She says she is really into the Hunger Games trilogy.  She also likes to travel and try new things.

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X-Ray Vision



Affinity’s new X-Scope 2000 X-ray system

Affinity engineers now have “x-ray vision” thanks to the acquisition of a new Scienscope X-Scope 2000 X-Ray Inspection System.

The X-Scope 2000 is a high resolution, fully programmable x-ray system.  Affinity will use the system for research and development, nondestructive testing and failure analysis.

The system features a 90 kV x-ray tube with 5-micron focal-spot size that offers excellent resolution and magnification up to 125X.  Kilovolt and milliamp settings are computer controlled and programmable.  The system also features a variable-speed X-Y table that can be tilted up to 75 degrees for optimum imaging of parts.


Affinity lab tech, David Moreno and
Staff Engineer, Jon Covach inspect
terminations in overmolded cable


High resolution X-Ray Image
from new Affinity system

“We have wanted the ability to accurately do non-destructive analysis of cables and connectors,” said Affinity engineer Doug McLaughlin.  “The X-Scope 2000 gives us that ability.  When we receive a return from a customer we need to determine if the cable failed due to normal wear-and-tear or if there was a material or manufacturing issue.  The new X-ray system will allow us to do our investigation faster and more accurately.”

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Announcements, Information and Trivia



St Andrews is often
considered the first
golf course
!


The term caddie
comes from the
French word cadet

Golf Trivia

Dimples – British golf balls have 330 dimples while U.S. golf balls have 336.

Most Courses per Person – Scotland has one golf course for every 9,400 persons, giving it the distinction of the country with the highest number of courses per capita!

Oldest Golf Course – Guinness Book of Records lists Scotland’s Musselburgh Links as being the oldest golf course in the world, being played as early as 1567.

India – The first golf course outside of The United Kingdom was built in Bangalore India in 1820.

Caddie – The golf term “caddie” derives from the French word “le cadet.”  The term used in golf is attributed to Mary Queen of Scots use of French Cadets to carry her golf clubs.

Japan – The longest hole in the world is a par 7 at the Sano Course at Satsuki Golf Club in Japan measuring 909 yards.

Hole-in-One – The first ever recorded hole-in-one was made by Tom Morris in 1868 during the Open Championship in Prestwick, Scotland.