The 2019 Quarter 2 issue of Updates to Standards includes articles on the following topics:

  • Chemical Storage
  • Medical Device Directive

Chemical Storage

As EHS auditors, it’s important for us to look at how our customers are storing their chemicals.   This applies to any quantity of chemical storage and can apply to any industry. 

Incompatible chemicals can produce violent and explosive reactions and/or can release toxic substances. 

Acids and bases are classified as Class 8 - Corrosive Substances, and they have the ability to damage other materials such as metal, stone and human flesh through complex chemical processes. 

Acids are substances that have a pH level less than 7 and taste sour. (BUT don’t try tasting it… just trust me.)  On the other hand, bases have a pH level greater 7 and taste bitter. (Again, don’t try tasting…) 

Most corrosive chemicals are either acids or bases, however there are other hazardous substances that also have corrosive properties as a sub-risk to their predominate hazardous property such as flammability.

Whenever acids and bases are stored in the workplace, it is very important to provide sufficient segregation between them. If acids and bases mix, it can result in violent neutralization reactions. 

For example; if a strong acid such as hydrochloric acid mixed with a strong base such as sodium hypochlorite, it would result in a violent chemical reaction that would produce a lot of heat and gas.

2HCl (aq) + NaClO(aq) → Cl2 (g) + H2O (l) + NaCl (aq) 

As you can see from the chemical formula, the mixing of these two acids and bases produces chlorine gas. Chlorine gas is very toxic, and if it is inhaled, it can cause acute chlorine gas poisoning. Chlorine gas poisoning symptoms include breathing difficulties, nose and throat irritation, nausea and headaches. 

During acid and base neutralization reactions, the production of gases causes the corrosive solution to splash. If the splashes from the solution come into contact with eyes or skin, it can easily result in acid burns and blindness.
To reduce the risk of acids and bases mixing, it is a good practice to store acids and bases in separate safety cabinets. If they cannot be stored in separate safety cabinets, acids and bases must be stored in separate compartments within the cabinet. These separate compartments must also have separate spill containment compounds.   
There are many different chemical compatibility charts f

loating around the internet to reference. Our auditors will check the chemical storage, but it is ultimately your responsibility to store them correctly in the first place. 

By: Candace Orbaugh, Sustainability Program Director 

Medical Device Directive 93/42/EEC

The Medical Device Directive 93/42/EEC (MDD) was established on June 14, 1998 and later amended on September 5, 2007.  This directive became mandatory on March 21, 2010.  The intent of the directive was to harmonize the regulatory requirements for medical devices with the European Union.

The amendment was necessary due to the continual advancements in technology within the medical device industry and development of international initiatives.  The Commission was made to constantly analyze the directives in order to ensure the protection of the patients.  This amendment also clarified which products were considered medical devices.  Currently medical devices under this directive are defined as any instrument, apparatus, appliance, software, material or other article intended by the manufacturer to be used for human beings in the purpose of:
Diagnosis, prevention, monitoring, treatment or alleviation of disease diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap investigation, replacement or modification of the anatomy or of a physiological process control of conception and which does achieve its principal intended action by pharmacological process, immunological or metabolic means but may be assisted in its function by such means.

Together with DQS Medizinprodukte GmbH (DQS Inc.’s holding), we are now preparing for the MDR transition.  In April 2019, DQS Inc. joined DQS Med in San Diego, CA to train our US staff and auditors to this new regulation.
DQS Inc. would like to extend a very special thank you to Mr. Mathias Notheis and Szymon Kurdyn of DQS Med for joining our medical auditors and staff in San Diego to train under the new regulations. 

Since the new European MDR began a 3-year transition period in May 2017, the deadline for transition will be May 26th, 2020.  

Europe’s new Medical Device Regulation (MDR) is expected to bring substantial changes to the way medical device manufacturers bring their devices to the European market, and will be required to maintain compliance throughout the product’s life cycle. The largest change with the transition includes products that were previously unregulated such as lab/research only applications, will now be required to be regulated as part of the IVDR. 
In celebration with five new MDSAP qualified auditors in the United States, we are looking forward to expanding our customer base and auditor qualifications in the near future.

By: Ashley Kelleher, Medical Device Program Manager

Sara Gulo

Sara Gulo is the Marketing Specialist for DQS Inc. in the USA. She's been with DQS for 10 years in various roles, including Verification and Customer Service Professional.