The world would be chaotic were it not for standards that allow the industrial community to simplify commerce. Standards promulgate a common language that promotes the flow of goods between buyer and seller and aids the common man by improving safety and safeguarding health. Some simple examples are; the use of nuts and bolts in both the metric or SI systems; a 92 octane gasoline that meets specific combustion ‘standards’ and state and federal regulations require that gasoline meet these standards so the consumer knows what he/she is pumping into their gas tanks; plugs (e.g. serial, parallel, RF) for connecting peripheral components to computers are all uniform worldwide for every type, make, and manufacturer of computers; medical devices are tested using standardized test methods so that performance specifications can be developed, and these same tests can be used to test the efficacy of similar or competing devices.  Standards create order where there is disorder.  In short, “buildings stand, planes fly, paint adheres, chairs support, and clothes fit because each is made to order by technical standards for materials, design, and performance”.

Complying with Standards
Generally speaking, most standards are used on a voluntary basis. That is, their use is based on some economic, competitive or commercial incentive that can be derived by using the standard. So, how do standards become incorporated into Directives and laws?  When a regulatory body such as the European Union (EU), Food and Drug Administration (FDA), Department of Transportation (DOT), develop regulations and reference standards that a product or process must conform to, it has essentially made the standard part of the law or Directive. Since the government is not in the business of developing products and performance specifications, it must rely on the private sector to develop the standards by which it will ensure fair competition, and safety of the public.  In the medical device industry the Federal Food, Drug, and Cosmetic Act was enacted to eliminate misbranding of medical devices. Through subsequent legislation (Medical Device Amendments – MDA, Safe Medical Device Act-SMDA) the laws provided the FDA with significant additional authority concerning the regulation of medical devices.  These laws were then the frame work for the issuance of more detailed regulations that would require specific requirements for compliance to the Law.  Likewise, the European Union with the adoption of the Common Market developed ‘Directives’ to which all entities interacting with the EU would be compelled to comply. For the medical device industry the Directive is the ‘Medical Device Directive”.

Of course, every industry has its own laws and directives that make commerce fair and safe. DOT regulates the transport of dangerous goods in the U.S., while the EU regulates the transport of dangerous goods by its joint regulations found in the Carriage of Dangerous Goods by Road (ADR), Carriage of Dangerous Goods by Rail (RID), Carriage of Dangerous Goods by Waterway (AND); Laws for environmental protection and packaging waste come from the Environmental Protection Agency (EPA), and in the EU are based on the “Packaging and Packaging Waste Directive”.

In the U.S., laws are developed through legislation and are vague mandates. The Agency then writes regulations interpreting as to how the law will be enforced.  Directives are legislative instruments developed by member states that replace individual national regulations and obligate member states to introduce them into their own laws.  Once compliance with all applicable Directives has been verified for a product, that product can be legally placed on the market of any EU member country 2.  The details of complying with the laws/directives are commonly incorporated in standards which the regulatory agency references in their documents. These standards may be specifications and test methods written by ASTM International or ISO (to name the two most common). These two are the most common because they are consensus organizations and they develop the most technically sound and credible standards.