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Standards and Regulations

 

Standards

A technical standard is an established norm or requirement in regard to technical systems. It is usually a formal document that establishes uniform engineering or technical criteria, methods, processes and practices. In contrast, a custom, convention, company product, corporate standard, etc. that becomes generally accepted and dominant is often called a de facto standard.


A technical standard can also be a controlled artifact or similar formal means used for calibration. Reference Standards and certified reference materials have an assigned value by direct comparison with a reference base. A primary standard is usually under the jurisdiction of a national standards body. Secondary, tertiary, check standards and standard materials may be used for reference in a metrology system.


A technical standard may be developed privately or unilaterally, for example by a corporation, regulatory body, military, etc. Standards can also be developed by groups such as trade unions, and trade associations. Standards organizations often have more diverse input and usually develop voluntary standards: these might become mandatory if adopted by a government, business contract, etc.

Regulations

A regulation is a legal norm intended to shape conduct that is a byproduct of imperfection. A regulation may be used to prescribe or proscribe conduct ("command-and-control" regulation), to calibrate incentives ("incentive" regulation), or to change preferences ("preferences shaping" regulation").


In general, regulations are written by executive agencies as a way to enforce laws passed by the legislature. Because of the actual or potential interference in choices, the idea of regulation and most issues related to regulation tend to be in controversy.

What are the differences between Standards and Regulations?

What are the differences between Standards and Regulations?
 
Standards 
Regulations

  • Recommendations
  • Use is voluntary
  • Available to the public
  • Established by consensus of all parties concerned
  • Based on consolidated results of science, technology and experience
  • Approved and published by recognized standardization body
  • Legislation
  • Use is mandatory
  • Available to the public
  • Developed by an authority under public observation
  • Provide technical specifications either directly or by reference, e.g. to standards
  • Adopted by an authority

Medical Equipment Standards

Medical equipment are regulated through many and different locally and internationally agencies, organizations and governments such as but not limited to:

Safety Standards Organizations

A number of standards organizations exist that promulgate safety standards. These may be voluntary organizations or government agencies. These agencies first define the safety standards, which they publish in the form of codes. They are also Accreditation Bodies and entitle independent third parties such as testing and certification agencies to inspect and ensure compliance to the standards they defined. For instance, the American Society of Mechanical Engineers (ASME) formulated a certain number of safety standards in its Boiler and Pressure Vessel Code (BPVC) and accredited TÜV Rheinland to provide certification services to guarantee product compliance to the defined safety regulations.[4]


United States
American National Standards Institute

A major American standards organization is the American National Standards Institute (ANSI). Usually, members of a particular industry will voluntarily form a committee to study safety issues and propose standards. Those standards are then recommended to ANSI, which reviews and adopts them. Many government regulations require that products sold or used must comply with a particular ANSI standard.


Government agencies

Many government agencies set safety standards for matters under their jurisdiction, such as:


Testing laboratories

Product safety testing, for the United States, is largely controlled by the Consumer Product Safety Commission. In addition, workplace related products come under the jurisdiction of the Occupational Safety and Health Administration (OSHA), which certifies independent testing companies as Nationally Recognized Testing Laboratories (NRTL), see.[5]


European Union
Institutions

Testing laboratories

The European Commission provides the legal framework, but the different Member States may authorize test laboratories to carry out safety testing.


Other countries
Standards institutions

Te
sting laboratories
Many countries have national organizations that have accreditation to test and/or submit test reports for safety certification. These are typically referred to as a Notified or Competent Body. "wikipedia"

Postmarket Surveillance for Medical Devices

Postmarket surveillance is the systematic

  • Collection,
  • Analysis,
  • Interpretation, and
  • Dissemination

Of health-related data to
  • Improve public health and
  • Reduce morbidity and mortality