Medical Industry Collections

The Medical Industry Collections contain vital data for manufacturers of medical devices and products.

Standards and EU Directive referenced standards are available in the collections from:

• Association for the Advancement of Medical Instrumentation (AAMI)
  • Biological
  • Dialysis
  • Sterilization
  • General collection
• ASTM International (ASTM)
  • Medical devices and services
  • General methods & instrumentation
  • Device standards library
• International Electrotechnical Commission (IEC)
  • Medical equipment standards
  • Devices standards library
• International Organization for Standardization (ISO)
  • Medical/consumer goods
  • Medical standards
  • Medical device standards
• EU Directives; referenced harmonized European standards
  • Medical devices based on EU Directive 93/42/EEC
  • Medical devices - active implantable based on EU Directive 90/385/EEC
  • Medical devices - in vitro diagnostic based on EU Directive 98/79/EC
  • Combined collections contain MD23 & MD123
  • Medical devices - low voltage equipment based on EU Directive 2006/95/EC
  • Electromagnetic compatibility based on EU Directive 2004/108/EC

In the EU, medical products are regulated by the three medical directives. US companies that sell medical products to the EU must provide the presumption of conformity with the directive's essential requirements and are subject to conformity assessment audits. All medical products sold in the EU must have the CE Mark affixed to demonstrate compliance to the directives. It is essential for companies doing business in the EU to have access to the harmonized European Standards that provide the presumption of conformity with the essential requirements of the EU Directives.

Related standards from other developing organizations

• American Society of Mechanical Engineers (ASME)
• American Society for Quality (ASQ)
• Canadian Standards Association (CSA)
• The Institute of Electrical and Electronics Engineers, Inc. (IEEE)
• Association Connecting Electronics Industries (IPC)
• Japanese Standards Association (JSA)
• National Electrical Manufacturers Association (NEMA)
• Society of Automotive Engineers (SAE)
• Underwriter's Laboratories, Inc. (UL)