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Industry Standards & Regulations

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  • Industry & Specialty Collections
  • Medical Devices Standards

Industry Standards & Regulations

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Medical Industry Collections

Medical industry standards from a variety of standards developing organizations (SDOs).

  • Overview
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  • Purchase
    Options
  • 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)
  • If you have multiple individuals and departments regularly accessing standards, then an online standards solution from IHS may be more cost effective for you.

    IHS Online Standards Solution

    The IHS online solution provides company-wide access to the standards you need from a collection of over 1.3 million standards documents. Whether you require documents from a single standards developing organization (SDO), multiple SDOs, segments and packages assembled by IHS content experts, or any combination in between, you can build your own standards library. The online standards management platform - IHS Standards Expert™ - furnishes you with the most comprehensive worldwide collection of industry specifications and standards.  Information is updated daily with easy, intuitive searching, navigation, and monitoring from any desktop.

    Custom Online Standards Collection

    If you need a collection of individual standards/documents, then the IHS custom standards collection works best for you. This option allows the greatest flexibility allowing you to pick and choose specific documents, whether they come from one or more SDOs. IHS does not require that you purchase a minimum number of documents to use this option. Your custom collection allows for multiple users at multiple locations to access the documents you have chosen.

    Individual Purchase

    All standards are also available for purchase as individual documents through the IHS Standards Store in PDF or hard copy formats. 

    Deposit Accounts

    Deposit accounts are a great way for a customer with online access to obtain the individual standards they need. Using a deposit account, an online customer can obtain PDF and hard copy documents outside of their online subscription. For the hard copy customer, this is perfect way to control purchasing and reduce paperwork. Most documents and publications purchased through a deposit account received a 10% discount from the regular price. To create your deposit account, simply download this pdf, fill it out and return it to the address noted on the form. A minimum $500 (US) is required to set up your deposit account.

    If you have questions or wish to set up your account by phone, please call +1 800 854-7179, ext 3

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