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Regulatory Issues

ISO Standards

The ISO (International Organization for Standardization) developed standards to coordinate efforts in developing standardized test methods for the biological evaluation of medical devices. The biocompatibility of a medical device is measured by the following biological effects:

ISO 13485

ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. Other specific differences include:

  • The promotion and awareness of regulatory requirements as a management responsibility. An example of market specific regulatory requirements is 21 CFR 820 Quality System Regulation for Medical Devices sold in the United States.
  • Controls in the work environment to ensure product safety
  • Focus on risk management activities and design transfer activities during product development
  • Specific requirements for inspection and traceability for implantable devices
  • Specific requirements for documentation and validation of processes for sterile medical devices
  • Specific requirements for verification of the effectiveness of corrective and preventive actions

ISO 10993

ISO 10993-1:2003 describes:

  • The general principles governing the biological evaluation of medical devices;
  • The categorization of devices based on the nature and duration of their contact with the body;
  • The selection of appropriate tests.
  • It does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure.
  • For details on ISO 10993, click here.


REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) was established in June of 2007 and applies to all chemicals imported or produced in the European Union. The program has a phased implementation plan spanning an eleven year period. The legislation was proposed for two reasons: protection of human health and protection of the environment. The program is also expected to increase competitiveness in the chemical industry through innovation. The initial stages of REACH have been implemented.

For further REACH facts, please visit the following websites:

European Chemical Industry Council
REACH Compliance


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