Regulatory and Compliance

Quality Assurance

SonoSite’s quality vision is simple:
Our job is to anticipate and meet our customers’ requirements through continuous
improvement in every aspect of our business practices.
  • The quality assurance management system that supports the design, development, manufacture, testing and release of SonoSite products is comprehensive, robust and meets the requirements of both regulatory agencies and customers.
  • SonoSite products are designed and manufactured in accordance with established United States FDAi quality system regulations (21 CFR 820) and other international quality system standards including ISOi 13485:2003 and ISO 9001-2000.
  • SonoSite product designs are verified and validated and meet design input requirements and specifications, intended uses, and user needs.
  • The materials used to manufacture SonoSite products meet the requirements of the quality system acceptance activities (inspection and test).
  • Delivered SonoSite products meet the requirements of the quality system acceptance activities (inspection and test).
 
Harmonized Standards

European harmonized standards that each SonoSite-marked product complies with are listed below.

Reference No. Title
980 Graphical symbols for use in the labeling of medical devices (2008)
1041 Information supplied by the manufacturer with medical devices (2008)
ISO 13485 Medical devices / Quality management systems / Requirements for regulatory purposes (2003)
ISO 14971 Medical devices / Application of risk management to medical devices (2007) (ISO 14971:2007) (Superseded standard: EN 1441)
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1 series)
60601-1 A1-A2 Medical electrical equipment. Part 1: General requirements for safety - IEC 601-1:1988/A1:1991/A2:1995 + corrigendum June 1995
60601-1-4 Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems (IEC 60601-1-4 Ed. 1.1 b:2000)
ISO 11135 series Sterilization of Health Care Products (Ethylene Oxide)
ISO 11137 series Sterilization of Health Care Products (Radiation)
60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment (IEC 60601-2-18 Ed. 3.0 b:2009)
60601-2-22 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment (IEC 60601-2-22 Ed. 3.0 b:2007)
60601-2-25 Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographs (IEC 60601-2-25 Ed. 1.0 b:1993)
60601-2-27 Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment (IEC 60601-2-27 Ed. 2.0 b:2005)
60601-1-1 Medical electrical equipment. Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems (2001) (IEC 601-1-1:2001)
60601-1-2 Medical electrical equipment / Part 1: General requirements for safety; 2. collateral standard: electromagnetic compatibility; requirements and tests (2001) (IEC 60601-1-2:2001)
60601-2-37 Medical electrical equipment -- Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (2001) (IEC 60601-2-37:2001)