SonoSite
- About Sonosite
- Product Line
- M-Turbo™
M-Turbo™
Ideal for broader applications, this versatile powerhouse with brilliant image quality can help you perform anything from abdominal to vascular, to cardiac exams with speed and accuracy.
- S Series™
S Series™
For situations where you need a streamlined device with fewer buttons, bells and whistles, amazingly clear image quality and a fast, easy way to transport patient data.
- M-OB/GYN Office™
M-OB/GYN Office
More specialized ultrasound = more focused medicine. We engineered the M-OB/GYN office ultrasound tool to be just what you need in a point-of-care system.
- MicroMaxx®
MicroMaxx®
A laptop-sized, durable unit representing the technology crossover point between hand-carried ultrasound and larger, high-performance, cart-based systems.
- More Products
More Products
SonoSite software and previous generations.
- Trade In, Trade Up
- M-Turbo™
- Resources
- globe
The SonoSite Regulatory & Compliance web pages provide SonoSite customers information on key elements of medical device compliance.
Regulatory Compliance
Regulatory & Compliance / Quality Assurance / Additional Standards
Harmonized Standards
European harmonized standards with which each SonoSite СЄ marked product complies are listed below.
| REFERENCE NO. | TITLE |
|
EN 540 |
Clinical investigation of medical devices for human subjects (1993) |
|
EN 980 A1 |
Graphical symbols for use in the labeling of medical devices (2003) |
|
EN 1041 |
Information supplied by the manufacturer with medical devices (1998) |
|
EN ISO 13485 |
Medical devices / Quality management systems / Requirements for regulatory purposes (2003) |
|
EN ISO 14971 |
Medical devices / Application of risk management to medical devices (2000) (ISO 14971:2000) (Superseded standard: EN 1441) |
|
EN ISO 10993-1 |
Biological evaluation of medical devices - Part 1: Evaluation and testing (1997) (ISO 10993-1:1997) |
|
EN 60601-1 |
Medical electrical equipment. Part 1: General requirements for safety - IEC 601-1:1988 |
|
EN 60601-1 Amendment A1 |
Medical electrical equipment. Part 1: General requirements for safety - IEC 601-1:1988/A1:1991 |
|
EN 60601-1 Amendment A2 |
Medical electrical equipment. Part 1: General requirements for safety - IEC 601-1:1988/A2:1995 + corrigendum June 1995 |
|
EN 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) |
|
EN 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) |
|
EN 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) |
Non-Harmonized Standards
The following are other standards with which each SonoSite СЄ marked product complies.
| REFERENCE NO. | TITLE |
|
- |
Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (AIUM), 1994 |
|
ANSI/AAMI EC53:1995 |
ECG Cables and Electrodes except for sections 4.4 and 4.5.9 |
|
ASTM D5276-98 |
Standard Test Methods for Drop Test of Loaded Containers by Free Fall |
|
ASTM D999-96 |
Standard Methods for Vibration Testing of Shipping Containers |
|
CEI/IEC 61157:1992 |
International Electrotechnical Commission, Requirements for the Declaration of the Acoustic Output of Medical Diagnostic Ultrasonic Equipment |
|
D00017 |
Quality System Manual (SonoSite) |
|
EN 60529 |
Degrees of protection provided by enclosures (IP Code) (1991 |
|
ISO 9001:2000 |
Quality management systems -- Requirements International Organization for Standardization (2000) |
|
ISO 13485:2003 |
Quality Systems / Model for quality assurance in design, development, production, installation and servicing |
|
JIS T 0601-1 |
Medical Electrical Equipment / Part 1: General Requirements for Safety (Japan) (1999) |
|
JIS T 1507 |
Electronic Linear Scanning Ultrasonic Diagnostic Equipment (Japan) (1989) |
|
NEMA UD 2-2004 |
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment |
|
NEMA UD 3-2004
|
Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine |
|
NO.169:2004 |
Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-vitro Diagnostic Reagents (2004) (Japan) |
|
RTCA/DO160D:1997 |
Radio Technical Commission for Aeronautics, Environmental Conditions and Test Procedures for Airborne Equipment, Section 21.0 Emission of Radio Frequency Energy, Category B |
|
Title 21 CFR Part 820 |
Quality System Regulation / Medical Devices: Current Good Manufacturing Practice (CGMP); Final Rule |
|
UL 60601-1 |
Underwriters Laboratories, Medical Electrical Equipment-Part 1: General Requirements for Safety (2003) |
|
ACR-NEMA DICOM version 3.0 - 2003 |
Digital Imaging and Communications in Medicine |