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IEC60601-1-2:Medical Testing & its Standars



 Iec60601-1-2:Medical Testing This standard is published by the International Electrotechnical Commission (IEC). It is the international standard for the basic safety and essential performance of medical electrical equipment and systems. The standard covers a wide range of devices, from simple blood pressure monitors to complex MRI scanners. It covers both stand-alone devices and devices that are part of a larger system, such as an x-ray machine connected to a PACS system. The standard includes requirements for the design, manufacture, testing, and labeling of medical electrical equipment and systems. It also includes guidance on the use of medical electrical equipment and systems. 

The standard is divided into two parts: 

Part 1: General Requirements 

Part 2: Particular Requirements The first part of the standard, 

Part 1, contains general requirements that apply to all medical electrical equipment and systems. These requirements cover aspects such as electrical safety, electromagnetic compatibility, and software safety. 

Part 2 of the standard contains particular requirements that are specific to certain types of medical electrical equipment and systems. For example, there are particular requirements for devices that use x-rays or magnetic fields, such as x-ray machines and MRI scanners. There are also particular requirements for devices that are used in life support, such as ventilators and defibrillators. The particular requirements in Part 2 of the standard supplement the general requirements in 

Part 1. They do not replace them. This standard is important for manufacturers of medical electrical equipment and systems, as well as for users of such equipment and systems. The standard helps to ensure the safety of patients, users, and operators of medical electrical equipment and systems. It also helps to ensure the compatibility of medical electrical equipment and systems with other equipment and systems in the healthcare environment. This standard is one of a series of standards that make up the IEC 60601 series.

 Other standards in this series include:

 IEC 60601-1-1: General Requirements for Safety IEC 60601-1-3: Collateral Standard: Usability IEC 60601-2-22: Particular Requirements for Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Surgical Equipment used in Maternal/Foetal Medicine

 IEC 60601-2-25: Particular Requirements for the Basic Safety and Essential Performance of X-Ray Equipment for Interventional Radiology, Fluoroscopy and Image Guided Surgery IEC 60601-2-34: Particular Requirements for the Safety of Electromagnetic Compatibility (EMC) of Medical Electrical Equipment and Systems IEC 60601-2-37: Particular Requirements for the Safety of Optical Radiation Emitting Medical Electrical Equipment This standard is available from the IEC website (www.iec.org). It is also available from national standards bodies that are members of the IEC.

The Standard medical electrical equipment must meet in order to be sold, this includes general requirements that apply to all medical electrical equipment and systems. Particular requirements that are specific to certain types of medical electrical equipment and systems such as x-ray machines, MRI scanners, devices used in life support, etc. 

The IEC 60601 series contains a number of standards that manufacturers must adhere to in order to sell their products. 

Other standards in the series include:

IEC 60601-1-1: General Requirements for Safety

IEC 60601-1-3: Collateral Standard: Usability


  • IEC 60601-2-22: Particular Requirements for Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Surgical Equipment used in Maternal/Foetal Medicine
  • IEC 60601-2-25: Particular Requirements for the Basic Safety and Essential Performance of X-Ray Equipment for Interventional Radiology, Fluoroscopy and Image Guided Surgery
  • IEC 60601-2-34: Particular Requirements for the Safety of Electromagnetic Compatibility (EMC) of Medical Electrical Equipment and Systems
  • IEC 60601-2-37: Particular Requirements for the Safety of Optical Radiation Emitting Medical Electrical Equipment

This standard is important for manufacturers of medical electrical equipment and systems, as well as for users of such equipment and systems. The standard helps to ensure the safety of patients, users, and operators of medical electrical equipment and systems. It also helps to ensure the compatibility of medical electrical equipment and systems with other equipment and systems in the healthcare environment. 

Ensuring that medical electrical equipment meets the requirements of the IEC 60601 series helps to protect patients, users, and operators from potential harm. It also helps to ensure that medical electrical equipment is compatible with other equipment in the healthcare environment, reducing the risk of errors and incidents.

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