Medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
Medical device which is operated by electrical energy is included in active medical device. For medical devices every region and/or countries have conformity assessment procedures and only when the device fulfills regulatory requirements it can be placed on the market.
In case of medical device, test of product is included in the conformity assessment procedure and through the test manufacturer verify that products are fulfilling the requirements of international standards or national standards.
For the test, we use standards which are published by region or country. ISO and IEC are international standard and EN is European Standard. Korea, Japan and China have their own national standards such as KS, JIS and GB
|International Standard||IEC||ISO||IEC, ISO Standards|
|Regional Standard||CENELEC||CEN||EN Standards|
|National Standard||MFDS||Standard and specification of MFDS|
|Association Standard||Specific Association||ex) NEMA|
Main standards which are applied to medical electrical equipment and correlation of these standards are as follows.
Publication status of IEC 60601-1 standard is as follow
|Standard No||Title of the standard|
|IEC 601-1:1977 Ed1.0||Safety of medical electrical equipment - Part 1: General requirements|
|IEC 60601-1:1988 Ed2.0||Medical electrical equipment - Part 1: General requirements for safety
Amendment 1: 1991
Amendment 2: 1995
|IEC 60601-1:2005 Ed3.0||Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Amendment 1: 2012
|IEC 60601-1:2012 Ed3.1||Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1: 2005 + Amendment 1: 2012
Required documents for the testing of medical electrical equipment and conformity assessment procedures are as following steps.
|Manual, Marking||Accompaning document, Markings|
|Software validation||Software Documents (PEMS)|
|Risk management||Risk Management files|