applied part definition iec
Preferred terms are the primary terms for a given concept. The preferred term is the form which is used throughout the main body of the text. They are written in bold type (with the exception of symbols, which shall be presented as used in running text). Introduction to Applied Part (AP) Type B, BF & C. DATE: 2015/04/19. Applied Parts (AP) is a part of Medical. Electrical Equipment that in normal use. necessarily comes into physical contact with the. patient for Medical Electrical Equipment or a. Medical Electrical System to perform its. Applied Part: Type B, BF or CF. IEC 60601-1 uses the term applied part to refer to the part of the medical device which come into physical contact with the patient in order for the device to carry out its intended function. Applied parts are classified as Type B, Type BF or Type CF according to the nature of the device and the type of contact. WHAT IS IEC 60601-1. IEC 60601 is a series of technical standards. for the safety and effectiveness of medical. electrical equipment. The primary standard governing medical device. design is IEC 60601-1 (medical electrical equipment. - Part 1: general requirements for basic safety and. essential performance). •Major IEC 60601-1 3rd Ed. FDA has announced an official date of 2010-06 when they will accept submissions to 3 rd edition. The EU date of 2012-06-01 has been published in the Official Journal. CB Scheme mandatory use for 3 rd edition varies per the policy of each member country. However, only the part of. these “medical devices” that may come in. contact with a patient during normal operation is. classified as an “Applied Part.”. It is the responsibility of the medical product. manufacturer to determine the classification of. AP types (B/BF/CF) in the final product with. proper evaluation. Introductory wording. If all the specific terms and definitions are provided in Clause 3, use the following introductory text: For the purposes of this document, the following terms and definitions apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: Terminology may take the form of an independent terminology standard (a vocabulary, nomenclature, or list of equivalent terms in different languages) or be included in a Terms and definitions clause in a document that also deals with other aspects. IEC 60601-1 Definition of Patient Applied Parts. This article reviews the IEC 60601-1 definition of patient applied parts for medical electrical equipment. It includes examples, as well. 2nd 3rd optional. FDA has announced an official date of 2010-06 when they will accept submissions to 3 rd edition. The 3 rd Edition will be Mandatory 2013-06-01. Health Canada has announced a mandatory date of 2012-06-01. The EU date of 2012-06-01 has been published in the Official Journal.
IEC 60601-1 uses the term applied part to refer to the part of the medical device which come into physical contact with the patient in order for the device to carry out its intended function.