The primary standard the primary standard governing medical device design is formally known as iec 60601 1 medical electrical equipment part 1. Annex cc informative the ctdi100 concept in iec 60601244. This particular standard establishes requirements to be complied with by manufacturers in the design and construction of electron accelerators for use in radiotherapy. This is accomplished by defining alarm categories priorities by degree of urgency, consistent alarm signals and. Collateral standard iec 60601 1x x representing a collateral. It is already acceptable to use the standard in some markets, and many. The primary standard governing medical device design is formally known as iec 606011. The evaluation package is a summary of the iec 60601 1. Based on these considerations ctdi100 and the ctdifree air have. The new philosophy of the 3rd edition september 2010 intertek 70 codman hill road boxborough, ma. This document cancels and replaces the first edition of iec 60601, published in 1994 which replaced iec 407 issued in 1973. Iec 606011 medical design standards for power supplies cui inc. Missing page numbers correspond to the frenchlanguage pages.
We have produced our free guide to iec 60601 as a guideline for people involved in testing medical devices, an important part of keeping people safe. Particular requirements for the basic safety and essential performance of nerve and muscle stimulators iec 60601210. A laser product may consist of a single laser with or without a separate power supply or may incorporate one or more lasers in a complex optical, electrical, or mechanical system. Iec 60601 is a series of technical standards for the safety and effectiveness of medical electrical equipment. It also includes information and interpretations for the clause requirements, as applicable. New medical emc standard iec 6060112 4th edition globtek. First published in 1977 and regularly updated and restructured, as of 2011 it consists of a general standard, about 10 collateral standards, and about 80 particular standards. Plan now to ensure your medical devices comply with new emc requirements by the december 2018 effective date. The evaluation package is a summary of the iec 606011.
The iec 60601 was first published in 1977, then referred to as iec 601, and handles the electrical safety of both mechanical and electrical issues. European union eu the latest edition is now listed in the eu official journal as en 6060112. After that date, they will only recognize docs which show testing according to the iec 6060112 edition 4. Important changes need to know iec 6060112 applies to the electromagnetic compatibility emc of electrical medical equipment.
Changes from 2nd to 3rd edition 8 while the 3rd edition of iec 606011 now includes ep requirements, the manufacturers ep requirements may vary from the standards, depending on the proposed use of the. Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. Requirements for the development of physiologic closedloop controllers. The contents of the corrigendum of july 2014 have been included in this copy. Iec 60601 1 and iec 60601 2, each builtup from a number of basic or collateral standards.
The date of cessation of presumption of conformity of the. The international electrotechnical commission iec is charged with international standards for electric rotating machines, i. Representatives from some 45 national iec committees ncs, including 15 countries with observer status, work together on the development of motor standards in the technical committee 2 tc2. General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. Iec 6060118 constitutes a collateral standard to iec 606011. These are all part of the concerns for risk and safety with medical devices in the third edition of iec 606011. General requirements for basic safety and essential performance, has just had interpretation sheet 3 released. When the manufacturer analyzes the risks of the environment and its device per iec 606011 third edition, it must assess the impact of wireless interference or crosstalk on the safety and essential performance of its device. Iec 606011 2 nd edition published in 1988 is being replaced by. This edition has been restructured and aligned to iec 6060112005 and focussed on general requirements for radiation protection that apply to all diagnostic xray equipment.
Annex d informative guidance in the application of iec 6060112. Welcome to rigel medical, weve been pioneers of biomedical testing and measurement equipment for over 37 years. The interpretation sheet is available from document center inc. Hf surgical equipment having a rated output power not exceeding 50 w for example for microcoagulation, or for use in dentistry or ophthalmology is exempt from certain of the requirements of this particular standard. The international electrotechnical commission iec is an international body that issues standards on a wide range of electronicsrelated topics.
Iec 608251 is applicable to safety of laser products emitting laser radiation in the wavelength range 180 nm to 1 mm. Standard format for iec standards learning from motor. Electromagnetic disturbances requirements and tests. The iec 606011 standard defines electromedical products as equipment provided with no more than one connection to a particular supply mains and intended to diagnose, treat or monitor the patient under medical supervision, and which makes physical or electrical contact with the patient andor transfers energy to or from the patient andor detects such energy transfer to or from. Iec 60601 is a series of technical standards that ensure the safety and effectiveness of medical electrical equipment. General requirements for basic safety and essential performance collateral standard.
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