Medical Electrical Equipment Part 1 2 General Requirements For Safety Collateral Standards Electromagnetic Compatibility Requirements And Tests

Preface Development in the feld of medical technology has resulted in a manifold of medical devices enabling us to diagnose illnesses more reliably, treat them more effciently and compensate for handicaps more effectively. However, these improvements are also - sociated with safety risks. Today, patients are in contact with an increasing number of medical devices longer and more intensively then before. Applied parts are put into contact with the body, probes may be introduced into the body via natural or surgical orifces, and even whole devices may be implanted for many years. The application of devices is no longer restricted to medical locations only. Home use by lay people is increasing and involves even critical devices such as for dialysis, nerve and muscle stimulation and ventilation. In contrast to users’ patients are in a special situation. Their life could depend on the performance of a device, they might be unconscious, may have impaired reactions, or have been made insensitive to pain by medication, and hence they may be exposed to hazards without their awareness and protection by their own reaction. Therefore, medical devices must meet particularly stringent safety requirements. However, the question arises how safe is safe enough? The readiness to accept risks depends on a variety of accompanying circumstances. In fact, subjective risk p- ception varies among individuals and differs from country to country, and frequently only in rare cases it is in agreement with assessments of objective scientifc ana- ses.

Many of us in science have this "Aha!" moment when the mental puzzle is put together and you get a clear picture of a product, which will change the world. Moreover, you have a clear understanding of how it can be a commercial success. So, you decide to start a new company, a startup, and have a clear path to success. However, soon you come face to face with reality, where things are much more complicated. Only a minute fraction of startups survives and becomes successful. This is particularly true in the complex world of medical devices. There are many good books on startups but this book is specifically about startups specializing in medical devices, which are very different from other ones. It is written by a MedDev entrepreneur for first-time MedTech entrepreneurs.

This book gives a step-by-step approach to CE marking of electrical and electronic equipment including risk assessment. It covers, in detail, five important directives viz. low voltage directive (LVD), electromagnetic compatibility (EMC) directive, medical devices directive (MDD), radio equipment directive (RED) and the RoHS directive. It provides insights into product design and test methodologies especially EMC and product SAFETY so that the product meets the technical requirements of the applicable standards. It also seeks to clarify the many doubts and misconceptions about CE marking. The book begins with a chapter that introduces the reader to the nuances of the CE marking process, the conformity assessment modules and to compile supporting documents that illustrate the process. This is followed by the chapter on product safety which describes the principles of safety as found in the international IEC and European harmonized safety standards. It provides ways and means to improve product design so as to ensure reasonable compliance when a product is subject to safety evaluation by a test laboratory. Then, there are two chapters dedicated to EMC. One explains the EMC fundamentals, standards and the test methodology while the other deals with EMC design. The design chapter contains ways and means to incorporate EMC measures like line filters, shielding, grounding and cable routing at the design stage so that the product can comply with the EMC tests with a minimum of iterations. The design means discussed are very practical in nature and are given in such a way that the design engineer can immediately incorporate them without worrying too much about theory. All the directives now-a-days require a detailed risk assessment to be carried out in addition to testing as per standards. Thereafter the risk assessment needs to be documented so as to demonstrate how the risks have been reduced/eliminated. The book deals with the risk assessment in detail for all the directives under consideration. And last but not the least, the CE marking procedure is not complete unless the entire process is documented through the so-called technical file or technical documentation. The last chapter explains the compilation of technical documentation as required by the directives and the European surveillance authorities.

This document provides the comprehensive list of Chinese Industry Standards - Category: YY; YY/T; YYT.

The clauses and subclauses of this section of the General Standard apply.