AAMI CR500 pdf free download

AAMI CR500 pdf free download.Basic Introduction to the IEC 60601 Series.
1.2 The general standard The general standard specifies the scope and purpose of the IEC 60601 series and provides definitions of key terms. It also provides general requirements for mitigating a wide range of hazardous situations arising from the design and use of electromedical (electrical medical) equipment and systems, including mechanical, electrical, biocompatibility, human factors, and software design aspects as well as exposure to environmental influences such as mechanical shock and vibration, chemicals, water, and dust. The general standard specifies both constructional and performance requirements deemed necessary for basic safety and essential performance. In many cases, test methods or references to test methods in other standards are prescribed to verify the effectiveness of the specified mitigations. Table 1 lists the clauses of the general standard, IEC 60601-1. A review of the table provides an indication of the breadth of the standard. Clauses 1 through 7 establish the basic framework of the standard, whereas clauses 8 through 17 focus on specific mitigations for a wide range of different kinds of hazards that are commonly encountered when designing MEE/MES.1.3 Collateral standards The collateral standards are extensions of the general standard. Several of the collateral standards specify general requirements that are applicable to homogeneous subgroups of medical equipment, such as radiological equipment, home use equipment, and emergency medical service equipment. Other collateral standards elaborate requirements for MEE/MES basic safety and essential performance that are not fully addressed in the general standard, such as electromagnetic compatibility and usability/human factors. To the extent that a collateral standard applies to a given MEE/MES, its requirements are considered to be indispensable to the general standard. The reader might have noticed a few gaps in the numbering scheme for the collaterals. Over time, as the standards evolved, a few of the collateral standards have been withdrawn, largely because of restructuring of some requirements into the general standard or specific particular standards. 1.4 Particular standards The second branch of the family tree consists of the so-called Part 2 standards, also known as particular standards. There are a lot of these–80 and counting–and they focus on the hazardous situations and risk mitigations that are specific to a category of MEE/MES, from ECG monitors and surgical luminaires to infusion pumps and proton therapy systems. The particular standards expand on the requirements of the general standard in two ways. First, a particular standard might specify mitigations for hazardous situations that are unique to a MEE/MES category or type of MEE/MES by adding to, subtracting from, or modifying requirements of the general standard. Second, many particular standards specify the essential performance of that MEE/MES category. Requirements in a particular standard may modify or supersede the corresponding requirements in the general standard and collateral standards. 1.5 Technical reports The third branch of the family tree consists of the so-called Part 4s. These are a relatively new addition to the family, and there are currently just a handful of them in existence or under development. They actually aren’t standards at all, but technical reports (TRs). The development of TRs by the subcommittees within TC 62 is not a new concept but classifying them as Part 4s is. These TRs provide guidance on the application of 60601 and contain no normative requirements (they are informational in nature), although 60601-4-2 provides recommendations for evaluating the ability of an MEE/MES to perform without degradation in the presence of electromagnetic disturbances. The reader might be wondering why there are Part 4s but no Part 3s. A handful of Part 3 standards were written to address performance aspects of MEE/MES in the days before the general standard had clearly delineated the concept of essential performance. They have all been withdrawn.AAMI CR500  pdf download.