AAMI CR500 2019
$93.55
AAMI CR500:2019 – Basic Introduction to the IEC 60601 Series
| Published By | Publication Date | Number of Pages |
| AAMI | 2019 | 26 |
This document provides information regarding concepts and principles that underlie the IEC 60601 series of standards. (The IEC 60601 series is defined in the Introduction.) This document is intended to clarify and to point out the importance of the series as well as to provide guidance to understanding and to implementing the series.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI CR500:2019; Basic Introduction to the IEC 60601 Series |
| 3 | Title page |
| 4 | AAMI Consensus Report Copyright information |
| 5 | Contents Page |
| 6 | Committee representation |
| 7 | Foreword |
| 8 | Introduction |
| 11 | 1 Overview of the 60601 Series 1.1 Scope and structure |
| 12 | Figure 1—Structure of the 60601 family 1.2 The general standard Table 1—Contents of the general standard |
| 13 | 1.3 Collateral standards 1.4 Particular standards |
| 14 | 1.5 Technical reports 1.6 U.S. national deviations |
| 15 | Table 2—Evolution of 60601-1 |
| 16 | 2 Demystifying the Scope of IEC 60601 2.1 General considerations 2.2 Patient safety focus |
| 17 | 2.3 Basic safety and essential performance 2.3.1 Basic safety |
| 19 | 2.3.2 Essential performance 2.3.3 Regulatory perspective |
| 20 | Figure 2—Regulatory perspective for MEE/MESs |
| 21 | 2.3.4 Determining essential performance |
| 22 | 2.3.5 Distinguishing between engineering and clinical concerns |
| 23 | 2.3.6 Other considerations |
| 24 | 2.4 Conformity assessment |
| 25 | 3 Risk management and IEC 60601 |
