IEC 60601-1-10:2007+AMD1:2013 CSV

FOREWORD
INTRODUCTION
INTRODUCTION TO THE AMENDMENT
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 ME EQUIPMENT identification, marking and documents
6 Accuracy of controls and instruments and protection
  against hazardous outputs
7 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
8 Requirements for PHYSIOLOGIC CLOSED-LOOP CONTROLLER
  (PCLC) development
Annex A (informative) - General guidance and rationale
Annex B (informative) - Description of dynamic performance
        of a PCLCS
Annex C (informative) - Guide to marking and labelling
        requirements for ME EQUIPMENT and ME SYSTEMS
Bibliography
Index of defined terms used in this collateral standard

IEC 60601-1-10:2007+A1:2013 Specifies requirements for the development (analysis, design, verification and validation) of a physiologic closed-loop controller (PCLC) as part of a physiologic closed-loop control system (PCLCS) in medical electrical equipment and medical electrical systems to control a physiologic variable. This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive, fuzzy, neural networks. This collateral standard applies to a closed-loop controller that sets the controller output variable in order to adjust (i.e., change or maintain) the measured physiologic variable by relating it to the reference variable. This consolidated version consists of the first edition (2007) and its amendment 1 (2013). Therefore, no need to order amendment in addition to this publication.