I.S. EN 60601-1-10:2008&A1:2015&A2:2021
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers (IEC 60601-1-10:2007/A2:2020)
Hardcopy , PDF
English
02-08-2021
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FOREWORD
INTRODUCTION
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
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