I.S. EN 60601-1-10:2008/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
This collateral standard 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) to control at least one PATIENT VARIABLE (i.e. a PHYSIOLOGIC VARIABLE) in ME EQUIPMENT and ME SYSTEMS.
| Committee |
ISO/TC 121/SC 3
|
| DocumentType |
Standard
|
| ISBN |
978-2-8322-8622-7
|
| Pages |
144
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| IEC 60601-1-10:2007/AMD2:2020 | Identical |
| EN 60601-1-10:2008/A2:2021 | Identical |
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