BS EN 60601-1-8:2007+A1:2013:2014 Edition
$215.11
Medical electrical equipment – General requirements for basic safety and essential performance. Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
| Published By | Publication Date | Number of Pages |
| BSI | 2014 | 96 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 6 | CONTENTS |
| 8 | INTRODUCTION |
| 9 | 1 Scope, object and related standards 1.1 Scope 1.2 Object 1.3 Related standards |
| 10 | 2 Normative references 3 Terms and definitions |
| 14 | 4 General requirements |
| 15 | 5 ME equipment identification marking and documents 5.1 Indicator lights and controls 5.2 Accompanying documents 6 Alarm systems 6.1 Alarm condition |
| 16 | 6.2 Disclosures for intelligent alarm system Table 1 – Alarm condition priorities |
| 17 | 6.3 Generation of alarm signals Table 2 – Characteristics of alarm indicator lights |
| 19 | Table 3 – Characteristics of the burst of auditory alarm signals Table 4 – Characteristics of the pulse of auditory alarm signals |
| 20 | Figure 1 – Illustration of temporal characteristics of auditory alarm signals |
| 21 | Untitled |
| 23 | 6.4 Disclosure of delays 6.5 Alarm presets |
| 26 | 6.6 Alarm limit |
| 27 | 6.7 Alarm system security 6.8 Alarm signal inactivation states |
| 30 | 6.9 Alarm reset 6.10 Non-latching and latching alarm signals Table 5 – Alarm signal inactivation states |
| 31 | 6.11 Distributed alarm system Untitled |
| 33 | 6.12 Alarm condition logging |
| 34 | Annex A (informative) General guidance and rationale |
| 55 | Figure A.1 – Graphical representation of components of alarm system delay |
| 72 | Untitled |
| 73 | Table A.1 – Reference interpretation of Table F.1 |
| 74 | Table A.2 – Reference interpretation of Table F.2 |
| 75 | Annex B (informative) Guide to marking and labelling requirements for ME equipment and ME systems Table B.1 – Cross-reference of marking |
| 76 | Table B.2 – Cross-reference of accompanying documents Table B.3 – Cross-reference of instructions for use |
| 77 | Table B.4 – Cross-reference of technical description |
| 78 | Annex C (normative) Symbols on marking Table C.1 – Graphical symbols for alarm systems |
| 83 | Table C.2 – Alternative alarm system related markings |
| 84 | Annex D (informative) Guidance for auditory alarm signals Table D.1 – Attributes of perceived urgency |
| 85 | Annex E (informative) Verbal alarm signals |
| 88 | Annex F (normative) Reserved melodies for alarm signals Table F.1 – Equipment encoded auditory alarm signals categorized by alarm condition and priority complying with Table 3 and Table 4 Table F.2 – Auditory low priority alarm signal complying with Table 3 and Table 4 |
| 89 | Bibliography |
