BSI 15/30329828 DC:2015 Edition
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BS EN 60601-2-22. Medical electrical equipment. Part 2-22. Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
| Published By | Publication Date | Number of Pages |
| BSI | 2015 | 28 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 8 | 201.1 Scope, object and related standards 201.1.1 Scope* 201.1.2 Object |
| 9 | 201.1.3 Collateral standards 201.1.4 Particular standards 201.2 Normative references |
| 10 | 201.3 Terms and definitions |
| 12 | 201.7 Me equipment identification, marking and documents 201.7.2 Marking on the outside of me Equipment or me equipment parts 201.7.9 Accompanying documents 201.7.9.1 General |
| 13 | 201.7.9.2 Instructions for use 201.7.9.2.13 Maintenance 201.7.9.2.101 Laser specific information for the responsible organization and for the laser operator |
| 14 | 201.8 Protection against electrical hazards from me equipment 201.8.5 Separation of parts 201.8.7 Leakage currents and patient auxiliary currents 201.8.10 Components and wiring 201.8.10.4 Cord-connected hand-held parts and cord-connected foot-operated control devices |
| 15 | 201.8.10.4.101 Footswitch 201.8.11 Mains parts, components and layout 201.8.11.101 Use of water for cooling 201.9 Protection against mechanical hazards of me equipment and me systems 201.10 Protection against unwanted and excessive radiation hazards 201.10.4 Lasers and light emitting diodes (LEDs) Note: LEDs are not covered by this part two standard |
| 18 | 201.11 Protection against excessive temperatures and other hazards 201.11.8 Interruption of the power supply /supply mains to me equipment 201.11.8.101 Interruption of emission 201.12 Accuracy of controls and instruments and protection against hazardous outputs 201.12.1 Accuracy of controls and instruments 201.12.1.101 Indication of laser output 201.12.4 Protection against hazardous output This subclause of the General Standard applies, except as follows: 201.12.4.2 Indication of parameters relevant to safety |
| 19 | 201.12.4.4* Incorrect output 201.12.4.4.101 Emergency laser stop 201.13 Hazardous situations and fault conditions 201.13.1 Specific hazardous situations 201.13.1.101 Specific laser considerations 201.13.2 Single fault conditions |
| 20 | 201.13.2.101 Excessive laser output 201.13.2.102 Failure of exposure termination 201.13.2.103 Failure of components with limited reliability 201.14 Programmable electrical medical systems (pems) 201.15 Construction of me equipment 201.15.101 Target indicating device (see Annex AA, rationale to 201.10.4 f)) |
| 21 | Annexes |
| 22 | Annex D (informative) Symbols on marking |
| 24 | Annex AA (informative) Particular guidance and rationale |
