BSI 19/30357110 DC:2019 Edition
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BS IEC 60601-1 AMD2. Medical electrical equipment – Part 1. General requirements for basic safety and essential performance
| Published By | Publication Date | Number of Pages |
| BSI | 2019 | 51 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | 30357110 |
| 13 | 62A_1320e_CDV 7.1.2 * Legibility of markings 7.2.3 * Consult accompanying documents 7.2.5 * Me equipment intended to receive power from other equipment 7.2.9 IP classification 7.2.10 * Applied parts |
| 14 | 7.2.13 Physiological effects (safety signs and warning statements) 7.3.2 * High voltage parts 7.3.3 Batteries 7.3.7 Supply terminals 7.4.1 * Power switches |
| 15 | 7.8.1 Colours of indicator lights 7.9.2 Instructions for use (see also Table C.5) 7.9.2.1 * General 7.9.3 Technical description (see also Table C.6) 7.9.3.1 * General |
| 16 | 8.4.2 Accessible parts and applied parts 8.5.1 * Means of protection (mop) 8.5.1.1 General |
| 17 | 8.5.1.2 * Means of patient protection (mopp) |
| 18 | 8.5.1.3 Means of operator protection (moop) |
| 19 | 8.5.2 Separation of patient connections 8.5.2.2 * Type b applied parts 8.5.2.3 * Patient leads or patient cables 8.5.3 * Maximum mains voltage 8.5.4 * Working voltage |
| 20 | 8.5.5 Defibrillation-proof applied parts |
| 21 | 8.7.3 * Allowable values 8.7.4.2 * Measuring supply circuits 8.7.4.7 Measurement of the patient leakage current 8.8.1 * General 8.8.3 * Dielectric strength |
| 22 | 8.9.1 * Values 8.9.1.12 Secondary circuits 8.9.1.15 * Creepage distances and air clearances for defibrillation-proof applied parts |
| 23 | 8.9.1.16 Conductive surface coatings 8.9.2 * Application 8.11.3 Power supply cords 8.11.3.3 Cross-sectional area of power supply cord conductors 8.11.5 * Mains fuses and over-current releases |
| 24 | 9.2.1 * General 9.4.2 * Instability – overbalance 9.4.2.3 Instability from horizontal and vertical forces 9.4.3 * Instability from unwanted lateral movement (including sliding) 9.4.3.1 Instability in transport position 9.6 Acoustic energy (including infra- and ultrasound) and vibration 9.6.2 * Acoustic energy 9.7 * Pressure vessels and parts subject to pneumatic and hydraulic pressure 9.7.3 Maximum pressure |
| 25 | 9.7.6 Pressure-control device 9.7.7 Pressure-relief device 9.8 * Mechanical hazards associated with support systems 9.8.2 * Tensile safety factor 9.8.3 * Strength of patient or operator support or suspension systems 9.8.3.3 * Dynamic forces due to loading from persons The body upper-carriage module with appropriate mass is dropped from a distance of 150 mm from the lowest edge of the foam to the area where a patient or operator can sit. 9.8.4 * Systems with mechanical protective devices 9.8.4.3 Mechanical protective device intended for single activation 10.1.1 * Me equipment not intended to produce diagnostic or therapeutic X-radiation |
| 28 | 13.1.3 Exceeding leakage current or voltage limits 13.2 Single fault conditions 13.2.1 General |
| 29 | 13.2.8 Locking of moving parts 13.2.13 * Overload 13.2.13.1 * General overload test conditions 14.6.1 * Identification of known and foreseeable hazards |
| 30 | 15.3 Mechanical strength 15.3.4 * Drop test 15.3.4.1 Hand-held me equipment 15.3.4.2 * Portable me equipment 15.3.5 * Rough handling test 16.9.2 Mains parts, components and layout 16.9.2.1 * Multiple socket-outlet 16.9.2.2 * Protective earth connections in me systems |
