60601-1-10 | Protective Earth Connection | 0 |
60601-1-11 | Home Healthcare Environment | 0 |
60601-1-12 | Emergency Medical Services Environment | 0 |
60601-1-13 | Software Lifecycle (IEC 62304) | 0 |
60601-1-14 | Programmable Electrical Medical System (PEMS) | 0 |
60601-1-15 | Construction and Components | 0 |
60601-1-16 | Marking, Labelling and Documents | 0 |
60601-1-2 | Electromagnetic Compatibility | 0 |
60601-1-4.2 | Risk Management Process | 0 |
60601-1-4.3 | Essential Performance | 0 |
60601-1-4.5 | Equivalent Safety | 0 |
60601-1-6 | Usability Engineering | 0 |
60601-1-7 | Mechanical Hazards | 0 |
60601-1-8 | Alarm Systems | 0 |
60601-1-9 | Leakage Current Testing | 0 |
60601-1-CYB | Cybersecurity for Networked Equipment | 0 |
60601-1-PMS | Post-Market Surveillance Feedback | 0 |
60601-1-PROD | Production and Routine Testing | 0 |
60601-1.1 | Scope, object, and related standards | 0 |
60601-1.10 | Protection against radiation hazards | 0 |
60601-1.11 | Protection against excessive temperatures and other hazards | 0 |
60601-1.12 | Accuracy of controls and instruments | 17 |
60601-1.13 | Hazardous situations and fault conditions | 10 |
60601-1.14 | Programmable electrical medical systems (PEMS) | 0 |
60601-1.15 | Construction of ME equipment | 0 |
60601-1.16 | ME systems | 0 |
60601-1.17 | Electromagnetic compatibility (EMC) | 0 |
60601-1.3 | Terminology and definitions | 169 |
60601-1.4.1 | General requirements | 217 |
60601-1.4.2 | Risk management process | 91 |
60601-1.5.1 | General requirements for testing | 92 |
60601-1.5.2 | Test conditions and environment | 0 |
60601-1.6 | Classification of ME equipment and systems | 0 |
60601-1.7.1 | Equipment identification and marking | 51 |
60601-1.7.2 | Documents and instructions for use | 0 |
60601-1.8 | Protection against electrical hazards | 0 |
60601-1.9 | Protection against mechanical hazards | 0 |
10 | Clause 10: Protection against unwanted and excessive radiation hazards | 0 |
10.1 | 10.1 X-Radiation | 0 |
10.2 | 10.2 Alpha, beta, gamma, neutron and other particle radiation | 0 |
10.3 | 10.3 Microwave radiation | 0 |
10.4 | 10.4 Lasers and light emitting diodes (LEDs) | 0 |
10.5 | 10.5 Other visible electromagnetic radiation | 0 |
10.6 | 10.6 Infrared radiation | 0 |
10.7 | 10.7 Ultraviolet radiation | 0 |
11 | Clause 11: Protection against excessive temperatures and other hazards | 0 |
11.1 | 11.1 Excessive temperatures in ME equipment | 0 |
11.2 | 11.2 Fire prevention | 0 |
11.3 | 11.3 Constructional requirements for fire enclosures of ME equipment | 0 |
11.4 | 11.4 ME equipment and ME systems intended for use with flammable anaesthetics | 0 |
11.5 | 11.5 ME equipment and ME systems intended for use in conjunction with flammable agents | 0 |
11.6 | 11.6 Overflow, spillage, leakage, ingress of water or particulate matter, cleaning, disinfection, sterilization and compatibility with substances used with the ME equipment | 0 |
11.7 | 11.7 Biocompatibility of ME equipment and ME systems | 0 |
11.8 | 11.8 Interruption of the power supply / supply mains to ME equipment | 0 |
12 | Clause 12: Accuracy of controls and instruments and protection against hazardous outputs | 0 |
12.1 | 12.1 Accuracy of controls and instruments | 0 |
12.2 | 12.2 Usability of ME equipment | 0 |
12.3 | 12.3 Alarm systems | 0 |
12.4 | 12.4 Protection against hazardous output | 0 |
13 | Clause 13: Hazardous situations and fault conditions for ME equipment | 0 |
13.1 | 13.1 Specific hazardous situations | 0 |
13.2 | 13.2 Single fault conditions | 0 |
14 | Clause 14: Programmable electrical medical systems (PEMS) | 0 |
14.1 | 14.1 General | 0 |
14.10 | 14.10 Verification | 0 |
14.11 | 14.11 PEMS validation | 0 |
14.12 | 14.12 Modification | 0 |
14.13 | 14.13 Connection of PEMS by network/data coupling to other equipment (PEMS intended to be incorporated into an IT-network) | 0 |
14.2 | 14.2 Documentation | 0 |
14.3 | 14.3 Risk management plan | 0 |
14.4 | 14.4 PEMS development life - cycle | 0 |
14.5 | 14.5 Problem resolution | 0 |
14.6 | 14.6 Risk management process | 0 |
14.7 | 14.7 Requirement specification | 0 |
14.8 | 14.8 Architecture | 0 |
14.9 | 14.9 Design and implementation | 0 |
15 | Clause 15: Construction of ME equipment | 0 |
15.1 | 15.1 Arrangements of controls and indicators of ME equipment | 0 |
15.2 | 15.2 Serviceability | 0 |
15.3 | 15.3 Mechanical strength | 0 |
15.4 | 15.4 ME equipment components and general assembly | 0 |
15.5 | 15.5 Mains supply transformers of ME equipment and transformers providing separation in accordance with 8.5 | 0 |
16 | Clause 16: ME systems | 0 |
16.1 | 16.1 General requirements for the ME systems | 0 |
16.2 | 16.2 Accompanying documents of an ME system | 0 |
16.3 | 16.3 Power supply | 0 |
16.4 | 16.4 Enclosures | 0 |
16.5 | 16.5 Separation devices | 0 |
16.6 | 16.6 Leakage currents | 0 |
16.7 | 16.7 Protection against mechanical hazards | 0 |
16.8 | 16.8 Interruption of the power supply to parts of an ME system | 0 |
16.9 | 16.9 ME system connections and wiring | 0 |
17 | 17 Electromagnetic compatibility of ME equipment and ME systems | 0 |
4 | Clause 4: General requirements | 0 |
4.1 | 4.1 Conditions for application to ME equipment or ME systems | 0 |
4.10 | 4.10 Power supply | 0 |
4.11 | 4.11 Power input | 0 |
4.2 | 4.2 Risk management process for ME equipment or ME systems | 0 |
4.3 | 4.3 Essential performance | 0 |
4.4 | 4.4 Expected service life | 0 |
4.5 | 4.5 Equivalent safety for ME equipment or ME systems (alternative risk control measures or test methods) | 0 |
4.6 | 4.6 ME equipment or ME system parts that contact the patient | 0 |
4.7 | 4.7 Single fault condition for ME equipment | 0 |
4.8 | 4.8 Components of ME equipment | 0 |
4.9 | 4.9 Use of components with high - integrity characteristics in ME equipment | 0 |
5 | Clause 5: General requirements for testing ME equipment | 0 |
5.1 | 5.1 Type tests | 0 |
5.2 | 5.2 Number of samples | 0 |
5.3 | 5.3 Ambient temperature, humidity, atmospheric pressure | 0 |
5.4 | 5.4 Other conditions | 0 |
5.5 | 5.5 Supply voltages, type of current, nature of supply, frequency | 0 |
5.6 | 5.6 Repairs and modifications | 0 |
5.7 | 5.7 Humidity preconditioning treatment | 0 |
5.8 | 5.8 Sequence of tests | 0 |
5.9 | 5.9 Determination of applied parts and accessible parts | 0 |
6 | Clause 6: Classification of ME equipment and ME systems | 0 |
6.1 | 6.1 General | 0 |
6.2 | 6.2 Protection against electric shock | 0 |
6.3 | 6.3 Protection against harmful ingress of water or particulate matter | 0 |
6.4 | 6.4 Method(s) of sterilization | 0 |
6.5 | 6.5 Suitability for use in an oxygen rich environment | 0 |
6.6 | 6.6 Mode of operation | 0 |
7 | Clause 7: ME equipment identification, marking and documents | 0 |
7.1 | 7.1 General | 0 |
7.2 | 7.2 Marking on the outside of ME equipment or ME equipment parts | 0 |
7.3 | 7.3 Marking on the inside of ME equipment or ME equipment parts | 0 |
7.4 | 7.4 Marking of controls and instruments | 0 |
7.5 | 7.5 Safety signs | 0 |
7.6 | 7.6 Symbols | 0 |
7.7 | 7.7 Colours of the insulation of conductors | 0 |
7.8 | 7.8 Indicator lights and controls | 0 |
7.9 | 7.9 Accompanying documents | 0 |
8 | Clause 8: Protection against electrical hazards from ME equipment | 0 |
8.1 | 8.1 Fundamental rule of protection against electric shock | 0 |
8.10 | 8.10 Components and wiring | 0 |
8.11 | 8.11 Mains parts , components and layout | 0 |
8.2 | 8.2 Requirements related to power sources | 0 |
8.3 | 8.3 Classification of applied parts | 0 |
8.4 | 8.4 Limitation of voltage, current or energy | 0 |
8.5 | 8.5 Separation of parts | 0 |
8.6 | 8.6 Protective earthing, functional earthing and potential equalization of ME equipment | 0 |
8.7 | 8.7 Leakage currents and patient auxiliary currents | 0 |
8.8 | 8.8 Insulation | 0 |
8.9 | 8.9 Creepage distances and air clearances | 0 |
9 | Clause 9: Protection against mechanical hazards of ME equipment and ME systems | 0 |
9.1 | 9.1 Mechanical hazards of ME equipment (index of clause 9) | 0 |
9.2 | 9.2 Mechanical hazards associated with moving parts | 0 |
9.3 | 9.3 Mechanical hazard associated with surfaces, corners and edges | 0 |
9.4 | 9.4 Instability hazards | 0 |
9.5 | 9.5 Expelled parts hazard | 0 |
9.6 | 9.6 Acoustic energy (including infra- and ultrasound) and vibration | 0 |
9.7 | 9.7 Pressure vessels and parts subject to pneumatic and hydraulic pressure | 0 |
9.8 | 9.8 Mechanical hazards associated with support systems | 0 |
ANNEXES | Annexes A to M: rationale, test sequence, marking guide, symbols, measuring circuits, flammable anaesthetics, PEMS guidance, ME systems, insulation paths, leakage diagrams, winding | 0 |
SCOPE | Clauses 1 to 3: scope, normative references and terminology | 0 |
STANDARD | IEC 60601-1: the standard, its editions, amendments and what is held | 0 |