AAMI 60601 2 2 2017
$140.32
ANSI/AAMI/IEC 60601-2-2:2017 – Medical electrical equipment-Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
| Published By | Publication Date | Number of Pages |
| AAMI | 2017 | 84 |
Applies to medical electrical equipment which generates high frequency currents intended for the performance of surgical tasks and to surgical accessories intended to conduct, supplement or monitor high frequency energy applied to the patient from high frequency surgical equipment.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/IEC 60601-2-2:2017; Medical electrical equipment— Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents Page |
| 6 | Committee representation |
| 7 | Background of ANSI/AAMI adoption of IEC 60601-2-2:2017 |
| 8 | Foreword |
| 10 | Introduction |
| 11 | 201.1 Scope, object and related standards 201.1. 1 * Scope 201.1. 2 Object 201.1. 3 Collateral standards 201.1. 4 Particular standards |
| 12 | 201.2 Normative references |
| 13 | 201.3 Terms and definitions |
| 16 | 201.4 General requirements |
| 17 | 201.4. 1.101 * Additional conditions for application 201.4. 2.3.101 * Evaluating risk 201.4. 3 * Essential performance 201.4. 7 Single fault condition for me equipment 201.4. 7.101 Specific single fault conditions 201.4. 11 Power input 201.5 General requirements for testing of me equipment 201.5. 4 * Other conditions 201.6 Classification of me equipment and me systems 201.7 Me equipment identification, marking and documents |
| 18 | 201.7. 2.8.2 Other power sources 201.7. 2.10 Applied parts 201.7. 2.10.101 * hf surgical accessories 201.7. 4.2 * Control devices 201.7. 8.1 * Colours of indicator lights |
| 19 | 201.7. 8.2 * Colours of controls 201.7. 9.2.2 Warning and safety notices 201.7. 9.2.2.101 Additional information in instructions for use |
| 21 | 201.7. 9.2.14 * Accessories, supplementary equipment, used material 201.7. 9.2.15 Environmental protection |
| 22 | 201.7.9.3 Technical description 201.7.9.3.1 * General 201.8 Protection against electrical hazards from me equipment 201.8. 4 Limitation of voltage, current or energy 201.8. 4.101 * Neutral electrode monitoring circuit |
| 24 | 201.8. 4.102 * Neuromuscular stimulation 201.8. 5.1.2 * Means of patient protection (mopp) 201.8. 5.2.3 * Patient leads or patient cables 201.8. 5.5 * Defibrillation-proof applied parts 201.8. 6.1 * Applicability of requirements |
| 25 | 201.8. 7.1 * General requirements 201.8. 7.3 * Allowable values 201.8. 7.3.101 Thermal effects of hf leakage currents |
| 30 | 201.8. 8.2 Distance through solid insulation or use of thin sheet material 201.8. 8.3 Dielectric strength 201.8. 8.3.101 * Active accessory insulation 201.8. 8.3.102 * Active accessory hf leakage |
| 32 | 201.8. 8.3.103 * Active accessory hf dielectric strength |
| 33 | 201.8. 8.3.104 * Active accessory mains frequency dielectric strength 201.8. 9.1.5 Me equipment rated for high altitudes 201.8. 10.4 Cord-connected hand-held parts and cord-connected foot-operated control devices 201.8. 10.4.1 Limitation of operating voltages 201.8. 10.4.2 * Connection cords |
| 35 | 201.8. 10.4.101 * Switch sensors 201.8. 10.4.101.1 General 201.8. 10.4.101.2 Non-continuous activation 201.8. 10.4.101.3 Impedance sensing activation |
| 36 | 201.8. 10.4.101.4 Footswitches 201.9 Protection against mechanical hazards of me equipment and me systems 201.10 Protection against unwanted and excessive radiation hazards 201.11 Protection against excessive temperatures and other hazards 201.11. 1.1 * Maximum temperature during normal use 201.11. 1.2.1 Applied parts intended to supply heat to a patient 201.11. 1.2.2 Applied parts not intended to supply heat to a patient 201.11. 6.3 * Spillage on me equipment and me systems |
| 37 | 201.11. 6.5 Ingress of water or particulate matter into me equipment and me systems 201.11. 6.7 * Sterilization of me equipment and me systems 201.11. 8 Interruption of the power supply / supply mains to me equipment 201.12 Accuracy of controls and instruments and protection against hazardous outputs 201.12. 1 Accuracy of controls and instruments |
| 38 | 201.12. 1.101 Accuracy of output control setting 201.12. 1.102 Monotonicity of output control setting |
| 40 | 201.12. 1.103 * Accuracy of maximum output voltage 201.12. 2 Usability of me equipment |
| 41 | 201.12. 4 Protection against hazardous output 201.12. 4.101 * Use of high current mode 201.12. 4.2 * Indication relevant to safety 201.12. 4.2.101 Output indicator |
| 42 | 201.12. 4.3 Accidental selection of excessive output values 201.12. 4.3.101 * Output reduction means 201.12. 4.4 Incorrect output 201.12. 4.4.101 * Maximum allowed output power in single fault conditions 201.12. 4.4.102 * Output power during simultaneous activation |
| 43 | 201.13 Hazardous situations and fault conditions for me equipment 201.13. 2.13 Overload 201.13. 2.13.101 * Protection against the effects of short-circuiting of the electrodes |
| 44 | 201.14 Programmable electrical medical systems (pems) 201.15 Construction of me equipment 201.15. 4.1 Construction of connectors 201.15. 4.1.101 * Compatibility with third party active electrodes 201.15. 4.1.102 * Retention of detachable active electrodes 201.15. 101 * Neutral electrodes 201.15. 101.1 General requirements for neutral electrodes 201.15. 101.2 * Ne cord attachment |
| 45 | 201.15. 101.3 * Ne cord connector 201.15. 101.4 * Ne cord insulation 201.15. 101.5 * Ne thermal performance |
| 46 | 201.15. 101.6 * Ne contact impedance |
| 47 | 201.15. 101.7 * NE adhesion 201.15. 101.8 * Ne shelf life |
| 48 | 201.15. 101.9 * Adult neutral electrodes for conventional procedures 201.16 Me systems 201.17 Electromagnetic compatibility of me equipment and me systems 202 * Electromagnetic disturbances – Requirements and tests 202.2 Normative references 202.3 Terms and definitions 202.5.2.2.4 Requirements applicable to me equipment that includes RF transmitters 202.5.2.2.6 Requirements applicable to me equipment and me systems that claim compatibility with hf surgical equipment 202.7 electromagnetic emissions requirements for me equipment and me systems 202.7.1.2 Operating modes |
| 49 | 202.8 Electromagnetic immunity requirements for me equipment and me systems 202.8.1 General 202.101 Index of defined terms 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems |
| 50 | Annexes |
| 51 | Annex AA (informative) Particular guidance and rationale AA.1 General guidance AA.2 Rationale for particular clauses and subclauses |
| 74 | Annex BB (informative) Electromagnetic disturbances created by hf surgical equipment BB.1 Overview BB.2 Terms and definitions BB.3 Technical information BB.3.1 General information about hf surgical equipment |
| 75 | BB.3.2 Types of emissions created by hf surgical equipment BB.3.2.1 Radiated BB.3.2.2 Conducted through the mains power supply cord BB.3.2.3 Conducted through the patient BB.3.3 Measurement techniques |
| 76 | BB.3.3.1 E-field measurements |
| 77 | BB.3.3.2 H-field measurements BB.3.3.3 Mains conducted measurements |
| 78 | BB.3.4 Data summary BB.3.4.1 E-field emissions BB.3.4.2 H-field emissions BB.3.4.3 Mains conducted emissions BB.3.4.4 Maximum emission levels of hf surgical equipment |
| 79 | BB.4 Suggested tests BB.4.1 BB.4.2 |
| 80 | BB.4.3 BB.4.4 |
| 81 | BB.4.5 BB.4.6 |
| 82 | 201.18 Bibliography |
| 83 | Index of defined terms used in this particular standard |
