AAMI 60601 2 16 2012 RL
$154.18
ANSI/AAMI/IEC 60601-2-16:2012 Red-line Format – Medical electrical equipment – Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment
| Published By | Publication Date | Number of Pages |
| AAMI | 2012 | 166 |
Specifies the minimum safety requirements for single-patient hemodialysis, hemodiafiltration and hemofiltration equipment. These devices are intended for use either by medical staff or under the supervision of medical expertise, including hemodialysis, hemodiafiltration and hemofiltration equipment operated by the patient.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/IEC 60601-2-16:2012 – RED-LINE ANSI/AAMI/IEC 60601-2-16:2012, Medical electricalequipment — Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | CONTENTS |
| 7 | Glossary of equivalent standards |
| 10 | Committee representation |
| 12 | Background on of ANSI/AAMI adoption of IEC 60601-2-16:2012 |
| 13 | FOREWORD |
| 16 | INTRODUCTION |
| 17 | 201.1 Scope, object and related standards 201.1. 1 Scope |
| 18 | 201.1. 2 Object 201.1. 3 Collateral standards 201.1. 4 Particular standards |
| 19 | 201.2 Normative references |
| 20 | 201.3 Terms and definitions |
| 24 | 201.4 General requirements 201.4. 3 * Essential performance 201.4. 3.101 * Additional essential performance requirements |
| 25 | 201.4.3.102Blood flow 201.4.3.103 dialysis fluid flow 201.4.3.104 net fluid removal |
| 26 | 201.4.3.105 Substitution fluid flow |
| 27 | 201.4.3.108 dialysis fluid temperature 201.4.3.109Substitution fluid temperature |
| 28 | 201.4.7 single fault condition for me equipment 201.5 General requirements for testing of me equipment 201.6 Classification of me equipment and me systems 201.7 Me equipment identification, marking and documents 201.7.4.3 Units of measure |
| 29 | 201.7.9.2Instructions for use |
| 32 | 201.7.9.3 Technical description |
| 33 | 201.8 Protection against electrical hazards from me equipment 201.8.3* Classification of applied parts |
| 34 | 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 |
| 35 | 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 |
| 36 | 201.12.4.4 Incorrect output 201.12.3 Alarm systems 201.12.3.101 *Visual and audible alarm signals 201.12.3.102 *Audible alarm signals 201.12.4.4 Incorrect output |
| 37 | 201.12.4.4.101*dialysis fluid composition |
| 38 | 201.12.4.4.102*dialysis fluid and substitution fluid temperature |
| 39 | 201.12.4.4.103 *net fluid removal |
| 40 | 201.12.4.4.104 Extracorporeal blood loss |
| 46 | 201.13 hazardous situations and fault conditions 201.13.2.6 * Leakage of liquid |
| 47 | 201.14 programmable electrical medical systems (pems) 201.14.13 *Connection of pems by network/data coupling to other equipment 201.15 Construction of me equipment 201.15.4.1 Construction of connectors 201.15.4.1.101 * Dialysis fluid concentrate connectors |
| 48 | 201.16 * Me systems 201.16.2 Accompanying documents of an me system 201.16.6.3 patient leakage current |
| 49 | 201.17 Electromagnetic compatibility of me equipment and me systems 202 Electromagnetic compatibility – Requirements and tests 203 General requirements for radiation protection in diagnostic X-ray equipment 206 Usability 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 208.4 *General requirements |
| 50 | 208.6.3 Generation of alarm signals 208.6.3.1 *General 208.6.3.3.2 *Volume of auditory alarm signals and information signals |
| 51 | 209 Requirements for the reduction of environmental impacts 208.6.3.3.101 *Special characteristics of auditory alarm signals for hemodialysis equipment 210 Process requirements for the development of physiologic closed-loop controllers |
| 52 | 211 * Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| 53 | Annexes |
| 54 | Annex G (normative) Protection against HAZARDS of ignition of flammable anesthetic mixtures |
| 55 | Annex AA (informative) Particular guidance and rationale AA.1 General guidance AA.2 Rationale for particular clauses and subclauses |
| 76 | Annex BB (informative) Examples of hazards, foreseeable sequences of events, and hazardous situations in hemodialysis equipment |
| 84 | Bibliography |
| 85 | Index of defined terms used in this particular standard |
| 87 | ANSI/AAMI/IEC 60601-2-16:2012 ANSI/AAMI/IEC 60601-2-16:2012 , Medical electrical equipment — Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment |
| 88 | Objectives and uses of AAMI standards and recommended practices |
| 89 | Title page |
| 90 | AAMI Standard Copyright information |
| 91 | CONTENTS |
| 93 | Glossary of equivalent standards |
| 96 | Committee representation |
| 98 | Background of ANSI/AAMI adoption of IEC 60601-2-16:2012 |
| 99 | FOREWORD |
| 102 | INTRODUCTION |
| 103 | 201.1 Scope, object and related standards 201.1. 1 Scope |
| 104 | 201.1. 2 Object 201.1. 3 Collateral standards 201.1. 4 Particular standards |
| 105 | 201.2 Normative references |
| 106 | 201.3 Terms and definitions |
| 108 | 201.4 General requirements |
| 109 | 201.4. 3 * Essential performance 201.4. 3.101 * Additional essential performance requirements 201.4.3.102 Blood flow 201.4.3.103 Dialysis fluid flow |
| 110 | 201.4.3.104 Net fluid removal 201.4.3.105 Substitution fluid flow |
| 111 | 201.4.3.106 Dialysis time 201.4.3.107 * Dialysis fluid composition 201.4.3.108 Dialysis fluid temperature |
| 112 | 201.4.3.109 Substitution fluid temperature 201.4.7 Single fault condition for ME equipment 201.5 General requirements for testing of me equipment |
| 113 | 201.6 Classification of me equipment and me systems 201.7 ME equipment identification, marking and documents 201.7.4.3 Units of measure 201.7.9.2 Instructions for use 201.7.9.2.2 Warning and safety notices |
| 114 | 201.7.9.2.5 ME equipment description |
| 115 | 201.7.9.2.6 Installation 201.7.9.2.12 Cleaning, disinfection and sterilization 201.7.9.2.14 Accessories, supplementary equipment, used material |
| 116 | 201.7.9.3 Technical description 201.7.9.3.1 General |
| 117 | 201.8 Protection against electrical hazards from ME equipment 201.8.3 * Classification of applied parts 201.8.7.4.7 Measurement of the patient leakage current |
| 118 | 201.8.11.2 * Multiple socket-outlets 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 201.11.6.3 Spillage on ME equipment and ME systems 201.11.6.6 *Cleaning and disinfection of ME equipment and ME systems 201.11.8 *Interruption of the power supply / supply mains to ME equipment |
| 119 | 201.12 * Accuracy of controls and instruments and protection against hazardous outputs 201.12.4.4 Incorrect output 201.12.4.4.101 *Dialysis fluid composition |
| 121 | 201.12.4.4.102 *Dialysis fluid and substitution fluid temperature 201.12.4.4.103 *Net fluid removal |
| 122 | 201.12.4.4.104 Extracorporeal blood loss 201.12.4.4.104.1 Extracorporeal blood loss to the environment |
| 123 | 201.12.4.4.104.2 *Blood leak to the dialysis fluid 201.12.4.4.104.3 * Extracorporeal blood loss due to coagulation |
| 124 | 201.12.4.4.105 * Air infusion |
| 127 | 201.12.4.4.106 Alarm override modes |
| 128 | 201.12.4.4.107 Protective systems 201.12.4.4.108 Prevention of contamination by chemicals 201.12.4.4.109 *Blood pump(s) and/or substitution pump(s) reversal |
| 129 | 201.12.4.4.110 Selection and change of operation modes 201.12.4.4.111 Online HDF and online HF 201.13 Hazardous situations and fault conditions 201.13.2.6 * Leakage of liquid |
| 130 | 201.14 Programmable electrical medical systems (PEMS) 201.14.13 *Connection of PEMS by network/data coupling to other equipment 201.15 Construction of ME equipment 201.15.4.1 Construction of connectors 201.15.4.1.101 * Dialysis fluid concentrate connectors |
| 131 | 201.15.4.1.102 *Connectors for blood pressure transducers 201.16 * ME systems 201.16.1 General requirements for the ME systems 201.16.2 Accompanying documents of an ME system 201.16.6.3 Patient leakage current 201.16.9.1 * Connection terminals and connectors |
| 132 | 201.17 Electromagnetic compatibility of ME equipment and ME systems 202 Electromagnetic compatibility – Requirements and tests 202.3.18 Life-supporting ME equipment or ME system 208 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 208.4 *General requirements |
| 133 | 208.5.2.1 Instructions for use 208.6.3 Generation of alarm signals 208.6.3.1 *General 208.6.3.3.2 *Volume of auditory alarm signals and information signals 208.6.3.3.101 *Special characteristics of auditory alarm signals for hemodialysis equipment |
| 134 | 210 Process requirements for the development of physiologic closed-loop controllers 211 * Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment Annexes (general) |
| 135 | Annex G (normative) Protection against hazards of ignition of flammable anesthetic mixtures |
| 136 | Annex AA (informative) Particular guidance and rationale AA.1 General guidance AA.2 Rationale for particular clauses and subclauses |
| 156 | Annex BB (informative) Examples of hazards, foreseeable sequences of events, and hazardous situations in hemodialysis equipment |
| 164 | Bibliography |
| 165 | Index of defined terms used in this particular standard |
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