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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, 2012
- ANSI/AAMI/IEC 60601-2-16:2012 - RED-LINE [Go to Page]
- 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
- Objectives and uses of AAMI standards and recommended practices
- Title page
- AAMI Standard
- Copyright information
- CONTENTS
- Glossary of equivalent standards
- Committee representation
- Background on of ANSI/AAMI adoption of IEC 60601-2-16:2012
- FOREWORD
- INTRODUCTION
- 201.1 Scope, object and related standards [Go to Page]
- 201.1. 1 Scope
- 201.1. 2 Object
- 201.1. 3 Collateral standards
- 201.1. 4 Particular standards
- 201.2 Normative references
- 201.3 Terms and definitions
- 201.4 General requirements [Go to Page]
- 201.4. 3 * Essential performance
- 201.4. 3.101 * Additional essential performance requirements [Go to Page]
- 201.4.3.102Blood flow
- 201.4.3.103 dialysis fluid flow
- 201.4.3.104 net fluid removal
- 201.4.3.105 Substitution fluid flow
- 201.4.3.108 dialysis fluid temperature
- 201.4.3.109Substitution fluid temperature
- 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 [Go to Page]
- 201.7.4.3 Units of measure
- 201.7.9.2Instructions for use
- 201.7.9.3 Technical description
- 201.8 Protection against electrical hazards from me equipment [Go to Page]
- 201.8.3* Classification of applied parts
- 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 [Go to Page]
- 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 [Go to Page]
- 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 [Go to Page]
- 201.12.4.4 Incorrect output
- 201.12.4.4.101*dialysis fluid composition
- 201.12.4.4.102*dialysis fluid and substitution fluid temperature
- 201.12.4.4.103 *net fluid removal
- 201.12.4.4.104 Extracorporeal blood loss
- 201.13 hazardous situations and fault conditions [Go to Page]
- 201.13.2.6 * Leakage of liquid
- 201.14 programmable electrical medical systems (pems) [Go to Page]
- 201.14.13 *Connection of pems by network/data coupling to other equipment
- 201.15 Construction of me equipment [Go to Page]
- 201.15.4.1 Construction of connectors
- 201.15.4.1.101 * Dialysis fluid concentrate connectors
- 201.16 * Me systems [Go to Page]
- 201.16.2 Accompanying documents of an me system [Go to Page]
- 201.16.6.3 patient leakage current
- 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 [Go to Page]
- 208.4 *General requirements
- 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
- 209 Requirements for the reduction of environmental impacts [Go to Page]
- 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
- 211 * Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- Annexes
- Annex G (normative) Protection against HAZARDS of ignition of flammable anesthetic mixtures
- Annex AA (informative) Particular guidance and rationale [Go to Page]
- AA.1 General guidance
- AA.2 Rationale for particular clauses and subclauses
- Annex BB (informative) Examples of hazards, foreseeable sequences of events, and hazardous situations in hemodialysis equipment
- Bibliography
- Index of defined terms used in this particular standard
- ANSI/AAMI/IEC 60601-2-16:2012 [Go to Page]
- 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
- Objectives and uses of AAMI standards and recommended practices
- Title page
- AAMI Standard
- Copyright information
- CONTENTS
- Glossary of equivalent standards
- Committee representation
- Background of ANSI/AAMI adoption of IEC 60601-2-16:2012
- FOREWORD
- INTRODUCTION
- 201.1 Scope, object and related standards [Go to Page]
- 201.1. 1 Scope
- 201.1. 2 Object
- 201.1. 3 Collateral standards
- 201.1. 4 Particular standards
- 201.2 Normative references
- 201.3 Terms and definitions
- 201.4 General requirements [Go to Page]
- 201.4. 3 * Essential performance [Go to Page]
- 201.4. 3.101 * Additional essential performance requirements
- 201.4.3.102 Blood flow
- 201.4.3.103 Dialysis fluid flow
- 201.4.3.104 Net fluid removal
- 201.4.3.105 Substitution fluid flow
- 201.4.3.106 Dialysis time
- 201.4.3.107 * Dialysis fluid composition
- 201.4.3.108 Dialysis fluid temperature
- 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
- 201.6 Classification of me equipment and me systems
- 201.7 ME equipment identification, marking and documents [Go to Page]
- 201.7.4.3 Units of measure
- 201.7.9.2 Instructions for use [Go to Page]
- 201.7.9.2.2 Warning and safety notices
- 201.7.9.2.5 ME equipment description
- 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
- 201.7.9.3 Technical description [Go to Page]
- 201.7.9.3.1 General
- 201.8 Protection against electrical hazards from ME equipment [Go to Page]
- 201.8.3 * Classification of applied parts
- 201.8.7.4.7 Measurement of the patient leakage current
- 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 [Go to Page]
- 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
- 201.12 * Accuracy of controls and instruments and protection against hazardous outputs [Go to Page]
- 201.12.4.4 Incorrect output
- 201.12.4.4.101 *Dialysis fluid composition
- 201.12.4.4.102 *Dialysis fluid and substitution fluid temperature
- 201.12.4.4.103 *Net fluid removal
- 201.12.4.4.104 Extracorporeal blood loss [Go to Page]
- 201.12.4.4.104.1 Extracorporeal blood loss to the environment
- 201.12.4.4.104.2 *Blood leak to the dialysis fluid
- 201.12.4.4.104.3 * Extracorporeal blood loss due to coagulation
- 201.12.4.4.105 * Air infusion
- 201.12.4.4.106 Alarm override modes
- 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
- 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 [Go to Page]
- 201.13.2.6 * Leakage of liquid
- 201.14 Programmable electrical medical systems (PEMS) [Go to Page]
- 201.14.13 *Connection of PEMS by network/data coupling to other equipment
- 201.15 Construction of ME equipment [Go to Page]
- 201.15.4.1 Construction of connectors [Go to Page]
- 201.15.4.1.101 * Dialysis fluid concentrate connectors
- 201.15.4.1.102 *Connectors for blood pressure transducers
- 201.16 * ME systems [Go to Page]
- 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
- 201.17 Electromagnetic compatibility of ME equipment and ME systems
- 202 Electromagnetic compatibility – Requirements and tests [Go to Page]
- 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 [Go to Page]
- 208.4 *General requirements
- 208.5.2.1 Instructions for use
- 208.6.3 Generation of alarm signals [Go to Page]
- 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
- 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)
- Annex G (normative) Protection against hazards
of ignition of flammable anesthetic mixtures
- Annex AA (informative) Particular guidance and rationale [Go to Page]
- AA.1 General guidance
- AA.2 Rationale for particular clauses and subclauses
- Annex BB (informative) Examples of hazards, foreseeable sequences of events, and hazardous situations in hemodialysis equipment
- Bibliography
- Index of defined terms used in this particular standard [Go to Page]