Name: AAMI 60601 2 16 2012 PDF - PDF Standards Store
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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.

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PDF Pages	PDF Title
1	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
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 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
22	201.4 General requirements
23	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
24	201.4.3.104 Net fluid removal 201.4.3.105 Substitution fluid flow
25	201.4.3.106 Dialysis time 201.4.3.107 * Dialysis fluid composition 201.4.3.108 Dialysis fluid temperature
26	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
27	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
28	201.7.9.2.5 ME equipment description
29	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
30	201.7.9.3 Technical description 201.7.9.3.1 General
31	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
32	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
33	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
35	201.12.4.4.102 Dialysis fluid and substitution fluid temperature 201.12.4.4.103 Net fluid removal
36	201.12.4.4.104 Extracorporeal blood loss 201.12.4.4.104.1 Extracorporeal blood loss to the environment
37	201.12.4.4.104.2 Blood leak to the dialysis fluid 201.12.4.4.104.3 Extracorporeal blood loss due to coagulation
38	201.12.4.4.105 * Air infusion
41	201.12.4.4.106 Alarm override modes
42	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
43	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
44	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
45	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
46	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
47	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
48	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)
49	Annex G (normative) Protection against hazards of ignition of flammable anesthetic mixtures
50	Annex AA (informative) Particular guidance and rationale AA.1 General guidance AA.2 Rationale for particular clauses and subclauses
70	Annex BB (informative) Examples of hazards, foreseeable sequences of events, and hazardous situations in hemodialysis equipment
78	Bibliography
79	Index of defined terms used in this particular standard

Published By	Publication Date	Number of Pages
AAMI	2012	80


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Standard Title	ANSI/AAMI/IEC 60601-2-16:2012 – Medical electrical equipment – Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
Published Code	AAMI
Publication Date	2012
Pages Count	80

AAMI 60601 2 16 2012

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