kSIST FprEN IEC 60601-2-16:2024

Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

Appareils électromédicaux - Partie 2-16: Exigences particulières pour la sécurité de base et les performances essentielles des appareils d'hémodialyse, d'hémodiafiltration et d'hémofiltration

Medicinska električna oprema - 2-16. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za hemodializo, hemodiafiltracijo in hemofiltracijo

General Information

• Status: Not Published
• Public Enquiry End Date: 31-Jan-2023
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• ICS: 11.040.25 - Syringes, needles an catheters
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 5020 - Formal vote (FV) (Adopted Project)
• Start Date: 19-Aug-2024
• Due Date: 07-Oct-2024
• Completion Date: 20-Aug-2024
• Ref Project: FprEN IEC 60601-2-16:2024 - Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

Relations

• Revised: SIST EN IEC 60601-2-16:2019 - Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:2018)
• Effective Date: 21-Oct-2021

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN IEC 60601-2-16:2023
01-januar-2023
Medicinska električna oprema - 2-16. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za hemodializo, hemodiafiltracijo in hemofiltracijo
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and
essential performance of haemodialysis, haemodiafiltration and haemofiltration
equipment
Appareils électromédicaux - Partie 2-16: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils d'hémodialyse, d'hémodiafiltration et
d'hémofiltration
Ta slovenski standard je istoveten z: prEN IEC 60601-2-16:2022
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
oSIST prEN IEC 60601-2-16:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN IEC 60601-2-16:2023

oSIST prEN IEC 60601-2-16:2023
62D/1988/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-16 ED6
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-11-11 2023-02-03
SUPERSEDES DOCUMENTS:
62D/1912/CD, 62D/1937A/CC
IEC SC 62D : ELECTROMEDICAL EQUIPMENT
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:

Other TC/SCs are requested to indicate their interest, if any, in this
CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY
SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING
Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.
This document is still under study and subject to change. It should not be used for reference purposes.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which they
are aware and to provide supporting documentation.

TITLE:
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential
performance of haemodialysis, haemodiafiltration and haemofiltration equipment

PROPOSED STABILITY DATE: 2028
NOTE FROM TC/SC OFFICERS:
electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions. You
may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without permis sion
in writing from IEC.
oSIST prEN IEC 60601-2-16:2023
62D/1988/CDV – 2 – IEC 60601-2-16:Ed 6.0 © IEC 2022
1 CONTENTS
2 FOREWORD . 4
3 INTRODUCTION . 7
4 Scope, object and related standards . 8
5 Normative references . 10
6 Terms and definitions . 10
7 General requirements . 14
8 General requirements for testing ME EQUIPMENT. 17
9 Classification of ME EQUIPMENT and ME SYSTEMS . 18
10 ME EQUIPMENT identification, marking and documents . 18
11 Protection against electrical HAZARDS from ME EQUIPMENT . 23
12 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 24
13 Protection against unwanted and excessive radiation HAZARDS . 24
14 Protection against excessive temperatures and other HAZARDS . 24
15 * Accuracy of controls and instruments and protection against hazardous
16 outputs . 27
17 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 37
18 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 38
19 Construction of ME EQUIPMENT . 39
20 * ME SYSTEMS . 40
21 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 41
22 202 Electromagnetic disturbances – Requirements and tests . 41
23 208 General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL
24 ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 42
25 209 Requirements for environmentally conscious design . 44
26 210 Requirements for the development of PHYSIOLOGIC CLOSED-LOOP CONTROLLERS . 44
27 211 * Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL
28 SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT . 45
29 Annexes . 46
30 Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
31 mixtures . 47
32 Annex AA (informative) Particular guidance and rationale . 48
33 Annex BB (informative) Examples of HAZARDS, foreseeable sequences of events, and
34 HAZARDOUS SITUATIONS in HAEMODIALYSIS EQUIPMENT . 75
35 Annex CC (informative) Example of an open alarm interface specification . 83
36 Bibliography . 87
37 Index of defined terms used in this particular standard. 90
39 Figure 201.101 – Air infusion test setup with example dimensions . 34
40 Figure AA.1 – Example of a HAEMODIALYSIS ME SYSTEM . 70
41 Figure CC.1 – Simplified circuit diagram . 84
43 Table 201.101 – ESSENTIAL PERFORMANCE requirements . 14

oSIST prEN IEC 60601-2-16:2023
IEC 60601-2-16:Ed. 6.0 © IEC 2022 – 3 – 62D/1988/CDV
44 Table AA.1 – Example of ALARM CONDITION priorities according to 6.1.2 of IEC 60601-1-
45 8:2006, IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2:2020,
46 adapted for HAEMODIALYSIS EQUIPMENT needs . 73
47 Table BB.1 – Example of HAZARDOUS SITUATIONS list following ISO 14971:2019,
48 Annex C . 75
49 Table CC.1 – Periodic functional check of the INPUT INTERFACE . 85
50 Table CC.2 – Reaction of HAEMODIALYSIS EQUIPMENT . 85
51 Table CC.3 – Signal result of signal input to INTERNAL SIGNAL PROCESSING unit . 85
52 Table CC.4 – Reaction of HAEMODIALYSIS EQUIPMENT during the treatment . 86
oSIST prEN IEC 60601-2-16:2023
62D/1988/CDV – 4 – IEC 60601-2-16:Ed 6.0 © IEC 2022
55 INTERNATIONAL ELECTROTECHNICAL COMMISSION
56 ____________
58 MEDICAL ELECTRICAL EQUIPMENT –
60 Part 2-16: Particular requirements for the basic safety and
61 essential performance of haemodialysis, haemodiafiltration
62 and haemofiltration equipment
64 FOREWORD
65 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
66 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
67 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
68 in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
69 Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC Publication(s)"). Their
70 preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
71 may participate in this preparatory work. International, governmental and non-governmental organizations liaising
72 with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
73 Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
74 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
75 consensus of opinion on the relevant subjects since each technical committee has representation from all
76 interested IEC National Committees.
77 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
78 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
79 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
80 misinterpretation by any end user.
81 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
82 transparently to the maximum extent possible in their national and regional publications. Any divergence between
83 any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
84 5) IEC itself does not provide any attestation of conformity. Independent certificati on bodies provide conformity
85 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
86 services carried out by independent certification bodies.
87 6) All users should ensure that they have the latest edition of this publication.
88 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
89 members of its technical committees and IEC National Committees for any personal injury, property damage or
90 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
91 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
92 Publications.
93 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
94 indispensable for the correct application of this publication.
95 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
96 rights. IEC shall not be held responsible for identifying any or all such patent rights.
97 International standard IEC 60601-2-16 has been prepared by IEC subcommittee 62D:
98 Electromedical equipment, of IEC technical committee 62: Electrical equipment in medi cal
99 practice.
100 This edition cancels and replaces the fifth edition of IEC 60601-2-16 published in 2018. This
101 edition constitutes a technical revision.
102 This edition includes the following significant technical changes with respect to the previous
103 edition:
104 a) update of references to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
105 1:2005/AMD2:2020, of references to IEC 60601-1-2:2014 and IEC 60601-1-
106 2:2014/AMD1:2020, of references to IEC 60601-1-6:2010, IEC 60601-1-
107 6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020, of references to IEC 60601-1-
108 8:2006, IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2:2020, of
109 references to
oSIST prEN IEC 60601-2-16:2023
IEC 60601-2-16:Ed. 6.0 © IEC 2022 – 5 – 62D/1988/CDV
110 IEC 60601-1-9:2007, IEC 60601-1-9:2007/AMD1:2013 and IEC 60601-1-
111 9:2007/AMD2:2020, of references to IEC 60601-1-10:2007, IEC 60601-1-
112 10:2007/AMD1:2013 and IEC 60601-1-10:2007/AMD2:2020and of references to
113 IEC 60601-1-11:2015 and IEC 60601-1-11:2015/AMD1:2020;
114 b) consideration of ESSENTIAL PERFORMANCE in SINGLE FAULT CONDITION regarding IEC 60601-
115 1:2005/AMD1:2012/ISH1:2021;
116 c) including the information given in the document 62D/1771A/INF regarding subclause
117 201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT;
118 d) including withdrawn IEC PAS 63023 as Annex CC;
119 e) including SECURITY (CYBERSECURITY) requirements;
120 f) consideration of HAEMODIALYSIS EQUIPMENT using pre-manufactured DIALYSIS FLUID bags;
121 g) improvements for labeling;
122 h) other minor technical improvements;
123 i) editorial improvements.
124 The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/1557/FDIS 62D/1585/RVD
126 Full information on the voting for the approval of this particular standard can be found in the
127 report on voting indicated in the above table.
128 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
129 In this document, the following print types are used:
130 – requirements and definitions: roman type;
131 – test specifications: italic type;
132 – informative material appearing outside of tables, such as notes, examples and
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