oSIST prEN IEC 60601-2-16:2023
(Main)Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
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
Relations
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.
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oSIST prEN IEC 60601-2-16:2023
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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:
Copyright © 2022 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this
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.
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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
38
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
42
43 Table 201.101 – ESSENTIAL PERFORMANCE requirements . 14
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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
53
54
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55 INTERNATIONAL ELECTROTECHNICAL COMMISSION
56 ____________
57
58 MEDICAL ELECTRICAL EQUIPMENT –
59
60 Part 2-16: Particular requirements for the basic safety and
61 essential performance of haemodialysis, haemodiafiltration
62 and haemofiltration equipment
63
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
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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
125
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 references: in smaller type.
133 Normative text of tables is also in a smaller type;
134 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
135 NOTED: SMALL CAPITALS.
136 In referring to the structure of this document, the term
137 – "clause" means one of the seventeen numbered divisions within the table of contents,
138 inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
139 – "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
140 subclauses of Clause 7).
141 References to clauses within this document are preceded by the term "Clause" followed by the
142 clause number. References to subclauses within this particular standard are by number only.
143 In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
144 combination of the conditions is true.
145 The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC
146 Directives, Part 2. For the purposes of this document, the auxiliary verb:
147 – "shall" means that compliance with a requirement or a test is mandatory for compliance with
148 this document;
149 – "should" means that compliance with a requirement or a test is recommended but is not
150 mandatory for compliance with this document;
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151 – "may" is used to describe a permissible way to achieve compliance with a requirement or
152 test.
153 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
154 indicates that there is guidance or rationale related to that item in Annex AA.
155 A list of all parts of the IEC 60601 series, published under the general title Medical electrical
156 equipment, can be found on the IEC website.
157 The committee has decided that the contents of this publication will remain unchanged until the
158 stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
159 the specific publication. At this date, the publication will be
160 • reconfirmed,
161 • withdrawn,
162 • replaced by a revised edition, or
163 • amended.
164
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this document using a colour printer.
165
166 NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
167 organizations may need a transitional period following publication of a new, amended or revised IEC publication in
168 which to make products in accordance with the new requirements and to equip themselves for conducting new or
169 revised tests. It is the recommendation of the committees that the content of this publication be adopted for
170 implementation nationally not earlier than 3 years from the date of publication.
171
172
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173 INTRODUCTION
174 The minimum safety requirements specified in this particular standard are considered to provide
175 for a practical degree of safety in the operation of HAEMODIALYSIS, HAEMODIAFILTRATION and
176 HAEMOFILTRATION EQUIPMENT.
177
178
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179 MEDICAL ELECTRICAL EQUIPMENT –
180
181 Part 2-16: Particular requirements for the basic safety and
182 essential performance of haemodialysis, haemodiafiltration
183 and haemofiltration equipment
184
185
186
187 Scope, object and related standards
1
188 Clause 1 of the general standard applies, except as follows:
189 201.1.1 * Scope
190 Replacement:
191 This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
192 HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as
193 HAEMODIALYSIS EQUIPMENT. It applies to HAEMODIALYSIS EQUIPMENT intended for use either by
194 medical staff or under the supervision of medical experts, including HAEMODIALYSIS EQUIPMENT
195 operated by the PATIENT, regardless of whether the HAEMODIALYSIS EQUIPMENT is used in a
196 hospital or domestic environment.
197 If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
198 ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
199 case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
200 This document does not take into consideration specific safety details of the DIALYSIS FLUID
201 control system of HAEMODIALYSIS EQUIPMENT using regeneration of DIALYSIS FLUID or CENTRAL
202 DELIVERY SYSTEMS for DIALYSIS FLUID. It does, however, take into consideration the specific
203 safety requirements of such HAEMODIALYSIS EQUIPMENT concerning electrical safety and PATIENT
204 safety.
205 This document specifies the minimum safety requirements for HAEMODIALYSIS EQUIPMENT. These
206 HAEMODIALYSIS EQUIPMENT are intended for use either by medical staff or for use by the PATIENT
207 or other trained personnel under medical supervision.
208 This document includes all ME EQUIPMENT that is intended to deliver a HAEMODIALYSIS,
209 HAEMODIAFILTRATION and HAEMOFILTRATION treatment to a PATIENT, independent of the treatment
210 duration and location.
211 If applicable, this document applies to the relevant parts of ME EQUIPMENT intended for other
212 extracorporeal blood purification treatments.
213 The particular requirements in this document do not apply to:
2
214 – EXTRACORPOREAL CIRCUITS (see ISO 8637-2, [5] );
215 – DIALYSERS (see ISO 8637-1, [4]);
216 – DIALYSIS FLUID CONCENTRATES (see ISO 23500-4, [11]);
___________
1
The general standard is IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
1:2005/AMD2:2020, Medical electrical equipment – Part 1: General requirements for basic safety and essential
performance.
2
Numbers in square brackets refer to the Bibliography.
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217 – pre-manufactured DIALYSIS FLUID bags;
218 – DIALYSIS WATER supply systems (see ISO 23500-2, [9]);
219 – CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID CONCENTRATES (see ISO 23500-4, [11]),
220 described as systems for bulk mixing concentrate at a dialysis facility ;
221 – equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39, [2]).
222 201.1.2 Object
223 Replacement:
224 The object of this particular standard is to establish BASIC SAFETY and ESSENTIAL PERFORMANCE
225 requirements for HAEMODIALYSIS EQUIPMENT.
226 201.1.3 Collateral standards
227 Addition:
228 This particular standard refers to those applicable collateral standards that are listed in Clause
229 2 of the general standard and Subclause 201.2 of this particular standard.
230 IEC 60601-1-2:2014 and IEC 60601-1-2:2014 /AMD1:2020, IEC 60601-1-8:2006, IEC 60601-1-
231 8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2:2020, IEC 60601-1-10:2007, IEC 60601-1-
232 10:2007/AMD1:2013 and IEC 60601-1-10:2007/AMD2:2020, IEC 60601-1-11:2015 and
233 IEC 60601-1-11:2015/AMD1:2020 apply as modified in Clauses 202, 208, 210 and 211.
234 IEC 60601-1-3 does not apply. IEC 60601-1-9:2007, IEC 60601-1-9:2007/AMD1:2013 and
235 IEC 60601-1-9:2007/AMD2:2020 does not apply as noted in Clause 209.
236 All other published collateral standards in the IEC 60601-1 series apply as published.
237 201.1.4 Particular standards
238 Replacement:
239 In the IEC 60601 series, particular standards may modify, replace or delete requirements
240 contained in the general standard and collateral standards as appropriate for the particular
241 ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
242 PERFORMANCE requirements.
243 A requirement of a particular standard takes priority over the general standard.
244 For brevity, IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
245 1:2005/AMD2:2020 are referred to in this particular standard as the general standard. Collateral
246 standards are referred to by their document number.
247 The numbering of clauses and subclauses of this particular standard corresponds to that of the
248 general standard with the prefix "201" (e.g. 201.1 in this document addresses the content of
249 Clause 1 of the general standard) or applicable collateral standard with the prefix "20x" where
250 x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular
251 standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 in
252 this particular standard addresses the content of Clause 4 of the IEC 60601-1-3 collateral
253 standard, etc.). The changes to the text of the general standard are specified by the use of the
254 following words:
255 "Replacement" means that the clause or subclause of the general standard or applicable
256 collateral standard is replaced completely by the text of this particular standard.
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257 "Addition" means that the text of this particular standard is additional to the requirements of the
258 general standard or applicable collateral standard.
259 "Amendment" means that the clause or subclause of the general standard or applicable
260 collateral standard is amended as indicated by the text of this particular standard .
261 Subclauses, figures or tables which are additional to those of the general standard are
262 numbered starting from 201.101. However, due to the fact that definitions in the general
263 standard are numbered 3.1 through 3.154, additional definitions in this document are numbered
264 beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items
265 aa), bb), etc.
266 Subclauses, figures or tables which are additional to those of a collateral standard are
267 numbered starting from 20x, where "x" is the number of the collateral standard, for example
268 202 for IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
269 The term "this document" is used to make reference to the general standard, any applicable
270 collateral standards and this particular standard taken together.
271 Where there is no corresponding clause or subclause in this particular standard, the clause or
272 subclause of the general standard or applicable collateral standard, although possibly not
273 relevant, applies without modification; where it is intended that any part of the general standard
274 or applicable collateral standard, although possibly relevant, is not to be applied, a statement
275 to that effect is given in this particular standard.
276 Normative references
277 NOTE Informative references are listed in the bibliography.
278 Clause 2 of the general standard applies, except as follows:
279 Addition:
280 IEC 60601-1-10:2007, Medical electrical equipment – Part 1-10: General requirements for basic
281 safety and essential performance – Collateral Standard: Requirements for the development of
282 physiologic closed-loop controllers
283 Amendment 1:2013
284 Amendment 2:2020
285 IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: General requirements for basic
286 safety and essential performance – Collateral Standard: Requirements for medical electrical
287 equipment and medical electrical systems used in the home healthcare environment .
288 Amendment 1:2020
289 IEC 61672-1:2013, Electroacoustics – Sound level meters – Part 1: Specifications
290 ISO 3744:2010, Acoustics – Determination of sound power levels and sound energy levels of
291 noise sources using sound pressure – Engineering method in an essentially free field over a
292 reflecting plane
293 Terms and definitions
294 For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
295 IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, IEC 60601-1-2:2014 and
296 IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012 and
297 IEC 60601-1-8:2006/AMD2:2020, IEC 60601-1-10:2007, IEC 60601-1-10:2007/AMD1:2013
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298 and IEC 60601-1-10:2007/AMD2:2020, IEC 60601-1-11:2015 and IEC 60601-1-
299 11:2015/AMD1:2020, and the following apply.
300 ISO and IEC maintain terminological databases for use in standardization at the following
301 addresses:
302 IEC Electropedia: available at http://www.electropedia.org/
303 ISO Online browsing platform: available at http://www.iso.org/obp
304 NOTE Refer to section “Index of defined terms used in this particular standard” for the index of defined terms.
305 201.3.8
306 * APPLIED PART
307 Replacement:
308 EXTRACORPOREAL CIRCUIT and all parts permanently and conductively connected to it (e.g.
309 DIALYSIS FLUID circuit)
310 Note 1 to entry: See Figure AA.1 in Informative Annex Subclause 201.16 and see 201.16.6.3.
311 Note 2 to entry: One example of an APPLIED PART is the EXTRACORPOREAL CIRCUIT including any pre-manufactured
312 DIALYSIS FLUID bags, extension lines, and drain bags in a stand-alone system connected during treatment.
313 Note 3 to entry: Another example of an APPLIED PART is the EXTRACORPOREAL CIRCUIT including connected DIALYSIS
314 FLUID bags, that are online prepared before treatment without the patient connected and drain bags. During treatment
315 the online preparation part of the HAEMODIALYSIS EQUIPMENT is conductively disconnected.
316 Note 4 to entry: Another example of an APPLIED PART is the EXTRACORPOREAL CIRCUIT including all HAEMODIALYSIS
317 EQUIPMENT used for online production of DIALYSIS FLUID bags and/or the connection to a drain during the treatment.
318 201.3.78
319 PATIENT CONNECTION
320 Addition:
321 Note 1 to entry: The PATIENT blood lines connectors are the individual points on the APPLIED PART through which a
322 current can flow between the PATIENT and the HAEMODIALYSIS EQUIPMENT in NORMAL CONDITION or SINGLE FAULT
323 CONDITION.
324 Additional terms and definitions:
325 201.3.201
326 ARTERIAL PRESSURE
327 pressure measured in the blood withdrawal line of the EXTRACORPOREAL CIRCUIT between the
328 PATIENT CONNECTION and DIALYSER connection
329 Note 1 to entry: A difference can be made between the pre-pump pressure, which is ups
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