oSIST prEN IEC 60601-2-39:2023
(Main)Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
Medizinische elektrische Geräte - Teil 2-39: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Peritoneal-Dialyse-Geräten
Appareils électromédicaux - Partie 2-39: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de dialyse péritonéale
Medicinska električna oprema - 2-39. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za trebušno dializo
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN IEC 60601-2-39:2023
01-januar-2023
Medicinska električna oprema - 2-39. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za trebušno dializo
Medical electrical equipment - Part 2-39: Particular requirements for basic safety and
essential performance of peritoneal dialysis equipment
Medizinische elektrische Geräte - Teil 2-39: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Peritoneal-Dialyse-Geräten
Appareils électromédicaux - Partie 2-39: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de dialyse péritonéale
Ta slovenski standard je istoveten z: prEN IEC 60601-2-39:2022
ICS:
11.040.99 Druga medicinska oprema Other medical equipment
oSIST prEN IEC 60601-2-39:2023 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN IEC 60601-2-39:2023
62D/1992/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-39 ED4
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-11-11 2023-02-03
SUPERSEDES DOCUMENTS:
62D/1913/CD, 62D/1934A/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 2-39: Particular requirements for basic safety and essential
performance of peritoneal dialysis 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
permission in writing from IEC.
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62D/1992/CDV – 2 – IEC/CDV 60601-2-39:Ed. 4 © IEC 2022
1 CONTENTS
2 CONTENTS . 2
3 FOREWORD . 3
4 INTRODUCTION . 6
5 Scope, object and related standards . 7
6 Normative references . 9
7 Terms and definitions . 9
8 General requirements . 11
9 General requirements for testing ME EQUIPMENT . 15
10 Classification of ME EQUIPMENT and ME SYSTEMS . 15
11 ME EQUIPMENT identification, marking and documents . 15
12 Protection against electrical HAZARDS from ME EQUIPMENT . 19
13 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 20
14 Protection against unwanted and excessive radiation HAZARDS . 20
15 Protection against excessive temperatures and other HAZARDS . 20
16 Accuracy of controls and instruments and protection against hazardous outputs . 23
17 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 25
18 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 26
19 Construction of ME EQUIPMENT . 27
20 * ME SYSTEMS . 28
21 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS. 29
22 202 Electromagnetic disturbances – Requirements and tests . 29
23 208 * General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL
24 ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS . 30
25 209 Requirements for environmentally conscious design . 32
26 211 Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS
27 used in the HOME HEALTHCARE ENVIRONMENT . 33
28 Annexes . 34
29 Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
30 mixtures . 35
31 Annex AA (informative) Particular guidance and rationale . 36
32 Bibliography . 48
33 Index of defined terms used in this particular standard . 49
34
35 Table 201.101 – ESSENTIAL PERFORMANCE requirements . 12
36
37
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38 INTERNATIONAL ELECTROTECHNICAL COMMISSION
39 ____________
40
41 MEDICAL ELECTRICAL EQUIPMENT –
42
43 Part 2-39: Particular requirements for basic safety and essential
44 performance of peritoneal dialysis equipment
45
46 FOREWORD
47 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
48 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international
49 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and
50 in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,
51 Publicly Available Specifications (PAS) and Guides (hereafter referred to as "IEC Publication(s)"). Their
52 preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with
53 may participate in this preparatory work. International, governmental and non-governmental organizations liaising
54 with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for
55 Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.
56 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
57 consensus of opinion on the relevant subjects since each technical committee has representation from all
58 interested IEC National Committees.
59 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
60 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
61 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
62 misinterpretation by any end user.
63 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
64 transparently to the maximum extent possible in their national and regional publications. Any diverg ence between
65 any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.
66 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
67 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
68 services carried out by independent certification bodies.
69 6) All users should ensure that they have the latest edition of this publication.
70 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
71 members of its technical committees and IEC National Committees for any personal injury, property damage or
72 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
73 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
74 Publications.
75 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
76 indispensable for the correct application of this publication.
77 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of patent
78 rights. IEC shall not be held responsible for identifying any or all such patent rights.
79 International standard IEC 60601-2-39 has been prepared by IEC subcommittee 62D:
80 Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
81 practice.
82 This edition cancels and replaces the third edition of IEC 60601-2-39 published in 2018. This
83 edition constitutes a technical revision.
84 This edition includes the following significant technical changes with respect to the previous
85 edition:
86 a) update of references to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
87 1:2005/AMD2:2020, of references to IEC 60601-1-2:2014 and IEC 60601-1-
88 2:2014/AMD1:2020, of references to IEC 60601-1-6:2010, IEC 60601-1-
89 6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020, of references to IEC 60601-1-
90 8:2006, IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2:2020, of
91 references to IEC 60601-1-9:2007, IEC 60601-1-9:2007/AMD1:2013 and IEC 60601-1-
92 9:2007/AMD2:2020, of references to IEC 60601-1-10:2007, IEC 60601-1-
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93 10:2007/AMD1:2013 and IEC 60601-1-10:2007/AMD2:2020 and of references to
94 IEC 60601-1-11:2015 and IEC 60601-1-11:2015/AMD1:2020;
95 b) consideration of ESSENTIAL PERFORMANCE in SINGLE FAULT CONDITION regarding IEC 60601-
96 1:2005/AMD1:2012/ISH1:2021;
97 c) including the information given in the document 62D/1771A/INF regarding clause 201.11.8
98 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT;
99 d) including the information given in the document 62D/1734/INF regarding technical issues of
100 the previous edition;
101 e) including SECURITY (CYBERSECURITY) requirements;
102 f) additions related to online PD SOLUTION generation (ONLINE PD);
103 g) improvements regarding the definition of the APPLIED PART;
104 h) improvement of the essential performance requirements clause/subclauses;
105 i) improvements for labelling;
106 j) other minor technical improvements;
107 k) editorial improvements.
108 The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/xxxx/FDIS 62D/xxxx/RVD
109
110 Full information on the voting for the approval of this particular standard can be found in the
111 report on voting indicated in the above table.
112 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
113 In this document, the following print types are used:
114 – requirements and definitions: roman type;
115 – test specifications: italic type;
116 – informative material appearing outside of tables, such as notes, examples and references: in smaller type.
117 Normative text of tables is also in a smaller type;
118 – TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
119 NOTED: SMALL CAPITALS.
120 In referring to the structure of this document, the term
121 – "clause" means one of the seventeen numbered divisions within the table of contents,
122 inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
123 – "subclause" means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
124 subclauses of Clause 7).
125 References to clauses within this document are preceded by the term "Clause" followed by the
126 clause number. References to subclauses within this particular standard are by number only.
127 In this document, the conjunctive "or" is used as an "inclusive or" so a statement is true if any
128 combination of the conditions is true.
129 The verbal forms used in this document conform to usage described in Clause 7 of the ISO/IEC
130 Directives, Part 2. For the purposes of this document, the auxiliary verb:
131 – "shall" means that compliance with a requirement or a test is mandatory for compliance with
132 this document;
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133 – "should" means that compliance with a requirement or a test is recommended but is not
134 mandatory for compliance with this document;
135 – "may" is used to describe a permissible way to achieve compliance with a requirement or
136 test.
137 An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title
138 indicates that there is guidance or rationale related to that item in Annex A A.
139 A list of all parts of the IEC 60601 series, published under the general title Medical electrical
140 equipment, can be found on the IEC website.
141 The committee has decided that the contents of this publication will remain unchanged until the
142 stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
143 the specific publication. At this date, the publication will be
144 • reconfirmed,
145 • withdrawn,
146 • replaced by a revised edition, or
147 • amended.
148 NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing
149 organizations may need a transitional period following publication of a new, amended or revised IEC publication in
150 which to make products in accordance with the new requirements and to equip themselves for conducting new or
151 revised tests. It is the recommendation of the committees that the content of this publication be adopted for
152 implementation nationally not earlier than 3 years from the date of publication.
153
154
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155 INTRODUCTION
156 The minimum safety requirements specified in this particular standard are considered to provide
157 for a practical degree of safety in the operation of PERITONEAL DIALYSIS ME EQUIPMENT.
158
159
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160 MEDICAL ELECTRICAL EQUIPMENT –
161
162 Part 2-39: Particular requirements for basic safety and essential
163 performance of peritoneal dialysis equipment
164
165
166
167 Scope, object and related standards
1
168 Clause 1 of the general standard applies, except as follows:
169 201.1.1 Scope
170 Replacement:
171 This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PERITONEAL
172 DIALYSIS ME EQUIPMENT, hereafter referred to as PD EQUIPMENT. It applies to PD EQUIPMENT
173 intended for use either by medical staff or under the supervision of medical experts, including
174 PD EQUIPMENT operated by the PATIENT, regardless of whether the PD EQUIPMENT is used in a
175 hospital or domestic environment.
176 If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
177 ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
178 case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
179 This document does not take into consideration specific safety details of the DIALYSING SOLUTION
180 control system of PD EQUIPMENT using regeneration of DIALYSING SOLUTION or CENTRAL DELIVERY
181 SYSTEMS for DIALYSING SOLUTION. It does, however, take into consideration the specific safety
182 requirements of such PD EQUIPMENT concerning electrical safety and PATIENT safety.
183 This document specifies the minimum safety requirements for PD EQUIPMENT. These PD
184 EQUIPMENT are intended for use either by medical staff or for use by the PATIENT or other trained
185 personnel under medical supervision.
186 This document includes all ME EQUIPMENT that is intended to deliver a PERITONEAL DIALYSIS
187 treatment to a PATIENT, independent of the treatment duration and location.
188 These particular requirements do not apply to pre-manufactured DIALYSING SOLUTION bags,
189 DIALYSING SOLUTION CIRCUITS and DIALYSING SOLUTION CONCENTRATE.
190 201.1.2 Object
191 Replacement:
192 The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL
193 PERFORMANCE requirements for PD EQUIPMENT.
194 201.1.3 Collateral standards
195 Addition:
______________
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.
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196 This particular standard refers to those applicable collateral standards that are listed in Clause
197 2 of the general standard and Clause 201.2 of this particular standard.
198 IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-8:2006, IEC 60601-1-
199 8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2:2020, IEC 60601-1-10:2007, IEC 60601-
200 1-10:2007/AMD1:2013 and IEC 60601-1-10:2007/ AMD2:2020, IEC 60601-1-11:2015 and IEC
201 60601-1-11:2015/AMD1:2020 apply as modified in Clauses 202, 208, 210 and 211.
202 IEC 60601-1-3 does not apply. IEC 60601-1-9:2007, IEC 60601-1-9:2007/AMD1:2013 and IEC
203 60601-1-9:2007/AMD2:2020 does not apply as noted in Clause 209.
204 All other published collateral standards in the IEC 60601-1 series apply as published.
205 201.1.4 Particular standards
206 Replacement:
207 In the IEC 60601 series, particular standards may modify, replace or delete requirements
208 contained in the general standard and collateral standards as appropriate for the particular
209 ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL
210 PERFORMANCE requirements.
211 A requirement of a particular standard takes priority over the general standard.
212 For brevity, IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-
213 1:2005/AMD2:2020 are referred to in this particular standard as the general standard.
214 Collateral standards are referred to by their document number.
215 The numbering of clauses and subclauses of this particular standard corresponds to that of the
216 general standard with the prefix "201" (e.g. 201.1 in this document addresses the content of
217 Clause 1 of the general standard) or applicable collateral standard with the prefix "20x" where
218 x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular
219 standard addresses the content of Clause 4 of the 60601-1-2 collateral standard, 203.4 in this
220 particular standard addresses the content of Clause 4 of the 60601-1-3 collateral standard,
221 etc.). The changes to the text of the general standard are specified by the use of the following
222 words:
223 "Replacement" means that the clause or subclause of the general standard or applicable
224 collateral standard is replaced completely by the text of this particular standard.
225 "Addition" means that the text of this particular standard is additional to the require ments of the
226 general standard or applicable collateral standard.
227 "Amendment" means that the clause or subclause of the general standard or applicable
228 collateral standard is amended as indicated by the text of this particular standard.
229 Subclauses, figures or tables which are additional to those of the general standard are
230 numbered starting from 201.101. However, due to the fact that definitions in the general
231 standard are numbered 3.1 through 3.154, additional definitions in this document are numbered
232 beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items
233 aa), bb), etc.
234 Subclauses, figures or tables which are additional to those of a collateral standard are
235 numbered starting from 20x, where "x" is the number of the collateral standard, for example 202
236 for IEC 60601-1-2, 203 for IEC 60601-1-3, etc.
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237 The term "this document" is used to make reference to the general standard, any applicable
238 collateral standards and this particular standard taken together.
239 Where there is no corresponding clause or subclause in this particular standard, the clause or
240 subclause of the general standard or applicable collateral standard, although possibly not
241 relevant, applies without modification; where it is intended that any part of the general s tandard
242 or applicable collateral standard, although possibly relevant, is not to be applied, a statement
243 to that effect is given in this particular standard.
244 Normative references
245 NOTE Informative references are listed in the bibliography.
246 Clause 2 of the general standard applies, except as follows:
247 Addition:
248 IEC 60601-1-10:2007, Medical electrical equipment – Part 1-10: General requirements for
249 basic safety and essential performance – Collateral Standard: Requirements for the
250 development of physiologic closed-loop controllers
251 Amendment 1:2013
252 Amendment 2:2020
253 IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: General requirements for
254 basic safety and essential performance – Collateral Standard: Requirements for medical
255 electrical equipment and medical electrical systems used in the home healthcare environment
256 Amendment 1:2020
257 IEC 61672-1:2013, Electroacoustics – Sound level meters – Part 1: Specifications
258 ISO 3744:2010, Acoustics – Determination of sound power levels and sound energy levels of
259 noise sources using sound pressure – Engineering method in an essentially free field over a
260 reflecting plane
261
262 Terms and definitions
263 For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
264 IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, IEC 60601-1-2:2014 and
265 IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012 and
266 IEC 60601-1-8:2006/AMD2:2020, IEC 60601-1-10:2007, IEC 60601-1-10:2007/AMD1:2013
267 and IEC 60601-1-10:2007/AMD2:2020, IEC 60601-1-11:2015 and IEC 60601-1-
268 11:2015/AMD1:2020, and the following apply.
269 ISO and IEC maintain terminological databases for use in standardization at the following
270 addresses:
271 IEC Electropedia: available at http://www.electropedia.org/
272 ISO Online browsing platform: available at http://www.iso.org/obp
273 NOTE Refer to section “Index of defined terms used in this particular standard” for the index of defined terms.
274
275 201.3.8
276 * APPLIED PART
277 Replacement:
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278 DIALYZING SOLUTION CIRCUIT and all parts permanently and conductively connected to it
279 Note 1 to entry: See Annex AA Figure AA.1 in Informative Annex Subclause 201.16 and Clause 201.16.6.3.
280 Note 2 to entry: One example of an APPLIED PART is the DIALYSING SOLUTION CIRCUIT including pre-manufactured
281 DIALYSING SOLUTION bags, extension lines, and drain bags in a stand-alone system connected during treatment.
282 Note 3 to entry: Another example of an APPLIED PART is the DIALYSING SOLUTION CIRCUIT including connected
283 DIALYSING SOLUTION bags, that are online prepared before treatment without the PATIENT connected and drain bags.
284 During treatment the online preparation part of the PD EQUIPMENT is conductively disconnected.
285 Note 4 to entry: Another example of an APPLIED PART is the DIALYSING SOLUTION CIRCUIT including all PD EQUIPMENT
286 used for online production of DIALYSING SOLUTION bags and/or the connection to a drain during the treatment.
287
288 201.3.78
289 PATIENT CONNECTION
290 Addition:
291 Note 1 to entry: The PATIENT connector(s) is/are the individual point(s) on the APPLIED PART through which a current
292 can flow between the PATIENT and the PD EQUIPMENT in NORMAL CONDITION or SINGLE FAULT CONDITION.
293 Additional terms and definitions:
294 201.3.201
295 APD ME EQUIPMENT
296 ME EQUIPMENT used to perform AUTOMATED PERITONEAL DIALYSIS
297 201.3.202
298 AUTOMATED PERITONEAL DIALYSIS
299 APD
300 method to perform dialysis with automated fluid exchanges in the peritoneum
301 201.3.203
302 CENTRAL DELIVERY SYSTEM
303 part of a ME SYSTEM which proportions DIALYSING SOLUTION CONCENTRATE and DIALYSIS WATER
304 for distribution as DIALYSING SOLUTION to the PD EQUIPMENT or distributes DIALYSING SOLUTION
305 CONCENTRATE
306 201.3.204
307 DIALYSING SOLUTION
308 PD SOLUTION
309 aqueous fluid containing electrolytes and, usually, buffer and glucose, and which is intended to
310 exchange solutes during PERITONEAL DIALYSIS
311 Note 1 to entry: The DIALYSING SOLUTION could be pre-manufactured in bags as pharmaceuticals according to the
312 relevant pharmacopoeia monograph or be prepared by the PD EQUIPMENT or be influenced in composition by the PD
313 EQUIPMENT.
314 201.3.205
315 DIALYSING SOLUTION CIRCUIT
316 part of the fluid circuit that conveys DIALYSING SOLUTION from the PD EQUIPMENT to the peritoneal
317 cavity of the PATIENT, from the PATIENT to the PD EQUIPMENT, and from the PD EQUIPMENT to a
318 drainage bag or drain.
319 201.3.206
320 DIALYSING SOLUTION CONCENTRATE
321 substances which, when appropriately diluted or dissolved with DIALYSIS WATER, produce the
322 DIALYSING SOLUTION
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323 201.3.207
324 DIALYSIS WATER
325 water that has been treated to meet the requirements of ISO 23500-3:2019 [13] and which is
326 suitable for use in PD applications, including the preparation of DIALYZING SOLUTION and
327 preparation of DIALYSING SOLUTION CONCENTRATE
328 Note 1 to entry: The words "water for dialysis", "permeate", "reverse osmosis water" and "purified water" are
329 commonly used as synonyms of DIALYSIS WATER.
330 [SOURCE: ISO 23500-1:2019 [11], 3.17, modified – The reference number "[13]" has been
331 added in the definition, as well as the note.]
332 201.3.208
333 INFLOW
334 phase during which the peritoneal cavity is filled
335 Note 1 to entry: The term "fill" is commonly used as a synonym for "INFLOW".
336 201.3.209
337 ONLINE PD
338 PERITONEAL DIALYSIS PROCEDURE where the PD EQUIPMENT produces the DIALYSING SOLUTION for the PERITONEAL
339 DIALYSIS treatment
340 201.3.210
341 OUTFLOW
342 phase during which the peritoneal cavity is emptied
343 Note 1 to entry: The term "drain" is commonly used as a synonym for "OUTFLOW".
344 201.3.211
345 PERITONEAL DIALYSIS
346 PD
347 PROCESS whereby a DIALYSING SOLUTION is introduced into the peritoneal cavity of the PATIENT
348 and is subsequently removed
349 Note 1 to entry: The DIALYSING SOLUTION may be left in the peritoneal cavity for a dwell time or may be continuously
350 exchanged.
351 201.3.212
352 PERITONEAL DIALYSIS ME EQUIPMENT
353 PD EQUIPMENT
354 ME EQUIPMENT used to perform PERITONEAL DIALYSIS including APD ME EQUIPMENT
355 201.3.213
356 PROTECTIVE SYS
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