oSIST prEN IEC 80601-2-23:2024
(Main)Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
2019-05-29 IP: Link to legislation (MDD) removed following CLC/TC 62 decision 02/2019 decision (May 2019 plenary)
Medizinische elektrische Geräte - Teil 2-23: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Geräten für die transkutane Partialdrucküberwachung
Appareils électromédicaux - Partie 2-23: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de surveillance de la pression partielle transcutanée
Medicinska električna oprema - 2-23. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za skozikožno (transkutano) nadzorovanje delnega (parcialnega) krvnega tlaka
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2024
Medicinska električna oprema - 2-23. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za skozikožno (transkutano) nadzorovanje delnega
(parcialnega) krvnega tlaka
Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and
essential performance of transcutaneous partial pressure monitoring equipment
Medizinische elektrische Geräte - Teil 2-23: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Geräten für die transkutane
Partialdrucküberwachung
Appareils électromédicaux - Partie 2-23: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de surveillance de la pression partielle
transcutanée
Ta slovenski standard je istoveten z: prEN IEC 80601-2-23:2024
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
62D/2133/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 80601-2-23 ED1
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2024-06-07 2024-08-30
SUPERSEDES DOCUMENTS:
62D/2037A/RR
IEC SC 62D : PARTICULAR MEDICAL EQUIPMENT, SOFTWARE, AND SYSTEMS
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 t hey
are aware and to provide supporting documentation.
Recipients of this document are invited to submit, with their comments, notification of any relevant “In Some Countries” clau ses
to be included should this proposal proceed. Recipients are reminded that the CDV stage is the final stage for submitting ISC
clauses. (SEE AC/22/2007 OR NEW GUIDANCE DOC).
TITLE:
Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential
performance of transcutaneous partial pressure monitoring equipment
PROPOSED STABILITY DATE: 2030
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.
62D/2133/CDV – 2 – IEC CDV 80601-2-23 © IEC:2024
1 CONTENTS
2 FOREWORD . 5
3 INTRODUCTION . 9
4 201.1 Scope, object and related standards. 10
5 201.1.1 * Scope . 10
6 201.1.2 Object . 10
7 201.1.3 Collateral standards . 11
8 201.1.4 Particular standards . 11
9 201.2 Normative references . 12
10 201.3 Terms and definitions . 12
11 201.4 General requirements . 13
12 201.4.7 SINGLE FAULT CONDITION for ME EQUIPMENT . 13
13 201.4.101 Additional ESSENTIAL PERFORMANCE requirements . 13
14 201.5 General requirements for testing of ME EQUIPMENT . 14
15 201.5.4 Other conditions . 14
16 201.5.8 * Sequence of tests . 14
17 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 14
18 201.6.2 * Protection against electric shock . 14
19 201.6.6 Mode of operation. 14
20 201.7 ME EQUIPMENT identification, marking and documents . 15
21 201.7.9.2 Instructions for use . 15
22 201.7.9.2.2 Warning and safety notices . 15
23 201.7.9.2.101 Additional instructions for use . 15
24 201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 16
25 201.8.101 * TRANSDUCERS and cables . 16
26 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 17
27 201.10 Protection against unwanted and excessive radiation HAZARDS . 17
28 201.11 Protection against excessive temperatures and other HAZARDS . 17
29 201.11.1.2 Temperature of APPLIED PARTS . 17
30 201.11.1.2.2 * APPLIED PARTS not intended to supply heat to a PATIENT . 17
31 201.11.1.2.2.101 Heater in the APPLIED PART . 17
32 201.11.1.2.2.102 Indication of SET TEMPERATURE . 17
33 201.11.1.2.2.103 SET TEMPERATURE . 17
34 201.11.1.2.2.104 Temperature overshoot . 17
35 201.11.1.2.2.105 TEMPERATURE LIMITER . 18
36 201.11.1.2.2.106 * Indication of temperature deviation in SINGLE
37 FAULT CONDITION 19
38 201.11.1.2.2.107 Timer indicating an elapsed time . 19
39 201.11.6.5 * Ingress of water or particulate matter into ME EQUIPMENT
40 and ME SYSTEMS . 19
41 201.11.8 * Interruption of the power supply / SUPPLY MAINS to
42 ME EQUIPMENT . 19
43 201.11.8.101 * Protection against depletion of battery . 20
44 201.12 Accuracy of controls and instruments and protection against hazardous
45 outputs . 21
46 201.12.1 Accuracy of controls and instruments . 21
47 201.12.1.101 * Non-linearity and hysteresis . 21
IEC 80601-2-23 © IEC:2024 – 3 – 62D/2133/CDV
48 201.12.1.102 * Drift . 26
49 201.12.1.103 Response time . 26
50 201.12.3 Alarm systems . 26
51 201.13 HAZARDOUS SITUATIONS and fault conditions . 26
52 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 26
53 201.15 Construction of ME EQUIPMENT . 26
54 201.15.3.4.1 * HAND-HELD ME EQUIPMENT . 26
55 201.15.4.2 Temperature and overload control devices . 27
56 201.15.4.4 Indicators . 27
57 201.15.4.4.101 Indicator of battery operation and battery status . 27
58 201.16 ME SYSTEMS. 27
59 201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 27
60 202 Electromagnetic disturbances – Requirements and tests . 27
61 202.4.3.1 Configurations . 27
62 202.8.1 * General . 29
63 206 Usability . 30
64 206.101 Primary operating functions . 30
65 208 General requirements, tests and guidance for alarm systems in medical electrical
66 equipment and medical electrical systems . 30
67 208.6 ALARM SYSTEMS . 31
68 208.6.1 Alarm condition. 31
69 208.6.1.2 * Determination of ALARM CONDITIONS and assignment of priority . 31
70 208.6.4.1 ALARM SYSTEM delays . 31
71 208.6.4.1.101 Additional requirements for ALARM SYSTEM delays . 31
72 208.6.4.1.102 * Time to alarm for TECHNICAL ALARM CONDITIONS . 32
73 208.6.5 ALARM PRESETS . 32
74 208.6.5.2 Manufacturer-configured ALARM PRESETS . 32
75 208.6.6 ALARM LIMIT . 32
76 208.6.6.1 General requirements . 32
77 208.6.6.1.101 * Adjustment range of pO and pCO ALARM LIMITS . 32
2 2
78 208.6.6.1.102 Resolution of ALARM LIMIT settings . 33
79 208.6.8 ALARM SIGNAL inactivation states . 33
80 208.6.8.1 * General . 33
81 208.6.10 * NON-LATCHING and LATCHING ALARM SIGNALS . 33
82 208.6.12 ALARM SYSTEM logging . 34
83 208.6.12.1 General . 34
84 208.6.12.2 OPERATOR ALARM SYSTEM logging . 34
85 208.6.12.3 RESPONSIBLE ORGANIZATION ALARM SYSTEM logging . 34
86 Annexes . 34
87 Annex AA (informative) Particular guidance and rationale . 35
88 Guidance and rationale for particular clauses . 35
89 Index of defined terms used in this particular standard . 41
91 Figure 201.101 – TRANSDUCER cable strain relief test . 16
92 Figure 201.102 – Foam block test (see 201.11.1.2.2.104 and 201.11.1.2.2.105) . 18
93 Figure 201.103 – Linearity and hysteresis test set-up – Gas mix chamber, assembled . 23
94 Figure 202.101 – Set-up for radiated and conducted EMISSIONS testing . 28
62D/2133/CDV – 4 – IEC CDV 80601-2-23 © IEC:2024
95 Figure 202.102 – Set-up for conducted and radiated immunity test . 29
97 Table 201.101 – Distributed ESSENTIAL PERFORMANCE requirements . 13
98 Table 201.102 – Required readings and tolerances . 21
99 Table 201.103 – Calibration test gases . 22
IEC 80601-2-23 © IEC:2024 – 5 – 62D/2133/CDV
102 INTERNATIONAL ELECTROTECHNICAL COMMISSION
103 ____________
105 MEDICAL ELECTRICAL EQUIPMENT –
107 Part 2-23: Particular requirements for the basic safety and
108 essential performance of transcutaneous partial
109 pressure monitoring equipment
112 FOREWORD
113 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
114 all national electrotechnical committees (IEC National Committees). The object of IEC is
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.