prEN IEC 60601-2-66:2026

SLOVENSKI STANDARD
01-marec-2026
Medicinska električna oprema - 2-66. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti slušnih pripomočkov in sistemov
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and
essential performance of hearing aids and hearing aid systems
Medizinische elektrische Geräte - Teil 2-66: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Hörgeräten und
Hörgerätesystemen
Appareils électromédicaux - Partie 2-66: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils de correction auditive et des systèmes de
correction auditive
Ta slovenski standard je istoveten z: prEN IEC 60601-2-66:2026
ICS:
11.180.15 Pripomočki za gluhe osebe in Aids for deaf and hearing
osebe z okvaro sluha impaired people
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

29/1227/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-66 ED4
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2026-01-16 2026-04-10
SUPERSEDES DOCUMENTS:
29/1203A/CD, 29/1208A/CC
IEC TC 29 : ELECTROACOUSTICS
SECRETARIAT: SECRETARY:
Denmark Ms Lise Aagesen
OF INTEREST TO THE FOLLOWING COMMITTEES: HORIZONTAL FUNCTION(S):

ASPECTS CONCERNED:
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.
Recipients of this document are invited to submit, with their comments, notification of any relevant “In Some
Countries” clauses 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 2-66: Particular requirements for the basic safety and
essential performance of hearing aids and hearing aid systems

PROPOSED STABILITY DATE: 2028
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, o r any part of it,
for any other purpose without permission in writing from IEC.

NOTE FROM TC/SC OFFICERS:
At its meeting in September 2025 in New Delhi, TC 29 took the following decision, doc. 29/1219/DL
refers:
DECISION 8
TC 29 decides to proceed with 3CD 60601-2-66 "Medical electrical equipment – Part 2-66: Particular
requirements for the basic safety and essential performance of hearing aids and hearing aid systems"
as a CDV with the following target dates:
CDV: 2026-01-31
FDIS: 2026-12-31
Publication: 2027-03-31.
IEC CDV 60601-2-66 © IEC 2026
1 CONTENTS
3 FOREWORD . 10
4 INTRODUCTION . 13
5 201.1 Scope, object and related standards . 14
6 201.1.1 * Scope. 14
7 201.1.2 Object . 15
8 201.1.3 * Collateral standards . 15
9 201.1.4 Particular standards . 15
10 201.2 Normative references . 16
11 201.3 Terminology and definitions . 18
12 201.4 General requirements . 22
13 201.4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS . 22
14 4.2 * RISK MANAGEMENT PROCESS for ME EQUIPMENT or ME SYSTEMS . 22
15 4.2.1 Introduction to RISK MANAGEMENT . 22
16 4.2.2 General requirement for RISK MANAGEMENT . 22
17 4.2.3 Evaluating RISK . 22
18 4.2.3.1 HAZARDS identified in the IEC 60601- series . 22
19 4.2.3.2 HAZARDS not identified in the IEC 60601-series. 22
20 201.4.3 ESSENTIAL PERFORMANCE . 22
21 4.4 * EXPECTED SERVICE LIFE . 23
22 4.5 * Alternative RISK CONTROL measures or test methods for ME EQUIPMENT
23 or ME SYSTEMS . 23
24 201.4.6 ME EQUIPMENT or ME SYSTEMS parts that contact the PATIENT . 23
25 4.7 * SINGLE FAULT CONDITION for ME EQUIPMENT . 23
26 4.8 * Components of ME EQUIPMENT . 23
27 4.9 * Use of COMPONENTS WITH HIGH INTEGRITY CHARACTERISTICS in ME
28 EQUIPMENT . 23
29 201.4.10 Power supply . 23
30 201.4.11 Power input [does not apply] . 23
31 201.5 General requirements for testing ME EQUIPMENT . 23
32 5.1 * TYPE TESTS . 23
33 201.5.2 Number of samples . 23
34 201.5.3 Ambient temperature, humidity, atmospheric pressure . 23
35 201.5.4 Other conditions . 23
36 201.5.5 Supply voltages, type of current, nature of supply, frequency . 24
37 5.6 Repairs and modifications . 24
38 201.5.7 Humidity preconditioning treatment . 24
39 5.8 Sequence of tests . 25
40 201.5.9 Determination of APPLIED PARTS and ACCESSIBLE PARTS . 25
41 201.5.9.1 * APPLIED PARTS . 25
42 201.5.9.2 ACCESSIBLE PARTS . 25
43 201.5.9.2.1 Test finger . 25
44 201.5.9.2.2 Test hook [does not apply] . 25
45 201.5.9.2.3 Actuating mechanism [does not apply] . 25
46 201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 25
47 6.1 General . 25
IEC CDV 60601-2-66 © IEC 2026
48 201.6.2 Protection against electric shock . 25
49 201.6.3 Protection against harmful ingress of water or particulate matter . 25
50 201.6.4 Method(s) of sterilization [does not apply] . 26
51 6.5 Suitability for use in an OXYGEN RICH ATMOSPHERE . 26
52 201.6.6 Mode of operation . 26
53 201.7 ME EQUIPMENT identification, marking and documents . 26
54 201.7.1 General . 26
55 201.7.1.1 USABILITY of the identification, marking and documents. 26
56 201.7.1.2 Legibility of markings . 26
57 201.7.1.3 Durability of markings . 26
58 201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts . 27
59 201.7.2.1 Minimum requirements for marking on ME EQUIPMENT and on
60 interchangeable parts . 27
61 201.7.2.2 Identification . 27
62 201.7.2.3 Consult ACCOMPANYING DOCUMENTS [does not apply] . 27
63 7.2.4 * Accessories . 27
64 201.7.2.5 ME EQUIPMENT intended to receive power from other equipment [does
65 not apply] . 27
66 201.7.2.6 Connection to the SUPPLY MAINS . 27
67 201.7.2.7 Electrical input power from the SUPPLY MAINS . 28
68 201.7.2.8 Output connectors [does not apply] . 28
69 201.7.2.9 IP classification . 28
70 201.7.2.10 APPLIED PARTS [does not apply] . 28
71 201.7.2.11 Mode of operation [does not apply] . 28
72 201.7.2.12 Fuses [does not apply] . 28
73 201.7.2.13 Physiological effects (SAFETY SIGNS and warning
74 statements) [does not apply] . 28
75 201.7.2.14 HIGH VOLTAGE TERMINAL DEVICES [does not apply] . 28
76 201.7.2.15 Cooling conditions [does not apply] . 28
77 201.7.2.16 Mechanical stability [does not apply] . 28
78 201.7.2.17 Protective packaging . 28
79 201.7.2.18 External pressure source [does not apply] . 29
80 201.7.2.19 FUNCTIONAL EARTH TERMINALS [does not apply] . 29
81 201.7.2.20 Removable protective means [does not apply] . 29
82 201.7.2.21 Mass of MOBILE ME EQUIPMENT [does not apply]. 29
83 201.7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts (see also
84 Table C.2) . 29
85 201.7.3.3 Batteries . 29
86 201.7.4 Marking of controls and instruments . 29
87 201.7.4.1 Power switches . 29
88 201.7.4.2 Control devices . 29
89 201.7.4.3 Units of measurement [does not apply] . 29
90 201.7.5 SAFETY SIGNS [does not apply] . 29
91 201.7.6 Symbols [does not apply] . 29
92 201.7.7 Colours of the insulation of conductors [does not apply] . 29
93 201.7.8  * Indicator lights and controls. 30
94 201.7.8.1 Colours of indicator lights . 30
95 201.7.9 ACCOMPANYING DOCUMENTS . 30
96 201.7.9.1 General . 30
97 201.7.9.2 Instructions for use (see also Table C.5) . 30
IEC CDV 60601-2-66 © IEC 2026
98 201.7.9.2.1 General . 30
99 201.7.9.2.2 Warning and safety notices . 31
100 201.7.9.2.3  ME EQUIPMENT specified for connection to a separate power supply . 32
101 201.7.9.2.4 Electrical power source . 32
102 201.7.9.2.5 ME EQUIPMENT description . 32
103 201.7.9.2.6 Installation [does not apply] . 33
104 201.7.9.2.7 Isolation from the SUPPLY MAINS [does not apply] . 33
105 201.7.9.2.8 Start-up PROCEDURE . 33
106 201.7.9.2.9 Operating instructions . 33
107 201.7.9.2.10 Messages [does not apply] . 33
108 201.7.9.2.11 Shutdown PROCEDURE . 33
109 201.7.9.2.12 Cleaning, disinfection and sterilization . 33
110 201.7.9.2.13 Maintenance . 34
111 201.7.9.2.14 ACCESSORIES, supplementary equipment, used material . 34
112 201.7.9.2.15 Environmental protection . 34
113 201.7.9.2.16 Reference to the technical description. 34
114 201.7.9.2.17 ME EQUIPMENT emitting radiation [does not apply] . 34
115 201.7.9.2.18 ME EQUIPMENT and ACCESSORIES sterile [does not apply] . 34
116 201.7.9.2.19 Unique version identifier . 34
117 201.7.9.3 Technical description . 34
118 201.7.9.3.1 General . 35
119 201.7.9.3.3 Circuit diagrams, components parts lists, etc. . 35
120 201.7.9.3.101 Technical data sheet . 35
121 201.7.9.3.102 DIRECT-TO-CONSUMER HEARING AID technical data sheet . 35
122 201.8 * Protection against electrical HAZARDS from ME EQUIPMENT . 35
123 201.8.1 Fundamental rule of protection against electric shock . 36
124 201.8.2 Requirements related to power sources . 37
125 201.8.2.1 Connection to a separate power source . 37
126 201.8.2.2 Connection to an external d.c. power source . 38
127 201.8.3 Classification of APPLIED PARTS . 38
128 201.8.4 Limitation of voltage, current and energy . 38
129 201.8.4.1 PATENT CONNECTIONS intended to deliver current [does not apply] . 38
130 201.8.4.2 ACCESSIBLE PARTS and APPLIED PARTS . 38
131 201.8.4.3 ME EQUIPMENT intended to be connected to a power source by a plug
132 [does not apply] . 38
133 201.8.4.4 Internal capacitive circuits [does not apply] . 38
134 201.8.5 Separation of parts [does not apply] . 38
135 201.8.6 Protective earthing, functional earthing and potential equalization of ME
136 EQUIPMENT [does not apply] . 38
137 201.8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS . 39
138 201.8.7.1 General requirements . 39
139 201.8.7.2 SINGLE FAULT CONDITIONS . 39
140 201.8.7.3 Allowable values . 39
141 201.8.7.4 Measurements . 39
142 201.8.7.4.1 General . 39
143 201.8.7.4.2  Measuring supply circuit . 40
144 8.7.4.3 * Connection to the measuring supply circuit . 40
145 8.7.4.4 Measuring device (MD) . 40
IEC CDV 60601-2-66 © IEC 2026
146 201.8.7.4.5 Measurement of the EARTH LEAKAGE CURRENT and current in
147 functional earth connection [does not apply] . 40
148 201.8.7.4.6 Measurement of the TOUCH CURRENT . 40
149 201.8.7.4.7 Measurement of the PATIENT LEAKAGE CURRENT . 40
150 201.8.7.4.8 Measurement of the PATENT AUXILIARY CURRENT . 41
151 201.8.7.4.9 ME EQUIPMENT with multiple PATIENT CONNECTIONS [does not apply] . 41
152 201.8.8 Insulation [does not apply] . 41
153 201.8.9 CREEPAGE DISTANCES and AIR CLEARANCES [does not apply] . 41
154 201.8.10 Components and wiring [does not apply] . 41
155 201.8.11 MAINS PARTS, components and layout . 41
156 201.9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 41
157 201.9.1 MECHANICAL HAZARDS of ME EQUIPMENT . 41
158 201.9.2 MECHANICAL HAZARDS associated with moving parts [does not apply] . 42
159 201.9.3 MECHANICAL HAZARDS associated with surfaces, corners and edges . 42
160 201.9.4 Instability HAZARDS [does not apply] . 42
161 201.9.5 Expelled parts HAZARDS [does not apply] . 42
162 201.9.6. Acoustic energy (including infra- and ultrasound) and vibration . 42
163 9.6.1 *General . 42
164 201.9.6.2 Acoustic energy . 42
165 201.9.6.2.1 *Audible acoustic energy . 42
166 201.9.6.2.1.101 Requirements for all HEARING AIDS . 42
167 201.9.6.2.1.102 Additional requirements for DIRECT-TO-CONSUMER HEARING AIDS . 43
168 201.9.6.2.2 Infrasound and ultrasound energy [does not apply] . 43
169 201.9.6.3 Hand-transmitted vibration [does not apply] . 43
170 201.9.7 Pressure vessels and parts subject to pneumatic and hydraulic pressure
171 [does not apply] . 43
172 201.9.8 MECHANICAL HAZARDS associated with support systems [does not apply] . 43
173 201.9.101 HAZARD of entanglement . 43
174 201.9.102 HAZARDS of parts of a HEARING AID remaining in the ear canal . 44
175 201.9.103 Choking/ingestion HAZARD of loose parts of a HEARING AID . 44
176 201.10 * Protection against unwanted and excessive radiation HAZARDS . 44
177 201.10.5 Other visible electromagnetic radiation . 44
178 201.11 * Protection against excessive temperatures and other HAZARDS . 44
179 201.11.1 * Excessive temperatures in ME EQUIPMENT . 44
180 201.11.1.1 Maximum temperature during NORMAL USE . 44
181 201.11.1.2 Temperature of APPLIED PARTS . 45
182 201.11.1.2.1 APPLIED PARTS intended to supply heat to the PATIENT [does
183 not apply] 45
184 201.11.1.2.2 APPLIED PARTS not intended to supply heat to the PATIENT . 45
185 201.11.1.3 Measurements . 45
186 201.11.1.4 Guards [does not apply] . 45
187 201.11.2 Fire prevention [does not apply] . 46
188 201.11.3 Constructional requirements for fire ENCLOSURES of ME EQUIPMENT [does
189 not apply] . 46
190 201.11.4 ME EQUIPMENT and ME SYSTEMS intended for use with flammable
191 anaesthetics [does not apply] . 46
192 201.11.5 ME EQUIPMENT and ME SYSTEMS intended for use in conjunction with
193 flammable agents [does not apply] . 46
IEC CDV 60601-2-66 © IEC 2026
194 201.11.6 Overflow, spillage, leakage, ingress of water or particulate matter,
195 cleaning, disinfection, sterilization and compatibility with substances used
196 with the ME EQUIPMENT . 46
197 201.11.6.1 General . 46
198 201.11.6.2 Overflow in ME EQUIPMENT [does not apply] . 46
199 201.11.6.3 Spillage on ME EQUIPMENt and ME SYSTEMS [does not apply] . 46
200 201.11.6.4 Leakage [does not apply] . 46
201 201.11.6.5 Ingress of water or particulate matter into ME EQUIPMENT
202 and ME SYSTEMS 46
203 201.11.6.6 Cleaning and disinfection of ME EQUIPMENT and ME SYSTEMS . 46
204 201.11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMS [does not
205 apply] 47
206 201.11.6.8 Compatibility with substances used with the ME EQUIPMENT
207 [does not apply] 47
208 201.11.7 Biocompatibility of ME EQUIPMENt and ME SYSTEMS . 47
209 201.11.8 Interruption of power supply / SUPPLY MAINS to ME EQUIPMENT [does not
210 apply] . 47
211 201.12 Accuracy of controls and instruments and protection against hazardous
212 outputs . 47
213 12.1 Accuracy of controls and instruments . 47
214 201.12.2 * USABILITY of ME EQUIPMENT . 47
215 201.12.3 ALARM SYSTEMS [does not apply] . 48
216 201.12.4 Protection against hazardous output . 48
217 201.12.4.1 Intentional exceeding of safety limits . 48
218 201.12.4.2 Indication relevant to safety . 48
219 201.12.4.3 Accidental selection of excessive output values . 48
220 201.12.4.4 Incorrect output . 48
221 201.12.4.5 Diagnostic or therapeutic radiation [does not apply] . 48
222 201.12.4.6 Diagnostic or therapeutic acoustic pressure . 48
223 201.13 * HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 49
224 201.13.1 Specific HAZARDOUS SITUATIONS . 49
225 201.13.1.1 * General . 49
226 201.13.1.2 Emissions, deformation of ENCLOSURE or exceeding
227 maximum temperature . 49
228 201.13.1.3 Exceeding LEAKAGE CURRENT or voltage limits [does not
229 apply] 49
230 201.13.1.4 Specific MECHANICAL HAZARDS . 49
231 201.13.2 SINGLE FAULT CONDITIONS . 49
232 201.13.2.1 General . 50
233 201.13.2.2 Electrical SINGLE FAULT CONDITION . 50
234 201.13.2.11 Failure of components in ME EQUIPMENT used in conjunction
235 with OXYGEN RICH ENVIRONMENTS . 50
236 201.13.2.12 Failure of parts that might result in a MECHANICAL HAZARD . 50
237 201.14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 50
238 201.14.1 General . 50
239 14.2 Documentation . 51
240 14.3 RISK MANAGEMENT plan . 51
241 14.4 PEMS DEVELOPMENT LIFE-CYCLE [does not apply] . 51
242 14.5 Problem resolution [does not apply] . 51
243 14.6 RISK MANAGEMENT PROCESS . 51
244 14.6.1 Identification of known and foreseeable HAZARDS . 51
IEC CDV 60601-2-66 © IEC 2026
245 14.6.2 Risk control [does not apply] . 51
246 14.7 Requirement specification [does not apply] . 51
247 14.8 Architecture [does not apply] . 51
248 14.9 Design and implementation [does not apply] . 51
249 14.10 VERIFICATION [does not apply] . 51
250 14.11 PEMS VALIDATION . 51
251 14.12 Modification [does not apply] . 51
252 14.13 PEMS intended to be incorporated into an IT-NETWORK [does not apply]. 51
253 201.15 * Construction of ME EQUIPMENT . 51
254 201.15.1 Arrangement of controls and indicators of ME EQUIPMENT [does not
255 apply] . 51
256 201.15.2 Serviceability . 51
257 201.15.3 Mechanical strength. 52
258 201.15.3.1 General . 52
259 201.15.3.2 Push test . 52
260 201.15.3.3 Impact test . 52
261 201.15.3.4 Drop test . 52
262 201.15.3.4.101 Drop test for HEARING AIDS . 52
263 201.15.3.5 Rough handling test . 52
264 201.15.3.6 Mould stress relief test . 53
265 201.15.3.7 Environmental influences . 53
266 201.15.3.101 Mechanical design requirements for HEARING AIDS intended
267 for use by infants with age less than 36 months and persons with intellectual
268 disabilities 53
269 201.15.4 ME EQUIPMENT components and general assembly . 53
270 201.15.4.1 Construction of connectors [does not apply] . 53
271 201.15.4.2 Temperature and overload control devices [does not apply] . 54
272 201.15.4.3 *Batteries . 54
273 201.15.4.3.1 Housing . 54
274 201.15.4.3.2 Connection. 54
275 201.15.4.3.3 Protection against overcharging . 54
276 15.4.3.4 Lithium batteries . 54
277 201.15.4.3.5 Excessive current and voltage protection [does not apply] . 54
278 201.15.4.3.101 HEARING AID batteries . 54
279 201.15.4.4 Indicators . 55
280 201.15.4.5 Pre-set controls. 55
281 201.15.4.6 Actuating parts of controls of ME EQUIPMENT [does not
282 apply] 55
283 201.15.4.7 Cord-connected HAND-HELD and foot operated devices (see
284 also 8.10.4) [does not apply] . 55
285 201.15.4.8 Internal wiring of ME EQUIPMENT [does not apply] . 55
286 201.15.4.9 Oil containers [does not apply] . 55
287 201.15.5 MAINS SUPPLY TRANSFORMERS of ME EQUIPMENT and transformers
288 providing separation in accordance with 8.5 [does not apply] . 55
289 201.16 *ME SYSTEMS . 55
290 16.1 General requirements for the ME SYSTEMS . 55
291 201.16.2 ACCOMPANYING DOCUMENTS of an ME SYSTEMS . 55
292 201.16.3 Power Supply . 55
293 201.16.4 ENCLOSURES . 56
294 201.16.5 SEPARATION DEVICES [does not apply] . 56
IEC CDV 60601-2-66 © IEC 2026
295 201.16.6 Leakage currents . 56
296 201.16.6.1 TOUCH CURRENT . 56
297 201.16.6.2 EARTH LEAKAGE CURRENT of MULTIPLE SOCKET-OUTLET [does
298 not apply] 56
299 201.16.6.3 PATIENT LEAKAGE CURRENT . 56
300 201.16.6.4 Measurements . 56
301 201.16.6.4.1 General condition for ME SYSTEM . 56
302 201.16.6.4.2 Connection of the ME SYSTEM to the measuring supply
303 circuit 56
304 16.7 Protection against MECHANICAL HAZARDS. 56
305 16.8 Interruption of the power supply to parts of an ME SYSTEM . 56
306 201.16.9 ME SYSTEM connection and wiring . 56
307 201.16.9.1 Connection terminals and connectors . 56
308 201.16.9.2 MAINS PARTS, components and layout . 57
309 201.16.9.2.1 MULTIPLE SOCKET-OUTLET [does not apply] . 57
310 201.16.9.2.2 PROTECTIVE EARTH CONNECTIONS in ME SYSTEM [does not
311 apply] 57
312 16.9.2.3 Protection of conductors . 57
313 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 57
314 Annexes . 58
315 Annex E (informative) Examples of the connection of the measuring device (MD) for
316 measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT
317 [does not apply] . 59
318 Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic
319 mixtures [does not apply] . 60
320 Annex H (informative) PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and
321 documentation [does not apply] . 61
322 Annex I (informative) ME SYSTEMS aspects [does not apply] . 62
323 Annex J (informative) Survey of insulation paths [does not apply] . 63
324 Annex K (informative) Simplified PATIENT LEAKAGE CURRENT diagrams [does not apply] . 64
325 Annex L (normative) Insulated winding wires for use without interleaved insulation
326 [does not apply] . 65
327 Annex M (normative) Reduction of pollution degrees (see 8.9.1.8) [does not apply] . 66
328 Annex AA (informative) Particular guidance and rationale . 67
329 AA.1 General Guidance . 67
330 AA.2 Definition of safety requirements for HEARING AIDS . 67
331 AA.3 Rationale for particular clauses and subclauses . 69
332 Annex BB (informative) Abbreviations . 83
333 Annex CC (informative) Essential performance . 84
334 Annex DD (informative) Electromagnetic compatibility of ME EQUIPMENT . 85
335 Annex EE (informative) SOUND EXPOSURE limitation by level-dependent gain limits . 87
336 EE.1 General . 87
337 EE.2 Input signal for use for calculation . 87
338 EE.3 SOUND EXPOSURE limits . 87
339 EE.4 General rules to apply for calculation . 87
340 EE.5 Calculation of output L . 87
Aeq,24h
341 EE.6 Achievable gain for an equal output L Aeq,t of 63,8 dB . 89
342 Annex FF (informative) Calculational input signal . 90
IEC CDV 60601-2-66 © IEC 2026
343 FF.1 General . 90
344 FF.2 Input signal L =68 dB . 90
Aeq,24h
345 Annex GG (informative) Coupler based measurement procedure for L Aeq,24h verification. 92
346 GG.1 General . 92
347 GG.2 Measurement signal . 92
348 GG.2.1 Measurement signal IEC 60118-2/A2 . 92
349 GG.2.2 Measurement signal IEC 60118-15 . 92
350 GG.3 Venting . 92
351 GG.4 Coupler measurement . 93
352 GG.5 Alternative use of free-field data . 95
353 Annex HH (informative) Embedded SOUND DOSE meter verification . 96
354 HH.1 General . 96
355 HH.2 Set-up for SOUND DOSE meter conformance test . 96
356 HH.3 Sound dose meter conformance test procedure . 96
357 Annex II (informative) SOUND EXPOSURE limitation by SOUND EXPOSURE controlled
358 compression . 98
359 II.1 General . 98
360 II.2 Comparison of SPL controlled and SOUND EXPOSURE controlled
361 compression . 98
362 II.3 Realization concept . 100
363 Bibliography . 102
364 Index of defined terms used in this particular standard . 104
366 Figure 201.101 – Measuring circuit for LEAKAGE CURRENT (see 201.8.7.4.7) . 40
367 Figure AA.101 – Growth and decay of TTS . 72
368 Figure AA.102 – ATS as a function of the EQUIVALENT A-WEIGHTED CONTINUOUS SPL in
369 dB 72
370 Figure AA.103 – Maximum allowable steady-state TTS (ATS) versus sensorineural
371 hearing loss (4 kHz) . 73
372 Figure AA.104 – Block diagram showing signal transmission path . 75
373 Figure AA.105 – Example of a HEARING AID input-output characteristics with indicated
374 linear and USE-CONDITION setting . 76
375 Figure AA.106 – Conversion of LAeq,40h,week to LAeq,24h . 78
376 Figure AA.107 – HEARING AID safe range and range where ear-protection is required . 78
377 Figure AA.108 – Examples of skin contact temperatures with ABS plastic material . 81
378 Figure EE.101 – Illustration of output L calculation . 88
Aeq,24h
379 Figure II.101 – Illustration of SPL- and SOUND EXPOSURE controlled compression
380 characteristics . 99
381 Figure II.102 – Gain characteristics for various Input L Aeq,24 . 100
382 Figure II.103 – Simplified circuit for sound exposure contro
...