oSIST prEN IEC 61010-2-020:2020

SLOVENSKI STANDARD
oSIST prEN IEC 61010-2-020:2020
01-marec-2020
Varnostne zahteve za električno opremo za meritve, nadzor in laboratorijsko
uporabo - 2-020. del: Posebne zahteve za laboratorijske centrifuge
Safety requirements for electrical equipment for measurement, control, and laboratory
use - Part 2-020: Particular requirements for laboratory centrifuges
Règles de sécurité pour appareils électriques de mesurage, de régulation et de
laboratoire - Partie 2-020: Exigences particulières pour centrifugeuses de laboratoire
Ta slovenski standard je istoveten z: prEN IEC 61010-2-020:2020
ICS:
19.080 Električno in elektronsko Electrical and electronic
preskušanje testing
71.040.10 Kemijski laboratoriji. Chemical laboratories.
Laboratorijska oprema Laboratory equipment
oSIST prEN IEC 61010-2-020:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN IEC 61010-2-020:2020
66/711/CDV

COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 61010-2-020 ED4
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2020-01-10 2020-04-03
SUPERSEDES DOCUMENTS:
66/682/RR

IEC TC 66 : SAFETY OF MEASURING, CONTROL AND LABORATORY EQUIPMENT
SECRETARIAT: SECRETARY:
United Kingdom Mr David Hyde
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:
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part
2-020: Particular requirements for laboratory centrifuges

PROPOSED STABILITY DATE: 2024

NOTE FROM TC/SC OFFICERS:
The revision is to align IEC 61010-2-020:2016 with IEC 61010-1:2010 and its amendment 1:2016. A
revision this soon is justified by the large number of significant changes introduced by this amendment
1. With this revision IEC 61010-2-020 will be in line with the latest requirements of IEC 61010-1 + A1.
Establishment of a new edition is for better readability instead of amending edition 3.

Copyright © 2019 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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1 CONTENTS
2 FOREWORD . 3
3 1 Scope and object . 5
4 2 Normative references . 6
5 3 Terms and definitions . 6
6 4 Tests . 8
7 5 Marking and documentation . 8
8 6 Protection against electric shock . 11
9 7 Protection against mechanical HAZARDS . 11
10 8 Mechanical resistance to shock and impact . 17
11 9 Protection against the spread of fire . 17
12 10 Equipment temperature limits and resistance to heat . 17
13 11 Protection against HAZARDS from fluids . 17
14 12 Protection against radiation, including laser sources, and against sonic and
15 ultrasonic pressure . 19
16 13 Protection against liberated gases and substances, explosion and implosion . 19
17 14 Components . 19
18 15 Protection by interlocks . 19
19 16 Hazards resulting from application . 19
20 17 Risk assessment . 19
21 Annexes . 20
22 Annex L Index of defined terms . 20
23 Annex AA (normative) Dynamic microbiological test method for BIOSEALS . 21
24 Annex BB (informative) General guidance and rationale for particular subclauses . 24
25 Annex CC (informative) General guidance for an empirical method to determine the
26 kinetic energy of a ROTOR . 28
27 Bibliography . 30
28
29 Figure 101 – Rotor test setup . 28
30
31 Table 101 – Time-temperature conditions . 18
32
33

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34 INTERNATIONAL ELECTROTECHNICAL COMMISSION
35 ____________
36
37 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR
38 MEASUREMENT, CONTROL, AND LABORATORY USE –
39
40 Part 2-020: Particular requirements for LABORATORY CENTRIFUGES
41
42 FOREWORD
43 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
44 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
45 international co-operation on all questions concerning standardization in the electrical and electronic fields. To
46 this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
47 Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
48 Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
49 in the subject dealt with may participate in this preparatory work. International, governmental and non-
50 governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
51 with the International Organization for Standardization (ISO) in accordance with conditions determined by
52 agreement between the two organizations.
53 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
54 consensus of opinion on the relevant subjects since each technical committee has representation from all
55 interested IEC National Committees.
56 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
57 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
58 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
59 misinterpretation by any end user.
60 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
61 transparently to the maximum extent possible in their national and regional publications. Any divergence
62 between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
63 the latter.
64 5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
65 equipment declared to be in conformity with an IEC Publication.
66 6) All users should ensure that they have the latest edition of this publication.
67 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
68 members of its technical committees and IEC National Committees for any personal injury, property damage or
69 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
70 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
71 Publications.
72 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
73 indispensable for the correct application of this publication.
74 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
75 patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
76 International Standard IEC 61010-2-020 has been prepared by IEC technical committee 66:
77 Safety of measuring, control and laboratory equipment.
78 This fourth edition cancels and replaces the third edition published in 2016. It constitutes a
79 technical revision and includes the following significant changes from the second edition:
80 a) alignment with changes introduced by Amendment 1 of 61010-1 third edition.
81 It has the status of a product safety publication in accordance with IEC Guide 104.
82

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83 The text of this standard is based on the following documents:
CDV Report on voting
66/542/CDV 66/565A/RVC
84
85 Full information on the voting for the approval of this standard can be found in the report on
86 voting indicated in the above table.
87 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
88 This Part 2-020 is intended to be used in conjunction with IEC 61010-1. It was established on
89 the basis of the third edition (2010) and its Amendment 1 (2016).
90 This Part 2-020 supplements or modifies the corresponding clauses in IEC 61010-1 so as to
91 convert that publication into the IEC standard: Safety requirements for LABORATORY
92 CENTRIFUGES.
93 Where a particular subclause of Part 1 is not mentioned in this Part 2, that subclause applies
94 as far as is reasonable. Where this part states "addition", "modification" or "replacement", the
95 relevant requirement, test specification or note in Part 1 should be adapted accordingly.
96 In this standard:
97 1) the following print types are used:
98 – requirements: in roman type;
99 – NOTES: in small roman type;
100 – conformity and tests: in italic type;
101 – terms used throughout this standard which have been defined in Clause 3: SMALL
102 ROMAN CAPITALS.
103 2) subclauses, tables or figures which are additional to those in Part 1 are numbered starting
104 from 101; additional annexes are lettered AA, BB, etc.
105 A list of all parts of the IEC 61010 series, under the general title: Safety requirements for
106 electrical equipment for measurement, control, and laboratory use, may be found on the IEC
107 website.
108 The committee has decided that the contents of this publication will remain unchanged until
109 the stability date indicated on the IEC website under "http://webstore.iec.ch" in the data
110 related to the specific publication. At this date, the publication will be
111 • reconfirmed,
112 • withdrawn,
113 • replaced by a revised edition, or
114 • amended.
115
116

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117 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR
118 MEASUREMENT, CONTROL, AND LABORATORY USE –
119
120 Part 2-020: Particular requirements for laboratory centrifuges
121
122
123
124 1 Scope and object
125 This clause of Part 1 is applicable except as follows:
126 1.1.1 Scope
127 Replacement:
128 This Part 2 is applicable to electrically powered LABORATORY CENTRIFUGES.
129 It is possible that all or part of the equipment falls within the scope of one or more
130 other Part 2 standards of IEC  61010 as well as within the scope of this standard . In that
131 case, the requirements of those other Part 2 standards will also apply
132 This document is not applicable to electrically powered LABORATORY CENTRIFUGES.
133 manufactured before the date of its publication.
134 1.1.2 Equipment excluded from scope
135 Addition:
136 Add the following new item:
137 aa) IEC 60034 (Rotating electrical machinery);
138 1.2 Object
139 1.2.1 Aspects included in scope
140 Addition:
141 Add the following new items:
142 aa) contact with moving parts (see 7.3);
143 bb) LABORATORY CENTRIFUGE movement during any DISRUPTION (see 7.3.101);
144 cc) high energy chemical reaction after ROTOR DISRUPTION (see 7.7.2.2 l));
145 dd) ineffectiveness of BIOSEALS (see 13.101)
146 1.2.2 Aspects excluded from scope
147 Addition:
148 Add the following new items:
149 aa) additional precautions which may need to be observed when centrifuging materials
150 which are flammable or explosive (see 5.4.101);
151 bb) additional precautions which may need to be observed when centrifuging materials that
152 could react chemically with sufficient vigour to cause a HAZARD (see 5.4.101).

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153 1.4 Environmental conditions
154 1.4.1 Normal environmental conditions
155 Replacement:
156 Replace item c) by the following:
157 c) temperature 2 °C to 40 °C;
158 1.4.2 Extended environmental conditions
159 Replacement:
160 Replace item c) by the following:
161 c) ambient temperatures below 2 °C or above 40 °C;
162 2 Normative references
163 This clause of Part 1 is applicable except as follows:
164 Addition:
165 ISO 3864 (all parts), Graphical symbols – Safety colours and safety signs
166 3 Terms and definitions
167 This clause of Part 1 is applicable except as follows:
168 3.1 Equipment and states of equipment
169 Addition:
170 Add the following new terms and definitions:
171 3.1.101
172 LABORATORY CENTRIFUGE
173 apparatus intended for laboratory use that applies a centrifuging effect to sample materials
174 3.1.102
175 CENTRIFUGE-ROTOR COMBINATION
176 LABORATORY CENTRIFUGE and ROTOR ASSEMBLY that are intended to operate together and which
177 have to be evaluated together
178 3.1.103
179 DISRUPTION
180 event in which the ROTOR ASSEMBLY, or part of it, fails or becomes detached during rotation
181

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182 3.2 Parts and accessories
183 Addition:
184 Add the following new terms and definitions:
185 3.2.101
186 CHAMBER
187 enclosed space within a LABORATORY CENTRIFUGE in which the ROTOR ASSEMBLY rotates
188 3.2.102
189 ROTOR
190 primary component of a LABORATORY CENTRIFUGE which holds the material to be subjected to
191 centrifugal force and which is rotated by the DRIVE SYSTEM
192 3.2.103
193 BUCKET
194 sub-assembly of a ROTOR designed to support one or more containers
195 3.2.104
196 PROTECTIVE CASING
197 casing which completely surrounds the ROTOR ASSEMBLY and which includes the LID and its
198 securing devices
199 3.2.105
200 LID
201 access cover of the CHAMBER
202 3.2.106
203 ROTOR ASSEMBLY
204 ROTOR carrying a combination of ROTOR accessories specified by the manufacturer
205 Note 1 to entry: In the context of a ROTOR ASSEMBLY, ROTOR accessories include all components used with or in
206 the CENTRIFUGE ROTOR for the purpose of holding samples, including adaptors, tubes and bottles.
207 3.2.107
208 DRIVE SYSTEM
209 all components of the CENTRIFUGE associated with the provision of torque to, or the rotational
210 support of, the ROTOR ASSEMBLY
211 3.2.108
212 BIOSEAL
213 device or mechanism additional to, or integral with, a ROTOR or BUCKET and a closure
214 assembly, and which is designed to prevent the escape of contents, for example micro-
215 biological material, during centrifuging
216 3.5 Safety terms
217 Addition:
218 Add the following new terms and definitions:
219 3.5.101
220 CLEARANCE ENVELOPE
221 space around a LABORATORY CENTRIFUGE which is needed for safety
222

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223 3.5.102
224 MCA
225 MAXIMUM CREDIBLE ACCIDENT
226 planned event chosen to represent worst-case conditions for a test that will evaluate the
227 inherent mechanical safety of a CENTRIFUGE-ROTOR COMBINATION (see 7.7 and Annex BB)
228 4 Tests
229 This clause of Part 1 is applicable.
230 5 Marking and documentation
231 This clause of Part 1 is applicable except as follows.
232 5.1.2 Identification
233 Replacement:
234 Replace item b) by the following:
235 b) serial number or other means to identify the production batch of the equipment.
236 Addition:
237 Add the following addition:
238 5.1.3 Mains Supply
239 Addition:
240 Add the following note
241 NOTE - The maximum power or input current considered is usually during the acceleration phase of the rotor, with
242 any options such as cooling or heating energized.
243 Add the following new subclause:
244 5.1.101 ROTORS and accessories
245 All OPERATOR-replaceable ROTORS and ROTOR ASSEMBLIES, including ROTOR ACCESSORIES, shall
246 be marked with the manufacturer's or supplier's name or registered trade mark, and
247 identification code. (such as id code, serial number or batch number)
248 If components are too small, or are not suitable for such marking, the required information
249 shall be marked on the original packaging, as well as being stated in the documentation.
250 NOTE Packaging can be the outer box, an insert, etc.
251 If the manufacturer specifies that an individual part, for example a BUCKET, is to be fitted only
252 to a specific ROTOR or in specific ROTOR positions for balance or some other reason, each
253 BUCKET and ROTOR position should be identified by marking with corresponding numbers or
254 letters.
255 Conformity is checked by inspection.
256 5.4.2 Equipment ratings
257 Addition:

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258 Add the following new items:
259 aa) a list of all ROTORS and ROTOR accessories specified for use with a LABORATORY
260 CENTRIFUGE, together with their RATED rotational frequencies;
261 bb) any restrictions by the manufacturer warning against the use of particular materials to
262 be centrifuged;
263 cc) density and volume limits for ROTOR ASSEMBLY loading and, if applicable, derating
264 instructions.
265 5.4.3 Equipment installation
266 Addition:
267 Add, after item a), the following sub-items:
268 i) floor or bench area required for the CLEARANCE ENVELOPE for the intended use (see
269 7.4.101);
270 ii) total weight of the CENTRIFUGE;
271 iii) instructions for site preparation;
272 iv) methods for levelling of the CENTRIFUGE;
273 v) means for securing to the mounting surface.
274 5.4.4 Equipment operation
275 Addition:
276 Add the following new items:
277 aa) loading and balancing procedures;
278 bb) ROTOR changing procedure;
279 cc) any specific requirement for an OPERATOR to be present at stated phases of the
280 centrifuging procedure;
281 dd) necessary safeguards for personnel. Instructions shall include at least the following:
282 – not to lean on a LABORATORY CENTRIFUGE;
283 – not to stay within the CLEARANCE ENVELOPE longer than necessary for operational
284 reasons;
285 – not to deposit any potentially hazardous materials within the CLEARANCE ENVELOPE;
286 – methods for safe operation during open LID procedures (see 7.3.102.2);
287 ee) instructions for use of BIOSEALS and other biocontainment components, including the
288 proper closure techniques. These instructions shall indicate that BIOSEALS and related
289 components are intended to be part of biocontainment systems, as specified in
290 international and national biosafety guidelines. They are not to be relied on as the only
291 means of safeguarding workers and the environment when handling pathogenic micro-
292 organisms.
293 5.4.5 Equipment maintenance and service
294 Addition:
295 Add the following new paragraph:
296 Where applicable, the instructions shall specify:
297 aa) inspection of any means of fixing the equipment to the mounting surface and the
298 condition of the mounting surface itself;
299 bb) safeguards for the OPERATOR during cleaning;

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300 cc) inspection of the PROTECTIVE CASING;
301 dd) inspection of the ROTOR ASSEMBLY, and safety considerations;
302 ee) checking the continuity of the PROTECTIVE BONDING;
303 ff) frequency of inspection, routine maintenance and the method of replacement of
304 BIOSEALS and other biocontainment components.
305 Addition:
306 Add the following new subclauses:
307 5.4.101 Hazardous substances
308 The instructions for use shall state the precautions to be observed when the materials to be
309 used with a LABORATORY CENTRIFUGE are known to be toxic, radioactive, or contaminated with
310 pathogenic micro-organisms.
311 NOTE This information is relevant to the safety of both OPERATORS and service personnel.
312 The use within the LABORATORY CENTRIFUGE of the following materials shall be prohibited in
313 the instructions for use:
314 a) flammable or explosive materials;
315 b) materials which could react chemically with sufficient vigour to cause a HAZARD.
316 Conformity is checked by inspection.
317 5.4.102 Cleaning and decontamination
318 Documentation shall include:
319 a) a statement that, if hazardous material is spilt on or inside the equipment, the user has
320 responsibility for carrying out appropriate decontamination;
321 b) manufacturer's recommendations for cleaning and, where necessary, decontaminating,
322 together with the recognized generic names of recommended materials for cleaning and
323 decontaminating:
324 c) the following statement:
325 "Before using any cleaning or decontamination methods except those recommended by
326 the manufacturer, users should check with the manufacturer that the proposed method will
327 not damage the equipment”
328 d) the following statement:
329 Cleaning and decontamination may be necessary as a safeguard before LABORATORY
330 CENTRIFUGES, ROTORS, and any accessories are maintained, repaired, or transferred.
331 Manufacturers may provide a format for users to document that such treatment has been
332 carried out
333 NOTE Be advised, there are national guidelines and the internationally recognized "Laboratory Biosafety Manual",
334 published in 1993 by the Wor5ld Health Organization in Geneva, which gives information on decontaminants, their
335 use, dilutions, properties, and potential applications.
336 Conformity is checked by inspection.
337 5.4.103 Effects of chemicals and environmental influences
338 To ensure continued safe use of a LABORATORY CENTRIFUGE the documentation shall identify
339 damage which could result from, for example:
340 a) the effect of chemicals;
341 b) environmental influences, including natural ultra-violet radiation likely to be encountered;
342 c) corrosion, and other weakening of construction materials that are part of the PROTECTIVE
343 CASING or other protective components.

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344 Conformity is checked by inspection of the documentation and the relevant data and/or
345 additional testing (if needed).
346 6 Protection against electric shock
347 This clause of Part 1 is applicable except as follows.
348 6.8.3.1 The AC voltage test
349
350 Replacement:
351
352 Replace the first sentence by the following new sentence:
353 The voltage tester shall be capable of maintaining the test voltage throughout the test within
354 ±5 % of the specified value.
355 7 Protection against mechanical HAZARDS
356 This clause of Part 1 is applicable except as follows.
357 7.1 General
358 Addition:
359 Add the following new note:
360 NOTE 101 A DISRUPTION, resulting in damage to a part of the PROTECTIVE CASING, for example a LID-locking
361 mechanism, is considered to be a SINGLE FAULT CONDITION.
362 7.3 Moving parts
363 Addition:
364 Add the following new subclauses.
365 7.3.101 LID
366 7.3.101.1 Requirements
367 The LID shall be locked closed when the ROTOR drive is energized, and shall remain locked
368 until the circumferential velocity of the ROTOR ASSEMBLY is not more than 2 m/s (see
369 Annex BB).
370 In the event of a power failure, the LID-locking mechanism shall not release, and subsequent
371 release shall require the use of a TOOL.
372 The LID shall be held closed with sufficient strength to withstand the results of testing
373 according to 7.7.3. Fragments produced by any DISRUPTION shall be contained as specified in
374 item a) of 7.7.
375 To evaluate which of the following points are appropriate for the CENTRIFUGE-ROTOR
376 COMBINATION under consideration, information shall be recorded showing the tests conducted
377 by the manufacturer or by a test facility:
378 a) mechanical abuse;
379 b) mislatching;
380 c) misalignment;
381 d) corrosion;
382 e) material degradation;

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383 f) material defects;
384 g) vibration;
385 h) cleaning and decontamination;
386 i) environmental influences;
387 j) other considerations appropriate for the design.
388 Conformity is checked by visual inspection; by the review of recorded information, by the tests
389 carried out under 7.7.3, and by any further tests considered appropriate for safety.
390 7.3.101.2 Exception
391 For LABORATORY CENTRIFUGES that satisfy all the following limitations, a device which merely
392 interrupts motor power may be used instead of an interlock mechanism (see Annex BB):
393 a) the LABORATORY CENTRIFUGE incorporates a device which holds the LID closed;
394 b) the device which interrupts motor power does not permit the drive motor to be
395 energized unless the LID is closed;
396 c) the rotational frequency of the ROTOR ASSEMBLY does not exceed 3 600 rpm;
397 d) the energy at maximum rotational frequency for the highest energy ROTOR ASSEMBLY when
398 fully loaded does not exceed 1 kJ;
399 e) the maximum centrifugal force does not exceed 2 000 g;
400 f) the largest ROTOR ASSEMBLY diameter does not exceed 250 mm;
401 g) a switch is provided for disconnecting motor power, independent of the LID position;
402 h) the ROTOR ASSEMBLY is visible when the LID is closed, to permit observation of any
403 rotation;
404 i) all ROTOR ASSEMBLIES used conform to 7.3 of Part 1;
405 j) if access is possible at a circumferential velocity of the ROTOR ASSEMBLY of more than
406 2 m/s, a warning label in accordance with ISO 3864 is provided on or near the access
407 point, indicating that the LID should not be opened until rotation has stopped. Where there
408 is insufficient space for such a label, symbol 14 of Table 1 is considered to be an
409 acceptable marking.
410 Conformity is checked by visual inspection and by the review of data to confirm that all the
411 above limitations are met.
412 7.3.102 ROTOR ASSEMBLIES
413 7.3.102.1 General
414 If a HAZARD could result from contact with moving parts of the ROTOR ASSEMBLY or DRIVE
415 SYSTEM in NORMAL CONDITION or SINGLE FAULT CONDITION, suitable protective means shall be
416 provided to prevent OPERATOR access, except as permitted by 7.3.101.2 and 7.3.102.2.
417 There
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