prEN IEC 61010-2-020:2024
(Main)Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-020: Particular requirements for laboratory centrifuges
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-020: Particular requirements for laboratory centrifuges
Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte - Teil 2-020: Besondere Anforderungen an Laborzentrifugen
Exigences de sécurité pour appareils électriques de mesurage, de régulation et de laboratoire - Partie 2-020: Exigences particulières pour centrifugeuses de laboratoire
Varnostne zahteve za električno opremo za meritve, nadzor in laboratorijsko uporabo - 2-020. del: Posebne zahteve za laboratorijske centrifuge
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2024
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
Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte - Teil 2
-020: Besondere Anforderungen an Laborzentrifugen
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 61010-2-020:2024
ICS:
19.080 Električno in elektronsko Electrical and electronic
preskušanje testing
71.040.10 Kemijski laboratoriji. Chemical laboratories.
Laboratorijska oprema Laboratory equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
66/820/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 61010-2-020 ED4
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2024-09-06 2024-11-29
SUPERSEDES DOCUMENTS:
66/816/RR
IEC TC 66 : SAFETY OF MEASURING, CONTROL AND LABORATORY EQUIPMENT
SECRETARIAT: SECRETARY:
United Kingdom Ms Stephanie Lavy
OF INTEREST TO THE FOLLOWING COMMITTEES: HORIZONTAL FUNCTION(S):
TC 66 Horizontal Group Safety
ASPECTS CONCERNED:
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:
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-020:
Particular requirements for laboratory centrifuges
PROPOSED STABILITY DATE: 2025
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.
66/820/CDV – 2 – IEC CDV 61010-2-020 © IEC 2024
1 CONTENTS
3 FOREWORD . 3
4 1 Scope and object . 5
5 2 Normative references . 6
6 3 Terms and definitions . 6
7 4 Tests . 8
8 5 Marking and documentation . 8
9 6 Protection against electric shock . 11
10 7 Protection against mechanical HAZARDS . 11
11 8 Resistance to mechanical stresses . 18
12 9 Protection against the spread of fire . 18
13 10 Equipment temperature limits and resistance to heat . 18
14 11 Protection against HAZARDS from fluids and solid foreign objects . 18
15 12 Protection against radiation, including laser sources, and against sonic and
16 ultrasonic pressure . 19
17 13 Protection against liberated gases and substances, explosion and implosion . 19
18 14 Components and subassemblies . 20
19 15 Protection by interlocks . 20
20 16 Hazards resulting from application . 20
21 17 Risk assessment . 20
22 Annexes . 21
23 Annex L Index of defined terms . 21
24 Annex AA (normative) Dynamic microbiological test method for BIOSEALS . 22
25 Annex BB (informative) General guidance and rationale for particular subclauses . 25
26 Annex CC (informative) General guidance for an empirical method to determine the
27 kinetic energy of a ROTOR . 29
28 Bibliography . 32
30 Figure 101 – Rotor test setup . 30
32 Table 101 – Time-temperature conditions . 18
IEC CDV 61010-2-020 © IEC 2024 – 3 – 66/820/CDV
36 INTERNATIONAL ELECTROTECHNICAL COMMISSION
37 ____________
39 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR
40 MEASUREMENT, CONTROL, AND LABORATORY USE –
42 Part 2-020: Particular requirements for LABORATORY CENTRIFUGES
44 FOREWORD
45 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
46 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
47 international co-operation on all questions concerning standardization in the electrical and electronic fields. To
48 this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
49 Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
50 Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
51 in the subject dealt with may participate in this preparatory work. International, governmental and non -
52 governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
53 with the International Organization for Standardization (ISO) in accordance with conditions determined by
54 agreement between the two organizations.
55 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
56 consensus of opinion on the relevant subjects since each technical committee has representation from all
57 interested IEC National Committees.
58 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
59 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
60 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
61 misinterpretation by any end user.
62 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
63 transparently to the maximum extent possible in their national and regional publications. Any divergence
64 between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
65 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
78 patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
79 International Standard IEC 61010-2-020 has been prepared by IEC technical committee 66:
80 Safety of measuring, control and laboratory equipment.
81 This fourth edition cancels and replaces the third edition published in 2016. This edition
82 constitutes a technical revision.
83 This edition includes the following significant technical changes with respect to the previous
84 edition:
85 a) alignment with changes introduced by Amendment 1 of IEC 61010-1:2010.
86 It has the status of a product safety publication in accordance with IEC Guide 104.
87 The text of this International Standard is based on the following documents:
66/820/CDV – 4 – IEC CDV 61010-2-020 © IEC 2024
CDV Report on voting
66/xxx/CDV 66/xxx/RVC
89 Full information on the voting for the approval of this International Standard can be found in
90 the report on voting indicated in the above table.
91 This document has been drafted in accordance with the ISO/IEC Directives, Part 2.
92 A list of all parts of the IEC 61010 series, published under the general title Safety
93 requirements for electrical equipment for measurement, control, and laboratory use , can be
94 found on the IEC website.
95 This Part 2-020 is intended to be used in conjunction with the latest edition of IEC 61010-1. It
96 was established on the basis of the third edition (2010) and its Amendment 1 (2016),
97 hereinafter referred to as Part 1.
98 This Part 2-020 supplements or modifies the corresponding clauses in IEC 61010-1 so as to
99 convert that publication into the IEC standard: Particular requirements for LABORATORY
100 CENTRIFUGES.
101 Where a particular subclause of Part 1 is not mentioned in this Part 2-020, that subclause
102 applies as far as is reasonable. Where this Part 2-020 states "addition", "modification" or
103 "replacement", the relevant requirement, test specification or note in Part 1 shall be adapted
104 accordingly.
105 In this standard:
106 1) the following print types are used:
107 – requirements: in roman type;
108 – NOTES: in small roman type;
109 – conformity and tests: in italic type;
110 – terms used throughout this standard which have been defined in Clause 3: SMALL
111 ROMAN CAPITALS.
112 2) subclauses, tables or figures which are additional to those in Part 1 are numbered starting
113 from 101. Additional annexes are lettered starting from AA.
114 The committee has decided that the contents of this document will remain unchanged until the
115 stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to
116 the specific document. At this date, the document will be
117 • reconfirmed,
118 • withdrawn,
119 • replaced by a revised edition, or
120 • amended.
IEC CDV 61010-2-020 © IEC 2024 – 5 – 66/820/CDV
123 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR
124 MEASUREMENT, CONTROL, AND LABORATORY USE –
126 Part 2-020: Particular requirements for LABORATORY CENTRIFUGES
130 1 Scope and object
131 This clause of Part 1 is applicable except as follows:
132 1.1 Scope
133 1.1.1 Equipment included in scope
134 Replacement:
135 This part of IEC 61010 is applicable to electrically powered LABORATORY CENTRIFUGES.
136 It is possible that all or part of the equipment falls within the scope of one or more other
137 Part 2 standards of IEC 61010 as well as within the scope of this standard. In that case, the
138 requirements of those other Part 2 standards will also apply.
139 1.1.2 Equipment excluded from scope
140 Addition:
141 Add the following new item:
142 aa) IEC 60034 (Rotating electrical machinery).
143 1.2 Object
144 1.2.1 Aspects included in scope
145 Addition:
146 Add the following new items:
147 aa) contact with moving parts (see 7.3);
148 bb) LABORATORY CENTRIFUGE movement during any DISRUPTION (see 7.4.101);
149 cc) high energy chemical reaction after ROTOR DISRUPTION (see 7.7.2.2 l));
150 dd) ineffectiveness of BIOSEALS (see 13.101).
151 1.2.2 Aspects excluded from scope
152 Addition:
153 Add the following new items:
154 aa) additional precautions which may need to be observed when centrifuging materials
155 which are flammable or explosive (see 5.4.101);
156 bb) additional precautions which may need to be observed when centrifuging materials that
157 could react chemically with sufficient vigour to cause a HAZARD (see 5.4.101).
66/820/CDV – 6 – IEC CDV 61010-2-020 © IEC 2024
158 1.4 Environmental conditions
159 1.4.1 Normal environmental conditions
160 Replacement:
161 Replace item c) by the following:
162 c) temperature 2 °C to 40 °C;
163 1.4.2 Extended environmental conditions
164 Replacement:
165 Replace item c) by the following:
166 c) ambient temperatures below 2 °C or above 40 °C;
167 2 Normative references
168 This clause of Part 1 is applicable except as follows:
169 Addition:
170 ISO 3864 (all parts), Graphical symbols – Safety colours and safety signs
171 3 Terms and definitions
172 This clause of Part 1 is applicable except as follows:
173 3.1 Equipment and states of equipment
174 Addition:
175 Add the following new terms and definitions:
176 3.1.101
177 LABORATORY CENTRIFUGE
178 apparatus intended for laboratory use that applies a centrifuging effect to sample materials
179 3.1.102
180 CENTRIFUGE-ROTOR COMBINATION
181 LABORATORY CENTRIFUGE and ROTOR ASSEMBLY that are intended to operate together and which
182 have to be evaluated together
183 3.1.103
184 DISRUPTION
185 event in which the ROTOR ASSEMBLY, or part of it, fails or becomes detached during rotation
IEC CDV 61010-2-020 © IEC 2024 – 7 – 66/820/CDV
186 3.2 Parts and accessories
187 Addition:
188 Add the following new terms and definitions:
189 3.2.101
190 CHAMBER
191 enclosed space within a LABORATORY CENTRIFUGE in which the ROTOR ASSEMBLY rotates
192 3.2.102
193 ROTOR
194 primary component of a LABORATORY CENTRIFUGE which holds the material to be subjected to
195 centrifugal force and which is rotated by the DRIVE SYSTEM
196 3.2.103
197 BUCKET
198 sub-assembly of a ROTOR designed to support one or more containers
199 3.2.104
200 PROTECTIVE CASING
201 casing which completely surrounds the ROTOR ASSEMBLY and which includes the LID and its
202 securing devices
203 3.2.105
204 LID
205 access cover of the CHAMBER
206 3.2.106
207 ROTOR ASSEMBLY
208 ROTOR carrying a combination of ROTOR accessories specified by the manufacturer
209 Note 1 to entry: In the context of a ROTOR ASSEMBLY, ROTOR accessories include all components used with or in
210 the centrifuge ROTOR for the purpose of holding samples, including adaptors, buckets, tubes and bottles.
211 3.2.107
212 DRIVE SYSTEM
213 all components of the LABORATORY CENTRIFUGE associated with the provision of torque to, or
214 the rotational support of, the ROTOR ASSEMBLY
215 3.2.108
216 BIOSEAL
217 device or mechanism additional to, or integral with, a ROTOR or BUCKET and a closure
218 assembly, and which is designed to prevent the escape of contents, for example micro -
219 biological material, during centrifuging
220 3.5 Safety terms
221 Addition:
222 Add the following new terms and definitions:
223 3.5.101
224 CLEARANCE ENVELOPE
225 space around a LABORATORY CENTRIFUGE which is needed for safety
66/820/CDV – 8 – IEC CDV 61010-2-020 © IEC 2024
226 3.5.102
227 MCA
228 MAXIMUM CREDIBLE ACCIDENT
229 event chosen to represent worst-case conditions for a test that will evaluate the inherent
230 mechanical safety of a CENTRIFUGE-ROTOR COMBINATION (see 7.7 and Annex BB)
231 4 Tests
232 This clause of Part 1 is applicable.
233 5 Marking and documentation
234 This clause of Part 1 is applicable except as follows.
235 5.1.2 Identification
236 Addition:
237 Add the following new list items c):
238 aa) serial number or other means to identify the production batch of the equipment.
240 5.1.3 MAINS supply
241 Addition:
242 Add the following note after the compliance statement.
243 NOTE 101 The maximum power or input current considered is usually during the acceleration phase of the ROTOR,
244 with any options such as cooling or heating energized.
245 Add the following new subclause:
246 5.1.101 ROTORS and accessories
247 All OPERATOR-replaceable ROTORS and ROTOR ASSEMBLIES, including ROTOR ACCESSORIES, shall
248 be marked with the manufacturer's or supplier's name or registered trade mark, and
249 identification code (such as ID code, serial number or batch number).
250 If components are too small, or are not suitable for such marking, the required information
251 shall be marked on the original packaging, as well as being stated in the documentation.
252 NOTE Packaging can be the outer box, an insert, etc.
253 If the manufacturer specifies that an individual part, for example a BUCKET, is to be fitted only
254 to a specific ROTOR or in specific ROTOR positions for balance or some other reason, each
255 BUCKET and ROTOR position shall be identified by marking with corresponding numbers or
256 letters.
257 Conformity is checked by inspection.
258 5.4.2 Equipment RATINGS
259 Addition:
IEC CDV 61010-2-020 © IEC 2024 – 9 – 66/820/CDV
260 Add the following new list items:
261 aa) a list of all ROTORS and ROTOR accessories specified for use with a LABORATORY
262 CENTRIFUGE, together with their RATED rotational frequencies;
263 bb) any restrictions by the manufacturer warning against the use of particular materials to
264 be centrifuged;
265 cc) density and volume limits for ROTOR ASSEMBLY loading and, if applicable, derating
266 instructions.
267 5.4.3 Equipment installation
268 Addition:
269 Add, after list item a), the following sublist items:
270 i) floor or bench area required for the CLEARANCE ENVELOPE for the intended use (see
271 7.4.101);
272 ii) total weight of the LABORATORY CENTRIFUGE;
273 iii) instructions for site preparation;
274 iv) methods for levelling of the LABORATORY CENTRIFUGE;
275 v) means for securing to the mounting surface;
276 5.4.4 Equipment operation
277 Addition:
278 Add the following new items:
279 aa) loading and balancing procedures;
280 bb) ROTOR changing procedure;
281 cc) any specific requirement for an OPERATOR to be present at stated phases of the
282 centrifuging procedure;
283 dd) necessary safeguards for personnel. Instructions shall include at least the following:
284 – not to lean on a LABORATORY CENTRIFUGE;
285 – not to stay within the CLEARANCE ENVELOPE longer than necessary for operational
286 reasons;
287 – not to deposit any potentially hazardous materials within the CLEARANCE ENVELOPE;
288 – methods for safe operation during open LID procedures (see 7.3.102.2);
289 ee) instructions for use of BIOSEALS and other biocontainment components, including the
290 proper closure techniques. These instructions shall indicate that BIOSEALS and related
291 components are intended to be part of biocontainment systems, as specified in
292 international and national biosafety guidelines. They are not to be relied on as the only
293 means of safeguarding workers and the environment when handling pathogenic micro-
294 organisms.
295 5.4.5 Equipment maintenance and service
296 Addition:
297 Add the following new text at the end of the subclause (before the compliance statement):
298 Where applicable, the instructions shall specify:
66/820/CDV – 10 – IEC CDV 61010-2-020 © IEC 2024
299 1) inspection of any means of fixing the equipment to the mounting surface and the
300 condition of the mounting surface itself;
301 2) safeguards for the OPERATOR during cleaning;
302 3) inspection of the PROTECTIVE CASING;
303 4) inspection of the ROTOR ASSEMBLY, and safety considerations;
304 5) checking the continuity of the PROTECTIVE BONDING;
305 6) frequency of inspection, routine maintenance and the method of replacement of
306 BIOSEALS and other biocontainment components.
307 Addition:
308 Add the following new subclauses:
309 5.4.101 Hazardous substances
310 The instructions for use shall state the precautions to be observed when the materials to be
311 used with a LABORATORY CENTRIFUGE are known to be toxic, radioactive, or contaminated with
312 pathogenic micro-organisms.
313 NOTE This information is relevant to the safety of both OPERATORS and service personnel.
314 The use within the LABORATORY CENTRIFUGE of the following materials shall be prohibited in
315 the instructions for use:
316 a) flammable or explosive materials;
317 b) materials which could react chemically with sufficient vigour to cause a HAZARD.
318 Conformity is checked by inspection.
319 5.4.102 Cleaning and decontamination
320 Documentation shall include:
321 a) a statement that, if hazardous material is spilt on or inside the equipment, the OPERATOR
322 has responsibility for carrying out appropriate decontamination;
323 b) manufacturer's recommendations for cleaning and, where necessary, decontaminating,
324 together with the recognized generic names of recommended materials for cleaning and
325 decontaminating;
326 c) the following statement:
327 "Before using any cleaning or decontamination methods other than those recommended
328 by the manufacturer, OPERATORS shall check with the manufacturer that the proposed
329 method will not damage the equipment"
330 d) the following statement:
331 "Cleaning and decontamination may be necessary as a safeguard before LABORATORY
332 CENTRIFUGES, ROTORS, and any accessories are maintained, repaired, or transferred.
333 Manufacturers may provide a format for the RESPONSIBLE BODY to document that such
334 treatment has been carried out."
335 NOTE Be advised, there are national guidelines and the internationally recognized "Laboratory Biosafety Manual",
336 published in 2004 by the World Health Organization in Geneva, which gives information on decontaminants, their
337 use, dilutions, properties, and potential applications.
338 Conformity is checked by inspection.
IEC CDV 61010-2-020 © IEC 2024 – 11 – 66/820/CDV
339 5.4.103 Effects of chemicals and environmental influences
340 To ensure continued safe use of a LABORATORY CENTRIFUGE the documentation shall identify
341 damage which could result from, for example:
342 a) the effect of chemicals;
343 b) environmental influences, including natural ultra-violet radiation likely to be encountered;
344 c) corrosion, and other weakening of construction materials that are part of the PROTECTIVE
345 CASING or other protective components.
346 Conformity is checked by inspection of the documentation and the relevant data and/or
347 additional testing (if needed).
348 6 Protection against electric shock
349 This clause of Part 1 is applicable.
350 7 Protection against mechanical HAZARDS
351 This clause of Part 1 is applicable except as follows.
352 7.1 General
353 Addition:
354 Add the following new note at the end of the subclause (before the compliance statement):
355 NOTE 101 A DISRUPTION, resulting in damage to a part of the PROTECTIVE CASING, for
356 example a LID-locking mechanism, is considered to be an easily noticed SINGLE FAULT
357 CONDITION.
358 7.3 Moving parts
359 Addition:
360 Add the following new subclauses.
361 7.3.101 LID
362 7.3.101.1 Requirements
363 The LID shall, unless excepted by subclause 7.3.102.1, be locked closed when the ROTOR
364 drive is energized, and shall remain locked until the circumferential velocity of the ROTOR
365 ASSEMBLY is not more than 2 m/s (see Annex BB).
366 In the event of a power failure, the LID-locking mechanism shall not release, and subsequent
367 release shall require the use of a TOOL.
368 The LID shall be held closed with sufficient strength to withstand the results of testing in
369 accordance with 7.7.3. Fragments produced by any DISRUPTION shall be contained as
370 specified in item a) of 7.7.1.
371 To evaluate which of the following points are appropriate for the CENTRIFUGE-ROTOR
372 COMBINATION under consideration, information shall be recorded showing the tests conducted
373 by the manufacturer or by a test facility:
66/820/CDV – 12 – IEC CDV 61010-2-020 © IEC 2024
374 a) mechanical abuse;
375 b) mislatching;
376 c) misalignment;
377 d) corrosion;
378 e) material degradation;
379 f) material defects;
380 g) vibration;
381 h) cleaning and decontamination;
382 i) environmental influences;
383 j) other considerations appropriate for the design.
384 Conformity is checked by visual inspection, by the review of recorded information, by the tests
385 carried out under 7.7.3, and by any further tests considered appropriate for safety.
386 7.3.101.2 Exception
387 For LABORATORY CENTRIFUGES that satisfy all the following limitations (list items a) to j)), a
388 device which merely interrupts motor power may be used instead of an interlock mechanism
389 (see Annex BB):
390 a) the LABORATORY CENTRIFUGE incorporates a device which holds the LID closed;
391 b) the device which interrupts motor power does not permit the drive motor to be
392 energized unless the LID is closed;
393 c) the rotational frequency of the ROTOR ASSEMBLY does not exceed 3 600 r/min;
394 d) the energy at maximum rotational frequency for the highest energy ROTOR ASSEMBLY when
395 fully loaded does not exceed 1 kJ;
396 e) the maximum centrifugal force does not exceed 2 000 g;
397 f) the largest ROTOR ASSEMBLY diameter does not exceed 250 mm;
398 g) a switch is provided for disconnecting motor power, independent of the LID position;
399 h) the ROTOR ASSEMBLY is visible when the LID is closed, to permit observation of any
400 rotation;
401 i) all ROTOR ASSEMBLIES used conform to 7.3 of Part 1;
402 j) if access is possible at a circumferential velocity of the ROTOR ASSEMBLY of more than
403 2 m/s, a warning label in accordance with ISO 3864 (all parts) is provided on or near the
404 access point, indicating that the LID should not be opened until rotation has stopped.
405 Where there is insufficient space for such a label, symbol 14 of Table 1 is considered to
406 be an acceptable marking.
407 Conformity is checked by visual inspection and by the review of data to confirm that all the
408 above limitations are met.
409 7.3.102 ROTOR ASSEMBLIES
410 7.3.102.1 General
411 If a HAZARD could result from contact with moving parts of the ROTOR ASSEMBLY or DRIVE
412 SYSTEM in NORMAL CONDITION or SINGLE FAULT CONDITION, suitable protective means shall be
413 provided to prevent OPERATOR access, except as permitted by 7.3.101.2 and 7.3.102.2.
414 There shall be no holes or other openings in the top of the CHAMBER which permit the
415 penetration of a 4 mm diameter pin.
416 Conformity is checked by inspection and by using the test fingers shown in Figure B.1 and
IEC CDV 61010-2-020 © IEC 2024 – 13 – 66/820/CDV
417 Figure B.2, and by checking openings in the top with a 4 mm diameter pin, in NORMAL
418 CONDITION and in SINGLE FAULT CONDITION.
419 The jointed test finger shown in Figure B.2 is applied in every possible position without
420 applying any force. If it is possible to touch a part by applying a force, the rigid test finger
421 shown in Figure B.1 is applied with a force of 10 N. The force is exerted against all outer
422 surfaces, including the bottom, by the tip of the test finger so as to avoid wedge or lever
423 action. The finger shall not touch any moving part that could cause a HAZARD.
424 7.3.102.2 ROTOR ASSEMBLIES requiring access during rotation
425 If the manufacturer supplies ROTOR ASSEMBLIES requiring OPERATOR interaction (e.g. zonal or
426 continuous-flow ROTOR ASSEMBLIES), LABORATORY CENTRIFUGES are permitted to have an
427 override control which allows the motor to be energized while the access LID is open, provided
428 that:
429 a) the override control allows the motor to be energized only by use of a device (which can
430 be a code or code-card) that makes it possible to override a protective system and
431 functions by means that cannot be performed using other TOOLS, or when a special guard
432 plate allows only limited access to the ROTOR ASSEMBLY;
433 b) means are provided to cancel the override function automatically when use of the ROTOR
434 ASSEMBLY requiring OPERATOR interaction is ended;
435 c) maximum speed while the LID is open is limited to 5 000 r/min.
436 Conformity is checked by inspection.
437 7.4 Stability
438 Addition:
439 Add a new paragraph :
440 No displacement of the LABORATORY CENTRIFUGE from its installed position shall be visible
441 during NORMAL USE.
442 Addition:
443 Add the following new subclause:
444 7.4.101 LABORATORY CENTRIFUGE movement during malfunction
445 After installation in accordance with the manufacturer's instructions, movement of a
446 LABORATORY CENTRIFUGE as a result of ROTOR ASSEMBLY imbalance, ROTOR ASSEMBLY
447 DISRUPTION, or DRIVE SYSTEM failure (seizure), shall not present a HAZARD.
448 Movement shall be limited either by design, or by fastening to the mounting surface, or a
449 combination of both, so that no part of the LABORATORY CENTRIFUGE moves outside a
450 CLEARANCE ENVELOPE extending 300 mm, or less if stated by the manufacturer, in any direction
451 from the outermost parts of the LABORATORY CENTRIFUGE in its original position (for rationale
452 see Clause BB.6).
66/820/CDV – 14 – IEC CDV 61010-2-020 © IEC 2024
453 Conformity is checked by testing to confirm that the 300 mm limit, or any lower limit stated
454 by the manufacturer, is not exceeded in NORMAL USE and after inducing the worst-case
455 situation according to 7.7.2.2 for:
456 a) imbalance;
457 Use of an imbalance sensor is acceptable as a means for limiting movement. Such sensors
458 shall either consist of redundant circuits, be provided with a watchdog, or apply means to
459 ensure that the imbalance sensor system can be considered as fail safe.
460 As an alternative method, the reliability and design requirements can be determined by
461 applying, for example IEC 62061 (SIL) or ISO 13849 (PL) (all parts) or other solutions
462 providing equivalent functional safety.
463 b) DISRUPTION of the ROTOR ASSEMBLY;
464 c) DRIVE SYSTEM failure;
465 d) seizure of the DRIVE SYSTEM.
466 NOTE The failure mode which will produce the greatest movement can be different from the failure mode of the
467 MCA determined for testing the PROTECTIVE CASING in accordance with 7.7.3. See Annex CC for additional
468 guidance in determining the worst-case conditions.
469 For these tests, the LABORATORY CENTRIFUGE is mounted on, or fixed to, a horizontal smooth
470 concrete test surface of dimensions appropriate for the size of LABORATORY CENTRIFUGE
471 being tested, and as specified in the manufacturer's instructions.
472 7.7 Expelled parts
473 Replacement:
474 Replace the existing title and text with the following new title and text.
475 7.7 Protection against expelled parts or projected parts
476 7.7.1 General
477 LABORATORY CENTRIFUGES shall be designed for safe operation in NORMAL USE and in SINGLE
478 FAULT CONDITION when used with ROTOR ASSEMBLIES specified by the manufacturer.
479 In the event of a DISRUPTION:
480 a) no parts or fragments of the ROTOR ASSEMBLY exceeding 5 mm in any dimension shall
481 completely penetrate the PROTECTIVE CASING. Smaller material (except for aerosols and
482 liquids) shall remain within a trajectory extending 1 m in any direction from the outermost
483 parts of the LABORATORY CENTRIFUGE. (See rationale in Clause BB.6.);
484 b) no part of the LABORATORY CENTRIFUGE shall become detached or expelled in such a way
485 as to present a HAZARD to personnel or the environment. In the case of parts detached or
486 expelled from the centrifuge (not part of the ROTOR ASSEMBLY) this is to be evaluated in
487 accordance with Clause 17;
488 c) the fastenings of the LID shall not be loosened, and there shall be no distortion which
489 could create an unimpeded path between any point on the ROTOR ASSEMBLY and any point
490 outside the LABORATORY CENTRIFUGE.
491 Conformity of every CENTRIFUGE-ROTOR COMBINATION specified by the manufacturer is checked
492 by testing as specified in 7.7.3, under MCA conditions, or by causing DISRUPTION by partially
493 cutting the ROTOR, or by overloading the ROTOR ASSEMBLY, or by other appropriate means. If
494 more than one worst-case ROTOR ASSEMBLY selection exists, each can be tested with a new
495 PROTECTIVE CASING.
IEC CDV 61010-2-020 © IEC 2024 – 15 – 66/820/CDV
496 After the tests, the criteria of items a) to c) above shall be met, and visible cracks shall be
497 examined to determine whether or not the PROTECTIVE CASING would have contained the
498 ROTOR parts irrespective of their trajectory. A questionable result shall require the test to be
499 repeated once only, and a further questionable result is considered to be a failure. The
500 equipment is checked to ensure that parts which are HAZARDOUS LIVE have not become
501 ACCESSIBLE and that ACCESSIBLE conductive parts do not exceed the values of 6.3.2. In the
502 event that the test causes the operation of an overcurrent protection device, if the device can
503 not be reset without operating again, the unit is considered to have failed safe. (See rationale
504 in Annex BB6.2.)
505 Alternatively, the safety of a CENTRIFUGE-ROTOR COMBINATION can be established by analytical
506 evaluation based on comparison with one or more of the CENTRIFUGE-ROTOR COMBINATIONS
507 already tested, to confirm that the PROTECTIVE CASING would have passed the relevant test of
508 7.7.3.
509 Note 1 The test specified in this clause may potentially be extremely hazardous to test personnel. The test shall be
510 conducted inside of a robust structure, e.g. a bunker, capable of containing any fragments which might be expelled
511 should its protective casing fail.
512 The structure shall allow for test personnel to be outside of the structure during testing. As necessary, the
513 centrifuge’s controls may be modified to enable starting from outside the test enclosure. It shall be possible to
514 safely isolate all power sources without entering the structure. Warning notices or similar must be used to indicate
515 when testing is in progress and the structure may not be entered.
516 NOTE 2 CENTRIFUGE-ROTOR COMBINATIONS designed such that satisfactory evaluation by comparison with another
517 CENTRIFUGE-ROTOR COMBINATION already tested cannot be made, are tested as specified in 7.7.3.
518 7.7.2 Considerations for MCA tests
519 7.7.2.1 Information to be recorded
520 Recorded information shall include:
521 a) corrosion effects to be expected;
522 b) material fatigue behaviour;
523 c) material degradation considerations, including effects of inspection, maintenance, and
524 component replacement schedules;
525 d) temperature limitation considerations;
526 e) material defect considerations;
527 f) improper BUCKET installation considerations;
528 g) relevant environmental considerations;
529 h) relevant maximum loading considerations;
530 i) electrical circuit diagram and functional descriptions;
531 j) material specifications and technical data;
532 k) pre-treatment methods to induce ROTOR ASSEMBLY failure;
533 l) traceability of all measuring instruments used during tests;
534 m) any other relevant information.
535 7.7.2.2 Considerations for worst-case conditions
536 All combinations of the following that are possible shall be considered:
537 a) ROTOR selection: the worst-case specified ROTOR ASSEMBLY or ROTOR ASSEMBLIES; (for
538 calculating the kinetic energy of ROTORS, refer to Annex CC);
539 b) rotational frequency control setting: the maximum that an OPERATOR can select;
540 c) supply voltage: 10 % above the maximum RATED voltage marked on the equipment;
66/820/CDV – 16 – IEC CDV 61010-2-020 © IEC 2024
541 d) ROTOR ASSEMBLY load: the maximum specified load, partial load, and no load, including
542 state and density of load (e.g. liquid, solid);
543 e) ROTOR accessories, worst-case loading of specified accessories used with or in the ROTOR
544 for the purpose of holding samples, including adaptors, tubes, and bottles;
545 f) ROTOR ASSEMBLY imbalance: the most severe condition;
546 g) altitude factors: the effect of reduced atmospheric pressure and density at increased
547 altitude on ROTOR DRIVE SYSTEMS which rely on windage to limit maximum rotational
548 frequency (see 1.4.1 b) and 1.4.2 b)).
549 NOTE 1 The windage limitation can be determined by conducting a rotational frequency test in a cabinet or
550 room in which the pressure is controlled to 80 kPa or less, or alternatively the rotational frequency n , which
551 would be reached at 2 000 m altitude, can be determined from:
552 n = n R
2 1
553 where
554 n is the maximum rotational frequency at standard atmospheric pressure at sea -level (101 kPa);
555 n is the corresponding maximum rotational frequency at an atmospheric pressure equivalent to 2 000 m;
556 R = 1,27 (the ratio of the density of air at sea-level, to that at 2 000 m).
557 h) ambient temperature: the effect on components of working at any temperature in the
558 permitted range from 2 °C to 40 °C, or within the rated temperature range, whichever is
559 larger;
560 i) a combination of ROTOR ASSEMBLY and drive unit causing an instability of the dynamic
561 behaviour;
562 j) installation as specified by the manufacturer;
563 k) the possibility of high energy chemical reaction after DISRUPTION.
564 NOTE 2 In LABORATORY CENTRIFUGES which develop energies of the order of 275 kJ and above, and which
565 are refrigerated under vacuum, it is possible for a DISRUPTION to cause a chemical explosion if parts of the
566 ROTOR ASSEMBLY are made of reactive material, such as aluminium and titanium. An explosion can occur due
567 to interaction at high energies of the ROTOR ASSEMBLY fragments with refrigerants and water.
568 In such cases, the worst-case conditions can be achieved by the following combination of
569 means:
570 i) disabling rotational frequency controls and limiting devices so that the highest
571 rotational frequency is reached;
572 ii) selecting whichever ROTOR of reactive material has the highest rotational energy, and
573 pretreating it so as to cause a DISRUPTION. The pre-treatment shall maximize the
574 surface area of the resulting fragments;
575 iii) adjusting the refrigeration system to have the maximum amount of refrigerant in the
576 evaporator which cools the CHAMBER;
577 iv) loading the ROTOR ASSEMBLY with water to 80 % of its nominal capacity;
578 v) running the LABORATORY CENTRIFUGE in worst-case conditions of all other unspecified
579 factors until a DISRUPTION occurs.
580 Test personnel should be aware that extraordinary energy release can result from the
581 tests where a high-energy chemical reaction is possible after disruption. A remote bunker
582 facility is recommended.
583 7.7.2.3 SINGLE FAULT CONDITIONS to be considered
584 The following SINGLE FAULT CONDITIONS shall be considered:
585 a) rotational frequency control condition: whichever SINGLE FAULT CONDITION that results in the
586 highest rotational frequency;
587 b) rotational frequency limiting system: whichever SINGLE FAULT CONDITION that permits the
588 highest rotational frequency;
IEC CDV 61010-2-020 © IEC 2024 – 17 – 66/820/CDV
589 c) MAINS power interruption: intermittent or permanent loss of MAINS power, if either presents
590 a hazardous condition;
591 d) DRIVE SYSTEM seizure: the sudden application of the rotational energy to the frame and
592 case of a LABORATORY CENTRIFUGE;
593 e) any component failure;
594 f) non-quantitative SINGLE FAULT CONDITIONS:
595 7.7.2.4 Transport, Normal Use and Aging.
596 a) corrosion effects, for example corrosion at the bottom of a bucket or cavity, stress
597 corrosion cracking of alloys, corrosion of welds in the protective casing, environmental
598 crazing of polymers, etc.;
599 b) material fatigue behaviour, which may affect the mode of failure;
600 c) material defects;
601 d) improper installation of a bucket or any other component that is fitted in a swinging bucket
602 system (e.g. the omission of a bucket), incorrect mounting of a bucket at its pivot points,
603 use of an incorrect bucket, and overloading a bucket;
604 e) temperature effects, such as expected extremes during transportation, high rotor assembly
605 temperatures during operation, and any necessary treatment specified by the
606 manufacturer.
607 7.7.3 Testing the PROTECTIVE CASING
608 For each worst-case ROTOR ASSEMBLY selection in each MCA, determined according to 7.7.2.2
609 to 7.7.2.4, testing as necessary shall be carried out to prove the adequacy of the PROTECTIVE
610 CASING, and to show that it would have contained the ROTOR parts irrespective
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.