IEC 61010-2-020:2016
(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
IEC 61010-2-020:2016 is applicable to electrically powered LABORATORY CENTRIFUGES. This third edition cancels and replaces the second edition published in 2006. It constitutes a technical revision and includes the following significant changes from the second edition:
a) This Part 2 is established on the basis of the third edition (2010) of IEC 61010-1. The changes listed in its foreword affect this Part 2, too.
b) The language has been updated to reflect current terminology for LABORATORY CENTRIFUGES used in the industry today.
It has the status of a group safety publication in accordance with IEC Guide 104.
This publication is to be read in conjunction with IEC 61010-1:2010
Règles de sécurité pour appareils électriques de mesurage, de régulation et de laboratoire - Partie 2-020: Exigences particulières pour centrifugeuses de laboratoire
L'IEC 61010-2-020:2016 s'applique aux CENTRIFUGEUSES DE LABORATOIRE alimentées en énergie électrique. Cette troisième édition annule et remplace la deuxième édition parue en 2006. Cette édition constitue une révision technique et inclut les modifications majeures suivantes par rapport à la deuxième édition:
a) La présente Partie 2 est établie sur la base de la troisième édition (2010) de l'IEC 61010-1. Les modifications énumérées dans son Avant-propos affectent également la présente Partie 2.
b) Le langage a été mis à jour pour refléter la terminologie des CENTRIFUGEUSES DE LABORATOIRE utilisée actuellement dans l'industrie. Elle a le statut d'une publication groupée de sécurité conformément au Guide IEC 104.
Cette publication doit être lue conjointement avec la IEC 61010-1:2010
General Information
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IEC 61010-2-020 ®
Edition 3.0 2016-05
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
GROUP SAFETY PUBLICATION
Safety requirements for electrical equipment for measurement, control, and
laboratory use –
Part 2-020: Particular requirements for laboratory centrifuges
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IEC 61010-2-020 ®
Edition 3.0 2016-05
REDLINE VERSION
INTERNATIONAL
STANDARD
colour
inside
GROUP SAFETY PUBLICATION
Safety requirements for electrical equipment for measurement, control, and
laboratory use –
Part 2-020: Particular requirements for laboratory centrifuges
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 19.080, 71.040.10 ISBN 978-2-8322-3442-6
– 2 – IEC 61010-2-020:2016 RLV IEC 2016
CONTENTS
FOREWORD . 3
1 Scope and object . 6
2 Normative references. 7
3 Terms and definitions . 7
4 Tests . 9
5 Marking and documentation . 9
6 Protection against electric shock . 12
7 Protection against mechanical HAZARDS . 12
8 Mechanical resistance to shock and impact . 19
9 Protection against the spread of fire . 19
10 Equipment temperature limits and resistance to heat . 19
11 Protection against HAZARDS from fluids . 19
12 Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure . 20
13 Protection against liberated gases and substances, explosion and implosion . 20
14 Components . 21
15 Protection by interlocks . 21
16 Test and measurement equipment Hazards resulting from application . 21
17 Risk assessment . 21
Annexes . 22
Annex H L Index of defined terms . 22
Annex AA (normative) Dynamic microbiological test method for BIOSEALS . 23
Annex BB (informative) General guidance and rationale for particular subclauses . 26
Annex CC (informative) General guidance for an empirical method to determine the
kinetic energy of a ROTOR . 30
Bibliography . 32
Figure 101 – Rotor test setup . 30
Table 101 – Time-temperature conditions . 20
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR
MEASUREMENT, CONTROL, AND LABORATORY USE –
Part 2-020: Particular requirements for LABORATORY CENTRIFUGES
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
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agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
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3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
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8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
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9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
This redline version of the official IEC Standard allows the user to identify the changes
made to the previous edition. A vertical bar appears in the margin wherever a change
has been made. Additions are in green text, deletions are in strikethrough red text.
– 4 – IEC 61010-2-020:2016 RLV IEC 2016
International Standard IEC 61010-2-020 has been prepared by IEC technical committee 66:
Safety of measuring, control and laboratory equipment.
This third edition cancels and replaces the second edition published in 2006. It constitutes a
technical revision and includes the following significant changes from the second edition:
a) This Part 2 is established on the basis of the third edition (2010) of IEC 61010-1.The
changes listed in its foreword affect this Part 2, too.
b) The language has been updated to reflect current terminology for LABORATORY
CENTRIFUGES used in the industry today.
It has the status of a group safety publication in accordance with IEC Guide 104.
The text of this standard is based on the following documents:
CDV Report on voting
66/542/CDV 66/565A/RVC
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
This Part 2-020 is intended to be used in conjunction with IEC 61010-1. It was established on
the basis of the third edition (2010).
This Part 2-020 supplements or modifies the corresponding clauses in IEC 61010-1 so as to
convert that publication into the IEC standard: Safety requirements for LABORATORY
CENTRIFUGES.
Where a particular subclause of Part 1 is not mentioned in this Part 2, that subclause applies
as far as is reasonable. Where this part states "addition", "modification" or "replacement", the
relevant requirement, test specification or note in Part 1 should be adapted accordingly.
In this standard:
1) the following print types are used:
– requirements: in roman type;
– NOTES: in small roman type;
– conformity and tests: in italic type;
– terms used throughout this standard which have been defined in Clause 3: SMALL
.
ROMAN CAPITALS
2) subclauses, tables or figures which are additional to those in Part 1 are numbered starting
from 101; additional annexes are lettered AA, BB, etc.
A list of all parts of the IEC 61010 series, under the general title: Safety requirements for
electrical equipment for measurement, control, and laboratory use, may be found on the IEC
website.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC website under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
IMPORTANT – The “colour inside” logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this publication using a colour printer.
– 6 – IEC 61010-2-020:2016 RLV IEC 2016
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR
MEASUREMENT, CONTROL, AND LABORATORY USE –
Part 2-020: Particular requirements for laboratory centrifuges
1 Scope and object
This clause of Part 1 is applicable except as follows:
1.1.1 Scope
Replacement:
This Part 2 is applicable to electrically powered LABORATORY CENTRIFUGES.
This group safety publication is primarily intended to be used as a product safety standard for
the products mentioned in the scope, but shall also be used by technical committees in the
preparation of its publications for products similar to those mentioned in the scope of this
standard, in accordance with the principles laid down in IEC Guide 104 and lSO/lEC
Guide 51.
NOTE If all or part of the equipment falls within the scope of one or more other Part 2 standards of IEC 61010 as
well as within the scope of this standard, it will also need to meet the requirements of those other Part 2 standards.
1.1.2 Equipment excluded from scope
Addition:
Add the following new item:
aa) IEC 60034 (Rotating electrical machinery);
1.2 Object
1.2.1 Aspects included in scope
Addition:
Add the following five new items:
aa) contact with moving parts (see 7.3);
bb) LABORATORY CENTRIFUGE movement during any DISRUPTION (see 7.3.101);
cc) high energy chemical reaction after ROTOR DISRUPTION (see 7.7.2.2 l));
dd) ineffectiveness of BIOSEALS (see 13.101)
1.2.2 Aspects excluded from scope
Addition:
Add the following two new items:
aa) additional precautions which may need to be observed when centrifuging materials
which are flammable or explosive (see 5.4.101);
bb) additional precautions which may need to be observed when centrifuging materials that
could react chemically with sufficient vigour to cause a HAZARD (see 5.4.101).
1.4 Environmental conditions
1.4.1 Normal environmental conditions
Modification Replacement:
Modify Replace item c) by the following:
c) temperature 2 °C to 40 °C;
1.4.2 Extended environmental conditions
Modification Replacement:
Modify Replace item c) by the following:
c) ambient temperatures below 2 °C or above 40 °C;
2 Normative references
This clause of Part 1 is applicable except as follows:
Addition:
ISO 3864 (all parts), Graphical symbols – Safety colours and safety signs
3 Terms and definitions
This clause of Part 1 is applicable except as follows:
3.1 Equipment and states of equipment
Additions:
Add the following three new terms and definitions:
3.1.101
LABORATORY CENTRIFUGE
apparatus intended for laboratory use that applies a centrifuging effect to sample materials
3.1.102
CENTRIFUGE-ROTOR COMBINATION
LABORATORY CENTRIFUGE and ROTOR ASSEMBLY that are intended to operate together and which
have to be evaluated together
3.1.103
DISRUPTION
event in which the ROTOR ASSEMBLY, or part of it, fails or becomes detached during rotation
– 8 – IEC 61010-2-020:2016 RLV IEC 2016
3.2 Parts and accessories
Additions:
Add the following eight new terms and definitions:
3.2.101
CHAMBER
enclosed space within a LABORATORY CENTRIFUGE in which the ROTOR ASSEMBLY rotates
3.2.102
ROTOR
primary component of a LABORATORY CENTRIFUGE which holds the material to be subjected to
centrifugal force and which is rotated by the DRIVE SYSTEM
3.2.103
BUCKET
sub-assembly of a ROTOR designed to support one or more containers
3.2.104
PROTECTIVE CASING
casing which completely surrounds the ROTOR ASSEMBLY and which includes the LID and its
securing devices
3.2.105
LID
access cover of the CHAMBER
3.2.106
ROTOR ASSEMBLY
ROTOR carrying a combination of ROTOR accessories specified by the manufacturer
Note 1 to entry: In the context of a ROTOR ASSEMBLY, ROTOR accessories include all components used with or in
the CENTRIFUGE ROTOR for the purpose of holding samples, including adaptors, tubes and bottles.
3.2.107
DRIVE SYSTEM
all components of the CENTRIFUGE associated with the provision of torque to, or the rotational
support of, the ROTOR ASSEMBLY
3.2.108
BIOSEAL
device or mechanism additional to, or integral with, a ROTOR or BUCKET and a closure
assembly, and which is designed to prevent the escape of contents, for example micro-
biological material, during centrifuging
3.5 Safety terms
Additions:
Add the following two new terms and definitions:
3.5.101
CLEARANCE ENVELOPE
space around a LABORATORY CENTRIFUGE which is needed for safety
3.5.102
MCA
MAXIMUM CREDIBLE ACCIDENT
planned event chosen to represent worst-case conditions for a test that will evaluate the
inherent mechanical safety of a CENTRIFUGE-ROTOR COMBINATION (see 7.7 and Annex BB)
4 Tests
This clause of Part 1 is applicable, except as follows.
4.3.1 Environmental conditions
Addition:
Add the following new note:
NOTE Consideration should be given to operating refrigerated centrifuges at the maximum humidity specified in
1.4.1 d) and 1.4.2 d) because of condensation concerns (see 11.101).
5 Marking and documentation
This clause of Part 1 is applicable except as follows.
5.1.2 Identification
Modification Replacement:
Modify Replace item b) by the following:
b) serial number or other means to identify the production batch of the equipment.
Addition:
Add the following new subclause:
5.1.101 ROTORS and accessories
All OPERATOR-replaceable ROTORS and ROTOR ASSEMBLIES, including ROTOR ACCESSORIES, shall
be marked with the manufacturer's or supplier's name or registered trade mark, and
identification code (such as id code, serial number or batch number).
If components are too small, or are not suitable for such marking, the required information
shall be marked on the original packaging, as well as being stated in the documentation.
NOTE 1 Packaging can be the outer box, an insert, etc.
NOTE 2 Each ROTOR should be marked with a serial number or with other means to identify uniquely the
production batch.
NOTE 3 Where If the manufacturer specifies that an individual part, for example a BUCKET, is to
be fitted only to a specific ROTOR or in specific ROTOR positions for balance or some other
reason, each BUCKET and ROTOR position should be identified by marking with corresponding
numbers or letters.
NOTE 4 ROTOR accessories designed to be used together as a set, for example in terms of weight, should be
marked with an identification of that same set.
Conformity is checked by inspection.
– 10 – IEC 61010-2-020:2016 RLV © IEC 2016
5.4.2 Equipment ratings
Addition:
Add the following three new items:
aa) a list of all ROTORS and ROTOR accessories specified for use with a LABORATORY
CENTRIFUGE, together with their RATED rotational frequencies;
bb) any restrictions by the manufacturer warning against the use of particular materials to
be centrifuged;
cc) density and volume limits for ROTOR ASSEMBLY loading and, if applicable, derating
instructions.
5.4.3 Equipment installation
Addition:
Add, after item a), the following five sub-items:
i) floor or bench area required for the CLEARANCE ENVELOPE for the intended use (see
7.4.101);
NOTE Subclause 7.3.101 limits the permitted movement of a LABORATORY CENTRIFUGE to 300 mm, in
the event of a DISRUPTION. The manufacturer's instructions should therefore include a requirement for the
user to mark this boundary around the CENTRIFUGE, or that laboratory management procedures should
require that no person or any hazardous materials be within such a boundary while the LABORATORY
CENTRIFUGEis operating.
ii) total weight of the CENTRIFUGE;
iii) instructions for site preparation;
iv) methods for levelling of the CENTRIFUGE;
v) means for securing to the mounting surface.
5.4.4 Equipment operation
Addition:
Add the following five new items:
aa) loading and balancing procedures;
bb) ROTOR changing procedure;
cc) any specific requirement for an OPERATOR to be present at stated phases of the
centrifuging procedure;
dd) necessary safeguards for personnel. Examples of Instructions shall include at least the
following:
– not to lean on a LABORATORY CENTRIFUGE;
– not to stay within the CLEARANCE ENVELOPE longer than necessary for operational
reasons;
– not to deposit any potentially hazardous materials within the CLEARANCE ENVELOPE;
– methods for safe operation during open LID procedures (see 7.3.102.2);
ee) instructions for use of BIOSEALS and other biocontainment components, including the
proper closure techniques. These instructions shall make clear to the OPERATOR indicate
that BIOSEALS and related components are intended to be part of biocontainment
systems, such as are specified in international and national biosafety guidelines, and
cannot. They are not to be relied on as the only means of safeguarding workers and the
environment when handling pathogenic micro-organisms.
5.4.5 Equipment maintenance
Addition:
Renumber the note to the first paragraph as Note 1 and Add the following new second
paragraph and Note 2:
Where applicable, the instructions shall specify:
aa) inspection of any means of fixing the equipment to the mounting surface and the
condition of the mounting surface itself;
bb) safeguards for the OPERATOR during cleaning;
cc) inspection of the PROTECTIVE CASING;
dd) inspection of the ROTOR ASSEMBLY, and safety considerations;
ee) checking the continuity of the PROTECTIVE BONDING;
ff) frequency of inspection, routine maintenance and the method of replacement of
BIOSEALS and other biocontainment components.
NOTE 2 These instructions should make clear to the OPERATOR that regular maintenance of BIOSEALS and other
biocontainment components as specified in the instructions is especially important to ensure safety in day-to-day
use.
Addition:
Add the following three new subclauses:
5.4.101 Hazardous substances
The instructions for use shall state the precautions to be observed when the materials to be
used with a LABORATORY CENTRIFUGE are known to be toxic, radioactive, or contaminated with
pathogenic micro-organisms.
NOTE 1 This information is relevant to the safety of both OPERATORS and service personnel.
The use within the LABORATORY CENTRIFUGE of the following materials shall be prohibited in
the instructions for use:
a) flammable or explosive materials;
b) materials which could react chemically with sufficient vigour to cause a HAZARD.
NOTE 2 CENTRIFUGES may be specifically designed to be safe when handling such materials, but such
centrifuges are not within the scope of this standard.
Conformity is checked by inspection.
5.4.102 Cleaning and decontamination
Documentation shall include:
a) a statement that, if hazardous material is spilt on or inside the equipment, the user has
responsibility for carrying out appropriate decontamination;
b) manufacturer's recommendations for cleaning and, where necessary, decontamination
decontaminating, together with the recognized generic names of recommended materials
for cleaning and decontaminating:
c) the following statement:
"Before using any cleaning or decontamination methods except those recommended by
the manufacturer, users should check with the manufacturer that the proposed method will
not damage the equipment”
– 12 – IEC 61010-2-020:2016 RLV IEC 2016
d) the following statement:
Cleaning and decontamination may be necessary as a safeguard before LABORATORY
CENTRIFUGES, ROTORS, and any accessories are maintained, repaired, or transferred.
Manufacturers may provide a format for users to document that such treatment has been
carried out
NOTE Be advised, there are national guidelines and the internationally recognized "Laboratory Biosafety Manual",
published in 1993 by the Wor5ld Health Organization in Geneva, which gives information on decontaminants, their
use, dilutions, properties, and potential applications.
Conformity is checked by inspection.
5.4.103 Effects of chemicals and environmental influences
To ensure continued safe use of a LABORATORY CENTRIFUGE the documentation shall identify
damage which could result from, for example:
a) the effect of chemicals;
b) environmental influences, including natural ultra-violet radiation likely to be encountered;
c) corrosion, and other weakening of construction materials that are part of the PROTECTIVE
CASING or other safety protective components.
NOTE Assessment may be based on existing data, for example that supplied by a materials supplier. The
manufacturer may have to arrange for additional tests with regard to the intended use of the LABORATORY
CENTRIFUGE.
Conformity is checked by inspection of the documentation and the relevant data and/or
additional testing (if needed).
6 Protection against electric shock
This clause of Part 1 is applicable.
7 Protection against mechanical HAZARDS
This clause of Part 1 is applicable except as follows.
7.1 General
Addition:
Renumber the existing note as Note 1 and Add the following new note 2:
NOTE 2 101 A DISRUPTION, resulting in damage to a part of the PROTECTIVE CASING, for example a LID-locking
mechanism, is considered to be a SINGLE FAULT CONDITION.
7.3 Moving parts
Addition:
Add the following four new subclauses.
7.3.101 LID
7.3.101.1 Requirements
The LID shall be locked closed when the ROTOR drive is energized, and shall remain locked
until the circumferential velocity of the ROTOR ASSEMBLY is not more than 2 m/s (see
Annex BB).
In the event of a power failure, the LID-locking mechanism shall not release, and subsequent
release shall require the use of a TOOL.
The LID shall be held closed with sufficient strength to withstand the results of testing
according to 7.7.3. Fragments produced by any DISRUPTION shall be contained as specified in
item a) of 7.7.
To evaluate which of the following points are appropriate for the CENTRIFUGE-ROTOR
COMBINATION under consideration, information shall be recorded showing the tests conducted
by the manufacturer or by a test facility:
a) mechanical abuse;
b) mislatching;
c) misalignment;
d) corrosion;
e) material degradation;
f) material defects;
g) vibration;
h) cleaning and decontamination;
i) environmental influences;
j) other considerations appropriate for the design.
Conformity is checked by visual inspection; by the review of recorded information, by the tests
carried out under 7.7.3, and by any further tests considered appropriate for safety.
7.3.101.2 Exception
For LABORATORY CENTRIFUGES that satisfy all the following limitations, a device which merely
interrupts motor power may be used instead of an interlock mechanism (see Annex BB):
a) the LABORATORY CENTRIFUGE incorporates a device which holds the LID closed;
b) the device which interrupts motor power does not permit the drive motor to be
energized unless the LID is closed;
c) the rotational frequency of the ROTOR ASSEMBLY does not exceed 3 600 rpm;
d) the energy at maximum rotational frequency for the highest energy ROTOR ASSEMBLY when
fully loaded does not exceed 1 kJ;
e) the maximum centrifugal force does not exceed 2 000 g;
f) the largest ROTOR ASSEMBLY diameter does not exceed 250 mm;
g) a switch is provided for disconnecting motor power, independent of the LID position;
h) the ROTOR ASSEMBLY is visible when the LID is closed, to permit observation of any
rotation;
i) all ROTOR ASSEMBLIES used conform to 7.3 of Part 1;
j) if access is possible at a circumferential velocity of the ROTOR ASSEMBLY of more than
2 m/s, a warning label in accordance with ISO 3864 is provided on or near the access
point, indicating that the LID should not be opened until rotation has stopped. Where there
is insufficient space for such a label, symbol 14 of Table 1 is considered to be an
acceptable marking.
Conformity is checked by visual inspection and by the review of data to confirm that all the
above limitations are met.
– 14 – IEC 61010-2-020:2016 RLV IEC 2016
7.3.102 ROTOR ASSEMBLIES
7.3.102.1 General
If a HAZARD could result from contact with moving parts of the ROTOR ASSEMBLY or DRIVE
SYSTEM in NORMAL CONDITION or SINGLE FAULT CONDITION, suitable protective means shall be
provided to prevent OPERATOR access, except as permitted by 7.3.101.2 and 7.3.102.2.
There shall be no holes or other openings in the top of the CHAMBER which permit the
penetration of a 4 mm diameter pin.
Conformity is checked by inspection and by using the test fingers shown in Figures B.1 and
B.2, and by checking openings in the top with a 4 mm diameter pin, in NORMAL CONDITION and
SINGLE FAULT CONDITION.
The jointed test finger shown in Figure B.2 is applied in every possible position without
applying any force. If it is possible to touch a part by applying a force, the rigid test finger
shown in Figure B.1 is applied with a force of 10 N. The force is exerted against all outer
surfaces, including the bottom, by the tip of the test finger so as to avoid wedge or lever
action. The finger shall not touch any moving part that could cause a HAZARD.
7.3.102.2 ROTOR ASSEMBLIES requiring access during rotation
If the manufacturer supplies ROTOR ASSEMBLIES requiring OPERATOR interaction (e.g. zonal or
continuous-flow ROTOR ASSEMBLIES), LABORATORY CENTRIFUGES are permitted to have an
override control which allows the motor to be energized while the access LID is open, provided
that:
a) the override control allows the motor to be energized only by use of a device (which can
be a code or code-card) that makes it possible to override a safety protective system and
functions by means that cannot be performed using other tools, or when a special guard
plate allows only limited access to the rotor assembly;
b) means are provided to cancel the override function automatically when use of the rotor
assembly requiring OPERATOR interaction is ended;
c) maximum speed while the LID is open is limited to 5 000 rpm.
Conformity is checked by inspection
7.4 Stability
Addition:
Add a new third paragraph as follows:
No displacement of the LABORATORY CENTRIFUGE from its installed position shall be visible
during NORMAL USE.
Addition:
Add the following new subclause:
7.4.101 LABORATORY CENTRIFUGE movement during malfunction
After installation according to the manufacturer's instructions, movement of a LABORATORY
CENTRIFUGE as a result of ROTOR ASSEMBLY imbalance, ROTOR ASSEMBLY DISRUPTION, or drive
failure (seizure), shall not present a HAZARD.
Movement shall be limited either by design, or by fastening to the mounting surface, or a
combination of both, so that no part of the LABORATORY CENTRIFUGE moves outside a
CLEARANCE ENVELOPE extending 300 mm, or less if stated by the manufacturer, in any direction
from the outermost parts of the LABORATORY CENTRIFUGE in its original position (for rationale
see Clause BB.6).
Conformity is checked by testing to confirm that the 300 mm limit, or any lower limit stated by
the manufacturer, is not exceeded in NORMAL USE and after inducing the worst-case situation
according to 7.7.2.2 for:
a) imbalance;
NOTE 1 Use of an imbalance sensor is acceptable as a means for limiting movement, due to
this cause, but unless the sensor is a HIGH INTEGRITY type, its possible failure should be
considered when determining the worst-case condition but its possible failure should be
considered when determining the worst-case condition unless examination of the equipment
and design demonstrates conclusively that the sensor will not fail.
b) disruption of the ROTOR ASSEMBLY;
c) DRIVE SYSTEM failure;
d) seizure of the DRIVE SYSTEM.
NOTE 2 The failure mode which will produce the greatest movement may can be different from the failure mode
of the MCA determined for testing the PROTECTIVE CASING according to 7.7.3. See Annex CC for additional
guidance in determining the worst case rotor.
For these tests, the LABORATORY CENTRIFUGE is mounted on, or fixed to, a horizontal smooth
concrete test surface of dimensions appropriate for the size of LABORATORY CENTRIFUGE
being tested, and as specified in the manufacturer's instructions.
7.7 Expelled parts
Replacement:
Replace the title and text by the following new title and five new subclauses text.
7.7 Protection against expelled parts or projected parts
7.7.1 General
LABORATORY CENTRIFUGES shall be designed for safe operation in NORMAL USE and SINGLE
FAULT CONDITION, when used with ROTOR ASSEMBLIES specified by the manufacturer.
In the event of a DISRUPTION:
a) no parts or fragments of the ROTOR ASSEMBLY exceeding 1,5 5 mm in any dimension shall
completely penetrate the PROTECTIVE CASING. Smaller material (except for aerosols and
liquids) shall remain within a CLEARANCE ENVELOPE trajectory extending 300 mm 1 m in any
direction from the outermost parts of the LABORATORY CENTRIFUGE. (See rationale in Annex
BB.6).
b) no part of the LABORATORY CENTRIFUGE shall become detached or expelled in such a way
as to present a HAZARD to personnel or the environment. In the case of parts detached or
expelled from the centrifuge (not part of the ROTOR ASSEMBLY) this is to be evaluated in
accordance with Clause 17.
c) the fastenings of the access LID shall not be loosened, and there shall be no distortion
which could create an unimpeded path between any point on the ROTOR ASSEMBLY and any
point outside the LABORATORY CENTRIFUGE.
Conformity of every CENTRIFUGE-ROTOR COMBINATION specified by the manufacturer is checked
by testing as specified in 7.7.3, under MCA conditions, or by causing DISRUPTION by partially
– 16 – IEC 61010-2-020:2016 RLV IEC 2016
cutting the ROTOR, or by overloading the ROTOR ASSEMBLY, or by other appropriate means. If
more than one worst-case ROTOR ASSEMBLY selection exists, each can be tested with a new
PROTECTIVE CASING.
After the tests, the criteria of a) to c) above shall be met, and visible cracks shall be examined
to determine whether or not the PROTECTIVE CASING would have contained the ROTOR parts
irrespective of their trajectory. A questionable result shall require the test to be repeated once
only, and a further questionable result is considered to be a failure. The voltage tests of 6.8
(without humidity pre-conditioning) are performed, and The equipment is checked to ensure
that parts which are HAZARDOUS LIVE have not become ACCESSIBLE and that ACCESSIBLE
conductive parts do not exceed the values of 6.3.2. In the event that the test causes the
operation of an overcurrent protection device, if the device can not be reset without operating
again, the unit is considered to have failed safe. (See rationale Annex BB6.2).
NOTE 1 Consideration should be given to the presence of temporary gaps in containment during the MCA test in
determining questionable results.
Alternatively, the safety of a CENTRIFUGE-ROTOR COMBINATION can be established by analytical
evaluation based on comparison with one of more of the CENTRIFUGE-ROTOR COMBINATIONS
already tested, to confirm that the PROTECTIVE CASING would have passed the relevant test of
7.7.3.
NOTE 2 CENTRIFUGE-ROTOR COMBINATIONS designed such that satisfactory evaluation by comparison with another
CENTRIFUGE-ROTOR COMBINATION already tested cannot be made are tested as specified in 7.7.3.
7.7.2 Considerations for MCA tests
7.7.2.1 Information to be recorded
Recorded information shall include:
a) corrosion effects to be expected;
b) material fatigue behaviour;
c) material degradation considerations, including effects of inspection, maintenance, and
component replacement schedules;
d) temperature limitation considerations;
e) material defect considerations;
f) improper BUCKET installation considerations;
g) relevant environmental considerations;
h) relevant maximum loading considerations;
i) electrical circuit diagram and functional descriptions;
j) material specifications and technical data;
k) pre-treatment methods to induce ROTOR ASSEMBLY failure;
l) traceability of all measuring instruments used during tests;
m) any other relevant information.
Conformity is checked by inspection of documentation relating to the above items.
7.7.2.2 Considerations for worst-case conditions
All combinations of the following that are possible shall be considered:
a) ROTOR selection: the worst-case specified ROTOR ASSEMBLY or ROTOR ASSEMBLIES; (for
calculating the kinetic energy of rotors, refer to annex CC)
b) rotational frequency control setting: the maximum that an OPERATOR can select;
c) supply voltage: 10 % above the maximum RATED voltage marked on the equipment;
d) ROTOR ASSEMBLY load: the maximum specified load, partial load, and no load, including
state and density of load (e.g. liquid, solid);
e) ROTOR accessories, worst case loading of specified accessories used with or in the ROTOR
for the purpose of holding samples, including adaptors, tubes, and bottles;
f) ROTOR ASSEMBLY imbalance: the most severe condition;
g) altitude factors: the effect of reduced atmospheric pressure and density at increased
altitude on ROTOR DRIVE SYSTEMS which rely on windage to limit maximum rotational
frequency (see 1.4.1 b) and 1.4.2 b)).
NOTE 1 The windage limitation can be determined by conducting a rotational frequency test in a cabinet or
room in which the pressure is controlled to 80 kPa or less, or alternatively the rotational frequency n , which
would be reached at 2 000 m altitude, can be determined from:
n = n × R
2 1
where
n is the maximum rotational frequency at standard atmospheric pressure at sea-level (101 kPa);
n is the corresponding maximum rotational frequency at an atmospheric pressure equivalent to 2 000 m;
R = 1,27 (the ratio of the density of air at sea-level, to that at 2 000 m).
h) friction between the LABORATORY CENTRIFUGE or LABORATORY CENTRIFUGE feet and the
surface on which the LABORATORY CENTRIFUGE is placed;
i) ambient temperature: the effect on components of working at any temperature in the
permitted range from 2 °C to 40 °C;
j) a combination of ROTOR ASSEMBLY and drive unit causing an instability of the dynamic
behaviour;
k) installation as specified by the manufacturer;
l) the possibility of high energy chemical reaction after DISRUPTION
NOTE 2 In LABORATORY CENTRIFUGES which develop energies of the order of 275 kJ and above, and which
are refrigerated under vacuum, it is possible for a DISRUPTION to cause a chemical explosion if parts of the
ROTOR ASSEMBLY are made of reactive material, such as aluminium and titanium. An explosion can occur due
to interaction at high energies of the ROTOR ASSEMBLY fragments with refrigerants and water.
In such cases, the worst-case conditions can be achieved by the following combination of
means:
i) disabling rotational frequency controls and limiting devices so that the highest
rotational frequency is reached;
ii) selecting whichever ROTOR of reactive material has the highest rotational energy, and
pretreating it so as to cause a DISRUPTION. The pre-treatment shall maximize the
surface area of the resulting fragments;
iii) adjusting the refrigeration system to have the maximum amount of refrigerant in the
evaporator which cools the CHAMBER;
iv) loading the ROTOR ASSEMBLY with water to 80 % of its nominal capacity;
v) running the LABORATORY CENTRIFUGE in worst-case conditions of all other unspecified
factors until a DISRUPTION occurs.
NOTE 3 Test personnel should be aware that extraordinary energy release may can result from the tests
where a high-energy chemical reaction is possible after DISRUPTION. A remote bunker facility is recommended.
Conformity is checked by inspection of documentation relating to the above items.
7.7.2.3 SINGLE FAULT CONDITIONS to be considered
The following SINGLE FAULT CONDITIONS shall be considered:
a) rotational frequency control condition: whichever SINGLE FAULT CONDITION that results in the
highest rotational frequency;
– 18 – IEC 61010-2-020:2016 RLV IEC 2016
b) rotational frequency limiting system whichever SINGLE FAULT CONDITION permits the highest
rotational frequency;
c) MAINS power interruption: intermittent or permanent loss of MAINS power, if either presents
a hazardous condition;
d) drive seizure: the sudden application of the rotational energy to the frame and case of a
LABORATORY CENTRIFUGE;
e) any component failure;
f) non-quantitative SINGLE FAULT CONDITIONS:
i) corrosion effects, for example corrosion at the bottom of a BUCKET or cavity, stress
corrosion cracking of alloys, corrosion of welds in the PROTECTIVE CASING,
environmental crazing of polymers, etc.;
ii) material fatigue behaviour, which may affect the mode of failure;
iii) material defects;
iv) improper installation of a BUCKET or any other component that is fitted in a swinging
BUCKET system (e.g. the omission of a BUCKET), incorrect mounting of a BUCKET at its
pivot points, use of an incorrect BUCKET, and overloading a BUCKET;
v) temperature effects, such as expected extremes during transportation, high ROTOR
ASSEMBLY temperatures during operation, and any necessary treatment specified by
the manufacturer.
NOTE Failure of HIGH INTEGRITY components need not be considered.
Conformity is checked by inspection of documentation relating to the above items.
7.7.3 Testing the PROTECTIVE CASING
For each worst-case ROTOR ASSEMBLY selection in each MCA, determined according to 7.7.2.1
to 7.7.2.3, testing as necessary shall be carried out to prove the adequacy of the PROTECTIVE
CASING, and to show that it would have contained the ROTOR parts irrespective of their
trajectory. No parts or fragments shall be expelled from the PROTECTIVE CASING during the
tests, other than those permitted by 7.7.1 a).
NOTE 1 Each test may be carried out with a new PROTECTIVE CASING.
NOTE 2 The ROTOR ASSEMBLY under test may first be appropriately weakened to induce it to fail
during the test of the PROT
...
IEC 61010-2-020 ®
Edition 3.0 2016-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
GROUP SAFETY PUBLICATION
PUBLICATION GROUPÉE DE SÉCURITÉ
Safety requirements for electrical equipment for measurement, control, and
laboratory use –
Part 2-020: Particular requirements for laboratory centrifuges
Exigences de sécurité pour appareils électriques de mesurage, de régulation et
de laboratoire –
Partie 2-020: Exigences particulières pour centrifugeuses de laboratoire
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IEC 61010-2-020 ®
Edition 3.0 2016-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
GROUP SAFETY PUBLICATION
PUBLICATION GROUPÉE DE SÉCURITÉ
Safety requirements for electrical equipment for measurement, control, and
laboratory use –
Part 2-020: Particular requirements for laboratory centrifuges
Exigences de sécurité pour appareils électriques de mesurage, de régulation et
de laboratoire –
Partie 2-020: Exigences particulières pour centrifugeuses de laboratoire
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 19.080, 71.040.10 ISBN 978-2-8322-3398-6
– 2 – IEC 61010-2-020:2016 IEC 2016
CONTENTS
FOREWORD . 3
1 Scope and object . 5
2 Normative references. 6
3 Terms and definitions . 6
4 Tests . 8
5 Marking and documentation . 8
6 Protection against electric shock . 11
7 Protection against mechanical HAZARDS . 11
8 Mechanical resistance to shock and impact . 17
9 Protection against the spread of fire . 17
10 Equipment temperature limits and resistance to heat . 17
11 Protection against HAZARDS from fluids . 17
12 Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure . 19
13 Protection against liberated gases and substances, explosion and implosion . 19
14 Components . 19
15 Protection by interlocks . 19
16 Hazards resulting from application . 19
17 Risk assessment . 19
Annexes . 20
Annex L Index of defined terms . 20
Annex AA (normative) Dynamic microbiological test method for BIOSEALS . 21
Annex BB (informative) General guidance and rationale for particular subclauses . 24
Annex CC (informative) General guidance for an empirical method to determine the
kinetic energy of a ROTOR . 28
Bibliography . 30
Figure 101 – Rotor test setup . 28
Table 101 – Time-temperature conditions . 18
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR
MEASUREMENT, CONTROL, AND LABORATORY USE –
Part 2-020: Particular requirements for LABORATORY CENTRIFUGES
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 61010-2-020 has been prepared by IEC technical committee 66:
Safety of measuring, control and laboratory equipment.
This third edition cancels and replaces the second edition published in 2006. It constitutes a
technical revision and includes the following significant changes from the second edition:
a) This Part 2 is established on the basis of the third edition (2010) of IEC 61010-1.The
changes listed in its foreword affect this Part 2, too.
b) The language has been updated to reflect current terminology for LABORATORY
CENTRIFUGES used in the industry today.
It has the status of a group safety publication in accordance with IEC Guide 104.
– 4 – IEC 61010-2-020:2016 IEC 2016
The text of this standard is based on the following documents:
CDV Report on voting
66/542/CDV 66/565A/RVC
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
This Part 2-020 is intended to be used in conjunction with IEC 61010-1. It was established on
the basis of the third edition (2010).
This Part 2-020 supplements or modifies the corresponding clauses in IEC 61010-1 so as to
LABORATORY
convert that publication into the IEC standard: Safety requirements for
CENTRIFUGES.
Where a particular subclause of Part 1 is not mentioned in this Part 2, that subclause applies
as far as is reasonable. Where this part states "addition", "modification" or "replacement", the
relevant requirement, test specification or note in Part 1 should be adapted accordingly.
In this standard:
1) the following print types are used:
– requirements: in roman type;
– NOTES: in small roman type;
– conformity and tests: in italic type;
– terms used throughout this standard which have been defined in Clause 3: SMALL
ROMAN CAPITALS.
2) subclauses, tables or figures which are additional to those in Part 1 are numbered starting
from 101; additional annexes are lettered AA, BB, etc.
A list of all parts of the IEC 61010 series, under the general title: Safety requirements for
electrical equipment for measurement, control, and laboratory use, may be found on the IEC
website.
The committee has decided that the contents of this publication will remain unchanged until
the stability date indicated on the IEC website under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR
MEASUREMENT, CONTROL, AND LABORATORY USE –
Part 2-020: Particular requirements for laboratory centrifuges
1 Scope and object
This clause of Part 1 is applicable except as follows:
1.1.1 Scope
Replacement:
This Part 2 is applicable to electrically powered LABORATORY CENTRIFUGES.
This group safety publication is primarily intended to be used as a product safety standard for
the products mentioned in the scope, but shall also be used by technical committees in the
preparation of its publications for products similar to those mentioned in the scope of this
standard, in accordance with the principles laid down in IEC Guide 104 and lSO/lEC Guide
51.
NOTE If all or part of the equipment falls within the scope of one or more other Part 2 standards of IEC 61010 as
well as within the scope of this standard, it will also need to meet the requirements of those other Part 2 standards.
1.1.2 Equipment excluded from scope
Addition:
Add the following new item:
aa) IEC 60034 (Rotating electrical machinery);
1.2 Object
1.2.1 Aspects included in scope
Addition:
Add the following new items:
aa) contact with moving parts (see 7.3);
LABORATORY CENTRIFUGE movement during any DISRUPTION (see 7.3.101);
bb)
cc) high energy chemical reaction after ROTOR DISRUPTION (see 7.7.2.2 l));
dd) ineffectiveness of BIOSEALS (see 13.101)
1.2.2 Aspects excluded from scope
Addition:
Add the following new items:
aa) additional precautions which may need to be observed when centrifuging materials
which are flammable or explosive (see 5.4.101);
– 6 – IEC 61010-2-020:2016 IEC 2016
bb) additional precautions which may need to be observed when centrifuging materials that
could react chemically with sufficient vigour to cause a HAZARD (see 5.4.101).
1.4 Environmental conditions
1.4.1 Normal environmental conditions
Replacement:
Replace item c) by the following:
c) temperature 2 °C to 40 °C;
1.4.2 Extended environmental conditions
Replacement:
Replace item c) by the following:
c) ambient temperatures below 2 °C or above 40 °C;
2 Normative references
This clause of Part 1 is applicable except as follows:
Addition:
ISO 3864 (all parts), Graphical symbols – Safety colours and safety signs
3 Terms and definitions
This clause of Part 1 is applicable except as follows:
3.1 Equipment and states of equipment
Addition:
Add the following new terms and definitions:
3.1.101
LABORATORY CENTRIFUGE
apparatus intended for laboratory use that applies a centrifuging effect to sample materials
3.1.102
CENTRIFUGE-ROTOR COMBINATION
LABORATORY CENTRIFUGE and ROTOR ASSEMBLY that are intended to operate together and which
have to be evaluated together
3.1.103
DISRUPTION
event in which the ROTOR ASSEMBLY, or part of it, fails or becomes detached during rotation
3.2 Parts and accessories
Addition:
Add the following new terms and definitions:
3.2.101
CHAMBER
enclosed space within a LABORATORY CENTRIFUGE in which the ROTOR ASSEMBLY rotates
3.2.102
ROTOR
primary component of a LABORATORY CENTRIFUGE which holds the material to be subjected to
centrifugal force and which is rotated by the DRIVE SYSTEM
3.2.103
BUCKET
sub-assembly of a ROTOR designed to support one or more containers
3.2.104
PROTECTIVE CASING
casing which completely surrounds the ROTOR ASSEMBLY and which includes the LID and its
securing devices
3.2.105
LID
access cover of the CHAMBER
3.2.106
ROTOR ASSEMBLY
ROTOR carrying a combination of ROTOR accessories specified by the manufacturer
Note 1 to entry: In the context of a ROTOR ASSEMBLY, ROTOR accessories include all components used with or in
the CENTRIFUGE ROTOR for the purpose of holding samples, including adaptors, tubes and bottles.
3.2.107
DRIVE SYSTEM
all components of the CENTRIFUGE associated with the provision of torque to, or the rotational
support of, the ROTOR ASSEMBLY
3.2.108
BIOSEAL
device or mechanism additional to, or integral with, a ROTOR or BUCKET and a closure
assembly, and which is designed to prevent the escape of contents, for example micro-
biological material, during centrifuging
3.5 Safety terms
Addition:
Add the following new terms and definitions:
3.5.101
CLEARANCE ENVELOPE
space around a LABORATORY CENTRIFUGE which is needed for safety
– 8 – IEC 61010-2-020:2016 IEC 2016
3.5.102
MCA
MAXIMUM CREDIBLE ACCIDENT
planned event chosen to represent worst-case conditions for a test that will evaluate the
inherent mechanical safety of a CENTRIFUGE-ROTOR COMBINATION (see 7.7 and Annex BB)
4 Tests
This clause of Part 1 is applicable.
5 Marking and documentation
This clause of Part 1 is applicable except as follows.
5.1.2 Identification
Replacement:
Replace item b) by the following:
b) serial number or other means to identify the production batch of the equipment.
Addition:
Add the following new subclause:
5.1.101 ROTORS and accessories
All OPERATOR-replaceable ROTORS and ROTOR ASSEMBLIES, including ROTOR ACCESSORIES, shall
be marked with the manufacturer's or supplier's name or registered trade mark, and
identification code.(such as id code, serial number or batch number)
If components are too small, or are not suitable for such marking, the required information
shall be marked on the original packaging, as well as being stated in the documentation.
NOTE Packaging can be the outer box, an insert, etc.
If the manufacturer specifies that an individual part, for example a BUCKET, is to be fitted only
to a specific ROTOR or in specific ROTOR positions for balance or some other reason, each
BUCKET and ROTOR position should be identified by marking with corresponding numbers or
letters.
Conformity is checked by inspection.
5.4.2 Equipment ratings
Addition:
Add the following new items:
aa) a list of all ROTORS and ROTOR accessories specified for use with a LABORATORY
CENTRIFUGE, together with their RATED rotational frequencies;
bb) any restrictions by the manufacturer warning against the use of particular materials to
be centrifuged;
cc) density and volume limits for ROTOR ASSEMBLY loading and, if applicable, derating
instructions.
5.4.3 Equipment installation
Addition:
Add, after item a), the following sub-items:
i) floor or bench area required for the CLEARANCE ENVELOPE for the intended use (see
7.4.101);
ii) total weight of the CENTRIFUGE;
iii) instructions for site preparation;
iv) methods for levelling of the CENTRIFUGE;
v) means for securing to the mounting surface.
5.4.4 Equipment operation
Addition:
Add the following new items:
aa) loading and balancing procedures;
bb) ROTOR changing procedure;
cc) any specific requirement for an OPERATOR to be present at stated phases of the
centrifuging procedure;
dd) necessary safeguards for personnel. Instructions shall include at least the following:
– not to lean on a LABORATORY CENTRIFUGE;
– not to stay within the CLEARANCE ENVELOPE longer than necessary for operational
reasons;
– not to deposit any potentially hazardous materials within the CLEARANCE ENVELOPE;
– methods for safe operation during open LID procedures (see 7.3.102.2);
ee) instructions for use of BIOSEALS and other biocontainment components, including the
proper closure techniques. These instructions shall indicate that BIOSEALS and related
components are intended to be part of biocontainment systems, as specified in
international and national biosafety guidelines. They are not to be relied on as the only
means of safeguarding workers and the environment when handling pathogenic micro-
organisms.
5.4.5 Equipment maintenance
Addition:
Add the following new paragraph:
Where applicable, the instructions shall specify:
aa) inspection of any means of fixing the equipment to the mounting surface and the
condition of the mounting surface itself;
bb) safeguards for the OPERATOR during cleaning;
cc) inspection of the PROTECTIVE CASING;
dd) inspection of the ROTOR ASSEMBLY, and safety considerations;
ee) checking the continuity of the PROTECTIVE BONDING;
ff) frequency of inspection, routine maintenance and the method of replacement of
BIOSEALS and other biocontainment components.
– 10 – IEC 61010-2-020:2016 IEC 2016
Addition:
Add the following new subclauses:
5.4.101 Hazardous substances
The instructions for use shall state the precautions to be observed when the materials to be
used with a LABORATORY CENTRIFUGE are known to be toxic, radioactive, or contaminated with
pathogenic micro-organisms.
NOTE This information is relevant to the safety of both OPERATORS and service personnel.
The use within the LABORATORY CENTRIFUGE of the following materials shall be prohibited in
the instructions for use:
a) flammable or explosive materials;
b) materials which could react chemically with sufficient vigour to cause a HAZARD.
Conformity is checked by inspection.
5.4.102 Cleaning and decontamination
Documentation shall include:
a) a statement that, if hazardous material is spilt on or inside the equipment, the user has
responsibility for carrying out appropriate decontamination;
b) manufacturer's recommendations for cleaning and, where necessary, decontaminating,
together with the recognized generic names of recommended materials for cleaning and
decontaminating:
c) the following statement:
"Before using any cleaning or decontamination methods except those recommended by
the manufacturer, users should check with the manufacturer that the proposed method will
not damage the equipment”
d) the following statement:
Cleaning and decontamination may be necessary as a safeguard before LABORATORY
CENTRIFUGES, ROTORS, and any accessories are maintained, repaired, or transferred.
Manufacturers may provide a format for users to document that such treatment has been
carried out
NOTE Be advised, there are national guidelines and the internationally recognized "Laboratory Biosafety Manual",
published in 1993 by the Wor5ld Health Organization in Geneva, which gives information on decontaminants, their
use, dilutions, properties, and potential applications.
Conformity is checked by inspection.
5.4.103 Effects of chemicals and environmental influences
To ensure continued safe use of a LABORATORY CENTRIFUGE the documentation shall identify
damage which could result from, for example:
a) the effect of chemicals;
b) environmental influences, including natural ultra-violet radiation likely to be encountered;
c) corrosion, and other weakening of construction materials that are part of the PROTECTIVE
CASING or other protective components.
Conformity is checked by inspection of the documentation and the relevant data and/or
additional testing (if needed).
6 Protection against electric shock
This clause of Part 1 is applicable.
7 Protection against mechanical HAZARDS
This clause of Part 1 is applicable except as follows.
7.1 General
Addition:
Add the following new note:
NOTE 101 A DISRUPTION, resulting in damage to a part of the PROTECTIVE CASING, for example a LID-locking
mechanism, is considered to be a SINGLE FAULT CONDITION.
7.3 Moving parts
Addition:
Add the following new subclauses.
7.3.101 LID
7.3.101.1 Requirements
The LID shall be locked closed when the ROTOR drive is energized, and shall remain locked
until the circumferential velocity of the ROTOR ASSEMBLY is not more than 2 m/s (see
Annex BB).
In the event of a power failure, the LID-locking mechanism shall not release, and subsequent
release shall require the use of a TOOL.
The LID shall be held closed with sufficient strength to withstand the results of testing
according to 7.7.3. Fragments produced by any DISRUPTION shall be contained as specified in
item a) of 7.7.
CENTRIFUGE-ROTOR
To evaluate which of the following points are appropriate for the
COMBINATION under consideration, information shall be recorded showing the tests conducted
by the manufacturer or by a test facility:
a) mechanical abuse;
b) mislatching;
c) misalignment;
d) corrosion;
e) material degradation;
f) material defects;
g) vibration;
h) cleaning and decontamination;
i) environmental influences;
j) other considerations appropriate for the design.
– 12 – IEC 61010-2-020:2016 IEC 2016
Conformity is checked by visual inspection; by the review of recorded information, by the tests
carried out under 7.7.3, and by any further tests considered appropriate for safety.
7.3.101.2 Exception
For LABORATORY CENTRIFUGES that satisfy all the following limitations, a device which merely
interrupts motor power may be used instead of an interlock mechanism (see Annex BB):
a) the LABORATORY CENTRIFUGE incorporates a device which holds the LID closed;
b) the device which interrupts motor power does not permit the drive motor to be
energized unless the LID is closed;
c) the rotational frequency of the ROTOR ASSEMBLY does not exceed 3 600 rpm;
d) the energy at maximum rotational frequency for the highest energy ROTOR ASSEMBLY when
fully loaded does not exceed 1 kJ;
e) the maximum centrifugal force does not exceed 2 000 g;
f) the largest ROTOR ASSEMBLY diameter does not exceed 250 mm;
g) a switch is provided for disconnecting motor power, independent of the LID position;
h) the ROTOR ASSEMBLY is visible when the LID is closed, to permit observation of any
rotation;
i) all ROTOR ASSEMBLIES used conform to 7.3 of Part 1;
j) if access is possible at a circumferential velocity of the ROTOR ASSEMBLY of more than
2 m/s, a warning label in accordance with ISO 3864 is provided on or near the access
point, indicating that the LID should not be opened until rotation has stopped. Where there
is insufficient space for such a label, symbol 14 of Table 1 is considered to be an
acceptable marking.
Conformity is checked by visual inspection and by the review of data to confirm that all the
above limitations are met.
7.3.102 ROTOR ASSEMBLIES
7.3.102.1 General
If a HAZARD could result from contact with moving parts of the ROTOR ASSEMBLY or DRIVE
SYSTEM in NORMAL CONDITION or SINGLE FAULT CONDITION, suitable protective means shall be
provided to prevent OPERATOR access, except as permitted by 7.3.101.2 and 7.3.102.2.
There shall be no holes or other openings in the top of the CHAMBER which permit the
penetration of a 4 mm diameter pin.
Conformity is checked by inspection and by using the test fingers shown in Figures B.1 and
B.2, and by checking openings in the top with a 4 mm diameter pin, in NORMAL CONDITION and
SINGLE FAULT CONDITION.
The jointed test finger shown in Figure B.2 is applied in every possible position without
applying any force. If it is possible to touch a part by applying a force, the rigid test finger
shown in Figure B.1 is applied with a force of 10 N. The force is exerted against all outer
surfaces, including the bottom, by the tip of the test finger so as to avoid wedge or lever
action. The finger shall not touch any moving part that could cause a HAZARD.
7.3.102.2 ROTOR ASSEMBLIES requiring access during rotation
If the manufacturer supplies ROTOR ASSEMBLIES requiring OPERATOR interaction (e.g. zonal or
continuous-flow ROTOR ASSEMBLIES), LABORATORY CENTRIFUGES are permitted to have an
override control which allows the motor to be energized while the access LID is open, provided
that:
a) the override control allows the motor to be energized only by use of a device (which can
be a code or code-card) that makes it possible to override a protective system and
functions by means that cannot be performed using other tools, or when a special guard
plate allows only limited access to the rotor assembly;
b) means are provided to cancel the override function automatically when use of the rotor
assembly requiring OPERATOR interaction is ended;
c) maximum speed while the LID is open is limited to 5 000 rpm.
Conformity is checked by inspection
7.4 Stability
Addition:
Add a new third paragraph as follows:
No displacement of the LABORATORY CENTRIFUGE from its installed position shall be visible
during NORMAL USE.
Addition:
Add the following new subclause:
7.4.101 LABORATORY CENTRIFUGE movement during malfunction
After installation according to the manufacturer's instructions, movement of a LABORATORY
CENTRIFUGE as a result of ROTOR ASSEMBLY imbalance, ROTOR ASSEMBLY DISRUPTION, or drive
failure (seizure), shall not present a HAZARD.
Movement shall be limited either by design, or by fastening to the mounting surface, or a
combination of both, so that no part of the LABORATORY CENTRIFUGE moves outside a
CLEARANCE ENVELOPE extending 300 mm, or less if stated by the manufacturer, in any direction
from the outermost parts of the LABORATORY CENTRIFUGE in its original position (for rationale
see Clause BB.6).
Conformity is checked by testing to confirm that the 300 mm limit, or any lower limit stated by
the manufacturer, is not exceeded in NORMAL USE and after inducing the worst-case situation
according to 7.7.2.2 for:
a) imbalance;
Use of an imbalance sensor is acceptable as a means for limiting movement. , but its possible
failure should be considered when determining the worst-case condition unless examination
of the equipment and design demonstrates conclusively that the sensor will not fail.
b) disruption of the ROTOR ASSEMBLY;
c) DRIVE SYSTEM failure;
d) seizure of the DRIVE SYSTEM.
NOTE The failure mode which will produce the greatest movement can be different from the failure mode of the
MCA determined for testing the PROTECTIVE CASING according to 7.7.3. See Annex CC for additional guidance in
determining the worst case rotor.
For these tests, the LABORATORY CENTRIFUGE is mounted on, or fixed to, a horizontal smooth
concrete test surface of dimensions appropriate for the size of LABORATORY CENTRIFUGE
being tested, and as specified in the manufacturer's instructions.
– 14 – IEC 61010-2-020:2016 IEC 2016
7.7 Expelled parts
Replacement:
Replace the title and text by the following new title and text.
7.7 Protection against expelled parts or projected parts
7.7.1 General
LABORATORY CENTRIFUGES shall be designed for safe operation in NORMAL USE and SINGLE
FAULT CONDITION, when used with ROTOR ASSEMBLIES specified by the manufacturer.
In the event of a DISRUPTION:
a) no parts or fragments of the ROTOR ASSEMBLY exceeding 5 mm in any dimension shall
completely penetrate the PROTECTIVE CASING. Smaller material (except for aerosols and
liquids) shall remain within a trajectory extending 1 m in any direction from the outermost
parts of the LABORATORY CENTRIFUGE; (See rationale in Annex BB.6)
b) no part of the LABORATORY CENTRIFUGE shall become detached or expelled in such a way
as to present a HAZARD to personnel or the environment. In the case of parts detached or
expelled from the centrifuge (not part of the ROTOR ASSEMBLY) this is to be evaluated in
accordance with Clause 17.
c) the fastenings of the access LID shall not be loosened, and there shall be no distortion
which could create an unimpeded path between any point on the ROTOR ASSEMBLY and any
point outside the LABORATORY CENTRIFUGE.
Conformity of every CENTRIFUGE-ROTOR COMBINATION specified by the manufacturer is checked
by testing as specified in 7.7.3, under MCA conditions, or by causing DISRUPTION by partially
cutting the ROTOR, or by overloading the ROTOR ASSEMBLY, or by other appropriate means. If
more than one worst-case ROTOR ASSEMBLY selection exists, each can be tested with a new
PROTECTIVE CASING.
After the tests, the criteria of a) to c) above shall be met, and visible cracks shall be examined
to determine whether or not the PROTECTIVE CASING would have contained the ROTOR parts
irrespective of their trajectory. A questionable result shall require the test to be repeated once
only, and a further questionable result is considered to be a failure. The equipment is checked
to ensure that parts which are HAZARDOUS LIVE have not become ACCESSIBLE and that
ACCESSIBLE conductive parts do not exceed the values of 6.3.2. In the event that the test
causes the operation of an overcurrent protection device, if the device can not be reset
without operating again, the unit is considered to have failed safe. (See rationale Annex
BB6.2)
NOTE 1 Consideration should be given to the presence of temporary gaps in containment during the MCA test in
determining questionable results.
Alternatively, the safety of a CENTRIFUGE-ROTOR COMBINATION can be established by analytical
evaluation based on comparison with one of more of the CENTRIFUGE-ROTOR COMBINATIONS
already tested, to confirm that the PROTECTIVE CASING would have passed the relevant test of
7.7.3.
NOTE 2 CENTRIFUGE-ROTOR COMBINATIONS designed such that satisfactory evaluation by comparison with another
CENTRIFUGE-ROTOR COMBINATION already tested cannot be made are tested as specified in 7.7.3.
7.7.2 Considerations for MCA tests
7.7.2.1 Information to be recorded
Recorded information shall include:
a) corrosion effects to be expected;
b) material fatigue behaviour;
c) material degradation considerations, including effects of inspection, maintenance, and
component replacement schedules;
d) temperature limitation considerations;
e) material defect considerations;
f) improper BUCKET installation considerations;
g) relevant environmental considerations;
h) relevant maximum loading considerations;
i) electrical circuit diagram and functional descriptions;
j) material specifications and technical data;
k) pre-treatment methods to induce ROTOR ASSEMBLY failure;
l) traceability of all measuring instruments used during tests;
m) any other relevant information.
Conformity is checked by inspection of documentation relating to the above items.
7.7.2.2 Considerations for worst-case conditions
All combinations of the following that are possible shall be considered:
a) ROTOR selection: the worst-case specified ROTOR ASSEMBLY or ROTOR ASSEMBLIES; (for
calculating the kinetic energy of rotors, refer to annex CC)
b) rotational frequency control setting: the maximum that an OPERATOR can select;
c) supply voltage: 10 % above the maximum RATED voltage marked on the equipment;
d) ROTOR ASSEMBLY load: the maximum specified load, partial load, and no load, including
state and density of load (e.g. liquid, solid);
e) ROTOR accessories, worst case loading of specified accessories used with or in the ROTOR
for the purpose of holding samples, including adaptors, tubes, and bottles;
f) ROTOR ASSEMBLY imbalance: the most severe condition;
g) altitude factors: the effect of reduced atmospheric pressure and density at increased
altitude on ROTOR DRIVE SYSTEMS which rely on windage to limit maximum rotational
frequency (see 1.4.1 b) and 1.4.2 b)).
NOTE 1 The windage limitation can be determined by conducting a rotational frequency test in a cabinet or
room in which the pressure is controlled to 80 kPa or less, or alternatively the rotational frequency n , which
would be reached at 2 000 m altitude, can be determined from:
n = n × R
2 1
where
n is the maximum rotational frequency at standard atmospheric pressure at sea-level (101 kPa);
n is the corresponding maximum rotational frequency at an atmospheric pressure equivalent to 2 000 m;
R = 1,27 (the ratio of the density of air at sea-level, to that at 2 000 m).
h) friction between the LABORATORY CENTRIFUGE or LABORATORY CENTRIFUGE feet and the
surface on which the LABORATORY CENTRIFUGE is placed;
i) ambient temperature: the effect on components of working at any temperature in the
permitted range from 2 °C to 40 °C;
j) a combination of ROTOR ASSEMBLY and drive unit causing an instability of the dynamic
behaviour;
k) installation as specified by the manufacturer;
l) the possibility of high energy chemical reaction after DISRUPTION
– 16 – IEC 61010-2-020:2016 IEC 2016
NOTE 2 In LABORATORY CENTRIFUGES which develop energies of the order of 275 kJ and above, and which
are refrigerated under vacuum, it is possible for a DISRUPTION to cause a chemical explosion if parts of the
ROTOR ASSEMBLY are made of reactive material, such as aluminium and titanium. An explosion can occur due
to interaction at high energies of the ROTOR ASSEMBLY fragments with refrigerants and water.
In such cases, the worst-case conditions can be achieved by the following combination of
means:
i) disabling rotational frequency controls and limiting devices so that the highest
rotational frequency is reached;
ii) selecting whichever ROTOR of reactive material has the highest rotational energy, and
pretreating it so as to cause a DISRUPTION. The pre-treatment shall maximize the
surface area of the resulting fragments;
iii) adjusting the refrigeration system to have the maximum amount of refrigerant in the
evaporator which cools the CHAMBER;
iv) loading the ROTOR ASSEMBLY with water to 80 % of its nominal capacity;
v) running the LABORATORY CENTRIFUGE in worst-case conditions of all other unspecified
factors until a DISRUPTION occurs.
NOTE 3 Test personnel should be aware that extraordinary energy release can result from the tests where a
high-energy chemical reaction is possible after DISRUPTION. A remote bunker facility is recommended.
Conformity is checked by inspection of documentation relating to the above items.
7.7.2.3 SINGLE FAULT CONDITIONS to be considered
The following SINGLE FAULT CONDITIONS shall be considered:
a) rotational frequency control condition: whichever SINGLE FAULT CONDITION that results in the
highest rotational frequency;
b) rotational frequency limiting system whichever SINGLE FAULT CONDITION permits the highest
rotational frequency;
c) MAINS power interruption: intermittent or permanent loss of MAINS power, if either presents
a hazardous condition;
d) drive seizure: the sudden application of the rotational energy to the frame and case of a
LABORATORY CENTRIFUGE;
e) any component failure;
f) non-quantitative SINGLE FAULT CONDITIONS:
i) corrosion effects, for example corrosion at the bottom of a BUCKET or cavity, stress
corrosion cracking of alloys, corrosion of welds in the PROTECTIVE CASING,
environmental crazing of polymers, etc.;
ii) material fatigue behaviour, which may affect the mode of failure;
iii) material defects;
iv) improper installation of a BUCKET or any other component that is fitted in a swinging
BUCKET system (e.g. the omission of a BUCKET), incorrect mounting of a BUCKET at its
pivot points, use of an incorrect BUCKET, and overloading a BUCKET;
v) temperature effects, such as expected extremes during transportation, high ROTOR
ASSEMBLY temperatures during operation, and any necessary treatment specified by
the manufacturer.
Conformity is checked by inspection of documentation relating to the above items.
7.7.3 Testing the PROTECTIVE CASING
For each worst-case ROTOR ASSEMBLY selection in each MCA, determined according to 7.7.2.1
to 7.7.2.3, testing as necessary shall be carried out to prove the adequacy of the PROTECTIVE
CASING, and to show that it would have contained the ROTOR parts irrespective of their
trajectory. No parts or fragments shall be expelle
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