prEN IEC 61010-2-101:2022/FprAA
(Amendment)Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
The scope of the Amendment is the same as EN 61010-2-101:2017. It applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes.
Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte - Teil 2-101: Besondere Anforderungen an In-vitro-Diagnostik (IVD) Medizingeräte
Exigences de sécurité pour appareils électriques de mesurage, de régulation et de laboratoire - Partie 2-101 : Exigences particulières pour le matériel médical de diagnostic in vitro (DIV)
Varnostne zahteve za električno opremo za meritve, nadzor in laboratorijsko uporabo - 2-101. del: Posebne zahteve za diagnostično in vitro (IVD) medicinsko opremo
General Information
RELATIONS
Standards Content (sample)
SLOVENSKI STANDARD
oSIST prEN 61010-2-101:2018/oprA11:2021
01-december-2021
Varnostne zahteve za električno opremo za meritve, nadzor in laboratorijsko
uporabo - 2-101. del: Posebne zahteve za diagnostično in vitro (IVD) medicinsko
opremo
Safety requirements for electrical equipment for measurement, control, and laboratory
use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte - Teil 2
-101: Besondere Anforderungen an In-vitro-Diagnostik (IVD) MedizingeräteExigences de sécurité pour appareils électriques de mesurage, de régulation et de
laboratoire - Partie 2-101 : Exigences particulières pour le matériel médical de diagnostic
in vitro (DIV)Ta slovenski standard je istoveten z: prEN 61010-2-101:2017/prA11
ICS:
11.100.10 Diagnostični preskusni In vitro diagnostic test
sistemi in vitro systems
19.080 Električno in elektronsko Electrical and electronic
preskušanje testing
71.040.10 Kemijski laboratoriji. Chemical laboratories.
Laboratorijska oprema Laboratory equipment
oSIST prEN 61010-2- en,fr,de
101:2018/oprA11:2021
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 61010-2-101:2018/oprA11:2021
EUROPEAN STANDARD DRAFT
prEN IEC 61010-2-101:2017
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA11
October 2021
ICS 11.040.55; 19.080
English Version
Safety requirements for electrical equipment for measurement,
control, and laboratory use - Part 2-101: Safety requirements for
in vitro diagnostic (IVD) medical equipment
Exigences de sécurité pour appareils électriques de Sicherheitsbestimmungen für elektrische Mess-, Steuer-,
mesurage, de régulation et de laboratoire - Partie 2-101 : Regel- und Laborgeräte - Teil 2-101: Besondere
Exigences particulières pour le matériel médical de Anforderungen an In-vitro-Diagnostik (IVD) Medizingeräte
diagnostic in vitro (DIV)This draft amendment prA11, if approved, will modify the European Standard prEN 61010-2-101:2017; it is submitted to CENELEC
members for enquiry.Deadline for CENELEC: 2022-01-21.
It has been drawn up by CLC/TC 66X.
If this draft becomes an amendment, CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which
stipulate the conditions for giving this amendment the status of a national standard without any alteration.
This draft amendment was established by CENELEC in three official versions (English, French, German).
A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to
the CEN-CENELEC Management Centre has the same status as the official versions.CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Project: 73775 Ref. No. prEN IEC 61010-2-101:2017/prA11 E---------------------- Page: 3 ----------------------
oSIST prEN 61010-2-101:2018/oprA11:2021
prEN IEC 61010-2-101:2017/prA11 (E)
European foreword
This document (prEN IEC 61010-2-101:2017/prA11) has been prepared by CLC/TC 66X "Safety of measuring,
control, and laboratory equipment".This document is currently submitted to the Enquiry.
The following dates are proposed:
• latest date by which the existence of this (doa) dor + 6 months
document has to be announced at national
level
• latest date by which this document has to be (dop) dor + 12 months
implemented at national level by publication of
an identical national standard or by
endorsement
• latest date by which the national standards (dow) dor + 36 months
conflicting with this document have to be (to be confirmed or
withdrawn modified when voting)
This document will amend prEN IEC 61010-2-101:2017.
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oSIST prEN 61010-2-101:2018/oprA11:2021
prEN IEC 61010-2-101:2017/prA11 (E)
1 Modifications to 1.1.1, "Equipment included in scope"
Replace the title as follows:
"1.1.1 General"
Replace the second paragraph with the following:
"This part of IEC 61010 provides particular safety requirements to equipment intended for in vitro diagnostic
(IVD) medical purposes, including self-test IVD medical purposes. It is intended to be used in conjunction of the
manufacturer’s risk management but not to replace it.NOTE 1 A good design practice of an equipment starts from the beginning with a risk management process according
to ISO 14971, which provides requirement and guidance for a comprehensive risk management process and identifies
hazards and risks related with the equipment."Replace the note with the following:
NOTE 2 A system, as specified by its manufacturer, is a combination of items of equipment, at least one of these is inter-
connected to another item. In the following text the term equipment is used for single equipment and systems.
It is possible that 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 document. In that case, the requirements of those other Part 2 standards will also apply."
2 Modifications to 1.1.2, "Equipment excluded from scope"Replace the title as follows:
"1.1.2 Exclusions from the scope"
3 Modifications to 1.2.1, "Aspects included in scope"
Replace the first paragraph with the following:
The purpose of the requirements of this document is to ensure that HAZARDS to the OPERATOR, the SERVICE
PERSONNEL and the surrounding area are reduced to a tolerable level."Add the following item to the list:
"cc) any other energy sources (see Clause 101)"
4 Modifications to 1.2.2, "Aspects excluded from scope"
Delete items b) and c).
5 Modifications to Clause 2, "Normative references"
Add the following references:
EN IEC 61326-2-6:— , Electrical equipment for measurement, control and laboratory use - EMC requirements
- Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
To be published.---------------------- Page: 5 ----------------------
oSIST prEN 61010-2-101:2018/oprA11:2021
prEN IEC 61010-2-101:2017/prA11 (E)
EN 61326-3-1, Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 3-
1: Immunity requirements for safety-related systems and for equipment intended to perform safety-related
functions (functional safety) - General industrial applicationsEN 62366-1, Medical devices - Part 1: Application of usability engineering to medical devices
ISO 13849-1, Safety of machinery - Safety-related parts of control systems - Part 1: General principles for design
6 Modifications to Clause 3.2, “Parts and accessories”Add the following new term and definition.
3.2.201
CONTROL SYSTEM
all the parts of the equipment forming a system to provide, for example, operational control, monitoring,
interlocking, communications, protection or safety-related control functionsNOTE 1 to entry: These parts include electrical, electronic and programmable electronic parts and devices as well as the
mechanical parts.NOTE 2 to entry: Safety-related control functions can be performed by a control system that is either integral to or
independent of those parts of a control system that performs non-safety-related functions.
7 Modifications to Clause 3.5, “Safety terms”Add the following new term and definition.
3.5.201
SERVICE PERSONNEL
person who is installing, changing or repairing the equipment, with the appropriate technical training, experience
and awareness of HAZARDS and of measures to minimize danger to himself/herself, other persons or to the
equipment.8 Modifications to Table 1 in 5.1.3, “Mains supply”
Add the following item to Table 1:
201 ISO 7010 – W010 (modified) Caution, risk of frostbite
9 Modification to Clause 5.1, “Marking”
Add the following new subclause:
"5.1.201 Limited lifetime
If equipment has a limited lifetime it shall be marked on the equipment. The information can be given in time,
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prEN IEC 61010-2-101:2017/prA11 (E)
10 Modification to Clause 5.4,3 “Equipment installation”
Add the following item and note to the list:
"zz) Minimum hardware, software, and other related requirements to operate the equipment as intended and to
connect it to a network to ensure safe operation.NOTE Guidance can be found in IEC 80001-1."
11 Modifications to Clause 7, "Protection against mechanical HAZARDS"
In 7.1 “General”:
Add the following items to the list:
aaa) being trapped inside the equipment (see 7.201).
bbb) slipping, tripping or falling (see 7.202).
ccc) hand transmitted vibrations (see 7.203)
Replace the conformity statement with the following text:
“Conformity is checked as specified in 7.2 to 7.7 and 7.201 to 7.203."
In 7.5.1 “General”:
Replace the first paragraph with the following text:
“Equipment or parts having a mass of 18 kg or more shall be provided with a means for lifting and carrying, or
directions shall be given in the documentation to ensure safe transport, storage, installation, and disposal (also
see 8.101).“Add the following new subclauses
7.201 Prevention of being trapped in the equipment
If risk evaluation shows that the OPERATOR or professional SERVICE PERSONNEL can be exposed to a
HAZARD of being trapped inside the equipment during normal use or during professional service, the design
shall ensure that— this situation is eliminated (inherent safety) or
— the trapped person is able to free herself or
— the trapped person can set an alarm to get help from another person.
In addition the instructions for use shall have a respective safety instruction.
Conformity is checked by inspection of the design and the instructions for use.
7.202 Prevention of slipping, tripping or falling
Surfaces belonging to the equipment on which OPERATOR or SERVICE PERSONNEL need to stand or step
to carry out their duties shall be equipped with a non-slip surface compatible with normal work footwear. Where
such surfaces are elevated by more than 0,3 m from the room floor or are narrower than 0,3 m (that is to say,
they don’t allow the whole foot to rest flat on the surface without twisting) handholds or handrails shall be
provided. Any steps built into the equipment shall provide for adequate engagement of the foot on the step. A
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prEN IEC 61010-2-101:2017/prA11 (E)
minimum of 0,15 m is considered adequate. The safe use of the handholds or handrails shall be explained in
the instructions for use.Conformity is checked by inspection and by testing that each handhold and handrail withstands a force of
3200N.Unless the mounting screws (if any) are secured against loosening, one screw is removed before performing
these tests. The force is applied uniformly over a 70 mm width at the center of the handhold, without clamping.
The force is steadily increased so that the test value is attained after 10 s and maintained for a period of 1 min.
After the tests the handhold shall not have broken loose from the equipment and there shall not be any
permanent distortion, cracking or other evidence of failure which could cause a HAZARDOUS SITUATION.
7.203 Hand-transmitted vibrationExcept for vibrations directly required to carry out the NORMAL USE of the equipment, information shall be
provided to protect the OPERATOR and other persons if in NORMAL USE the hand-transmitted frequency-
weighted RMS acceleration generated by the equipment exceeds the values below:— 2,5 m/s for a cumulative time of 8 h during a 24 h period; and
— 5,0 m/s for a cumulative time of 2 h during a 24 h period.
NOTE Interpolation or extrapolation is allowed for allowable acceleration in accordance with the following formula:
2,5 x √(8 h / t), in m/s², where t is the cumulative time over a 24 h period. (Example for 4 h instead of 8 h: = 2,5 m/s² x √(8 h
/ 4 h) = 3,54 m/s²).Conformity is checked by inspection and in case of doubt by measurements at points of equipment in hand
contact with the OPERATOR or other persons. Measurements are made in accordance with ISO 5349-1.
12 Modifications to Clause 8, "Resistance to mechanical stresses"Replace the title and the first two paragraphs of 8.101 with the following:
"8.101 Transport, storage and disposal
Equipment shall not cause a HAZARD when delivered in the manufacture’s packaging
1) to the persons involved in the transport, storage, during installation, and disposal of the equipment,
2) to the persons involved in NORMAL USE after transport or storage,if the equipment is handled in accordance with the instructions specified in the instruction for use and markings
on the equipment packaging (see 5.1.101 and 5.4.101).Provisions for lifting and carrying shall be provided as defined in 7.5.
If the manufacturer assumes responsibility for delivery, installation, and disposal, the above requirement is met
without inspection of test records."13 Modifications to Clause 10, "Equipment temperature limits and resistance to
heat"
Replace the title of Clause 10 as follows:
“10 Equipment temperature limits and resistance to heat and cold”
Replace the title of 10.1 as follows:
“10.1 Surface temperature limits for protection against burns and frostbite”
In 10.1, replace the conformity statement with the following text, table, and new conformity statement:
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prEN IEC 61010-2-101:2017/prA11 (E)
“Cold touchable surfaces in normal condition shall not be below the values of Table 201.
Table 201 — Cold surface temperature limits in NORMAL CONDITIONLimit
Part
1 Touchable outer surface of enclosure (unintentional contact)
a) metal, uncoated or anodized -20
b) metal, coated (paint, non-metallic) -30
c) plastics, plastic films, labels -40
d) glass and ceramics -30
2 Knobs (NORMAL USE contact for short periods up to 4s)
a) metal 2
b) plastics -40
c) glass and ceramics -20
3 Handles (NORMAL USE contact for periods up to 120s) 5
NOTE ISO 13732-3 gives information about the effect of the duration of contact.
Exception for temperatures lower than the values of Table 201 in NORMAL CONDITION and lower than -40°C
in SINGLE FAULT CONDITION are permitted, provided that they are recognizable as such by appearance or
function or are marked with symbol 201 (ISO 7010 – W010) of Table 1. Equipment cooled by its environment to
temperature values lower than the values in Table 201 in NORMAL CONDITION and -40°C in SINGLE FAULT
CONDITION need not to be marked with symbol 201 (ISO 7010 – 1818 W010).Conformity is checked by measurements as specified in 10.4, and by inspection of barriers to check that they
protect against accidentally touching surfaces that are at temperatures above the values of Table 19, or below
the values of Table 201, and that they cannot be removed without a TOOL.14 Modifications to Clause 12, "Protection against radiation, including laser sources,
and against sonic and ultrasonic pressure"In 12.1 “General”:
Replace the first sentence with the following text:
“The equipment shall provide protection against the effects of internally generated ultraviolet, ionizing and
microwave radiation, laser sources, sonic and ultrasonic pressure, and electromagnetic radiation.
NOTE Only safety aspects caused by the equipment are covered by this clause. General requirements for electromagnetic
compatibility are excluded.Conformity is checked as specified in 12.2 to 12.6 and 12.202.”
In 12.5.1 “Sound level”:
Replace the first two paragraphs and note 1 and note 2 with the following text:
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prEN IEC 61010-2-101:2017/prA11 (E)
“If the equipment can produce noise at a level which could cause harm to the OPERATOR, the manufacturer
shall measure the maximum sound pressure level which the equipment can produce in NORMAL USE. The
maximum sound pressure level does not apply to alarms and sound sources remote from the equipment.
If no level exceeds 70 dB(A) above a reference sound pressure of 20 μPa, this fact shall be stated in the
documentation. For equipment which produces a maximum sound pressure level >70 dB(A) above a reference
sound pressure of 20 μPa the following exposure threshold values limits shall not be exceeded.
LEX,8h = 80 dB(A) and LpC,peak = 135 dB(C) respectivelyNOTE The daily noise exposure level (LEX,8h) is the time-weighted average of the noise exposure levels on the basis
of an eight-hour shift. It comprises all noise events occurring at the workplace. Attention is drawn to the RESPONSIBLE BODY
that installation of equipment in a workplace with additional noise sources can create a HAZARDOUS SITUATION. The
peak sound pressure level (LpC,peak) is the maximum value of the instantaneous sound pressure level.
When applying the limit values, the attenuation provided by individual hearing protection worn by the operator
shall not be considered.Technical measures shall take precedence over organizational measures and shall have priority over the use
of Personal Protection Equipment.”and replace the first sentence of the conformity statement with the following text:
“Conformity is checked by measuring the maximum A-weighted sound pressure level at the OPERATOR
position and at bystander positions, but not further than 1 m from the equipment surfaces.”
Add the following new subclauses (to Clause 12):12.201 Safety aspect of electromagnetic disturbances
The protection for safety shall not be impaired by electromagnetic disturbances. The equipment shall comply
with EN IEC 61326-2-6:— .For equipment intended to be used in professional healthcare facility environment, the immunity requirements
table 101 and 103 of EN IEC 61326-2-6:— shall be applied.For equipment intended to be used in home healthcare environment, the immunity requirements table 102,103,
1 2104 of EN IEC 61326-2-6:— shall be applied.
Conformity is checked by inspection of the EN IEC 61326-2-6:— test documentation.
12.202 Safety aspect of electromagnetic emissionsEQUIPMENT that in
...
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