EN IEC 61010-2-101:2022/A11:2022
(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 - Dopolnilo A11
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2023
Varnostne zahteve za električno opremo za meritve, nadzor in laboratorijsko
uporabo - 2-101. del: Posebne zahteve za diagnostično in vitro (IVD) medicinsko
opremo - Dopolnilo A11
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) 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)
Ta slovenski standard je istoveten z: EN IEC 61010-2-101:2022/A11:2022
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 61010-2-101:2022/A11
NORME EUROPÉENNE
EUROPÄISCHE NORM November 2022
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 amendment A11 modifies the European Standard EN IEC 61010-2-101:2022; it was approved by CENELEC on 2022-09-26.
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.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This amendment exists 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,
Türkiye and the United Kingdom.
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
© 2022 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 61010-2-101:2022/A11:2022 E
European foreword
This document (EN IEC 61010-2-101:2022/A11:2022) has been prepared by CLC/TC 66X "Safety of
measuring, control, and laboratory equipment".
The following dates are fixed:
• latest date by which this document has to be (dop) 2023-09-26
implemented at national level by publication of
an identical national standard or by
endorsement
• latest date by which the national standards (dow) 2025-09-26
conflicting with this document have to be
withdrawn
This document amends EN IEC 61010-2-101:2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
This document is read in conjunction with EN 61010-1:2010 + A1:2019 as modified by
EN IEC 61010-2-101:2022 which results in the complete text of EN IEC 61010-2-101:2022. This A11 describes
how that text is modified.
Any feedback and questions on this document should be directed to the users’ national committee. A complete
listing of these bodies can be found on the CENELEC website.
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 with
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 201)"
4 Modifications to 1.2.2, "Aspects excluded from scope"
Delete item b).
Replace item c) with the following:
“c) EMC requirements, except when related to safety (see the IEC 61326 series);”
5 Modifications to Clause 2, "Normative references"
Add the following references:
"
EN IEC 61326-2-6:2021, Electrical equipment for measurement, control and laboratory use - EMC requirements
- Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
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 applications
EN IEC 62061:2021, Safety of machinery - Functional safety of safety-related control systems
EN 62366-1, Medical devices - Part 1: Application of usability engineering to medical devices
EN ISO 13849-1:2015, Safety of machinery - Safety-related parts of control systems - Part 1: General principles
for design (ISO 13849-1:2015)
EN ISO 13850, Safety of machinery - Emergency stop function - Principles for design (ISO 13850)
"
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 functions
NOTE 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,
date, or cycles, whatever is appropriate for the equipment."
10 Modification to Clause 5.4.3 “Equipment transportation, installation and assembly
instructions”
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,
instructions 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 assessment 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/himself 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 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 withstand 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 ±5 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 an exposure to a HAZARD.
7.203 Hand-transmitted vibration
Except 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 2
2,5 x √(8 h / t), in m/s , where t is the cumulative time over a 24 h period. (Example for 4 h instead of 8 h: = 2,5 m/s x √(8 h
/ 4 h) = 3,54 m/s ).
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 manufacturer’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.
The above requirement is excluded from the scope if the manufacturer assumes responsibility for delivery,
installation, and disposal."
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
...
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