EN IEC 61010-2-101:2022/A11:2022

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

• Status: Published
• Publication Date: 10-Nov-2022
• ICS: 11.040.55 - Diagnostic equipment
• ICS: 19.080 - Electrical and electronic testing
• Technical Committee: CLC/TC 66X - Safety of measuring, control, and laboratory equipment
• Drafting Committee: CLC/TC 66X/WG 4 - IVDD
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 11-Nov-2022
• Due Date: 09-Aug-2023
• Completion Date: 11-Nov-2022
• Directive: 2006/42/EC - Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast)
• Directive: 2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
• Mandate: M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Mandate: M/396 - Mandate to CEN and Cenelec for standardisation in the field of machinery
• Ref Project: SIST EN 61010-2-101:2023/A11:2023 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment

Relations

• Amends: EN IEC 61010-2-101:2022 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment
• Effective Date: 27-Apr-2021

Overview

EN IEC 61010-2-101:2022/A11:2022 is a CENELEC amendment to the European safety standard for electrical equipment for measurement, control and laboratory use specifically covering in vitro diagnostic (IVD) medical equipment, including self-test IVD devices. Amendment A11 modifies EN IEC 61010-2-101:2022 and is intended to be read together with EN 61010-1:2010 + A1:2019 as modified. The document focuses on reducing hazards to operators, service personnel and the surrounding area and integrates risk management principles (see ISO 14971 guidance).

Key topics and technical requirements

• Scope and risk management: Applies to IVD and self-test IVD equipment; requires use of manufacturer risk management processes (ISO 14971 recommended).
• New/clarified definitions: e.g., CONTROL SYSTEM (including electrical, electronic and programmable parts) and SERVICE PERSONNEL (qualified installers/repairers).
• EMC and safety: EMC requirements excluded except when related to safety; specific immunity requirements reference EN IEC 61326-2-6:2021 for IVD equipment and EN 61326-3-1 for safety-related immunity.
• Mechanical hazards: Prevention of being trapped, slipping/tripping/falling, and hand‑transmitted vibration controls. Lifting/carrying means required for equipment ≥ 18 kg; handhold/handrail tests require 3200 N load.
• Transport, installation and network guidance: Documentation must include minimum hardware/software and network connection requirements for safe operation (guidance: IEC 80001-1).
• Temperature and cold‑touch limits: Clause renamed to include cold. Cold surface limits are specified (examples: metal uncoated −20 °C, plastics −40 °C; knobs and handles have distinct limits). Equipment requiring marking for frostbite risk uses ISO 7010 symbol W010.
• Noise and acoustic safety: If max sound > 70 dB(A), document maximum levels; exposure limits LEX,8h = 80 dB(A) and LpC,peak = 135 dB(C) apply.
• Marking and lifetime: Equipment with limited lifetime must be marked (time, date, or cycles).

Applications and users

• Who uses it: IVD and laboratory equipment manufacturers, design engineers, compliance and regulatory teams, testing laboratories, procurement and facility managers, and service personnel.
• Practical uses: Device design reviews, compliance checklists, risk assessments, technical documentation for CE marking, factory acceptance tests, service and installation manuals, and procurement specifications for safe IVD products.

Related standards

• EN IEC 61326-2-6:2021 (EMC for IVD)
• EN 61010-1:2010 + A1:2019 (general safety)
• EN IEC 62061, EN ISO 13849-1 (functional safety / control systems)
• EN 62366-1 (usability engineering for medical devices)
• IEC 80001-1 (networked medical device safety guidance)

Keywords: EN IEC 61010-2-101:2022/A11:2022, IVD safety standard, in vitro diagnostic equipment, laboratory electrical safety, EMC for IVD, ISO 14971 risk management.

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:
“10.1 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:
"
Cold touchable surfaces in NORMAL CONDITION shall not be below the values of Table 201.
Table 201 — Cold surface temperature limits in NORMAL CONDITION
Limit
Part
°C
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 12.201 to 12.202.”
In 12.5.1 “Sound level”:
Replace the first two paragraphs and note 1 and note 2 with the following text:
“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 all levels are ≤ 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 maximum sound pressure value shall be stated in the documentation and the following exposure
threshold values limits shall not be exceeded.
L ,8h = 80 dB(A) and L ,peak = 135 dB(C) respectively
EX pC
NOTE 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 an exposure to HAZARD. 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 protective equipment.”
Replace the first sentence of the conformity statement with the following text:
“Conformity is checked by measuring the maximum A-weighted sound pressure level, and if required, the
maximum C-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 safety protection shall not be impaired by electromagnetic disturbances.
For equipment intended to be used in professional healthcare facility environment, the immunity requirements
of Table 101 of EN IEC 61326-2-6:2021 shall be applied.
For equipment intended to be used in home healthcare environment, the immunity requirements of Tables 102
and 103 of EN IEC 61326-2-6:2021 shall be applied.
Conformity is checked by inspection and the test of Clause 6 of EN IEC 61326-2-6:2021 test documentation.
12.202 Safety aspect of electromagnetic emissions
Equipment that includes components which emits intentionally electromagnetic fields shall be safe for
OPERATORS and SERVICE PERSONNEL. The emission requirements of EN IEC 61326-2-6:2021 shall be applied.
NOTE 1 Such components could be wireless com
...