Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement

2021-02-25: TC Off confirmed: can be published without link to legislation as agreed by BT D162/C064, link removed
2019-12-02: NEXT ACTION: TC to prepare ZZ
2019-12-02: TC decision to further process document
2019-01-28 - Assessment is missing.

Industrielle, wissenschaftliche und medizinische Geräte - Funkstörungen - Grenzwerte und Messverfahren

Appareils industriels, scientifiques et médicaux - Caractéristiques de perturbations radioélectriques - Limites et méthodes de mesure

Industrijska, znanstvena in medicinska oprema - Karakteristike občutljivosti za radijske motnje - Mejne vrednosti in merilne metode - Dopolnilo A2

General Information

Status
Published
Publication Date
09-May-2021
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
05-May-2021
Due Date
10-Jul-2021
Completion Date
10-May-2021

Relations

Overview

EN 55011:2016/A2:2021 (CISPR 11:2015/A2:2019) is a CENELEC amendment to the European standard for industrial, scientific and medical (ISM) equipment covering radio‑frequency disturbance characteristics - limits and methods of measurement. This amendment updates measurement procedures and emission limits, adds applicability to certain power conversion equipment and improves repeatability of measurements in the 1–18 GHz band. Keywords: EN 55011:2016/A2:2021, CISPR 11, radio‑frequency disturbance, EMC, ISM equipment.

Key topics

  • Scope and status: European adoption of CISPR 11 amendment A2 (approved 2019, published 2021).
  • New equipment coverage: Semiconductor power converters (SPC) specifically for photovoltaic systems and grid‑connected power converters (GCPCs) for energy storage.
  • LV d.c. power ports: applicability criteria based on cable length L (Table 19) - e.g., no measurements required for L < 3 m; measurement start frequency f(MHz) = 60/L for 3 m ≤ L < 30 m.
  • Measurement repeatability improvements for 1–18 GHz:
    • Alignment of LogAV (10 Hz VBW) and APD (Amplitude Probability Distribution) methods.
    • Increase of final frequency points (up to 7 for LogAV; 5 for APD) and extension of weighted measurement span to 20 MHz.
    • Peak measurement changes: require 2‑minute max‑hold peak measurement on all azimuths (no preliminary/final split).
  • Updated limits (measurement distance 3 m):
    • Peak limits for group 2 equipment above 400 MHz: 70 dB(µV/m) generally; harmonic bands may have higher values (see Table 13).
    • Weighted limits for group 2 above 400 MHz: 60 dB(µV/m) in defined sub‑ranges (Table 14).
    • APD level corresponding to 10% for Class B group 2: 70 dB(µV/m) (Table 15).

Practical applications

  • Defines how to measure and assess radiated emissions from ISM and related industrial equipment to ensure compatibility with radio receivers and digital services.
  • Applied during EMC compliance testing of:
    • Microwave ovens, industrial heaters, laboratory equipment
    • Photovoltaic inverters, d.c.–d.c. converters and GCPCs for energy storage
    • Other group 1 and group 2 industrial devices with RF emissions

Who should use this standard

  • EMC engineers and test laboratories performing radiated emission measurements
  • Manufacturers of ISM equipment and power converters preparing CE/market access documentation
  • Product compliance teams and technical regulators checking conformity with European EMC rules

Related standards

  • CISPR 11 (base publication)
  • Product‑specific EMC standards and IEC/CENELEC product standards that reference EN 55011 for emission criteria

This amendment focuses on measurement methods (LogAV, APD, peak), applicability to LV d.c. power ports and SPCs, and harmonized limits - essential for accurate, repeatable EMC testing of modern industrial and power‑conversion equipment.

Amendment
SIST EN 55011:2016/A2:2021
English language
13 pages
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Frequently Asked Questions

SIST EN 55011:2016/A2:2021 is a amendment published by the Slovenian Institute for Standardization (SIST). Its full title is "Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement". This standard covers: 2021-02-25: TC Off confirmed: can be published without link to legislation as agreed by BT D162/C064, link removed 2019-12-02: NEXT ACTION: TC to prepare ZZ 2019-12-02: TC decision to further process document 2019-01-28 - Assessment is missing.

2021-02-25: TC Off confirmed: can be published without link to legislation as agreed by BT D162/C064, link removed 2019-12-02: NEXT ACTION: TC to prepare ZZ 2019-12-02: TC decision to further process document 2019-01-28 - Assessment is missing.

SIST EN 55011:2016/A2:2021 is classified under the following ICS (International Classification for Standards) categories: 33.100.10 - Emission. The ICS classification helps identify the subject area and facilitates finding related standards.

SIST EN 55011:2016/A2:2021 has the following relationships with other standards: It is inter standard links to SIST EN IEC 55011:2025, SIST EN 55011:2016. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

SIST EN 55011:2016/A2:2021 is associated with the following European legislation: EU Directives/Regulations: 2014/30/EU, 2014/32/EU; Standardization Mandates: M/404, M/552. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

You can purchase SIST EN 55011:2016/A2:2021 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.

Standards Content (Sample)


SLOVENSKI STANDARD
01-junij-2021
Industrijska, znanstvena in medicinska oprema - Karakteristike občutljivosti za
radijske motnje - Mejne vrednosti in merilne metode - Dopolnilo A2
Industrial, scientific and medical equipment - Radio-frequency disturbance
characteristics - Limits and methods of measurement
Industrielle, wissenschaftliche und medizinische Geräte - Funkstörungen - Grenzwerte
und Messverfahren
Appareils industriels, scientifiques et médicaux - Caractéristiques de perturbations
radioélectriques - Limites et méthodes de mesure
Ta slovenski standard je istoveten z: EN 55011:2016/A2:2021
ICS:
33.100.10 Emisija Emission
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 55011:2016/A2

NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2021
ICS 33.100.10
English Version
Industrial, scientific and medical equipment - Radio-frequency
disturbance characteristics - Limits and methods of
measurement
(CISPR 11:2015/A2:2019)
Appareils industriels, scientifiques et médicaux - Industrielle, wissenschaftliche und medizinische Geräte -
Caractéristiques de perturbations radioélectriques - Limites Funkstörungen - Grenzwerte und Messverfahren
et méthodes de mesure (CISPR 11:2015/A2:2019)
(CISPR 11:2015/A2:2019)
This amendment A2 modifies the European Standard EN 55011:2016; it was approved by CENELEC on 2019-02-22. 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,
Turkey 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
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 55011:2016/A2:2021 E

European foreword
The text of document CIS/B/715A/FDIS, future CISPR 11/A2, prepared by CISPR SC B "Interference
relating to industrial, scientific and medical radio-frequency apparatus, to other (heavy) industrial
equipment, to overhead power lines, to high voltage equipment and to electric traction" of CISPR
"International special committee on radio interference" was submitted to the IEC-CENELEC parallel
vote and approved by CENELEC as EN 55011:2016/A2:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2021-10-09
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024-04-09
document have to be withdrawn
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 has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association.
Endorsement notice
The text of the International Standard CISPR 11:2015/A2:2019 was approved by CENELEC as a
European Standard without any modification.

CISPR 11 ®
Edition 6.0 2019-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
INT ERNATIONAL SPECIAL COMMITTEE ON RADIO INTERFERENCE

C OMITÉ INTERNATIONAL SPÉCIAL DES PERTURBATIONS RADIOÉLECTRIQUES

AMENDMENT 2
AMENDEMENT 2
Industrial, scientific and medical equipment – Radio-frequency disturbance

characteristics – Limits and methods of measurement

Appareils industriels, scientifiques et médicaux – Caractéristiques de

perturbations radioélectriques – Limites et méthodes de mesure

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 33.100.10 ISBN 978-2-8322-6379-2

– 2 – CISPR 11:2015/AMD2:2019 © IEC 2019
FOREWORD
This amendment has been prepared by CISPR Subcommittee B: Interference relating to
industrial, scientific and medical radio-frequency apparatus, to other (heavy) industrial
equipment, to overhead power lines, to high voltage equipment and to electric traction.
The text of this amendment is based on the following documents:
FDIS Report on voting
CIS/B/715A/FDIS CIS/B/719/RVD
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table.
The committee has decided that the contents of this amendment and the base 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.
_____________
Introduction to the amendment
This AMD 2 combines the contents of two fragments which have been circulated as
CIS/B/688/CDV (f2) and CIS/B/697/CDV (f3).
Fragment 2: Requirements for semiconductor power converters (SPC)
CISPR 11 Ed. 6.1 needs to be supplemented with further information for full inclusion of type
test requirements for SPCs specified hereafter. These requirements apply only to the
following types of equipment:
a) power conversion equipment intended for assembly into photovoltaic power generating
systems, such as grid connected power converters (GCPCs) and d.c. to d.c. converters,
b) GCPCs intended for assembly into energy storage systems.
Fragment 3: Improvement of repeatability for measurements in the frequency range 1-18 GHz
Based on the comments from the National Committees on CIS/B/662/DC, CIS/B/WG1 decided
on its meeting in Hangzhou 2016 to amend the test procedure for group 2 equipment in the
frequency range 1 to 18 GHz for the following reasons:
a) CISPR 11 allows final measurements on group 2 equipment operating at frequencies
above 400 MHz with two different weighting functions, the traditional “LogAV detector” with
a video bandwidth of 10 Hz and the new APD method, where the Amplitude Probability
Distribution is evaluated.
CISPR 11:2015/AMD2:2019 © IEC 2019 – 3 –
With the alignment of emission requirements for sources of fluctuating emissions with those
generating CW-type emissions (Fraction 4 of the last general maintenance of CISPR 11) for
most of the frequency range 1 to 18 GHz the peak detector is used mostly for preliminary
measurements, while the number of final measurements with the LogAV detector has been
increased from 2 frequencies to max. 7 frequencies.
In parallel, with fraction 3, the APD detector has been introduced, but only with the
traditional 2 final frequencies (one in the range 1 GHz to 2.4 GHz and one in the range
2,5 GHz to 18 GHz).
The number of final frequencies to be measured should be aligned for both weighting
functions.
b) During practical measurements cases have been observed, where the critical frequency
changed between preliminary and final measurement by more than 5 MHz. The range of
10 MHz for weighted measurements (±5 MHz from highest peak emission) seems
therefore not always to be sufficient.
An extension of this frequency range seems advisable and could increase the repeatability.
In the range 11,7 to 12,7 GHz, an EUT fails immediately if one peak exceeds the limit of
73 dB[µV/m]. Observations on a big number of different microwave ovens have shown that
during the final measurement (at least 2 min) such peaks may occur very seldom, and with a
very short duration, and an estimated overall duration of less than 1 % of the measuring time.
A state-of-the-art digital communication service should be able to tolerate such peaks.
Meanwhile, in countries where broadcasting systems, which are already standardized and
widely spread and is difficult to avoid disturbance by such peaks, are under operation,
additional limits could be separately introduced as necessary.
c) The repeatability of the peak measurement on microwave ovens is poor. Moreover, the
sheer height of the highest peak emission, without information on its duration and
repetition rate, provides very limited information on the real disturbance potential.
Measurements with both of the weighting methods have a significantly better repeatability and
should, by their physical nature, give a better judgement for the disturbing potential of the
EUT on digital radio services.
d) The conditions for preliminary and final measurements became ambiguous in Edition 6.0
(CISPR 11:2015), particularly regarding the required test time. Furthermore, it has been
found that, in some cases, a duration of 20 s for the preliminary peak measurement may
not be enough. To further increase the repeatability, WG1 decided not to divide the peak
measurements anymore into preliminary and final measurements, but to require a 2-
minute max hold peak measurement at every azimuth.
CISPR SC/B WG1 agreed to present the following proposals to the National Committees:
1) Define the same 7 final frequency ranges for the APD method as already defined for the
LogAV method (detector).
2) Extend the frequency range for the final weighted measurement to 20 MHz.
For the APD method this would mean to measure on 5 final frequencies, the critical frequency
itself, +/− 5 MHz and +/− 10 MHz.
For the LogAV detector, the requirement remains to perform for the final measurements at
least 5 consecutive sweeps in max hold mode. The test time increases accordingly, and
coverage of the fluctuations is the same as before.

– 4 – CISPR 11:2015/AMD2:2019 © IEC 2019
3) Change the peak limit in Table 13 to a constant value of 70 dB[µV/m] throughout the
frequency range and replace the requirement of a final peak measurement in the range
11,7 GHz to 12,7 GHz by a requirement of an additional weighted measurement at the
frequency of the highest peak emission in this range. This may lead to a maximum of
8 final weighted measurements.
4) Discard the distinction between preliminary and final peak measurements and make
instead the peak measurements on all azimuths for 2 minutes.

CISPR 11:2015/AMD2:2019 © IEC 2019 – 5 –
3 Terms and definitions
Add, after the existing definition 3.22 in CISPR 11:2015/AMD1:2016, the following new term
and definition:
3.23
power conversion equipment
electrical device converting one form of electrical power to another form of electrical power
with respect to voltage, current, frequency, phase and the number of phases
[SOURCE: IEC 62920:2017 3.3]
6.2.1.1 General
Replace the last paragraph by the following new paragraph:
The limits for the LV d.c. power ports specified hereafter apply only to the following types of
equipment:
a) power conversion equipment intended for assembly into photovoltaic power generating
systems;
b) grid connected power converters (GCPCs) intended for assembly into energy storage
systems.
6.2.1.3 Frequency range 150 kHz to 30 MHz
Add the following new paragraph and the new Table 19 after Table 5:
For measurements at LV d.c. power ports, the applicability criteria in accordance with
Table 19 apply.
...

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SIST EN 55011:2016/A2:2021 표준은 산업, 과학 및 의료 장비의 전파 주파수 방해 특성과 그 한계 및 측정 방법에 대해 다루고 있습니다. 이 표준의 범위는 전파 방해 특성의 측정 및 이를 준수하기 위한 상한선을 설정하는 데 중점을 두고 있으며, 이는 다양한 산업 분야에서 장비들이 규정된 한계를 초과하지 않도록 보장하는 데 필수적입니다. SIST EN 55011:2016/A2:2021의 강점은 그 신뢰성과 적용 가능성입니다. 이 표준은 전자기 호환성(EMC) 및 전파 방해에 대한 명확한 기준을 제공하여, 사용자가 전파 간섭으로 인한 문제 해결을 용이하게 합니다. 이를 통해 제조업체는 자신들의 제품이 시장에서 기대되는 성능과 규정을 충족할 수 있도록 지원합니다. 여기에 더해, 이 표준은 유럽 내에서의 기계 및 의료 장비의 수출 및 유통과 관련하여 중요한 역할을 합니다. 또한, SIST EN 55011:2016/A2:2021 표준은 최신의 기술 동향과 규제 요구 사항을 반영하여 지속적으로 업데이트되고 있습니다. 이는 사용자들에게 고품질의 산업 장비를 제공하고, 해당 장비의 성능을 개선하기 위한 근거로 작용하며, 광범위한 적용 가능성을 보장합니다. 결론적으로, SIST EN 55011:2016/A2:2021은 산업, 과학 및 의료 장비에서의 전파 방해 특성을 관리하는 데 있어 필수적인 표준으로, 그 유용성과 신뢰성이 잘 나타나 있습니다. 이 표준을 준수함으로써 기업들은 그들의 장비가 국제적으로 인정받도록 할 수 있습니다.

The SIST EN 55011:2016/A2:2021 standard addresses the radio-frequency disturbance characteristics of industrial, scientific, and medical equipment. Its scope focuses on establishing clear limits and methods for measuring these disturbances, which is crucial for ensuring compliance with electromagnetic compatibility (EMC) regulations. One of the significant strengths of this standard is its comprehensive framework that sets definitive parameters for testing and evaluation. By establishing limits for radio-frequency emissions, it helps organizations identify potential interference issues that may arise in various operational environments. This proactive approach not only facilitates compliance but also enhances the reliability and safety of equipment in use across different sectors. The relevance of SIST EN 55011:2016/A2:2021 cannot be overstated, as it provides manufacturers and engineers with essential guidelines that align with current technological advancements. The standard's updated methodologies ensure that it remains applicable to modern equipment, thereby promoting innovation while maintaining safety and compliance. It also reflects a commitment to harmonization within the European market, facilitating trade and enhancing competition by ensuring that all products meet agreed standards. In summary, the SIST EN 55011:2016/A2:2021 standard is a vital resource, showcasing strengths in its clear limits and measurement methods, while remaining crucial for compliance and operational efficacy in the industrial, scientific, and medical fields.

La norme SIST EN 55011:2016/A2:2021 traite des caractéristiques de perturbation radioélectrique des équipements industriels, scientifiques et médicaux. Son objectif principal est de définir les limites ainsi que les méthodes de mesure appropriées pour s'assurer que ces équipements ne causent pas de nuisances électromagnétiques significatives. Le champ d'application de cette norme est extrêmement pertinent dans le contexte actuel, où l'utilisation d'équipements électroniques est omniprésente. Elle s'avère cruciale pour garantir que les dispositifs de différents secteurs respectent les exigences de compatibilité électromagnétique, ce qui est essentiel pour le bon fonctionnement des systèmes électriques et électroniques utilisés dans divers environnements. Parmi les points forts de la norme SIST EN 55011:2016/A2:2021, on peut noter sa flexibilité et son adaptabilité à de nombreux types d'équipements. La norme offre des méthodes de mesure claires et détaillées, ce qui permet une évaluation précise des performances des équipements sur le plan des perturbations radioélectriques. De plus, l'absence de lien législatif, comme confirmé par le TC Off, permet une certaine agilité dans l'application de la norme, facilitant ainsi son adoption par les fabricants et les utilisateurs. La mise à jour de 2021, en particulier, améliore encore la sommes des connaissances et des exigences actuelles avec un accent sur l'importance croissante de la réduction des émissions pour des raisons environnementales et de santé publique. Cela se reflète également dans le consensus du TC sur la nécessité d'une évaluation approfondie, attestant d'une approche proactive pour s'assurer que les nouveaux développements technologiques respectent les standards les plus élevés en matière de compatibilité électromagnétique. En résumé, la norme SIST EN 55011:2016/A2:2021 joue un rôle essentiel dans la régulation des caractéristiques de perturbation radioélectrique, renforçant ainsi la confiance des consommateurs et des professionnels dans les équipements industriels, scientifiques et médicaux modernes.

Die Norm SIST EN 55011:2016/A2:2021 behandelt die radiofrequenten Störmerkmale von industriellen, wissenschaftlichen und medizinischen Geräten. Ihr Hauptaugenmerk liegt auf den Grenzwerten und den Methoden zur Messung dieser Störungen. Diese Norm stellt ein bedeutendes Regelwerk dar, das sowohl die Sicherheit als auch die Interoperabilität von elektronischen Geräten gewährleistet. Ein zentraler Aspekt der Norm ist ihr umfassender Anwendungsbereich. Sie richtet sich nicht nur an Hersteller von Geräten, sondern auch an Prüfstellen und Verbraucher, die sicherstellen möchten, dass die von ihnen verwendeten oder getesteten Geräte den geltenden Anforderungen entsprechen. Die klaren Grenzwerte in der Norm fördern ein einheitliches Verständnis der zulässigen Störpegel und tragen zur Vermeidung von Interferenzen bei. Die Stärken dieser Norm liegen in ihrer gründlichen Methodik zur Messung der Störungen. Die detaillierten Anforderungen und Prüfmethoden ermöglichen es, die Leistungsfähigkeit von Geräten präzise zu bewerten. Dies ist besonders wichtig in einem Zeitalter, in dem elektronische Geräte allgegenwärtig sind und eine immer größere Rolle im industriellen und wissenschaftlichen Sektor spielen. Die Zweideutigkeiten in den vorhergehenden Versionen der Norm wurden durch die aktualisierten Messmethoden erheblich verringert. Die Relevanz von SIST EN 55011:2016/A2:2021 kann nicht hoch genug eingeschätzt werden. In einer zunehmend vernetzten Welt, in der der sichere Betrieb von Geräten unerlässlich ist, bietet diese Norm einen klaren Rahmen, um die Kompatibilität und Sicherheit zu gewährleisten. Mit der Bestätigung durch den TC Off zur Veröffentlichung ohne Bezugnahme auf Rechtsvorschriften signalisiert die Norm zudem ihre Breitenwirkung und Akzeptanz in der Industrie. Zusammenfassend lässt sich sagen, dass die Norm SIST EN 55011:2016/A2:2021 eine essentielle Richtlinie für die Bewertung von radiofrequenten Störungen ist, die sich durch einen klaren Anwendungsbereich, stichhaltige Methoden zur Messung und eine hohe Relevanz in der heutigen technologischen Landschaft auszeichnet.

SIST EN 55011:2016/A2:2021は、産業用、科学用、および医療用機器に関連する電波干渉特性に関する標準文書であり、特に無線周波数の干渉とその測定方法の限界を定義しています。この標準の範囲は、無線周波数の干渉に関する評価基準を提供し、各種機器の適切な性能を保証することにあります。 この標準の強みは、無線周波数の干渉特性を測定するための明確で具体的な方法論を確立している点です。測定方法は、様々な産業や医療環境における機器の信頼性を向上させ、不必要な干渉を最小化するための指針となります。特に、産業用機器と科学機器の両方で、電波干渉の影響を受ける可能性がある装置に適用できるため、広範な範囲での適用性が高いと言えます。 また、SIST EN 55011:2016/A2:2021は、法律とのリンクが削除されても発行が確認されたことから、業界内での迅速な対応能力を示しています。これは、企業がこの標準に基づいてコンプライアンスを確保し、新技術の導入に伴うアダプテーションを促進するための重要な要素です。 この標準の関連性は、特に技術進化が進む中で、ますます重要になっています。無線通信技術の発展は、新しい産業機器や科学機器の設計に影響を与えるため、最新の測定基準を取り入れることが求められています。したがって、SIST EN 55011:2016/A2:2021は、技術的な信頼性と安全性を確保するための不可欠なガイドラインと言えるでしょう。