EN IEC 62061:2021/A1:2024

Safety of machinery - Functional safety of safety-related control systems

Sicherheit von Maschinen - Funktionale Sicherheit sicherheitsbezogener Steuerungssysteme

Sécurité des machines - Sécurité fonctionnelle des systèmes de commande relatifs à la sécurité

Varnost strojev - Funkcijska varnost nadzornih sistemov, povezanih z varnostjo - Dopolnilo A1 (IEC 62061:2021/AMD1:2024)

General Information

• Status: Published
• Publication Date: 27-Jun-2024
• ICS: 13.110 - Safety of machinery
• ICS: 25.040.99 - Other industrial automation systems
• ICS: 29.020 - Electrical engineering in general
• Technical Committee: CLC/TC 44X - Safety of machinery: electrotchnical aspects
• Drafting Committee: IEC/TC 44 - IEC_TC_44
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 28-Jun-2024
• Due Date: 30-Nov-2023
• Completion Date: 28-Jun-2024
• 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)
• Mandate: M/396 - Mandate to CEN and Cenelec for standardisation in the field of machinery
• Ref Project: SIST EN IEC 62061:2021/A1:2024 - Amendment 1 - Safety of machinery - Functional safety of safety-related control systems (IEC 62061:2021/AMD1:2024)

Relations

• Amends: EN IEC 62061:2021 - Safety of machinery - Functional safety of safety-related control systems
• Effective Date: 05-Oct-2021

Overview

EN IEC 62061:2021/A1:2024 (Amendment 1 to IEC 62061:2021) is the CLC-endorsed European version of the international standard on safety of machinery - functional safety of safety‑related control systems. This amendment clarifies terminology, updates normative references, and revises several calculation rules and lifecycle provisions used to demonstrate the functional safety of control systems for machinery. The standard provides one accepted route to conformity with the essential requirements of the EU Machinery Directive (2006/42/EC) for safety-related control systems.

Key topics and requirements

• Functional safety lifecycle: requirements for design, verification and validation activities across hardware and software safety lifecycles; updates to the software V‑model and SW level references.
• Risk reduction and SIL assignment: methods for determining required Safety Integrity Level (SIL) for safety functions, including matrices and Annex approaches.
• Hardware reliability metrics: revised definitions and formulae for Safe Failure Fraction (SFF) and Diagnostic Coverage (DC) used to estimate quantitative failure behavior of subsystems.
• Architectural constraints: limits on the maximum SIL claimable for subsystems depending on architecture and diagnostic measures.
• Systematic faults and management: requirements for control of systematic faults and traceability of design processes and changes.
• Security and EMC considerations: integration of security aspects (references updated to IEC TS 63074 and ISO/IEC 27001:2022) and electromagnetic compatibility guidance (IEC 61000‑1‑2).
• Normative references and terminology: alignment with related functional safety and machinery standards (see Related Standards).

Note: Amendment 1 makes specific editorial and technical corrections - e.g., terminology adjustments, updated normative references, corrected formulae and notes - improving consistency with IEC/ISO related documents.

Practical applications and users

• Machine builders and OEMs designing safety‑related control systems for industrial machinery.
• Functional safety engineers performing SIL selection, SFF/DC calculations, diagnostics design and verification.
• Software developers working to the SW safety lifecycle for safety PLCs and embedded controllers.
• Notified bodies, conformity assessment and certification organizations assessing compliance with EN IEC 62061 and the EU Machinery Directive.
• Systems integrators and end users implementing safety functions (e‑stops, guards, interlocks, light curtains).

Related standards

Key cross‑references included in the amendment:

• IEC 61508 (Parts 1–7) - Functional safety umbrella
• ISO 12100 - Risk assessment and reduction
• ISO 13849‑1 / ISO 13849‑2 - Safety‑related parts of control systems
• IEC 60204‑1 - Electrical equipment of machines
• IEC 61000‑1‑2 - EMC and functional safety
• IEC 61784‑3, IEC TS 63074, IEC TS 63394 - communication/security and guidance documents

Compliance dates noted in the amendment: national implementation by 2024‑12‑28; withdrawal of conflicting standards by 2027‑06‑28.

Keywords: EN IEC 62061:2021/A1:2024, functional safety, safety‑related control systems, machinery safety, SIL, safe failure fraction, diagnostic coverage, software safety lifecycle, Machinery Directive.

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2024
Varnost strojev - Funkcijska varnost nadzornih sistemov, povezanih z varnostjo -
Dopolnilo A1 (IEC 62061:2021/AMD1:2024)
Amendment 1 - Safety of machinery - Functional safety of safety-related control systems
(IEC 62061:2021/AMD1:2024)
Sicherheit von Maschinen - Funktionale Sicherheit sicherheitsbezogener
Steuerungssysteme (IEC 62061:2021/AMD1:2024)
Amendement 1 - Sécurité des machines - Sécurité fonctionnelle des systèmes de
commande relatifs à la sécurité (IEC 62061:2021/AMD1:2024)
Ta slovenski standard je istoveten z: EN IEC 62061:2021/A1:2024
ICS:
13.110 Varnost strojev Safety of machinery
25.040.40 Merjenje in krmiljenje Industrial process
industrijskih postopkov measurement and control
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN IEC 62061:2021/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM June 2024
ICS 13.110; 25.040.99; 29.020
English Version
Safety of machinery - Functional safety of safety-related control
systems
(IEC 62061:2021/AMD1:2024)
Sécurité des machines - Sécurité fonctionnelle des Sicherheit von Maschinen - Funktionale Sicherheit
systèmes de commande relatifs à la sécurité sicherheitsbezogener Steuerungssysteme
(IEC 62061:2021/AMD1:2024) (IEC 62061:2021/AMD1:2024)
This amendment A1 modifies the European Standard EN IEC 62061:2021; it was approved by CENELEC on 2024-03-11. 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
© 2024 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 62061:2021/A1:2024 E

European foreword
The text of document 44/1020/FDIS, future Amendment 1 of IEC 62061, prepared by IEC/TC 44 "Safety
of machinery - Electrotechnical aspects" was submitted to the IEC-CENELEC parallel vote and
approved by CENELEC as EN IEC 62061:2021/A1:2024.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2024-12-28
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2027-06-28
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 standardization request addressed to CENELEC by the
European Commission. The Standing Committee of the EFTA States subsequently approves these
requests for its Member States.
For the relationship with EU Legislation, see informative Annex ZZ, which is an integral part of this
document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN and CENELEC
websites.
Endorsement notice
The text of the International Standard IEC 62061:2021/AMD1:2024 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
EC 61784-3:2021 NOTE Approved as EN IEC 61784-3:2021 (not modified)
IEC/TS 63074:2023 NOTE Approved as CLC IEC/TS 63074:2024 (not modified)
IEC/TS 63394:2023 NOTE Approved as CLC IEC/TS 63394:2024 (not modified)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available
here: www.cencenelec.eu.
Publication Year Title EN/HD Year
IEC 60204-1 (mod) 2016 Safety of machinery - Electrical equipment of EN 60204-1 2018
machines - Part 1: General requirements
+ AMD1 2021 - -
IEC 61000-1-2 2016 Electromagnetic compatibility (EMC) - Part 1- EN 61000-1-2 2016
2: General - Methodology for the
achievement of functional safety of electrical
and electronic systems including equipment
with regard to electromagnetic phenomena
IEC 61508-1 2010 Functional safety of IEC 61508-1 2010
electrical/electronic/programmable electronic
safety-related systems – Part 1: General
requirements
IEC 61508-2 2010 Functional safety of EN 61508-2 2010
electrical/electronic/programmable electronic
safety-related systems - Part 2:
Requirements for
electrical/electronic/programmable electronic
safety-related systems
IEC 61508-3 2010 Functional safety of EN 61508-3 2010
electrical/electronic/programmable electronic
safety-related systems - Part 3: Software
requirements
IEC 61508-4 2010 Functional safety of EN 61508-4 2010
electrical/electronic/programmable electronic
safety-related systems - Part 4: Definitions
and abbreviations
IEC 61508-5 2010 Functional safety of EN 61508-5 2010
electrical/electronic/programmable electronic
safety-related systems - Part 5: Examples of
methods for the determination of safety
integrity levels
IEC 61508-6 2010 Functional safety of EN 61508-6 2010
electrical/electronic/programmable electronic
safety-related systems - Part 6: Guidelines on
the application of IEC 61508-2 and IEC
61508-3
Publication Year Title EN/HD Year
IEC 61508-7 2010 Functional safety of EN 61508-7 2010
electrical/electronic/programmable electronic
safety-related systems - Part 7: Overview of
techniques and measures
ISO 12100 2010 Safety of machinery - General principles for EN ISO 12100 2010
design - Risk assessment and risk reduction
ISO 13849-1 2023 Safety of machinery - Safety-related parts of EN ISO 13849-1 2023
control systems - Part 1: General principles
for design
ISO 13849-2 2012 Safety of machinery - Safety-related parts of EN ISO 13849-2 2012
control systems - Part 2: Validation

Annex ZZ
(informative)
Relationship between this European standard and the essential
requirements of Directive 2006/42/EC [2006 OJ L 157] aimed to be
covered
This European standard has been prepared under a Commission’s standardisation request “M/396” to
provide one voluntary means of conforming to essential requirements of 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) [2006 OJ L 157].
Once this standard is cited in the Official Journal of the European Union under that Directive, compliance
with the normative clauses of this standard given in Table ZZ.1 confers, within the limits of the scope of
this standard, a presumption of conformity with the corresponding essential requirements of that
Directive, and associated EFTA regulations.
Table ZZ.1 — Correspondence between this European standard and Annex 1 of Directive]
2006/42/EC [2006 OJ L 157]
The relevant Essential
Clause(s) / sub-clause(s)
Requirements of Directive Remarks / Notes
of this EN
2006/42/EC
1.2.1 Clauses 4, 5, 6, 7, 8, 9.
1.7.4.2 (e, g, i, r, s) 10.3 This subclause only deals with
the instruction for safety
functions
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European Union.
WARNING 2 — Other Union legislation may be applicable to the product(s) falling within the scope of
this standard.
IEC 62061 ®
Edition 2.0 2024-03
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Safety of machinery – Functional safety of safety-related control systems

Sécurité des machines – Sécurité fonctionnelle des systèmes de commande

relatifs à la sécurité
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 13.110, 25.040.99, 29.020 ISBN 978-2-8322-8509-1

– 2 – IEC 62061:2021/AMD1:2024
© IEC 2024
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
SAFETY OF MACHINERY –
FUNCTIONAL SAFETY OF SAFETY-RELATED CONTROL SYSTEMS

AMENDMENT 1
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 b
...