ISO 13849 and IEC 62061: machinery safety
Designing a safety function on a machine, emergency stop, interlocked movable guard, light curtain, two-hand control, means showing that the control part that carries it out is reliable enough for the risk it reduces. Two standards frame this work: ISO 13849-1, now in its fourth edition (2023), which rates functions by Performance Level (PL a to e), and IEC 62061, second edition (2021) with Amendment 1 (2024), which rates them by SIL 1 to 3 within the IEC 61508 framework. Both are harmonised under Directive 2006/42/EC, and the Official Journal currently lists two editions of ISO 13849-1 side by side. This page sets out the metrics of each standard, what changed in the latest editions, which references the OJ actually cites, and what Regulation (EU) 2023/1230 changes from 20 January 2027.
Key dates
Section titled “Key dates”| Date | Event | Source |
|---|---|---|
| 1999 | First edition of ISO 13849-1, based on EN 954-1:1996 (since withdrawn); second edition 2006, third 2015 | ISO 13849-1:2023, Introduction |
| 22 March 2021 | IEC 62061 Edition 2.0 cancels and replaces the 2005 edition and its amendments of 2012 and 2015 | IEC catalogue |
| April 2023 | ISO 13849-1:2023, fourth edition, replaces the 2015 edition | ISO 13849-1:2023, Foreword |
| 26 July 2023 | Decision (EU) 2023/1586 consolidates the machinery list: EN ISO 13849-1:2015, EN ISO 13849-2:2012, EN IEC 62061:2021 | OJ L 194, 2 August 2023 |
| 11 October 2023 | Withdrawal date set for the reference of EN 62061:2005 and its amendments | Decision (EU) 2023/1586 |
| 28 March 2024 | IEC 62061:2021+AMD1:2024 consolidated version (Edition 2.1) | IEC catalogue |
| 13 May 2024 | Decision (EU) 2024/1329 adds EN ISO 13849-1:2023 and sets the withdrawal of EN ISO 13849-1:2015 from 15 May 2027 | OJ, 15 May 2024 |
| 4 September 2026 | Decision (EU) 2026/2015 adds EN IEC 62061:2021/A1:2024 | OJ, 7 September 2026 |
| 20 January 2027 | Regulation (EU) 2023/1230 applies; Directive 2006/42/EC is repealed | Regulation (EU) 2023/1230, as corrected |
Two standards, one objective
Section titled “Two standards, one objective”ISO 13849-1 calls the object of the analysis an SRP/CS (safety-related part of a control system); IEC 62061 uses SCS (safety-related control system). Both aim to show that the safety function has a frequency of dangerous failure low enough for the risk it addresses, and both apply only to high demand or continuous mode. ISO 13849-1:2023 says in its scope that it does not apply to low demand mode and points to the IEC 61508 series for it.
ISO 13849-1 is a type-B1 standard in the ISO 12100 typology and comes from the European machinery tradition of EN 954-1. Its scope covers SRP/CS "regardless of the type of technology and energy (e.g. electrical, hydraulic, pneumatic, and mechanical)". IEC 62061 describes itself as "a machinery sector specific standard within the framework of IEC 61508". Its first edition was limited to electrical, electronic and programmable electronic systems; the 2021 edition lists "standard extended to non-electrical technologies" among its technical changes.
Side by side, parameter by parameter
Section titled “Side by side, parameter by parameter”| Parameter | ISO 13849-1:2023 | IEC 62061:2021+AMD1:2024 |
|---|---|---|
| Object | SRP/CS, decomposed into subsystems | SCS, decomposed into subsystems |
| Rating | Performance Level a to e | SIL 1 to 3 (no SIL 4) |
| Demand mode | High demand and continuous only | High demand and continuous (main body) |
| Technologies | Any (electrical, hydraulic, pneumatic, mechanical) | Extended to non-electrical technologies in 2021 |
| Complex programmable electronics | No such exclusion in the scope; software requirements in Clause 7 | Design of complex programmable electronic subsystems is outside the scope (IEC 61508) |
| Quantity | PFH (named PFHd up to the 2015 edition) | PFH |
| Architectures | Categories B, 1, 2, 3, 4 | Basic subsystem architectures A, B, C, D |
| Subsystem ceiling | Category, MTTFd, DCavg, CCF | Maximum SIL from hardware fault tolerance and safe failure fraction (SIL CL until 2005 edition) |
| Required level | PLr, informative risk graph in Annex A | Required SIL from the standard's own assignment method |
| Validation | Clause 10, which supersedes ISO 13849-2:2012 requirements | Clause 9 |
| Software | Clause 7, Annexes J and N | Clause 8 |
| Edition cited in the OJ (2006/42/EC) | EN ISO 13849-1:2015 and EN ISO 13849-1:2023 | EN IEC 62061:2021 and A1:2024 |
ISO 13849-1: Performance Level
Section titled “ISO 13849-1: Performance Level”The Performance Level is a discrete level from a to e. Each PL corresponds to a band of the average frequency of a dangerous failure per hour. The fourth edition renamed this quantity: the former "probability of dangerous failure per hour" (PFHd) is now the "average frequency of a dangerous failure per hour" (PFH), aligned with the IEC standards, without technical change (IFA, 2023).
| PL | PFH (per hour) |
|---|---|
| a | 10⁻⁵ to less than 10⁻⁴ |
| b | 3 × 10⁻⁶ to less than 10⁻⁵ |
| c | 10⁻⁶ to less than 3 × 10⁻⁶ |
| d | 10⁻⁷ to less than 10⁻⁶ |
| e | 10⁻⁸ to less than 10⁻⁷ |
Determining the required PL (PLr)
Section titled “Determining the required PL (PLr)”Annex A of the standard is informative: it can be used to determine the PLr when no type-C standard specifies it. Its risk graph uses three parameters:
- S (severity of injury): S1 slight, normally reversible; S2 serious, normally irreversible, or death.
- F (frequency and/or duration of exposure): F1 seldom to less often and/or short; F2 frequent to continuous and/or long.
- P (possibility of avoiding the hazard or limiting harm): P1 possible under specific conditions; P2 scarcely possible.
The 2023 edition changed two points (IFA, 2023). The probability of occurrence of the hazardous event is no longer merged with P: it is assumed high by default, and a one-level reduction of the PLr when it is low must now be justified and documented. The choice of P is guided by five factors, three of which (speed at which the hazardous situation arises, physical room to avoid it, perceptibility of the hazard) are each enough to justify P2.
The five categories
Section titled “The five categories”The category describes the structure of a subsystem and its behaviour under fault. In the 2023 edition, a category is assigned per subsystem, so one SRP/CS can combine subsystems of different categories and subsystems rated by SIL.
| Category | Principle | Behaviour on fault |
|---|---|---|
| B | Basic safety principles, components suited to the expected influences | A fault can lead to loss of the safety function |
| 1 | As B, with well-tried components and well-tried safety principles | A fault can still lead to loss of the safety function, with lower probability |
| 2 | Faults in the functional channel are detected by a test | Loss possible between tests; the 2023 edition requires a test rate at least 100 times the demand rate, or a test on demand, and a test channel MTTFd above half that of the functional channel |
| 3 | Single-fault tolerant structure | A single fault does not lead to loss of the function; not every fault is detected |
| 4 | Single-fault tolerant with high diagnostics | An accumulation of undetected faults does not lead to loss of the function |
MTTFd, DC and CCF
Section titled “MTTFd, DC and CCF”These three quantities, with the category, give the PL through the simplified procedure. Classes as given by the IFA for the 2015 edition (IFA Report 2/2017e):
| Quantity | Classes |
|---|---|
| MTTFd of each channel | Not suitable: below 3 years. Low: 3 to below 10 years. Medium: 10 to below 30 years. High: 30 to 100 years. Category 4 only: above 100 and up to 2,500 years |
| DC (diagnostic coverage) | None: below 60 %. Low: 60 to below 90 %. Medium: 90 to below 99 %. High: 99 % and above |
| CCF | Annex F scoring table, 100 points in total; at least 65 points required for categories 2, 3 and 4 |
The channel MTTFd is capped at 100 years in the calculation, and at 2,500 years in category 4. The simplified procedure is a bar chart (Figure 12 in the 2023 edition), with its numerical form in Annex K. The 2023 edition removed the table that repeated the bar chart in simplified form (IFA, 2023).
The fourth edition also added or changed:
- An alternative procedure for subsystems without reliability data, limited to mechanical, hydraulic and pneumatic components (including electro-hydraulic and electro-pneumatic) when the good engineering practice method of Annex C.2 cannot be applied. For the logic part, an MTTFd of 10 years per channel may be assumed in categories B, 2 and 3, and 30 years in category 1; it is not allowed in category 4, and the maximum is PL c.
- A PL e for a subsystem must not rest on fault exclusions alone.
- A functional safety plan (Annex G.5), a new Annex L on electromagnetic interference immunity, a new Annex N on software fault avoidance and a new Annex O on safety-related values of components.
SISTEMA, the software from the IFA (Institut für Arbeitsschutz der DGUV), automates the ISO 13849-1 evaluation. It is free of charge; version 3.x supports the 2023 edition and version 2.x the 2015 edition.
IEC 62061: maximum SIL of a subsystem
Section titled “IEC 62061: maximum SIL of a subsystem”IEC 62061 applies to machines that are not portable by hand while working, including groups of machines working together. The required SIL is set for each safety function, the function is decomposed into subsystems, and the SCS must reach both the PFH band of the target SIL and the architectural limits of each subsystem.
| SIL | PFH (per hour) |
|---|---|
| 1 | 10⁻⁶ to less than 10⁻⁵ |
| 2 | 10⁻⁷ to less than 10⁻⁶ |
| 3 | 10⁻⁸ to less than 10⁻⁷ |
SIL 4 is not considered in IEC 62061. The standard defines four basic subsystem architectures, distinguished by hardware fault tolerance (HFT) and the presence of a diagnostic function: A (HFT 0, no diagnostic function), B (HFT 1, no diagnostic function), C (HFT 0 with diagnostic function) and D (HFT 1 with diagnostic function). The highest SIL a subsystem can be used for follows from its HFT and safe failure fraction (SFF), on the same basis as Route 1H of IEC 61508-2.
The 2021 edition lists these technical changes, among others, in its catalogue record:
- structure updated to follow the design process of the safety function;
- extension to non-electrical technologies;
- functional safety plan and configuration management (Clause 4);
- expanded requirements on parametrization (Clause 6), a reference to security requirements (6.8) and requirements on periodic testing (6.9);
- shift from "SILCL" to "maximum SIL" of a subsystem (Clause 7);
- software use cases with requirements (Clause 8), and independence requirements for software verification (Clause 8) and validation (Clause 9);
- new informative annexes on typical MTTFd values, diagnostics and calculation methods for the architectures (Annexes C, D and H), and examples (Annex G).
PL to SIL correspondence
Section titled “PL to SIL correspondence”Both standards use the same PFH quantity, so their levels line up by band. ISO 13849-1:2023 treats the correlation in 6.1.2; for integrating subsystems developed under IEC 61508 or IEC 62061, it deals only with those for high demand or continuous mode designed according to Route 1H (IFA, 2023).
| Performance Level | PFH (per hour) | SIL |
|---|---|---|
| a | 10⁻⁵ to less than 10⁻⁴ | no correspondence |
| b | 3 × 10⁻⁶ to less than 10⁻⁵ | SIL 1 |
| c | 10⁻⁶ to less than 3 × 10⁻⁶ | SIL 1 |
| d | 10⁻⁷ to less than 10⁻⁶ | SIL 2 |
| e | 10⁻⁸ to less than 10⁻⁷ | SIL 3 |
The table aligns numbers, not methods. A subsystem with a SIL 2 rating still has to fit the structure and the software measures of the function in which it is used.
Choosing a standard
Section titled “Choosing a standard”| Situation | Usual choice | Reason |
|---|---|---|
| Function at PL a | ISO 13849-1 | PL a has no SIL counterpart |
| Mixed technologies (electrical sensor, pneumatic actuator) | Either | Both now cover non-electrical technologies |
| Designing a complex programmable electronic subsystem (a safety controller, for example) | IEC 61508 | Outside the scope of IEC 62061, which sits within the IEC 61508 framework |
| Integrating certified components rated in PL and in SIL | Either, as the method for the whole function | ISO 13849-1:2023 allows SIL-rated subsystems in an SRP/CS |
| Team already using IEC 61508 vocabulary and tools | IEC 62061 | Same framework, definitions aligned with IEC 61508-4 |
Whichever is chosen, the type-C standard for the machine, where one exists, comes first: it can set the required PL or SIL and override the general requirements.
Step by step procedure
Section titled “Step by step procedure”- Risk assessment under ISO 12100: identify hazards, estimate and evaluate risk, decide which risks are reduced by safety functions.
- Specify each safety function in a safety requirements specification: triggering event, required reaction and safe state, PLr or required SIL, response time, operating modes, interfaces, demand rate, behaviour on energy loss, conditions for restart. The 2023 edition of ISO 13849-1 requires a review of this specification before design starts.
- Decompose into subsystems (input, logic, output), and decide which are bought in with a PL or SIL and which are designed in-house.
- Design the architecture: category for ISO 13849-1, basic architecture A to D for IEC 62061.
- Quantify: MTTFd, DCavg, CCF and the bar chart for ISO 13849-1; PFH, HFT and SFF for IEC 62061. Add the PFH of subsystems in series.
- Software and systematic failures: apply the software clause of the chosen standard and the functional safety plan.
- Verify that the achieved PL is at least the PLr, or that the SCS reaches the required SIL.
- Validate by analysis and testing, and record the result.
- Document: technical file, information for use, and the conditions on which the PL or SIL depends (proof tests, replacement intervals).
Validation
Section titled “Validation”In ISO 13849-1:2023, Clause 10 takes over the validation requirements of ISO 13849-2 (Clauses 4 to 12 of part 2), with the content largely unchanged (IFA, 2023). It covers the validation plan, generic and specific fault lists, validation by analysis and by testing, validation of the safety functions and of safety integrity (subsystems, systematic failures, software, combination of subsystems), environmental requirements, the validation record and maintenance of validation. Whatever the category, at least a functional test of the safety functions is required in addition to analysis.
The informative annexes of ISO 13849-2:2012 keep their role: lists of basic and well-tried safety principles, well-tried components and fault lists by technology. A fault exclusion must be justified and documented. If you work to EN ISO 13849-1:2015, ISO 13849-2:2012 remains the validation method in full.
Harmonised status under Directive 2006/42/EC
Section titled “Harmonised status under Directive 2006/42/EC”Under Article 7 of the Directive, machinery built to a harmonised standard whose reference is published in the OJ is presumed to meet the essential health and safety requirements that standard covers. For control systems, the relevant requirement is 1.2.1 of Annex I (safety and reliability of control systems). The list is Annex I of Implementing Decision (EU) 2023/1586, amended several times since.
| Reference in the list | Status on 7 October 2026 | Act |
|---|---|---|
| EN ISO 13849-1:2015 | Cited; withdrawal applies from 15 May 2027 | Decisions (EU) 2023/1586 and 2024/1329 |
| EN ISO 13849-1:2023 | Cited (row 66a), no restriction | Decision (EU) 2024/1329 |
| EN ISO 13849-2:2012 | Cited | Decision (EU) 2023/1586 |
| EN IEC 62061:2021 | Cited | Decision (EU) 2023/1586 |
| EN IEC 62061:2021/A1:2024 | Cited with the base standard (row 104a) | Decision (EU) 2026/2015 |
| EN 62061:2005 and amendments | Withdrawn on 11 October 2023 | Decision (EU) 2023/1586 |
What Regulation (EU) 2023/1230 changes
Section titled “What Regulation (EU) 2023/1230 changes”The Regulation applies from 20 January 2027 and repeals the Directive from that date.
- Presumption of conformity: Article 20 keeps the mechanism, but for standards whose references are published in the OJ under the Regulation, against the requirements of its Annex III. On 7 October 2026, no standard had been cited under the Regulation.
- Control systems: requirement 1.2.1 of Annex III now asks that control systems withstand reasonably foreseeable malicious attempts by third parties leading to a hazardous situation, that the tracing log of interventions and of safety software versions uploaded after placing on the market be enabled for five years, and, for systems with self-evolving behaviour, that safety-related decision data be recorded and kept for one year.
- Conformity assessment (Article 25): Annex I Part A products always need EU type-examination with internal production control, full quality assurance or unit verification. Part A includes safety components, and machinery embedded systems, with fully or partially self-evolving behaviour using machine learning approaches that ensure safety functions. Part B lists, among others, protective devices designed to detect the presence of persons and logic units to ensure safety functions; for these, internal production control is allowed only when harmonised standards or common specifications covering all relevant requirements are applied.
- Instructions may be provided in digital format under Article 10(7), with conditions on access, printing and download.
- Substantial modification is defined in Article 3(16); whoever carries one out becomes the manufacturer under Article 18.
Conformity assessment under the Directive until then
Section titled “Conformity assessment under the Directive until then”Article 12 of the Directive applies until 20 January 2027. Machinery not in Annex IV follows internal checks (Annex VIII). Annex IV machinery, which includes presses, certain saws, protective devices designed to detect the presence of persons and logic units to ensure safety functions, may use internal checks only when it is built to harmonised standards covering all relevant requirements; otherwise the manufacturer applies EC type-examination (Annex IX) or full quality assurance (Annex X).
Claims the texts contradict
Section titled “Claims the texts contradict”| Common claim | What the texts say |
|---|---|
| "IEC 62061 rates subsystems by SIL CL" | The 2021 edition replaced SILCL by the "maximum SIL" of a subsystem (IEC catalogue record, Clause 7) |
| "Only EN ISO 13849-1:2015 is cited in the OJ" | Decision (EU) 2024/1329 added EN ISO 13849-1:2023 on 13 May 2024; the 2015 reference is withdrawn from 15 May 2027 |
| "IEC 62061 is the standard for complex programmable electronics" | Its scope excludes the design of complex programmable electronic subsystems or subsystem elements |
| "The channel MTTFd is always capped at 100 years" | The cap is 2,500 years in category 4 (IFA Report 2/2017e) |
| "Validation follows ISO 13849-2" | For ISO 13849-1:2023, Clause 10 supersedes the requirements of ISO 13849-2:2012, except its informative annexes |
| "Do not mix ISO 13849 and IEC 62061 within one safety function" | ISO 13849-1:2023 explicitly allows combining subsystems validated under another functional safety standard, including SIL-rated ones |
| "The PL is read from Table 7 and Annex K" | In the 2023 edition the simplified procedure is the bar chart of Figure 12, with Annex K as its numerical form; the simplified table was removed |
| "ISO 13849-1 covers low demand mode too" | Its scope excludes low demand mode and refers to IEC 61508 |
| "EN ISO 13849-1 and EN IEC 62061 give presumption under Regulation (EU) 2023/1230" | Nothing was cited under the Regulation on 7 October 2026; the current list is under Directive 2006/42/EC |
| "Annex IV machinery needs module B or module H" | Modules are the Regulation wording. The Directive uses EC type-examination (Annex IX) and full quality assurance (Annex X), and allows internal checks when full harmonised standards are applied |
Common pitfalls
Section titled “Common pitfalls”| Pitfall | Consequence | Mitigation |
|---|---|---|
| Comparing the achieved PL with nothing | Insufficient PL goes unnoticed | Specify the PLr or SIL in the safety requirements specification first |
| CCF below 65 points in category 2, 3 or 4 | Quantification not valid | Fill in the Annex F table during design, per subsystem |
| MTTFd above the cap | Overestimated PL | Cap at 100 years, or 2,500 years in category 4 only |
| Validation not documented | Claimed PL not justified | Validation plan, analysis, tests and a validation record |
| PL e resting only on fault exclusions | Not allowed by ISO 13849-1:2023 | Combine fault exclusions with structure and diagnostics |
| Citing an edition without checking the OJ list | Presumption may not apply | Check Decision (EU) 2023/1586 and its amendments, including withdrawal dates |
| Category 2 test rate too low | Category 2 not met in the 2023 edition | Test rate at least 100 times the demand rate, or test on demand |
| Waiting for the Regulation without a plan | Annex III 1.2.1 requirements not designed in | Address malicious attempts and software version logging in the design now |
Further reading
Section titled “Further reading”- Machinery Directive 2006/42/EC and Regulation 2023/1230
- IEC 61508: functional safety and SIL levels
- ISO 10218:2025: industrial robot safety
- Risk management: ISO 14971, IEC 31010, FMEA, FTA
- ISO 26262: automotive functional safety
- Technical documentation file contents
- Glossary of certification terms
Sources and references
Section titled “Sources and references”Sources & references
- ISO 13849-1:2023, Safety of machinery, Safety-related parts of control systems, Part 1: General principles for design (fourth edition), ISO www.iso.org/standard/73481.html
- ISO 13849-2:2012, Safety of machinery, Safety-related parts of control systems, Part 2: Validation, ISO www.iso.org/standard/53640.html
- IEC 62061:2021, Safety of machinery, Functional safety of safety-related control systems (catalogue record, list of technical changes), IEC webstore.iec.ch/publication/59927
- IEC 62061:2021+AMD1:2024 CSV, consolidated version (catalogue record), IEC webstore.iec.ch/en/publication/93654
- Directive 2006/42/EC on machinery, EUR-Lex eur-lex.europa.eu/eli/dir/2006/42/oj
- Regulation (EU) 2023/1230 on machinery, EUR-Lex eur-lex.europa.eu/eli/reg/2023/1230/oj
- Commission Implementing Decision (EU) 2023/1586 on harmonised standards for machinery (Directive 2006/42/EC), EUR-Lex eur-lex.europa.eu/eli/dec_impl/2023/1586/oj
- Commission Implementing Decision (EU) 2024/1329 (adds EN ISO 13849-1:2023, withdraws EN ISO 13849-1:2015 from 15 May 2027), EUR-Lex eur-lex.europa.eu/eli/dec_impl/2024/1329/oj
- Commission Implementing Decision (EU) 2026/2015 (adds EN IEC 62061:2021/A1:2024), EUR-Lex eur-lex.europa.eu/eli/dec_impl/2026/2015/oj
- IFA Report 2/2017e, Functional safety of machine controls, Application of EN ISO 13849 (based on the 2015 edition), IFA / DGUV www.dguv.de/medien/ifa/en/pub/rep/pdf/reports-2019/report0217e/rep0217e.pdf
- Fourth edition of EN ISO 13849-1, most important new features in 2023 at a glance, IFA / DGUV publikationen.dguv.de/widgets/pdf/download/article/4894
- SISTEMA software for ISO 13849-1 evaluation, IFA / DGUV www.dguv.de/ifa/praxishilfen/practical-solutions-machine-safety/software-sistema/index.jsp
- IEC 61508:2010, Functional safety of electrical/electronic/programmable electronic safety-related systems, IEC www.iec.ch/functional-safety
- ISO 12100:2010, Safety of machinery, General principles for design, Risk assessment and risk reduction, ISO www.iso.org/standard/51528.html
Frequently asked questions
- What is the difference between ISO 13849-1 and IEC 62061 ?
- Both specify how to design and validate the safety-related parts of a machine control system for high demand or continuous mode. ISO 13849-1 rates a safety function by Performance Level (PL a to e), built from a category (B, 1, 2, 3 or 4), the MTTFd of each channel, the average diagnostic coverage and measures against common cause failure. IEC 62061 is the machinery sector standard within the IEC 61508 framework and rates by SIL (1 to 3). Since its 2021 edition, IEC 62061 is extended to non-electrical technologies, so both now cover hydraulics and pneumatics. IEC 62061 excludes the design of complex programmable electronic subsystems, which stays under IEC 61508.
- How do PL and SIL correspond ?
- By ranges of the average frequency of dangerous failure per hour (PFH). PL a (10⁻⁵ to below 10⁻⁴ per hour) has no SIL counterpart, PL b and PL c fall within SIL 1, PL d corresponds to SIL 2 and PL e to SIL 3. SIL 4 is not used in IEC 62061. The correspondence is a numerical alignment, not an equivalence of methods: the categories, software measures and validation rules still have to be met in the standard you follow.
- Does IEC 62061 still use SIL CL ?
- No. The 2021 edition replaced the "SIL claim limit" (SILCL) of a subsystem by its "maximum SIL", according to the list of technical changes in the IEC catalogue record. The underlying idea is unchanged: the hardware fault tolerance and the safe failure fraction cap the SIL a subsystem can be used for. Documents and tools written for the 2005 edition still use SIL CL.
- What do MTTFd, DC and CCF mean ?
- MTTFd is the mean time to dangerous failure of a channel, classed low (3 to below 10 years), medium (10 to below 30 years) or high (30 to 100 years). Values above 100 years are capped at 100 years, except in category 4 where the cap is 2,500 years. DC is the diagnostic coverage, classed none (below 60 %), low (60 to below 90 %), medium (90 to below 99 %) or high (99 % and above). CCF measures are scored with the Annex F table, and categories 2, 3 and 4 need at least 65 of the 100 points.
- Which editions give presumption of conformity under the Machinery Directive ?
- The list in Implementing Decision (EU) 2023/1586, as amended. It contains EN ISO 13849-1:2015 and, since Decision (EU) 2024/1329 of 13 May 2024, EN ISO 13849-1:2023; the 2015 reference is withdrawn from 15 May 2027. It also lists EN ISO 13849-2:2012 and EN IEC 62061:2021, with amendment A1:2024 added by Decision (EU) 2026/2015 of 4 September 2026. The presumption covers only the essential requirements the standard addresses.
- Is ISO 13849-2 still needed ?
- Yes, but its role has changed. In ISO 13849-1:2023, the validation requirements were moved into Clause 10, and the introduction states that Clause 10 supersedes the requirements of ISO 13849-2:2012, excluding its informative annexes. Those annexes (basic and well-tried safety principles, well-tried components, fault lists) remain the reference for fault considerations and exclusions. If you design to EN ISO 13849-1:2015, ISO 13849-2:2012 is still the validation method.
- Does Regulation (EU) 2023/1230 change the use of ISO 13849 and IEC 62061 ?
- The Regulation applies from 20 January 2027 and repeals Directive 2006/42/EC from that date. Its Article 20 keeps the presumption of conformity for harmonised standards whose references are published in the Official Journal, but no standard had been cited under the Regulation on 7 October 2026. Requirement 1.2.1 of its Annex III adds control system duties the Directive did not have, such as resistance to reasonably foreseeable malicious attempts and a five-year log of safety software versions uploaded after placing on the market.
- Do you need a notified body for machinery covered by these standards ?
- It depends on the machinery category, not on the functional safety standard. Under the Directive, Annex IV machinery (which includes logic units to ensure safety functions and protective devices that detect persons) can use internal checks only when harmonised standards covering all relevant requirements are applied; otherwise EC type-examination or full quality assurance is required. Under the Regulation, Annex I Part A products always need a third-party procedure, and Part B products may use internal production control only with harmonised standards or common specifications.