At a glance
- At this page's reference date (01-09-2026) no AM standard is harmonised under the PED. The most recent list dates from 13-01-2026, following Implementing Decision (EU) 2026/79.
- A standard is not harmonised by CEN publishing it. That requires a standardisation request from the Commission, a HAS assessment, and publication of the reference (Article 12 PED; Regulation (EU) No 1025/2012 Article 10).
- The serious candidate is EN 13445-14, “additional requirements for pressure equipment and pressure parts fabricated with additive manufacturing methods”, which went out for public enquiry as a draft in 2025.
- The AM standards that do exist (the ISO/ASTM 52900 series, DNV-ST-B203, API 20S) remain usable as evidence and as the “existing document” of Guideline F-06 — they simply give no presumption of conformity.
Why “in development” means nothing in law
Article 12 of the PED ties the presumption of conformity to standards the references of which have been published in the Official Journal of the European Union. Not to standards that exist, not to standards that are good, and not to standards that are nearly finished. A notified body may not hold a published EN against you as a requirement, but you cannot rely on it as cover either.
That distinction costs money in both directions. Wait, and you build no file in the meantime and face the same questions two years on. Cite a non-harmonised standard in your declaration of conformity as though it gave cover, and the declaration comes back.
How a standard becomes harmonised
The route has six steps and the first three are the ones everybody sees. A technical committee adopts a work item, a draft goes out for public enquiry, and eventually CEN publishes an EN. At that moment the standard is voluntary and nothing more.
The last three steps are the ones that count. The Commission must have issued CEN a standardisation request covering the subject matter; without such a request a standard cannot be harmonised, however good it is. A HAS consultant then assesses whether the standard covers the essential safety requirements of the directive and whether Annex ZA is correct. Only when that closes does the Commission put the reference into an implementing decision and the presumption of conformity starts to work.
The practical consequence for additive manufacturing: an ISO or ASTM standard can never be harmonised directly. It must first be adopted as an EN and fall within a standardisation request. A European standard from a committee already working under a PED request — such as CEN/TC 54 for pressure vessels — therefore has a considerably shorter route than a standard from the AM corner.
The concrete candidate: EN 13445-14
EN 13445 is the European standard for unfired pressure vessels, and parts 1 to 6 are harmonised under the PED. A part for additive manufacturing is being added to that series:
| Number | EN 13445-14 |
|---|---|
| Title | Unfired pressure vessels — Part 14: Additional requirements for pressure equipment and pressure components fabricated with additive manufacturing methods |
| Subject | General requirements for applying additive processes to pressure vessels and parts, with separate annexes for individual processes and materials |
| Committee | CEN/TC 54 (unfired pressure vessels) |
| Status | Draft. Published in the Netherlands as NEN-EN 13445-14:2025 Ontw. Checked 01-09-2026; not yet a final EN, and no reference in the Official Journal |
Why this is the candidate and not an AM standard from the 52900 series: EN 13445 already sits inside the standardisation framework for the PED, the Annex ZA mechanics are already in it, and the committee already works with the essential safety requirements of Annex I. A new part of an existing harmonised series therefore has the shortest path to a citation.
An earlier work item on the same subject was stopped in 2021 and picked up again later. That is not a detail but a warning: standards development is not a timeline you can plan against.
The wider field: what exists and what it is worth
The standards below exist and are usable. At the reference date none of them gives a presumption of conformity under the PED.
| Standard | About | Harmonised under the PED? |
|---|---|---|
| EN 13445-14 (draft) | Additive manufacturing of pressure vessels and pressure parts | Not yet — draft |
| EN ISO/ASTM 52920:2023 | Qualification principles: requirements for industrial AM processes and production sites | No |
| ISO/ASTM 52926-1 to -5:2023 | Qualification of operators, per process family; part 5 covers DED-arc | No |
| ISO/ASTM TS 52930:2021 | Installation, operation and performance qualification (IQ/OQ/PQ) of PBF-LB equipment | No |
| ISO/ASTM 52900 | Terminology — the definitions the rest of the series rests on | No |
| DNV-ST-B203 | Additively manufactured parts for oil, gas and maritime; AMC classes 0 to 3 | No — sector standard |
| API 20S | Additively manufactured metallic components for oil and gas; AMSL 1 to 3 | No — sector standard |
| AWS D20.1 | US requirements for the fabrication of additively manufactured metal parts | No |
These standards are not a wasted investment. They do two things the directive explicitly allows: they are the existing document you may point to under PED Guideline F-06 when approving personnel where no harmonised standard exists, and they supply evidence inside your particular material appraisal. See Processes and qualification and File and sector frameworks.
What to do while you wait
- Build the evidence that stays necessary anyway. Testing in two directions, a fixed process window, traceability to batch and build: every route requires that, including a future harmonised standard.
- Use the existing standards explicitly. Name them in your file as the document your qualification rests on, with the reason you chose that document. That is exactly what Guideline F-06 asks of you.
- Write your file standard-independently. Refer to the essential safety requirements you cover, with the standard as the means. When the standard changes, the annex changes — not your whole file.
- Put a review point in your quality system. Check the harmonised standards list once a year, with a named owner. That is document control under ISO 9001 §7.5.3, not extra work.
- Do not count on transitional periods. If part 14 is harmonised, nothing changes about what you have already demonstrated; it only gives you a lighter route for the next project.
Frequently asked questions
Is there a harmonised standard for additive manufacturing under the PED yet?
No. The list of harmonised standards under Directive 2014/68/EU as drawn up on 13-01-2026, following Implementing Decision (EU) 2026/79, contains no AM standard. Checked on 01-09-2026. Without a reference in the Official Journal there is no presumption of conformity, however complete a standard may otherwise be.
What is EN 13445-14?
It is the part of the European pressure vessel standard that sets additional requirements for pressure equipment and pressure parts made by additive manufacturing methods. It is being drafted by CEN/TC 54 and went out for public enquiry as a draft in 2025, published in the Netherlands as NEN-EN 13445-14:2025 Ontw. It is not yet a final standard and its reference has not been published in the Official Journal.
When does a standard become harmonised?
Only when three things come together: the Commission has issued CEN a standardisation request covering the subject (Regulation (EU) No 1025/2012 Article 10), a HAS consultant has assessed whether the standard covers the essential safety requirements, and the Commission has published the reference in the Official Journal. Publication by CEN alone is not enough; that makes the standard voluntarily available, not legally covering.
Can an ISO or ASTM standard be harmonised under the PED?
Not directly. It must first be adopted as a European standard — then it is called EN ISO or EN ISO/ASTM — and it must fall within a standardisation request from the Commission. That is why a new part of a series already harmonised under the PED, such as EN 13445, has a considerably shorter path than a standard from AM standardisation.
Should I wait with my AM project until a standard exists?
No, and that is arithmetic rather than encouragement. Standards development has no reliable timeline — the earlier work item for the AM part of EN 13445 was stopped in 2021 and picked up again later. On top of that, the evidence you build now (testing in two directions, a fixed process window, traceability) stays necessary under any future standard. Waiting produces no evidence, only delay.
Do not wait for a standard — start with your category
The free check gives you the table, the category and the permitted modules. That tells you which evidence to build now, whatever gets published two years from now.
Run the free check or see the full report