At a glance
- A notified body does not assess a printer but a file. What it wants on the table can be listed — and it is more than a material certificate.
- None of the AM sector frameworks is harmonised under the PED. They therefore give no presumption of conformity, however complete they may be.
- What they are good for: as the “existing document” Guideline F-06 refers to, and as evidence inside your particular material appraisal.
- The saving is in the sequence: plan your sector qualification so that the tests the PMA needs run in the same campaign.
What the notified body wants to see on the table
For an additively manufactured pressure-bearing part in category II or above, this comes on top of the ordinary technical file:
| Document | What it must contain | Basis |
|---|---|---|
| Particular material appraisal (PMA) | Material and process window, properties per build direction, comparison with the characteristics of a harmonised standard for a similar grade | Annex I 4.2(b) 3rd indent; Guideline I-13 |
| Assessment report on the PMA | Specific assessment by the notified body — mandatory from category III | Annex I 4.2(c) |
| Build process qualification | Fixed process window with essential parameters, range of validity in build directions and thicknesses | Annex I 3.1.2 |
| Operator qualification | Equipment, degree of automatisation, test piece conditions, range and duration of validity | Annex I 3.1.2; Guideline F-06 |
| NDT plan with acceptance criteria | Method per surface, justification of why the criterion suits layer-built material, and which surfaces are machined to be inspectable | Annex I 3.1.3, 3.2 |
| Material and batch documentation | Inspection document from the wire manufacturer, traceability to batch and build, and for the main pressure-bearing parts a 3.1 on the part | Annex I 3.1.5, 4.3; Guidelines G-05, G-06, G-10 |
| Proof test record | Hydrostatic test under point 7.4, with the calculated test pressure and the test condition treated as a load case of its own | Annex I 3.2.2, 7.4 |
Whoever has these seven in order before calling the notified body keeps control of the schedule. Whoever builds them along the way lets the body set the pace.
Sector frameworks alongside the PED
Worked-out frameworks for qualifying AM fabrication now exist. They are useful, but it matters to know what they do and do not do.
| Framework | What it gives | Status under the PED |
|---|---|---|
| DNV-ST-B203 Additive manufacturing edition November 2025; from this edition non-metallic AM processes are in scope as well, hence the shortened title | Qualification of facility, build process and part, classified into four additive manufacturing categories: AMC 0 for non-critical parts (traceability and general quality management only, no qualification scheme), and AMC 1 to AMC 3 at rising criticality. For AMC 3 the critical section of the part is additionally defined | Not harmonised — no presumption of conformity |
| API 20S Additively manufactured metallic components for use in the petroleum and natural gas industries | Three specification levels — AMSL 1, 2 and 3 — with rising technical, quality and qualification requirements; covers powder bed fusion, directed energy deposition and binder jetting | Not harmonised |
| ISO/ASTM 52900 series | Terminology, qualification principles, process control; part 52926-5 specifically for DED-arc operators | Not harmonised |
| AWS D20.1 | American specification for the fabrication of metal components using additive manufacturing | Not harmonised |
| Class society requirements (ABS, DNV, Lloyd's and others) | Acceptance routes for marine and offshore applications | A regime of their own, alongside the PED |
None of these frameworks confers a presumption of conformity with the PED. What they do give is a structured justification that a notified body recognises — qualification of facility, process and part in the same order in which the PED wants its evidence. If you are running one of these routes anyway, it pays to draft the PMA and the build process qualification so that one set of tests serves both purposes. That saves a build cycle.
Concretely: your B203 operator qualification covers what Guideline F-06 asks for
This is where the two worlds meet, and the point is almost never made. Above, PED Guideline F-06 was shown to require four things of the document by which you approve personnel for permanent joining when no harmonised standard exists. DNV-ST-B203 governs the qualification of AM operators in section 5.4.2. Put them side by side:
| What F-06 requires | Where DNV-ST-B203 provides it |
|---|---|
| The equipment used by the personnel | § 5.4.2.3 — the procedure fixes the limitation to machine setup, brand and model |
| The degree of automatisation and the operations the personnel actually carry out | § 5.4.2.2 — the operator demonstrates the essential tasks: feedstock change, setup and operation, maintenance and calibration |
| The conditions for the test piece and the results to be achieved | § 5.4.2.2 — a practical and a theoretical element, with a minimum period of supervised on-the-job practice and a demonstrable knowledge test |
| The range of validity and its duration | § 5.4.2.4 and 5.4.2.5 — valid as long as the operator regularly performs the tasks, with re-qualification after an interruption defined by the manufacturer; and not transferable to another manufacturer |
All four covered. If you are already running a B203 route, you have the document F-06 asks for — you only have to offer it as such to the notified body, with the reference to F-06 attached, instead of presenting it as a stand-alone DNV document. That saves a discussion which otherwise easily costs two months.
The same connection sits in § 5.4.2.6: the standard expressly allows a nationally or internationally recognised qualification scheme for AM operators to be used instead of the manufacturer's own procedure. That is precisely the opening through which ISO/ASTM 52926-5 enters for DED-arc — and F-06 names such a draft standard or professional document in as many words as an acceptable basis.
Frequently asked questions
Can I use DNV-ST-B203 or API 20S to comply with the PED?
They help, but they do not satisfy it. Neither is harmonised under the PED, so they confer no presumption of conformity. On specific points they do connect: section 5.4.2 of DNV-ST-B203 on the qualification of AM operators covers all four elements PED Guideline F-06 requires of an approval document where a harmonised standard is missing. If you are already running a B203 route, offer that document as such, with the reference to F-06. Beyond that, draft your test plan so that one set of specimens serves both the sector framework and the particular material appraisal.
What do AMC and AMSL mean?
They are the criticality classifications of the two sector frameworks, and they are not interchangeable. DNV-ST-B203 has four additive manufacturing categories: AMC 0 for non-critical parts, where only traceability and general quality management apply and no qualification scheme is required, and AMC 1 to 3 at rising criticality, with the critical section separately defined at AMC 3. API 20S has three specification levels, AMSL 1 to 3. Neither classification says anything about your PED category: that follows from Annex II alone.
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