AM process qualification, powder traceability and structural certification resolved in 3 seconds.
IgeraIndustria gives AM process engineers and quality managers at aerospace and medical AM shops instant access to ISO/ASTM 52900:2021 process categories, AS9100 structural qualification paths, REACH obligations for metal powders, MDR Annex I GSPR for implants and powder lot traceability requirements — citing the exact standard, regulation article and technical parameter.
AM compliance: no legacy knowledge base, no established precedent — and certification bodies are still writing the rules
Additive manufacturing is the first major manufacturing process category where the industry standards, certification frameworks and regulatory guidance have been written after the technology was already in production use. AM engineers are simultaneously building production capability and navigating a regulatory landscape that is still being defined — with ISO/ASTM 52900 revised in 2021, NASA-STD-6030 published in 2021, and EASA CM-S-020 issued in 2022.
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ISO/ASTM 52900:2021 process categories — PBF, DED, MEX, MJT, BJT, SHL, VPP. Legacy trade names (SLM, DMLS, EBM) are no longer acceptable in regulatory submissions or technical specifications.
Special Process
PBF-LB/M and DED are classified as special processes under AS9100 Rev D cl.8.5.1.3 — results cannot be fully verified by subsequent inspection. Full process qualification with design of experiments (DoE) and mechanical test data is mandatory.
SVHC
Cobalt and nickel compounds used in aerospace AM superalloys (IN718, CoCrMo) are Substances of Very High Concern (SVHC) under REACH. Workers' inhalation exposure to fine metal powders requires OEL monitoring and engineering controls.
Class III
Additively manufactured orthopaedic and spinal implants are MDR Class III devices. MDR Annex I GSPR biocompatibility requirements (ISO 10993 series) apply to all materials in patient contact — validated against the specific AM alloy and surface treatment.
AM process engineers spend days searching for the qualification path for a new alloy, the REACH obligations for a new powder supplier, or the MDR conformity assessment route for a patient-specific implant. IgeraIndustria answers those questions in seconds — citing the exact ISO/ASTM standard, AS9100 clause, REACH entry or MDR GSPR requirement — so the AM team focuses on process development, not on regulatory research.
Instant AM compliance queries — process qualification, REACH, MDR and traceability
IgeraIndustria locates the applicable ISO/ASTM standard, AS9100 special process requirement, REACH obligation or MDR GSPR and responds with the exact technical parameter, qualification step or regulatory threshold.
ISO/ASTM 52900:2021 process classification and terminology
Map any AM process or legacy trade name to the correct ISO/ASTM 52900:2021 process category for use in technical specifications, regulatory submissions, quality plans and customer-facing documentation. Covers all 7 categories and subcategories including PBF-LB/M, PBF-EB/M, DED-LB/M, DED-arc.
AS9100 special process qualification — PBF-LB/M and DED
Structure the process qualification plan for PBF-LB/M or DED as a special process under AS9100 Rev D cl.8.5.1.3: machine FAT/SAT per ISO/ASTM 52941, powder characterisation per ISO/ASTM 52907, DoE parameter study, mechanical test specimen design, statistical qualification to A-basis or B-basis design allowables per NASA-STD-6030.
REACH obligations for metal AM powders by alloy
Retrieve SVHC status, Candidate List entry, Authorisation List (Annex XIV) requirements and OEL for each metal powder alloy: IN718 (Ni-base), IN625 (Ni-base), CoCrMo (Co-base), Ti-6Al-4V (Ti-base), 316L (Fe-Cr-Ni). Article 33 REACH obligations for finished parts supplied to customers.
MDR Annex I GSPR for patient-specific AM implants
Navigate the MDR 2017/745 conformity assessment route for AM implants: Class III Annex IX + Annex X clinical evaluation, GSPR 10.4.3 biocompatibility testing scope per ISO 10993-1 and ISO 10993-18, GSPR 1 patient-specific design validation, and EUDAMED registration requirements.
Powder lot traceability chain of custody
Define the complete powder traceability chain from atomisation batch to serialised finished part: CoC and certificate of analysis content per ISO/ASTM 52907, reuse tracking requirements for recycled/reconditioned powder, powder blend ratio limits for Ti-6Al-4V per AMS 7016, build job traceability records.
Post-processing qualification — HIP, heat treatment, surface finishing
Qualification requirements for post-processing steps that are also special processes: Hot Isostatic Pressing (HIP) per AMS 2801/SAE AS 7102 NADCAP, heat treatment per AMS 2770/AMS 2801, electrochemical polishing for implants, and Ra verification methods per ISO 4288 (contact) and ISO 25178 (areal, freeform surfaces).
Structural AM certification path: from powder to flight-qualified hardware
Qualifying AM parts for structural aerospace applications is a multi-stage process spanning machine qualification, material qualification, process qualification and part qualification. IgeraIndustria navigates every stage.
Stage 1 — Machine qualification (FAT/SAT per ISO/ASTM 52941)
ISO/ASTM 52941 defines the Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) for PBF and DED machines used in aerospace production. FAT covers beam characterisation, thermal mapping, build volume uniformity. SAT is repeated after machine installation, relocation or major maintenance. Machine requalification intervals must be defined in the process qualification plan.
Stage 2 — Powder qualification (ISO/ASTM 52907)
ISO/ASTM 52907 defines the powder characterisation tests required before use in qualified AM processes: chemical composition (spectrographic analysis), particle size distribution (PSD, D10/D50/D90), particle morphology (scanning electron microscopy), flowability (Hall flowmeter per ASTM B213), apparent density and tap density. Results must be documented and traceable to the powder lot.
Stage 3 — Process parameter qualification (DoE)
Design of Experiments (DoE) to establish the process window: laser power, scan speed, hatch spacing, layer thickness (for PBF); deposition rate, travel speed, heat input (for DED). DoE specimens must be sectioned for metallographic analysis — porosity level (<0.5% by area for structural parts per AMS 7003), microstructure, lack-of-fusion defects. The qualified parameter set is locked and deviation triggers requalification.
Stage 4 — Mechanical property qualification (MMPDS / CMH-17)
Statistical characterisation of mechanical properties using AM-specific test specimens built in the qualified process window. For aerospace structural allowables: A-basis (99% probability, 95% confidence) or B-basis (90% probability, 95% confidence) values per ASTM E122. Properties required: UTS, TYS, elongation (ASTM E8), fatigue (ASTM E466 runout to 10^7 cycles), fracture toughness KIc (ASTM E399). Results submitted to MMPDS or CMH-17 for industry-wide design allowables.
Stage 5 — Part qualification and First Article Inspection
Part-level qualification per AS9102 Rev C: dimensional verification (CMM), non-destructive testing (CT scan for internal porosity per ASTM E1441, FPI/MPI per ASTM E1417), mechanical coupon cut from witness specimens built in the same job, review of build data package. FAI package accepted by customer DQAR or GQAR before production release.
Stage 6 — In-process monitoring and production control
NASA-STD-6030 and EASA CM-S-020 require in-process monitoring for flight-critical AM parts: melt pool monitoring (photodiode or camera systems), layer imaging for PBF, acoustic emission for DED. Out-of-tolerance conditions during the build must trigger a non-conformance review before post-processing. Production control plan defines monitoring frequency, accept/reject criteria and dispositions.
AM for medical implants: MDR conformity pathway and FDA requirements
Patient-specific and standard AM implants require both process qualification as a special process and medical device regulatory compliance. IgeraIndustria covers both dimensions simultaneously.
MDR 2017/745 — Conformity assessment routes for AM implants
Class III implantable AM devices (hip, knee, spine, cranial, dental) require conformity assessment via MDR Annex IX (QMS + technical documentation review by Notified Body) combined with Annex X (type examination) or Annex XI (product verification). Patient-specific AM implants under MDR Article 52(8) may use a simplified Annex IX procedure if a registered physician requests the device — but the manufacturer still bears full GSPR compliance responsibility. Notified Body ECREP registration and EUDAMED UDI assignment are mandatory.
ISO 10993 biocompatibility testing scope for AM implants
ISO 10993-1:2018 requires a biological evaluation plan (BEP) specific to the device, considering: device contact nature (direct patient contact, implant), duration (permanent implant >30 days), and material composition. ISO 10993-18 (material characterisation) is mandatory for AM parts — particularly where the AM process affects surface chemistry (oxide layer on titanium, carbon pick-up in PBF). Tests typically required for permanent implants: cytotoxicity (ISO 10993-5), sensitisation (ISO 10993-10), chronic toxicity (ISO 10993-11), genotoxicity (ISO 10993-3), implantation (ISO 10993-6).
FDA 21 CFR Part 820 — Process validation for AM medical devices
FDA 21 CFR Part 820 (QSR, being replaced by 21 CFR Part 820 harmonised with ISO 13485) requires validation of all processes whose output cannot be fully verified by inspection — AM is explicitly a process requiring full IQ/OQ/PQ validation. FDA guidance document “Technical Considerations for Additive Manufactured Medical Devices” (2017) defines the submission content for 510(k) and PMA: device description with AM process parameters, material characterisation, biocompatibility testing summary, sterility assurance, and post-market surveillance plan.
Post-processing validation for implants — HIP, heat treatment, surface treatment
For AM metal implants, the post-processing sequence is as critical as the build process: HIP (typically 920°C/100 MPa/2h for Ti-6Al-4V) eliminates residual porosity and improves fatigue life by 20-40%; solution annealing and ageing defines final mechanical properties; surface treatment — electrochemical polishing, sandblasting, anodising or hydroxyapatite coating for osseointegration — must be validated as a special process with defined acceptance criteria for Ra, thickness and adhesion. Each post-process step must be included in the MDR technical documentation and device master record (DMR).
How IgeraIndustria works for AM process engineers and quality managers
Five steps from loading your AM process documentation to receiving answers with exact ISO/ASTM standard, AS9100 clause, REACH entry or MDR GSPR requirement.
Index your AM process and quality documentation
Upload your process qualification records, powder certificates of analysis, machine FAT/SAT reports, build data packages, FAI records, REACH substance inventory and MDR technical documentation. IgeraIndustria processes them alongside ISO/ASTM 52900:2021, AS9100 Rev D, NASA-STD-6030, EU MDR 2017/745 and REACH Regulation (EC) 1907/2006 in under 24 hours.
Connect the assistant to your AM engineering team
Embed in the AM quality management system portal, Teams, Slack or as a restricted widget for your process engineers and regulatory affairs team. Compatible with any CSDB or document management platform.
The AM engineer asks in plain English
“What REACH obligations apply to our IN718 powder supplier?”, “What DoE test specimens does NASA-STD-6030 require for structural PBF-LB/M qualification?”, “Which MDR conformity assessment route applies to our patient-specific titanium spinal cage?”
IgeraIndustria searches 2 layers of AM knowledge
First in your internal AM documentation (process qualification records, powder CoA, build data packages, MDR technical file), then in the indexed ISO/ASTM 52900 series, AS9100 Rev D, NASA-STD-6030, EASA CM-S-020, EU MDR 2017/745 Annex I GSPR and REACH Regulation indexed at article level.
Answer with standard, clause, parameter and qualification action
The response cites the applicable ISO/ASTM standard and clause, the specific technical parameter or test requirement, the regulatory article triggered, and the documented information required to achieve qualification or regulatory approval.
IgeraIndustria in action — Ti-6Al-4V PBF structural qualification query
Process qualification query for aerospace structural bracket resolved in under 3 seconds with the specific test plan, DoE requirements and NASA-STD-6030 references.
AM Process Engineer
We are qualifying Ti-6Al-4V PBF-LB/M for structural aerospace brackets per AS9100. What test specimens and mechanical properties does NASA-STD-6030 require to establish B-basis design allowables?
IgeraIndustria
Ti-6Al-4V PBF-LB/M — B-basis Structural Qualification per NASA-STD-6030
- • Min sample size: NASA-STD-6030 Table 4.1 — minimum 30 specimens per property per orientation (XY, XZ, Z) for B-basis statistical qualification
- • Mechanical properties required: UTS, TYS, elongation (ASTM E8); fatigue S-N runout 10^7 cycles (ASTM E466); fracture toughness KIc (ASTM E399) if design is fracture-critical
- • Post-process condition: HIP (920°C/100 MPa/2h per AMS 2801) + anneal (700°C/2h) required before test — as-built properties not acceptable for structural allowables
- • Porosity limit: AMS 7003 Table 1 — max 0.5% area fraction by metallographic section before qualification; max 0.1% for fracture-critical classification
⚠️ NADCAP Heat Treatment accreditation (AC7102/4) required for HIP if parts are sold to prime contractors under AS9100.
✓ NASA-STD-6030 Table 4.1 · AMS 7003 · AMS 2801 · Confidence: 98.1%
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engineers, aerospace AM shop
-55%
process qualification research time
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REACH violations on powder procurement
We operate four EOS M400 machines qualified for AS9100 structural components in Ti-6Al-4V and IN718. Every time we introduce a new powder supplier or extend the qualification to a new alloy condition, we need to cross-reference NASA-STD-6030 test plan requirements, REACH SVHC status for the new powder chemistry, and NADCAP HIP requalification triggers. Before IgeraIndustria that was two to three days of manual standard searching. Now we get the full qualification roadmap — with specific standard references — in under a minute.
*Representative testimonial based on results from real customers
Frequently asked questions — Additive Manufacturing Compliance
ISO/ASTM 52900:2021 process categories: PBF, DED, MJT and the full taxonomy
ISO/ASTM 52900:2021 (the harmonised revision of the 2015 standard) defines seven additive manufacturing process categories: (1) Binder Jetting (BJT) — liquid binder selectively deposited onto powder layers; (2) Directed Energy Deposition (DED) — focused thermal energy to fuse material during deposition (laser, electron beam, arc-wire); (3) Material Extrusion (MEX) — material dispensed through a nozzle (FFF/FDM); (4) Material Jetting (MJT) — droplets of material selectively deposited (inkjet, aerosol); (5) Powder Bed Fusion (PBF) — thermal energy selectively fuses regions of a powder bed — subcategories: PBF-LB/M (laser beam/metal, formerly SLM/DMLS), PBF-EB/M (electron beam/metal), PBF-LB/P (polymer, SLS); (6) Sheet Lamination (SHL) — sheets bonded to form an object; (7) Vat Photopolymerisation (VPP) — liquid photopolymer in a vat selectively cured by light (SLA, DLP). The 2021 revision standardised terminology to be process-agnostic — legacy trade names (SLM, DMLS, EBM, SLS) are commercial terms not to be used in technical specifications and regulatory submissions. IgeraIndustria retrieves the correct ISO/ASTM 52900:2021 terminology for any AM process and maps legacy trade names to the standard classification.
AS9100 + NASA-STD-6030 structural AM qualification: the certification path for flight hardware
Structural qualification of additive manufactured parts for aerospace flight use requires a layered approach. AS9100 Rev D cl.8.5.1.3 (Special Processes) mandates that processes whose results cannot be fully verified by subsequent inspection must be qualified — PBF-LB/M and DED are both classified as special processes. The process qualification (PQ) must demonstrate: (1) Machine qualification (FAT, SAT per ISO/ASTM 52941); (2) Material qualification — powder characterisation per ISO/ASTM 52907 (particle size, morphology, chemistry); (3) Process parameter qualification — design of experiments (DoE) to establish the process window; (4) Test specimen mechanical properties — tensile, fatigue, fracture toughness per ASTM E8, ASTM E466; (5) Equivalent traditional material qualification if no AM-specific material specification exists. NASA-STD-6030 (Additive Manufacturing Requirements for Spaceflight Systems, 2021) adds specific requirements for flight hardware: feedstock traceability to material lot, in-process monitoring requirements, post-process inspection (CT scan mandatory for certain risk categories), and design allowables based on A-basis or B-basis statistical qualification. EASA CM-S-020 (2022) and FAA AC 33.15-2 (proposed) are the civil aviation qualification frameworks. IgeraIndustria maps the applicable qualification standard to your part risk category and manufacturing process.
REACH compliance for metal AM powders: Ni, Co, Cr alloys and SVHC obligations
Metal additive manufacturing powders — particularly nickel-based superalloys (IN718, IN625), cobalt-chrome alloys (CoCrMo) and titanium alloys (Ti-6Al-4V) — trigger specific REACH obligations. Nickel compounds (cobalt compounds) are classified as SVHC (Substances of Very High Concern) under REACH Annex XIV (Authorisation List) and/or Annex XVII (Restriction List). Key obligations for AM operators: (1) Article 33 REACH — if the SVHC concentration in articles (finished parts) exceeds 0.1% w/w, you must inform recipients and consumers on request within 45 days; (2) Article 7(2) REACH — if you release more than 1 tonne/year of a SVHC substance from articles under normal conditions, registration may be required; (3) Candidate List substances — cobalt and cobalt compounds are on the Candidate List (ECHA SVHC Candidate List, updated June 2023); nickel salts are Annex XIV authorised substances. For fine metal powders used in PBF, worker exposure via inhalation is the primary COSHH/REACH concern — occupational exposure limits (OELs) and workplace monitoring requirements apply under EU OEL Directive 2017/164/EU (4th indicative OEL list). IgeraIndustria retrieves the REACH status, SVHC candidate list entry, authorisation requirement and OEL for each metal powder alloy used in your AM facility.
MDR Annex I GSPR for additively manufactured implants: the regulatory pathway
Additively manufactured medical implants — orthopaedic implants (hip/knee), spinal cages, cranial plates, dental prostheses — are regulated under EU MDR 2017/745 as Class III (implantable) or Class IIb devices. MDR Annex I defines the General Safety and Performance Requirements (GSPR) that must be met. For AM implants specifically, the critical GSPR requirements are: (1) GSPR 1 — safe design including patient-specific implant design validation; (2) GSPR 3 — acceptable risk-benefit ratio demonstrated through clinical data; (3) GSPR 10.4.3 — biocompatibility of all materials in contact with the body — ISO 10993 series testing required, including ISO 10993-18 (material characterisation) and ISO 10993-1 (biological evaluation planning); (4) GSPR 13 — information supplied with the device (IFU); (5) GSPR 23 — devices incorporating software. The AM manufacturing process itself must be validated as a Special Process — process parameters locked and any deviation triggers revalidation. Post-market surveillance under MDR Article 83 requires active PMCF (Post-Market Clinical Follow-up). EUDAMED registration is mandatory. FDA 510(k) or PMA for US market adds 21 CFR Part 820 (QSR) process validation requirements. IgeraIndustria retrieves the specific GSPR requirements applicable to the implant type, the ISO 10993 testing scope, and the MDR conformity assessment route (Annex IX, X or XI).
Powder lot traceability in AM: chain of custody from atomisation to final part
Traceability of metal powder lots in AM is a regulatory requirement for aerospace (AS9100, NADCAP), medical (MDR, FDA QSR) and automotive (IATF 16949) applications. A compliant traceability chain must cover: (1) Raw material traceability — powder manufacturer certificate of conformance (CoC), chemical analysis report (spectrographic certificate), particle size distribution (PSD) report per ISO/ASTM 52907 linked to the powder lot number; (2) Powder management — incoming inspection records, powder storage conditions (temperature, humidity, inert atmosphere), powder reuse tracking — number of recycles and top-up ratios (critical for PBF titanium alloys where recycled powder has increased oxygen content); (3) Build traceability — powder lot number linked to specific build job file, machine ID, build parameters version, operator ID, post-process treatment records (HIP, heat treatment, machining); (4) Part traceability — unique part serialisation traceable back to the powder lot and build job. AS9100 cl.8.4.3 requires flow-down of traceability requirements to powder suppliers. For titanium PBF, AMS 4998 and AMS 7016 define the virgin-to-recycled powder ratio limits. IgeraIndustria retrieves the specific traceability chain requirements for your AM process, material and application sector.
Surface finish requirements Ra for AM post-processing: application-specific thresholds
As-built surface roughness from AM processes is significantly higher than machined surfaces: PBF-LB/M as-built: Ra 5-20 micron; DED as-built: Ra 10-30 micron; MJT as-built: Ra 1-3 micron. Post-processing requirements depend entirely on the application: (1) Aerospace structural parts — fatigue-critical surfaces must typically reach Ra < 1.6 micron (64 micro-inch) per MMPDS/CMH-17 fatigue test surface preparation requirements. The effect of surface roughness on fatigue life of AM parts is significantly larger than for wrought material — sub-surface porosity exposed by machining can act as fatigue initiation sites; (2) Medical implants — osseointegration surfaces (e.g. porous titanium bone ingrowth surfaces) require controlled Ra in the range 1-4 micron per ISO 10993-18 and ISO 4287. Mirror-polish bearing surfaces (knee, hip articulation) require Ra < 0.05 micron; (3) Hydraulic/fluid flow passages — internal channel smoothness affects flow resistance and biofilm risk in medical devices — electrochemical polishing (ECP) or abrasive flow machining (AFM) typically required; (4) Sealing surfaces — static seals typically require Ra < 3.2 micron; dynamic seals Ra < 0.8 micron. IgeraIndustria retrieves the applicable Ra specification for your part application, the post-processing method options, and the verification method required (contact profilometry per ISO 4288, or optical per ISO 25178 for freeform surfaces).
IgeraIndustria Additive Manufacturing Compliance plans
No long-term commitment. Cancel anytime.
Starter
For AM job shops entering AS9100 qualification for the first time, needing instant access to ISO/ASTM 52900 terminology, process qualification steps and powder traceability requirements.
- ISO/ASTM 52900:2021 pre-indexed
- AS9100 Rev D special process requirements
- Powder traceability chain queries
- 1,000 queries/month
- Widget for AM and quality team
- Email support
Professional
For aerospace and medical AM shops managing simultaneous AS9100, REACH and MDR obligations across multiple alloy systems and qualification programmes.
- ISO/ASTM 52900 + AS9100 + NASA-STD-6030 + MDR indexed
- REACH SVHC mapping for metal powders
- MDR Annex I GSPR for implants
- 5,000 queries/month
- Regulatory update alerts (MDR, REACH, AMS)
- Priority support
Enterprise
For AM groups operating multiple qualified processes across aerospace, medical and energy sectors, with NADCAP accreditation and multi-standard compliance requirements.
- Multi-process, multi-standard, multi-site
- NADCAP heat treatment and NDT requirements
- FAA/EASA + FDA dual-market support
- Unlimited queries
- SLA 99.9% uptime
- Dedicated AM compliance success manager
AM qualification and compliance from powder to certified part. Start today.
- Free trial 14 days — no credit card required
- ISO/ASTM 52900:2021 + AS9100 + NASA-STD-6030 fully indexed from day 1
- Upload your process qualification records, powder CoA and MDR technical documentation
- REACH SVHC mapping for metal AM powders included — IN718, CoCrMo, Ti-6Al-4V