Implant-grade verification • Lot traceable • Professional manufacturingn

Calificación 23 Titanio Verified to ASTM F136n

Implant-grade titanium alloy (Ti-6Al-4V ELI / Calificación 23) with complete documentation, lot traceability, and an ISO 9001 quality management system.n Built for professional piercing applications where consistency and safety matter.n

Request Documentation View Certificationsn Documentation Checklistn

Traceability

Heat/Lot → Batch → Shipment

Entrega

PDF, signed/stamped on request

NDA

Available for compliance files

Material & Verificatio

Alloy / Calificación Ti-6Al-4V ELI (Calificación 23)

Specificatio ASTM F136 verificatio

Biocompatibilidad Test methods per ISO 10993 (on request)

100%

Lot Traceable

CoC

Each Shipment

Included by default

CoC (Certificate of Conformance/Compliance)
MTC / Mill Test Certificates (where applicable)
Batch/lot traceability statement

Material Excelencia

We focus on titanium manufacturing to support batch consistency, stable finishing, and reliable documentation for professional piercing supply chains.n

Why Titanium Focus?

Biocompatibility-first

Calificación 23 titanium alloy verified to ASTM F136 requirements for implant-grade expectations in high-sensitivity applications.

Batch-to-batch consistency

Standardized processes, dedicated tooling, and documented parameters reduce variability across production lots.

Traceability you can audit

Lot/heat references link raw material records to production batches and shipments for QA and regulatory needs.

Documentation-ready supply

CoC and supporting files can be prepared in PDF format; signed/stamped versions available upon request.

Specification vs Grade (Quick Reference)

Item

Calificación 23

Norma ASTM F136

What it is

Grado de material (Ti-6Al-4V ELI)

Standard/specification for surgical implant alloy requirements

Focus

Alloy identity

Chemistry, mechanicals, and quality requirements per the standard

How we use it

Primary alloy we manufacture

Verification basis for implant-grade expectations

Nota: Documentation availability and verification scope may vary by program and customer requirements.n Request files for the exact lot/batch you need.n

Documentation Checklist (Typical)

Material Files

Material statement (Calificación 23 / ASTM F136 basis)
Mill test certificates (si corresponde)
Chemistry / composition summary

Calidad & Traceability

CoC for each shipment
Lot/heat → batch → shipment traceability
Inspection / dimensional reports (as required)

Need a specific format (signed, stamped, or customer template)? Select “Additional Requirements” in the request form below.n

Compliance & Certificaciones

Quality management and ethical audit programs support consistent manufacturing and responsible supply chain expectations.n

ISO 9001

Quality Management System

ISO 9001 controls documentation, process consistency, and corrective/preventive action workflows across procurement, production, and final inspection.n

Document control and process standardizatio

Risk-based thinking and preventive actions

Customer requirements review and monitoring

Continuous improvement and internal audits

SMETA

Ethical Trade Audit Program

SMETA audit coverage supports responsible manufacturing practices and supply-chain transparency expectations.n

Labor standards and worker rights

Health and safety management

Environmental responsibility

Business ethics and anti-corruptio

Disponible Documentatio

A complete documentation package can be prepared for compliance review, QA validation, and customer onboarding.n

Certificates

ISO 9001 Certificate
SMETA Audit Report
Business / Export Credentials (as applicable)
NDA template (opcional)

Material Documentatio

Material statement (Calificación 23 / ASTM F136 basis)
Mill test certificates (si corresponde)
Lot/heat reference summary
Chemical composition summary

Quality Records

Inspection reports (visual/dimensional as required)
QC records (process/finish controls)
Batch traceability statement
CoC (each shipment)

Frequently Asked Preguntas

Common questions about titanium grades, documentation, trazabilidad, and quality assurance.n

What’s the difference between Grade 23 y ASTM F136?n

Calificación 23 refers to the titanium alloy (Ti-6Al-4V ELI). Norma ASTM F136 is a standard/specification that defines requirements for this alloy when used for surgical implant applications.n In practice, we manufacture with Grade 23 alloy and verify documentation and requirements against ASTM F136 expectations when requested.n

If you need a specific customer template or third-party verification scope, include it in the request form.n

Do you support lot traceability and third-party testing?

Lot Traceability: Heat/lot references link raw material records to production batches and shipment documentation.
Third-Party Testing: We can provide samples for independent lab verification (composición, superficie, or other tests), based on your required standard and scope.
Documentation: CoC, traceability statements, and inspection records can be prepared per program requirements.

How do you ensure consistent quality across batches?

Standardized processes: ISO 9001 procedures with controlled parameters and revision management.
Incoming qualification: Verification against required material documentation and specs per program.
In-process controls: Dimensional and finish checks defined in SOP and QC records.
Traceability: Lot linkage supports audit and rapid corrective action if needed.

What do you provide with each shipment?

CoC: Shipment-level certificate confirming conformance to the specified program requirements.
Traceability statement: Heat/lot → batch → shipment references (as applicable).
Inspection records: Dimensional/visual reports based on agreed QC plan.
Supporting material files: Material statements and mill certificates when included in your program.

Can you provide samples for verification?

Finished samples: Pieces from the same processing route for lab verification.
Documentation support: Samples can be paired with the relevant lot/batch references.
Lab coordination: We can align on your chosen accredited lab and required test scope.