Quality & Traceability
Quality Documents & Reports
Explore HTN’s management system certifications and available third-party testing documentation.
Management System Certifications
HTN maintains its management systems within the scope of its certification to support consistent quality management and well-documented supply coordination.
ISO 9001:2015 Quality Management System Certification
Size: 680 KB
Shaanxi Huatainuo Metal Co., Ltd. holds ISO 9001:2015 quality management system certification issued by Shanghai NQA Certification Co., Ltd. The certified scope is “Sales of titanium and titanium alloy materials (excluding products that require qualification permits).”Certificate No. 135339、Issue Date 19 September 2025、Valid Until 19 September 2028.
As a titanium materials supplier, HTN works with evaluated manufacturing partners and manages the steps between material sourcing and delivery. Our quality management approach focuses on confirming customer specifications, reviewing supplier and material documents, maintaining the connection between supplied material and its associated records, and addressing any discrepancies identified during an order.
For customers, this certification provides independent confirmation that our quality management system has been assessed against ISO 9001:2015 within the stated scope. Product specifications, inspection requirements and documents are confirmed for each order.
ISO 13485:2016 Quality Management System Certification
Size: 680 KB
Shaanxi Huatainuo Metal Co., Ltd. also holds ISO 13485:2016 quality management system certification issued by Shanghai NQA Certification Co., Ltd. The certified scope is “Sales of titanium and titanium alloy materials for surgical implants.”Certificate No. 135340、Issue Date 19 September 2025、Valid Until 19 September 2028.
Customers sourcing materials for surgical implant applications need clear specifications and dependable material records. Within our role as a material supplier, we work to confirm the applicable material requirements, review available manufacturer documentation, and keep material identification and supporting records connected through order fulfillment. Additional inspection or independent testing can be arranged when agreed for a specific order.
ISO 13485:2016 is a quality management standard developed for organizations involved in the medical device supply chain. HTN’s certification applies to the sales of titanium and titanium alloy materials for surgical implants. It does not certify HTN as a manufacturer of finished implants or serve as approval of any individual material for a particular medical use. Customers remain responsible for confirming that the ordered material and documentation meet their application and regulatory requirements.
HTN's ISO 13485 certification applies to the sales of titanium and titanium alloy materials for surgical implants. It does not certify HTN as a manufacturer of finished implants or serve as approval of any individual material for a particular medical use.
SGS Test Reports
SGS RoHS Test Report
Size: 859 KB
SGS tested the submitted sample for the 10 RoHS restricted substances listed in Report No. CANPC26022046201_1, dated 20 August 2026, with reference to Directive 2011/65/EU Annex II as amended by Directive (EU) 2015/863. The report records ND results for the tested items and a Pass conclusion for the stated test requirements. ND means “Not Detected” below the method detection limit (MDL); it does not mean zero substance content. Item-specific limits, units, MDLs and the separate hexavalent chromium interpretation are provided in the report. These results apply only to the submitted sample and test items identified in the report. They do not certify all HTN products, grades, product forms or supplied lots.
Selected titanium samples have been tested by SGS for the specified RoHS restricted substances.
SGS REACH SVHC Screening Report — 73 Listed Substances
Size: 732 KB
SGS screened the submitted sample for the 73 SVHC substances specified in Report No. CANPC26022046203_1, dated 20 August 2026. The scope comprises 62 inorganic substances and 11 organic metallic substances from the ECHA Candidate List published on or before 4 February 2026, as specified in the report.
Within this defined scope, the report records a Pass conclusion, with results for the 73 screened substances at or below 0.1% by weight in the submitted sample. Results shown as ND are below the report’s reporting limits (RL), which are separate from the evaluation threshold.
This report covers only the submitted sample and the 73 listed screening items. It does not demonstrate screening against the complete or latest ECHA Candidate List or certify overall REACH compliance. Grades and product forms listed under “Client Ref. Information” do not establish separate testing of each listed grade or form.
Results apply only to the submitted samples and screening items identified in the report.
Third-Party Laboratory Test Reports
HTN makes selected third-party laboratory reports available for reference. Each report identifies the submitted sample, test methods and results for the specific items tested.
Laboratory accreditation status and the accredited scope applicable to each test item are subject to verification against the specific report and the laboratory’s relevant accreditation records. Any items identified as outside the accredited scope must be distinguished accordingly.
These sample reports do not establish that all HTN bars, plates or wires have undergone the same tests. Order-specific inspection requirements, sampling arrangements and documentation are confirmed separately before order acceptance.
Industrial Titanium — Sample Test Reports
ASTM B348 Grade 5 Titanium Bar (10.0 mm)
Size: 408 KB
Test items: Chemical composition; room-temperature tensile testing; metallographic examination.
ASTM B265 Grade 2 Titanium Plate (5.0 mm)
Size: 388 KB
Test items: Chemical composition; room-temperature tensile testing; bend testing; metallographic examination.
Medical Titanium — Sample Test Reports
ASTM F136 Grade 23 Titanium Rod (8.0 mm)
Size: 405 KB
Test items: Chemical composition; room-temperature tensile testing; metallographic examination.
ASTM F67 Grade 2 Titanium Plate (3.0 mm)
Size: 404 KB
Test items: Chemical composition; room-temperature tensile testing; bend testing; metallographic examination.
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ASTM F67 Grade 4 Titanium Wire (4.0 mm)
Size: 395 KB
Test items: Chemical composition; room-temperature tensile testing; metallographic examination.
ASTM F136 Grade 23 Titanium Plate (2.0 mm)
Size: 279 KB
Test items: Chemical composition; room-temperature tensile testing; bend testing; metallographic examination.
ASTM F1295 Ti6Al7Nb Titanium Wire (6.0 mm)
Size: 243 KB
Test items: Hydrogen content only for chemical analysis; room-temperature tensile testing; metallographic examination.
The chemical composition table of this report only includes H, and does not contain complete analyses of elements such as Al, Nb, Fe, O, and N. Therefore, it cannot be labeled as “complete chemical composition test”, nor can it be regarded as a separate “complete ASTM F1295 compliance certificate”.
Sample reports are provided for reference and apply only to the samples and test items identified in each report. They do not automatically represent other products, supplied lots or orders. Documentation for a specific order is confirmed separately.
Material Test Certificates & Traceability
Original mill test certificates (MTCs) and heat or lot traceability records can be provided as agreed for each order. We verify the correspondence between material identification and supporting documents, and maintain agreed traceability identification through cutting, packing and dispatch. Documentation requirements and availability are confirmed before order acceptance.
Our Order Traceability Process
1. Customer Specification Confirmation
We confirm the material standard and edition, grade, dimensions, condition, quantity, inspection requirements and required documents before order acceptance.Records: Confirmed specifications and order documentation requirements.
2. Supplier & Mill Document Review
We review the supplier’s material documents and available original MTCs against the agreed order requirements, including material designation, heat or lot identification and reported test results. Identified discrepancies are resolved before release for dispatch.Records: Document review checklist and discrepancy resolution records, where applicable.
3. Material Identification & Heat/Lot Matching
We match the material or package identification to the relevant heat or lot number and supporting documents. Different heats or lots are kept separately identifiable.Records: Material identification checks and heat/lot-to-document reference records.
4. Identification Through Cutting & Packing
Where cutting or repacking is required, we maintain the link between the source material and the resulting pieces or packages through agreed labels and records. When handled by a supply partner, the identification requirements are communicated and the returned records are checked.Records: Cutting or repacking records and package identification details, where applicable.
5. Dispatch Verification
Before dispatch, we check the material identification, quantity, package labels and agreed document set against the order and packing list.Records: Dispatch checklist, packing list and document list.
6. Order Record Retention
We retain the confirmed specifications, material identification records, agreed certificates, relevant inspection records and dispatch documents under the order reference.Records: An order file linking the supplied material to its supporting documents.
Document Access & Reference
Documents displayed on this website are provided for reference. ISO certificates relate to HTN’s management systems within their stated certification scopes. SGS reports relate to the submitted samples and specified screening items. Third-party laboratory reports relate to the identified samples and tests, with accreditation applicability subject to the specific report and relevant laboratory scope.
Original mill MTCs are supplied for specific orders as agreed and are not routinely published on this website. Supplementary third-party sample reports do not replace the original MTC required for an order.
These documents support material supply and order documentation. They do not constitute approval or certification of finished medical devices, implants or their suitability for a specific clinical application.
Need Documents for Your Order?
Send us your material standard, grade, dimensions and required documents. We will confirm the available original mill MTCs, traceability records and any additional testing requirements before order acceptance.