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Chemical & Physico-Chemical Characterisation of Medical Device Materials

Under ISO 10993-1, you cannot evaluate a device's biocompatibility without first knowing what it is made of — material characterisation is the foundation of the entire biological evaluation. Auriga Research provides NABL-accredited medical device material characterisation per ISO 10993-18:2020 (chemical) and ISO 10993-19 (physico-chemical, morphological, and topographical), using FTIR, DSC, TGA, and ICP-MS to establish polymer identity, thermal behaviour, composition, and elemental content.

Our scope covers FTIR / ATR-FTIR polymer identification, DSC thermal transitions (on our TA Instruments DSC 2500), TGA compositional and thermal-stability analysis, and ICP-MS elemental characterisation, plus melting point, residue on ignition, incoming-material verification, and supplier-change equivalence assessment. The data underpins the biological evaluation plan (BEP), raw-material qualification, and change-control decisions.

Backed by the Arbro Group's analytical heritage — Arbro Lab since 1990, Auriga Research since 2007 — with NABL ISO/IEC 17025 accreditation, our reports are accepted by CDSCO licensing authorities, FDA 510(k) reviewers, and EU CE Notified Bodies, and are formatted for direct attachment to the biological evaluation file alongside extractables & leachables and biocompatibility data.

FTIR / DSC / TGA in 5–7 working days | Full panel 10–15 days | Express available

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Material Characterisation Scope

Each technique is mapped to the property it measures and the ISO 10993 part it supports so R&D and regulatory teams can match scope to the biological evaluation plan at a glance.

FTIR

Polymer Identification

FTIR / ATR-FTIR for polymer and material identity confirmation against reference spectra and supplier specifications.

DSC

Thermal Transitions

TA Instruments DSC 2500 — glass transition (Tg), melting (Tm), crystallinity, and curing / oxidation behaviour.

TGA

Compositional Analysis

Thermogravimetric analysis for filler / additive content, moisture, volatiles, and thermal decomposition profile.

ICP-MS

Elemental Analysis

Trace elemental and metal content per ISO 10993-18 / USP <232> / <233> for the chemical characterisation dataset.

ISO 10993-18

Chemical Characterisation

Material chemical characterisation per ISO 10993-18:2020 supporting the biological evaluation plan (BEP).

ISO 10993-19

Physico-Chemical / Morphological

Physico-chemical, morphological, and topographical characterisation of device materials per ISO 10993-19.

Melting Point

Thermal Properties

Melting point and softening behaviour for polymer-grade verification.

Ash / ROI

Inorganic Content

Sulphated ash / residue on ignition for inorganic and filler content.

Reference Match

Material Verification

Incoming-material verification against an approved reference standard or material specification.

Equivalence

Supplier-Change Equivalence

Material equivalence assessment when a polymer grade, additive, or supplier changes under change control.

How It Works

Get a Quote

Share your device or material type, the techniques you need (FTIR / DSC / TGA / ICP-MS), the regulatory target (CDSCO / FDA / CE), and whether this is a BEP foundation, a raw-material qualification, or a supplier-change equivalence study. Your dedicated SPOC confirms the test panel, the applicable ISO 10993-18 / -19 references, and the sample quantity before you dispatch anything.

Send Your Sample

Dispatch your material or finished device samples with a completed Test Request Form to the nearest Auriga lab. Each sample is individually bar coded and registered in YLIMS, Auriga's in-house Laboratory Information Management System, upon receipt. Testing begins within 24 hours of sample registration.

Testing and QA Review

Your sample is analysed by FTIR, DSC (TA Instruments DSC 2500), TGA, and ICP-MS as scoped, by Auriga's material-science and chemistry team. Spectra and thermograms are interpreted against reference standards, and every result passes through a formal internal QA review and sign-off before the report is generated.

Receive Your NABL Report

Your NABL-accredited material characterisation report is delivered digitally within the committed turnaround time. Reports carry Auriga's NABL accreditation under ISO/IEC 17025:2017, cite the exact ISO 10993-18 / -19 references applied, and are accepted by CDSCO, FDA 510(k), and CE Notified Bodies. You can track sample status in real time through YLIMS.

Turnaround Time

Service	Standard TAT	Express
FTIR / ATR-FTIR polymer identification	5–7 business days	Available
DSC thermal analysis (Tg, Tm, crystallinity)	5–7 business days	Available
TGA compositional / thermal stability	5–7 business days	Available
ICP-MS elemental analysis	10–14 business days	On request
Full characterisation panel (FTIR + DSC + TGA + ICP-MS)	10–15 business days	On request
Supplier-change equivalence study	10–15 business days	On request
Gap-fill / regulatory response addendum	48–72 hours	Express only

Who Needs Material Characterisation

Medical device manufacturers building the material-characterisation foundation of an ISO 10993-1 biological evaluation plan (BEP).
R&D teams selecting or qualifying a new polymer, additive, or material for a device design.
Quality teams running incoming-material verification against an approved reference or specification.
Manufacturers making a supplier, grade, resin-lot, or master-batch change that triggers change-control characterisation.
Implant manufacturers (orthopaedic, cardiovascular, ophthalmic) needing full chemical + physico-chemical characterisation for high-risk dossiers.
Drug-device combination product developers needing material identity to underpin the E&L and container-closure data.
Companies investigating a finished-device material issue — discolouration, embrittlement, or unexpected ageing.
Contract manufacturers (CMOs / CDMOs) supporting downstream sponsors' biological evaluation files.
Regulatory consultants assembling CDSCO Form MD-9 / MD-15, FDA 510(k), and EU MDR technical files.
Quality teams correlating material data with extractables & leachables and biocompatibility on the same device file.

Why Auriga for Material Characterisation

NABL scope covering ISO 10993-18 & -19

Material characterisation is performed under our NABL ISO/IEC 17025:2017 scope and reported against ISO 10993-18:2020 and ISO 10993-19 — CDSCO, FDA, and CE Notified Bodies accept the report as the biological-evaluation foundation.

FTIR, DSC, TGA, and ICP-MS in-house

Polymer identity (FTIR), thermal behaviour (DSC, on our TA Instruments DSC 2500), composition (TGA), and elemental content (ICP-MS) all run in one accredited laboratory — no cross-lab handover, and one consolidated characterisation report.

Foundation for the whole biological evaluation

Material characterisation feeds directly into the extractables & leachables and biocompatibility programmes — Auriga runs all three under one project lead, so the data sets reconcile within a single BEP.

Built for change-control and equivalence

Supplier-change, grade-change, and resin-lot equivalence studies are a routine workflow — the data regulators expect when a material input changes after the original submission.

CDSCO / FDA / CE acceptance trail

Reports routinely accepted in CDSCO Form MD-9 / MD-15 submissions, FDA 510(k) biocompatibility sections, and CE technical files reviewed by major Notified Bodies (BSI, TÜV SÜD, DEKRA, DNV).

Arbro Group analytical heritage

Established analytical heritage through the Arbro Group (Arbro Lab since 1990, Auriga Research since 2007), with NABL ISO/IEC 17025 accreditation — the audit trail device manufacturers and regulatory consultants look for in a material-science partner.

Related Services

Frequently Asked Questions

What is material characterisation and why is it required for medical devices?

Material characterisation establishes the chemical identity, composition, and physical / thermal properties of the materials a device is made from. Under ISO 10993-1, characterisation of materials is the starting point of the biological evaluation — you cannot assess biocompatibility without knowing what the device is made of. ISO 10993-18:2020 governs the chemical characterisation, and ISO 10993-19 governs the physico-chemical, morphological, and topographical characterisation. CDSCO, FDA, and EU MDR expect material characterisation data as the foundation of the biological evaluation plan (BEP), and for raw-material qualification, supplier-change control, and incoming-material verification.

What is the difference between ISO 10993-18 and ISO 10993-19?

ISO 10993-18:2020 covers the chemical characterisation of medical device materials — the identity and quantity of the chemical constituents and the extractables / leachables profile, using techniques such as FTIR, GC-MS, LC-MS, and ICP-MS. ISO 10993-19 covers the physico-chemical, morphological, and topographical (PMT) characterisation — properties such as thermal transitions (DSC), thermal stability and composition (TGA), surface morphology, crystallinity, and physical form. The two are complementary: ISO 10993-18 answers "what chemicals are present," ISO 10993-19 answers "what are the material's physical and thermal properties." A complete biological evaluation usually draws on both.

What does each instrument tell me — FTIR, DSC, TGA, and ICP-MS?

FTIR (and ATR-FTIR) identifies the polymer and confirms material identity by matching the infrared spectrum against reference spectra — the first check for "is this the material I specified." DSC (differential scanning calorimetry, on our TA Instruments DSC 2500) measures thermal transitions — glass transition (Tg), melting point (Tm), crystallinity, and curing or oxidation onset — which reveal grade, processing history, and ageing. TGA (thermogravimetric analysis) measures mass change with temperature to quantify filler / additive content, moisture and volatiles, and the thermal decomposition profile — the compositional fingerprint. ICP-MS quantifies trace elemental and metal content for the chemical characterisation and elemental-impurities dataset. Used together they give a complete identity-plus-composition-plus-thermal picture of the material.

What sample quantity is required for material characterisation?

Material characterisation is comparatively low-volume. FTIR and DSC each need only a few milligrams to a gram of material. TGA needs 10–50 mg per run. ICP-MS elemental analysis needs roughly 0.5–2 g depending on the trace levels required. For a full characterisation panel across all techniques, 5–10 g of representative material (or 3–5 finished device units from which material can be sampled) is typically sufficient. Confirm the exact quantity with your SPOC at the quote stage, particularly where the material must be taken from a finished, sterilised device rather than supplied as raw stock.

When does material characterisation need to be repeated?

Characterisation does not have a statutory expiry, but it must be repeated (or risk-assessed under your BEP) whenever a change could affect the material: (a) polymer grade, resin lot, or master-batch change; (b) additive, colourant, plasticiser, or adhesive change; (c) supplier change for any patient- or fluid-contact material; (d) a change in moulding / extrusion process parameters; (e) a change in sterilisation method that could alter the polymer; (f) a finished-device observation (discolouration, embrittlement) suggesting material drift. Material characterisation is also the standard first step whenever incoming material must be verified against an approved reference before it enters production.

What is the regulatory consequence of inadequate material characterisation data?

Material characterisation is the foundation of the biological evaluation, so gaps cascade. (1) CDSCO MD-9 / MD-15 applications with a weak material characterisation are returned with a biocompatibility-deficiency — typically blocking the registration by 3–6 months. (2) FDA 510(k) submissions where the BEP lacks ISO 10993-18 / -19 characterisation trigger an Additional Information (AI) request that pauses substantial equivalence review. (3) EU MDR technical files without adequate material characterisation are a leading Notified Body non-conformance. (4) A supplier or grade change made without characterisation evidence is a classic post-market audit finding and can invalidate the existing biocompatibility position. Characterising materials upfront is materially cheaper than reconstructing the data after a deficiency.

Can Auriga support contesting a CDSCO, FDA, or Notified Body finding with additional characterisation data?

Yes. Gap-fill material characterisation in response to a CDSCO deficiency, FDA AI request, or Notified Body non-conformance is a routine workflow. The path is: (1) review the regulator's specific finding with your SPOC; (2) identify whether the gap requires FTIR identity confirmation, DSC / TGA thermal-compositional data, ICP-MS elemental analysis, or a supplier-change equivalence assessment; (3) run the targeted top-up programme — not a full re-characterisation; (4) issue an NABL-accredited supplementary characterisation report formatted as an addendum to the original biological evaluation. Express turnaround is available for time-critical regulatory response windows.

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