New Standard for Adolescent Scoliosis Orthoses

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June 26, 2026 News 9707

In June 2026, the group standard T/CAME 91—2026, Customised Additively Manufactured Scoliosis Orthoses for Children and Adolescents, was officially released in China.

This is no armchair standard. Beijing Qing embedded years of real‑world testing data and clinical feedback directly into the provisions. From mechanical property thresholds for materials, to the design boundaries of lattice structures, to the methodology for cyclic open‑close fatigue testing—every key parameter is backed by lab‑generated evidence.

The standard covers the entire technical chain: classification and model selection, data acquisition, digital design, additive manufacturing, finished‑product inspection, and fitting requirements. It puts an end to the industry’s previous “everyone does their own thing” ambiguity, and achieves hard‑nosed breakthroughs in three dimensions:

First – concrete, quantitative metrics. The standard now mandates a tensile yield stress ≥30 MPa, elongation at break ≥250 %, and flexural modulus ≥800 MPa. These material specs guarantee that the final products have defined toughness, strength, and rigidity—no more vague promises.

Second – full‑process traceability. 3D scanning error is capped at ≤±1 mm; finished‑part thickness tolerance vs. the design model is ≤±0.2 mm, and girth tolerance ≤±1.0 mm. Every step is measurable and verifiable, meaning that equipment or processes failing to meet these limits simply cannot pass quality validation.

Third – rigorous validation far beyond daily use. The standard prescribes drop tests (from 1.6 m height, in five orientations, five times each), a static load of 1000 N held for 10 seconds, and impact tests with a 150 g steel ball dropped from 2 m—all must be passed for the product to be approved. These demanding conditions ensure a generous safety margin for real‑world wear.

In short, this standard draws a high baseline for the spinal health of children and adolescents, and gives customised 3D‑printed orthoses a much more reliable quality yardstick going forward.