1. Introduction and Scope of Application

This standard aims to provide detailed specifications for the classification, models, requirements, inspection methods, inspection rules, marking, packaging, transportation, and storage of cervical orthoses. It applies to finished products, custom-made products, and components of both soft and hard cervical orthoses used for fixation, correction, protection, support, and other purposes related to cervical spine injuries, inflammation, and other cervical diseases, as well as for auxiliary rehabilitation before and after cervical spine surgery.

2. Normative References

The following documents are essential for the implementation of this standard. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies:

• GB/T 191: Packaging and Storage Pictorial Marking
• GB/T 9174: General Technical Requirements for Packaging of Goods for Transportation
• GB/T 10000: Human Dimensions of Chinese Adults
• GB/T 14191.1: Terminology of Prostheses and Orthoses - Part 1: Basic Terminology for Limb Prostheses and Orthoses
• GB/T 16432: Classification and Terminology of Rehabilitation Assistive Devices
• GB/T 16886.5: Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
• GB/T 16886.10: Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Sensitization
• GB/T 23315: Hook and Loop Fasteners

3. Terms and Definitions

In addition to the terms defined in GB/T 14191.1 and GB/T 16432, the following terms and definitions are also applicable to this standard:

• Cervical Orthosis: An orthosis that surrounds all or part of the cervical spine.
• Soft Cervical Orthosis: A cervical orthosis made of soft materials such as composite fabrics and ethylene-vinyl acetate (EVA) foam.
• Hard Cervical Orthosis: A cervical orthosis made of rigid materials such as plastic and metal frames.
• Immobilizing Cervical Orthosis: An orthosis whose primary function is to immobilize the neck or restrict neck movement.
• Corrective Cervical Orthosis: An orthosis whose primary function is to correct and prevent neck deformities.
• Pressure-Relieving Cervical Orthosis: An orthosis whose primary function is to relieve pressure on the neck.

4. Classification and Models

4.1 Classification

4.1.1 By Material: Classified into soft cervical orthoses and hard cervical orthoses.
4.1.2 By Function: Classified into immobilizing, corrective, and pressure-relieving cervical orthoses.

4.2 Models

4.2.1 Model Composition: Composed of component code, function code, company abbreviation, design sequence number, and improvement sequence number.
4.2.2 Component Code: The component code for cervical orthosis parts is CO.
4.2.3 Function Code: F for immobilizing, O for corrective, and U for pressure-relieving.
4.2.4 Design Sequence Number: Represented by two Arabic numerals.
4.2.5 Improvement Sequence Number: Represented sequentially by English letters such as A, B, C, etc. The original design has no letter, and the first improvement is marked as A, and so on.

5. Requirements

5.1 Structural Requirements

5.1.1 General Requirements: Cervical orthoses are externally applied devices tailored to individuals. Their design should follow biomechanical principles, and product dimensions should comply with GB/T 10000.
5.1.2 Soft Cervical Orthosis: The structure should meet the requirements of restricting neck movement and providing a certain degree of support and warmth retention.
5.1.3 Hard Cervical Orthosis: The structure should meet the requirements of restricting neck movement and providing support from the mandible and occipital bone to the shoulders.
5.1.4 Corrective Cervical Orthosis: The structure should be designed according to biomechanical requirements to achieve corrective purposes.

5.2 Material Requirements

Materials in contact with the skin should be non-toxic and non-irritating and have undergone biological evaluation testing.
Lining foam materials should be odorless, fade-resistant, soft, elastic, and breathable.
Plastic sheets should have sufficient strength and comply with relevant standards.
Metal materials should be lightweight and corrosion-resistant alloys while ensuring strength.
Carbon fiber composite materials should comply with relevant national material testing standards.
Drawstrings and hook and loop fasteners should be sturdy and secure, with hook and loop fastener performance complying with GB/T 23315.

5.3 Appearance Requirements

The stitching of textile materials should be firm and uniform, with no obvious defects.
Plastic surfaces and edges should be smooth and free of burrs, and rivets should be securely fastened.
The product color should be uniform, with no cracks, scratches, sharp edges, or other defects that may cause harm to the human body.