GB/T 19544-2024Classification and general technology requirements of spinal orthoses (English PDF)

3 Terms and definitions

3.1 Spinal orthoses: a device used outside the body to correct the structural and functional characteristics of the neuromuscular and skeletal system of the spine. Note: some such devices are custom-made to meet an individual functional need and some are prefabricated to meet a particular functional requirement; among the prefabricated ones, some can be adjusted to suit the individual fitting and some are finished products that cannot be adjusted or need no adjustment.

3.2 Fixed spinal orthoses: a spinal orthosis used to immobilize the spine or to limit its movement.

3.3 Weight bearing spinal orthoses: a spinal orthosis used to reduce the pressure on the spine.

3.4 Orthotic spinal orthoses: a spinal orthosis used to correct or prevent a deformity of the spine.

3.5 Compensatory spinal orthoses: a spinal orthosis used to make up for or replace a lost function of the spine.

3.6 Cervical orthoses: an orthosis used on the whole or part of the cervical region, including the atlanto-occipital joint.

3.7 Cervico-thoracic orthoses: an orthosis used on the whole or part of the cervical and thoracic regions, including the atlanto-occipital joint.

3.8 Cervico-thoraco-lumbo-sacral orthoses: an orthosis used on the whole or part of the cervical, thoracic, lumbar and sacro-iliac regions, including the atlanto-occipital joint.

3.9 Thoraco orthoses: an orthosis used on the whole or part of the thoracic region of the trunk.

3.10 Thoraco-lumbar orthoses: an orthosis used on the whole or part of the thoracic and lumbar regions of the trunk.

3.11 Thoraco-lumbo-sacral orthoses: an orthosis used on the whole or part of the thoracic, lumbar and sacro-iliac regions of the trunk.

3.12 Lumbo-sacral orthoses: an orthosis used on the whole or part of the lumbar and sacro-iliac regions of the trunk.

3.13 Sacro-iliac orthoses: an orthosis used on the whole or part of the sacro-iliac region of the trunk.

4 Classification and model designation

4.1.1 By function, spinal orthoses are divided into fixed, weight bearing, orthotic and compensatory spinal orthoses. Note: one product may have two or more of these functions; in practice its main function or the function actually needed is settled and the other functions described.

4.1.2 By region, spinal orthoses are divided into cervical, cervico-thoracic, cervico-thoraco-lumbo-sacral, thoracic, thoraco-lumbar, thoraco-lumbo-sacral, lumbo-sacral and sacro-iliac orthoses.

4.2.1 The model designation of a spinal orthosis is made up of the region code, the function code, the abbreviated name of the company with the design serial number, and the improvement serial number. Example 1: CO-F-XX-01, the fixed cervical orthosis of original design with design number 01 of the company abbreviated XX. Example 2: LSO-O-XX-02-A, the orthotic lumbo-sacral orthosis with design number 02 of the company abbreviated XX, first improved design. Example 3: TLSO-U-XX-03-B, the weight bearing thoraco-lumbo-sacral orthosis with design number 03 of the company abbreviated XX, second improved design.

4.2.2 The region code follows Table 1 and uses the initial letters of the English name of the region together with the word orthosis. Table 1 has two rows, eight regions and eight codes: cervical CO, cervico-thoracic CTO, cervico-thoraco-lumbo-sacral CTLSO, thoracic TO, thoraco-lumbar TLO, thoraco-lumbo-sacral TLSO, lumbo-sacral LSO and sacro-iliac SO.

4.2.3 The function code follows Table 2 and uses the initial letter of the English name of the functional class. Table 2 gives four functions and four codes: fixed F, weight bearing W, orthotic O and compensatory C.

4.2.4 The design serial number of the product is written with two Arabic numerals.

4.2.5 The improvement serial number is written with one letter, A, B, C and so on in order; an original design carries no letter and the first improvement is marked A.

5.1 Appearance quality

5.1.1 Seams in soft materials shall be firmly sewn, with even stitching free of obvious defects.

5.1.2 Riveted joints shall be firm, with a smooth surface free of burrs and sharp faces.

5.1.3 The surface shall be even in colour and free of scratches and cracks, and free of sharp edges, sharp corners or burrs liable to injure the body.

5.2 Design and structure

5.2.1 General requirement. The design starts from the examination result and the prescription, which settle whether the main function of the orthosis is fixing, weight bearing, correction or compensation. A fixed spinal orthosis shall give the affected part stable fixation and protection: one acting as a complete fixation shall limit movement of the spinal segments concerned in the sagittal, coronal and transverse planes so as to avoid injury to nerves, bone and ligaments, and one acting as a partial fixation shall limit movement of the spine within a given angle or degree of freedom. A weight bearing spinal orthosis shall relieve the affected part, reducing the overall vertical pressure on the spine and the stress in parts of the structure such as the vertebral body or the vertebral arch. An orthotic spinal orthosis shall apply the correct corrective force to the deformed part, the magnitude, direction and point of application of the force being accurate, so as to correct in three dimensions a deformity or abnormal posture that departs from the physiological position of the spine. A compensatory spinal orthosis shall provide assisting force or stored energy to help the spine move and so make up for the lost function.

5.2.2 Cervical orthoses. Table 3 gives, for each functional class, the design and structure requirements and examples of products. For the fixed and weight bearing class, the orthosis limits flexion, extension, lateral bending and rotation of the neck, reduces the pressure on the cervical spine and gives support and protection; the upper end reaches the mandible in front and the occiput behind, and the lower end is fixed with the shoulders as the stable base, reaching the manubrium in front and the spinous process of the second thoracic vertebra behind, leaving the scapulae free at both sides; the inner wall in contact with the body is of soft composite material and the outer wall of hard supporting material, and the flexion and extension angle and the supporting force are adjusted by changing the angle and height of the chin support and the occipital support; the structure is either two-piece front and back or one-piece, with the opening at both sides or at one side and closed by an adjustable soft strap so that the girth can be adjusted to the user. Products listed as examples are the cervical fixation device, the moulded fixed collar, the height-adjustable collar, the three-piece collar and the inflatable collar. For the orthotic and compensatory class, the compensatory function, the points of application of the corrective force and the release space are designed on biomechanical requirements and the three-point force principle, correction preferably being made in the over-corrected position with the balance of the body force line as the aim; the upper end reaches the mandible in front and the occiput behind, and the lower end reaches the manubrium in front and the spinous processes of the fourth to sixth thoracic vertebrae behind; the same material, structure and strap arrangement apply, and the magnitude and point of application of the corrective force are finely adjustable. The product listed as an example is the torticollis orthosis.

5.2.3 Cervico-thoracic orthoses. Table 4 gives the same three columns. For the fixed and weight bearing class, the orthosis limits flexion, extension, lateral bending and rotation of the cervical spine, reduces the pressure on it and gives support and protection; the upper end reaches the mandible in front and the occiput behind or extends forward to the temporal bone, leaving the ears free, and the lower end is fixed with the shoulders and chest as the stable base, reaching the thorax in front, leaving the breasts free for female users, and reaching below the scapulae behind, leaving the scapulae free at both sides without hindering shoulder movement; the inner wall in contact with the body is of soft composite material and the outer wall of hard supporting material; the whole is made of a front and a back piece, each of one-piece or component construction, adjustable in height, length and angle, the two pieces joined by an adjustable soft strap so that the girth can be adjusted without hindering breathing. Products listed as examples are the head-band cervico-thoracic orthosis, the halo cervico-thoracic orthosis, the post-reinforced cervical orthosis, the front and back shell cervico-thoracic orthosis and the frame cervico-thoracic orthosis. The orthotic and compensatory class adds the three-point force design and the fine adjustment of the corrective force, with the additive manufactured cervico-thoracic orthosis listed as an example.

5.2.4 Cervico-thoraco-lumbo-sacral orthoses. Table 5 gives the same three columns. For the fixed and weight bearing class, the orthosis limits movement of the cervical, thoracic and lumbar regions, reduces the pressure on the spine and gives support and protection; the upper end reaches the mandible in front and the occiput behind, and the lower end is fixed with the pelvis as the stable base, reaching the lower edge of the abdomen in front without hindering hip flexion and reaching above the widest girth of the buttocks behind without hindering sitting down; in the head and neck segment the inner wall in contact with the body is of soft composite material and the outer wall of hard supporting material; the structure is one-piece with a front or rear opening closed by an adjustable soft strap so that the girth can be adjusted without hindering breathing or shoulder movement, the breasts being left free for female users. Products listed as examples are the moulded cervico-thoraco-lumbo-sacral orthosis, the frame cervico-thoraco-lumbo-sacral orthosis and the cervico-lumbar traction device. The orthotic and compensatory class adds the three-point force design and the fine adjustment of the corrective force, with the scoliosis orthosis and the additive manufactured cervico-thoraco-lumbo-sacral orthosis listed as examples.

5.2.5 Thoracic orthoses. Table 6 gives the same three columns. For the fixed and weight bearing class, the orthosis limits movement of the thoracic region, reduces the pressure on the spine and gives support and protection; the structure is two-piece front and back or one-piece, with the opening at both sides or at one side and closed by an adjustable soft strap so that the girth can be adjusted without hindering breathing or shoulder movement. Products listed as examples are the moulded thoracic fixation orthosis, the additive manufactured thoracic orthosis and the rib belt. For the orthotic and compensatory class, the compensatory function, the points of application of the corrective force and the release space are designed on biomechanical requirements; the applied force is adjusted by soft straps, suction cups and the like to correct a protrusion or depression of the anterior chest wall in the middle and lower sternum; and the magnitude and point of application of the corrective force are finely adjustable. Products listed as examples are the pectus carinatum orthosis and the pectus excavatum orthosis.

5.2.6 Thoraco-lumbar orthoses. Table 7 gives the same three columns but carries only the fixed and weight bearing row. That orthosis limits flexion, extension, lateral bending and rotation of the thoracic and lumbar spine, reduces the pressure on the spine and gives support and protection; the upper end reaches the lower edge of the thorax in front without hindering breathing and is no higher than the middle of the scapula behind, without hindering shoulder movement, and the lower end is fixed with the upper edge of the pelvis as the stable base; for a user who does not need complete fixation, a one-piece structure of elastic soft fabric is used, reinforced with strips of elastic metal or plastic and with elastic bands added at particular positions according to the user and to biomechanical requirements. Products listed as examples are the high lumbar support with built-in stays in elastic fabric, in canvas and in leather, the abdominal and back support type high lumbar support, and the posture correction belt.

5.2.7 Thoraco-lumbo-sacral orthoses. Table 8 gives the same three columns. For the fixed and weight bearing class, the orthosis limits flexion, extension, lateral bending and rotation of the thoracic and lumbar spine, reduces the pressure on the spine and gives support and protection; the upper end is released over the chest in front so as not to hinder breathing and is no higher than the middle of the scapula behind, and the lower end is fixed with the pelvis as the stable base, reaching the lower edge of the abdomen in front without hindering hip flexion and reaching above the widest girth of the buttocks behind without hindering sitting down; the structure is one-piece with a front or rear opening closed by an adjustable soft strap, the breasts being left free for female users; for a user who does not need complete fixation, a one-piece elastic soft fabric structure reinforced with elastic strips is used. Products listed as examples are the thoraco-lumbo-sacral fixation device, the fixation jacket type orthosis, the stay-fixed orthosis and the moulded jacket type orthosis. The orthotic and compensatory class adds the three-point force design, an upper end reaching the lower edge of the thorax in front, and the fine adjustment of the corrective force, with the hyperextension orthosis, the scoliosis orthosis and the kyphosis orthosis listed as examples.

5.2.8 Lumbo-sacral orthoses. Table 9 gives the same three columns. For the fixed and weight bearing class, the orthosis limits flexion, extension, lateral bending and rotation of the lumbar spine, reduces the pressure on the spine and gives support and protection; the upper end reaches the lower edge of the thorax in front and is no higher than the tenth thoracic vertebral body behind, and the lower end is fixed with the pelvis as the stable base, reaching the lower edge of the abdomen in front without hindering hip flexion and reaching above the widest girth of the buttocks behind without hindering sitting down; the structure is one-piece with a front or rear opening closed by an adjustable soft strap, and for a user who does not need complete fixation a one-piece elastic soft fabric structure reinforced with elastic strips is used. The product listed as an example is the lumbo-sacral fixation device. The orthotic and compensatory class adds the three-point force design, an upper end no higher than the middle of the scapula behind, and the fine adjustment of the corrective force, with the lumbar traction belt, the lumbo-sacral flexion or extension limiting orthosis and the additive manufactured lumbo-sacral orthosis listed as examples.

5.2.9 Sacro-iliac orthoses. Table 10 gives the same three columns and carries only the fixed and weight bearing row. That orthosis stabilizes the pelvis, fixes and protects the sacro-iliac joint and the pubic symphysis and gives support and protection; the upper end reaches below the middle of the abdomen at the navel in front and is no higher than the third lumbar vertebral body behind, and the lower end reaches above the pubic symphysis in front without hindering hip flexion and above the widest girth of the buttocks behind without hindering sitting down, the greater trochanters being left free or not at both sides according to the user and to biomechanical requirements; the structure is one-piece in elastic soft fabric reinforced with strips of elastic metal or plastic, with elastic bands added at particular positions. Products listed as examples are the sacro-iliac belt, the trochanter belt, the moulded sacro-iliac orthosis and the additive manufactured sacro-iliac orthosis.

5.3 Materials and dimensions

5.3.1 Material in direct contact with the skin shall meet the safety requirements of MZ/T 191.

5.3.2 Textile materials used shall meet GB 18401.

5.3.3 Hook and loop fastener tape shall meet GB/T 23315, its intrinsic quality meeting the requirements for ordinary hook and loop fastener tape.

5.4.1 The dimensions of mass-produced spinal orthoses shall suit the part of the body that the orthosis fixes, unloads, corrects or compensates; under GB/T 10000 the sizes of spinal orthoses are divided into extra small (XS), small (S), medium (M), large (L) and extra large (XL).

5.4.2 The girth sizes and tolerances follow Table 11, which has three rows for neck girth, chest girth and waist girth and five size columns, all values in millimetres. For neck girth the values are below 260 +/-5, 260 to 300 +/-5, 280 to 360 +/-5, 340 to 460 +/-5 and above 460 +/-5. For chest girth they are below 680 +/-10, 680 to 760 +/-10, 760 to 840 +/-10, 840 to 920 +/-10 and above 920 +/-10. For waist girth they are below 620 +/-10, 620 to 700 +/-10, 700 to 800 +/-10, 800 to 900 +/-10 and above 900 +/-10.

5.4.3 The height sizes shall match the girth sizes while suiting the spinal segments concerned, or the structure shall be adjustable in height so as to suit a special body shape.

5.6 Strength shall meet GB/T 30659.

5.5 Fitting

5.5.1 General requirement. When the spinal orthosis is handed over to the user it shall be tried on under the guidance of a professional and a fitting check made. The check covers whether the prescription has been met; whether the design and structure requirements and the intended function have been met; whether the user can put the orthosis on and take it off correctly, alone or with help; that it preferably does not hinder normal physiological activity such as breathing and the heartbeat; that it preferably does not hinder basic daily activity such as standing, sitting, lying down, eating and using the lavatory; that it preferably does not hinder normal movement such as running, jumping and walking; that an orthosis worn for a long period does not hinder the growth and development of a user still growing; that an orthosis worn for a long period preferably reduces unnecessary containment of the body and restriction of movement so as to lessen the ill effects of fixation; and that it does not cause a new spinal deformity or injury to the bones, joints or soft tissue of the spine.

5.5.2 Cervical check. For every spinal orthosis whose structure includes the head and neck, the inner upper edge of the sternal support shall be below the sternal notch and its outer upper edge below the clavicle, so that the sternal prominence and the clavicle are not pressed when the user leans forward with rounded shoulders; the centre of the upper edge of the occipital support shall be below the top of the external occipital protuberance so that the head can tilt back a little; there shall be a clearance of more than 10 mm between the throat and the orthosis; the chin support shall limit the movement of the head and neck effectively while preferably not hindering the opening and closing of the mandibular joint or interfering with eating; and all rigid parts, including the chin support, the occipital support and the sternal support, shall follow the physiological structure of the neck in shape, be of a suitable size and carry a soft pad.

5.5.3 Thoraco-lumbo-sacral check. For every spinal orthosis whose structure includes the thoracic, lumbar and sacral vertebrae, the pelvic seat of the orthosis shall be able to contain the pelvis, giving vertical support and resistance to torsion by fitting the shape of the two iliac wings and the buttocks, without pressing hard on bony prominences such as the iliac crest, the anterior superior iliac spine and the greater trochanter; the height of the upper part shall match the height required by the prescription and shall reach at least two vertebrae above the vertebra to be fixed, with an accurate and suitable point of application in the thoraco-lumbar segment so that flexion, extension and rotation of the spine are limited effectively; when the user sits wearing the orthosis, the lower rear edge shall be at least 20 mm from the seat surface and the middle of the lower front edge at least 20 mm from the upper edge of the pubic symphysis, the outer part of the lower front edge shall not press on the root of the thigh, the lower abdomen or the pubic symphysis, and the user shall not be hindered in putting on shoes and socks; the hip flexion angle shall be not less than 90°; the breathing movement of the thorax, that is the outward expansion of the costal arch and the sternum on inspiration, and the movement of the upper limbs preferably are not hindered; and there shall be no excessive compression of the abdomen, abdominal breathing of an infant preferably not being hindered and eating not being hindered.

5.5.4 Correction check, applying to orthotic spinal orthoses only. Besides 5.5.1 to 5.5.3, the immediate correction effect is checked against the prescription, against the consensus of orthotic practice, or against what the professional expects for the user: for an orthotic scoliosis orthosis, the aim of stopping the deformity from getting worse, or of improving and correcting it, is regarded as reached only when the immediate correction effect is greater than 40 % and the vertebral rotation has improved by more than one measurement grade; for an orthotic kyphosis or lordosis orthosis, only when the immediate correction effect is greater than 50 %. The three-point corrective force system is checked: the upper edge of the point of application shall be no higher than the apical vertebra and no lower than the height of the rib joined to it, and the pressure point of the rotational corrective force shall lie posterolateral or anterolateral to the external prominence caused by the rotation; the suitability of the pressure is checked against the degree and the flexibility of the deformity, and the rotational corrective force shall reduce the rotation of the vertebral body effectively; and the release area shall lie on the concave side of the curve and on the side opposite the abnormal prominence, the release amount, that is the gap between the inner wall of the orthosis and the area to be released, leaving the space the body needs to move back into position as the curve and the rotation are corrected. The active breathing correction is checked, the user being allowed, on maximum inspiration and chest expansion, to reach the correction effect through the expansion of the thorax and the movement away from the pad, guided together by the three-point force system and the release space. The balance position of the spine is checked: in the coronal plane the balance position shall help the user improve the curve of the spine and shall not increase it, the spinous process of the seventh cervical vertebra shall lie in the mid-sagittal plane, and the distance from that vertebra and from every apical vertebra to the mid-sagittal plane shall be smaller than in the initial state; in the sagittal plane the balance position shall help the user improve the deformity of the physiological curve and shall not make that curve more abnormal.

6 Inspection methods

6.1 Inspection equipment and tools: laser alignment instrument, X-ray machine, tape measure, straight rule, angle measuring device, plumb line and tear resistance gauge.

6.2.1 Appearance quality is inspected by feel, by eye and by comparison with a sample.

6.2.2 Design and structure are inspected by a professional against 5.2, on the basis of the examination result and the prescription.

6.2.3 Materials: the safety performance test follows the method laid down in MZ/T 119; the safety requirements for textile materials are tested by the method of GB 18401; and hook and loop fastener tape is tested by the method of GB/T 23315.

6.2.4 Dimensions: mass-produced spinal orthoses are checked against the dimensional requirements of 5.4 with a tape measure against the size chart.

6.2.5.1 Fitting is checked by a professional, who verifies the fitting requirements of 5.5 and checks the orthosis against the prescription, the wearer reporting no obvious discomfort.

6.2.5.2 For an orthotic scoliosis orthosis the immediate correction effect is checked as follows. Standing anteroposterior and lateral X-ray films of the spine are taken before and after the orthosis is worn, the alignment of the three-point pressure system is checked, and the following are measured: the angle between the extension of the upper edge of the upper end vertebra and the extension of the lower edge of the lower end vertebra, recorded as the curve angle, that is the Cobb angle; and the degree of rotational deformity of the trunk, the rotation of the vertebral body being measured and recorded on the anteroposterior film, clockwise rotation seen from above being taken as positive and recorded with a plus sign and anticlockwise rotation as negative and recorded with a minus sign. The curve angles measured before and after the orthosis is worn are compared and the percentage of the reduction in the curve angle to the original curve angle is calculated and recorded as the immediate correction effect on the curve angle. The vertebral rotation values measured before and after are compared and the change recorded as the immediate correction effect on the vertebral rotation. Note: while a scoliosis orthosis is being worn, X-ray films are taken at intervals of 6 to 12 months according to the expected progress of the deformity; according to the correction originally expected and the appearance of the scoliosis, either a film taken 2 h after the orthosis has been taken off or a film taken with it on is used. At a review or a change of orthosis, palpation of the spinous processes, or comparison of the appearance of the spinous process curve and the paravertebral prominence after the orthosis has been taken off, may also be used to assess the correction effect and so reduce how often the user is X-rayed.

6.2.5.3 For an orthotic kyphosis or lordosis orthosis the immediate correction effect is checked as follows. Standing anteroposterior and lateral X-ray films of the spine are taken before and after the orthosis is worn, the alignment of the three-point pressure system is checked, and the following are measured: on the lateral film, the angle between the extension of the upper edge of the upper end vertebra and the extension of the lower edge of the lower end vertebra, recorded as the angle of the abnormal kyphosis or lordosis, that is the Cobb angle; and the abnormal alignment of the sagittal plane of the body and its change before and after wearing. The measurements before and after are compared, the curve angle and the degree of rotation are checked, and the percentage of the reduction in the curve angle to the original curve angle is calculated and recorded as the immediate correction effect.

6.2.6 Strength is tested under the relevant provisions of GB/T 30659.

7 Marking and label, instructions for use

7.1 The marking and label of a finished spinal orthosis shall carry at least the product name; the name of the manufacturing enterprise and the place of manufacture; the date of manufacture; and the model designation and the size.

7.2 The instructions for use of the product shall carry at least the product name; the name of the manufacturing enterprise, the place of manufacture, the contact details and the after-sales service contact details; the performance, main structure and field of use of the product; instructions for use or illustrations, precautions where there are any, and any other information that has to be warned of or pointed out; and the methods of maintenance and care of the product together with any special storage conditions and methods.

8 Packaging, transport and storage

8.1.1 Every finished product shall be put in a dust bag.

8.1.2 An inspection conformity certificate shall be put in the dust bag, carrying at least the name of the manufacturing enterprise; the product name, model designation and size; the date of inspection; and the signature or code of the inspector.

8.1.3 The instructions for use of the product and the warranty card shall be put in the dust bag.

8.2 During transport the product shall be protected against severe shock, heavy pressure, vibration, rain and snow and strong sunlight. The transport packing case shall meet GB/T 9174 and the packaging, storage and transport pictorial markings shall meet GB/T 191.

8.3 The product shall be stored indoors at an ambient temperature of -35 °C to 35 °C and a relative humidity not greater than 80 %, in a dry, well ventilated place, isolated from harmful substances such as flammable goods and chemically corrosive goods.