Before crutches and multi-legged walking sticks go to registration, export or a buyer's incoming inspection, three questions come up again and again: should the product be tested to ISO 11334 or to GB/T 19545; which part applies to elbow crutches, axillary crutches and walking sticks with three or more legs; and which accreditation mark can the report carry. This article answers those questions against the current accreditation scope of Hefei SUNGO Medical Technology Co., Ltd. (the Hefei laboratory). The test item tables are taken line by line from the accreditation schedules, so regulatory, quality, R&D and sourcing teams can check them before placing an order.
Key points first
- Crutch and walking stick testing is performed at the Hefei laboratory. The scope of Shanghai SUNGO Medical Technology Co., Ltd. does not include these standards.
- The CNAS scope lists five standards: elbow crutches to ISO 11334-1:2007 and GB/T 19545.1-2012; axillary crutches to GB/T 19545.2-2009; walking sticks with three or more legs to ISO 11334-4:2024 and GB/T 19545.4-2008.
- From the ISO 11334 series, SUNGO's scope contains only Part 1 (elbow crutches) and Part 4 (walking sticks with three or more legs). For axillary crutches, the scope contains only the Chinese national standard GB/T 19545.2. The dedicated standards for walking sticks with seat and for crutch tips are not in the scope.
- CNAS covers all five standards (limited to the clauses listed in the tables below). CMA covers only GB/T 19545.2-2009 and GB/T 19545.4-2008. The IAS scope lists ISO 11334-1, ISO 11334-4, GB/T 19545.1, GB/T 19545.2 and GB/T 19545.4 without edition years, with ISO 11334-4 and GB/T 19545.4 listed "except for 4.4 Materials".
- GB/T 19545.4-2008 is an identical adoption of the withdrawn ISO 11334-4:1999. In the scope, its clause numbers differ from those listed for ISO 11334-4:2024, so the standard has to be chosen according to the target market or the customer's specification.
- GB/T 19545.2-2009, the Chinese axillary crutch standard, was withdrawn on 2026-08-01 and replaced by GB/T 19545.2-2026. The CNAS and CMA scopes list the 2009 edition, and the IAS scope gives no edition year. Confirm the required edition before ordering.
- Biocompatibility (biological tests such as cytotoxicity, sensitization, irritation and implantation) is subcontracted by SUNGO to a laboratory with the appropriate qualifications. Under accreditation rules, the client's consent is obtained in advance, and the report identifies the subcontracted items and the subcontractor.
Standards and scope
ISO 11334 and GB/T 19545 are both series for walking aids manipulated by one arm, split into parts by product design. The part titles look alike, and the most common mistake is matching elbow crutches, axillary crutches and multi-legged sticks to the wrong part. Each product is covered below. For full technical requirements, refer to the standard text.
Elbow crutches: ISO 11334-1:2007 and GB/T 19545.1-2012
ISO 11334-1:2007, Assistive products for walking manipulated by one arm — Requirements and test methods — Part 1: Elbow crutches, is edition 2, published in February 2007. The ISO website states that it was last reviewed and confirmed in 2022 and remains current.
According to the abstract published by ISO, it specifies requirements and test methods for elbow crutches fully equipped with handgrip and tip, with test methods covering separation, static load capacity, fatigue and resistance to low-temperature embrittlement. It also gives requirements for safety, ergonomics, performance and information supplied by the manufacturer, including marking and labelling. The requirements and tests are based on everyday use of elbow crutches in the through-swing gait, for a maximum user mass specified by the manufacturer, and the standard applies to elbow crutches specified for a user mass of not less than 35 kg. Requirements and test methods for friction of rubber tips against the walking surface are dealt with separately.
GB/T 19545.1-2012 (Walking aids manipulated by one arm — Requirements and test methods — Part 1: Elbow crutches) was published on 2012-12-31 and took effect on 2013-05-01. The national standards information platform lists it as an identical adoption of ISO 11334-1:2007, and its 2025 review concluded that it remains valid. In SUNGO's CNAS scope, the two standards list the same test items with the same clause numbers.
Axillary crutches: GB/T 19545.2
For axillary crutches, SUNGO's scope contains only the Chinese national standard. CNAS and CMA list GB/T 19545.2-2009 (Walking aids manipulated by one arm — Requirements and test methods — Part 2: Axillary crutches); the IAS scope lists GB/T 19545.2 without an edition year.
Check the edition. According to the national standards information platform, GB/T 19545.2-2009 was withdrawn on 2026-08-01 and fully replaced by GB/T 19545.2-2026, published on 2026-01-28 and effective from 2026-08-01. The CNAS and CMA scopes list the 2009 edition; the 2026 edition is not among the editions listed in the CNAS and CMA scopes. Please confirm which edition your market or customer requires.
Walking sticks with three or more legs: ISO 11334-4:2024 and GB/T 19545.4-2008
ISO 11334-4:2024, Assistive products for walking, manipulated by one arm — Requirements and test methods — Part 4: Walking sticks with three or more legs, is edition 2, published in October 2024. It replaced ISO 11334-4:1999, which is now withdrawn.
According to the ISO abstract, it specifies requirements and test methods for walking sticks with three or more legs used as assistive products for walking manipulated by one arm, tested without accessories unless the particular test procedure says otherwise. It also gives requirements for safety, ergonomics, performance and information supplied by the manufacturer, including marking and labelling. The requirements and tests are based on everyday use for a maximum user mass specified by the manufacturer, and the standard applies to products specified for a user mass of no less than 35 kg. It does not apply to multi-legged sticks with underarm or forearm support, or with moving parts such as a universal joint. Products sold as tripod or quad canes should therefore be checked against these exclusions.
GB/T 19545.4-2008 (Walking aids manipulated by one arm — Requirements and test methods — Part 4: Walking sticks with three or more legs) was published on 2008-12-31, took effect on 2009-09-01, and is an identical adoption of ISO 11334-4:1999. It is still current. The platform shows that its latest review concluded "revise" and that a revision project (20260828-T-314) is being drafted. In other words, the current Chinese edition corresponds to the old ISO edition, not to ISO 11334-4:2024. The clause numbers in the scope differ as well (see Tables 3 and 4).
Related products and standards not in the scope
- Walking sticks with seat: GB/T 19545.5-2021 (Part 5: Walking sticks and canes with seat) is not in SUNGO's scope.
- Crutch tips: GB/T 40889.1-2021 (friction of tips, an identical adoption of ISO 24415-1:2009) and GB/T 40889.2-2021 (durability of tips for crutches, an identical adoption of ISO 24415-2:2011) are not in SUNGO's scope.
- Single-point walking sticks: ISO 11334-4 and GB/T 19545.4 cover sticks with three or more legs, and the scope contains no dedicated standard for single-point sticks.
Test item tables
Tables 1 to 4 are taken line by line from the Hefei laboratory's CNAS scope schedule. Clause numbers are as listed. Item names are translated from the Chinese-language schedule and may differ from the clause headings in the standards. The "Notes / limitations" column shows CMA coverage and any limitation stated in the scope. Clauses not listed are outside the CNAS scope. The IAS scope gives no edition years and does not map line by line onto these tables, so it is listed separately after them.
Table 1 Elbow crutches: ISO 11334-1:2007 and GB/T 19545.1-2012
| Item | Clause | Notes / limitations |
|---|---|---|
| Elbow support | 4.1 | Same clause number in both standards; no limitation stated |
| Handle | 4.2 | Same clause number in both standards; no limitation stated |
| Leg and tip | 4.3 | Same clause number in both standards; no limitation stated |
| Adjustment device | 4.4 | Same clause number in both standards; no limitation stated |
| Materials | 4.5 | Same clause number in both standards; no limitation stated |
| Mechanical strength | 4.6 | Same clause number in both standards; no limitation stated |
Neither standard is in the Hefei CMA scope.
Table 2 Axillary crutches: GB/T 19545.2-2009
| Item | Clause | Notes / limitations |
|---|---|---|
| Structural dimensions | 5.1 | Listed in CNAS and CMA; no limitation stated |
| Underarm support and handle | 5.2 | Listed in CNAS and CMA; no limitation stated |
| Tip | 5.3 | Listed in CNAS and CMA; no limitation stated |
| Assembly and adjustment | 5.4 | Listed in CNAS and CMA; no limitation stated |
| Appearance | 5.5 | Listed in CNAS and CMA; no limitation stated |
| Mechanical strength | 5.6 | Listed in CNAS and CMA; no limitation stated |
Table 3 Walking sticks with three or more legs: GB/T 19545.4-2008
| Item | Clause | Notes / limitations |
|---|---|---|
| Handgrip | 4.1 | Listed in CNAS and CMA; no limitation stated |
| Legs and tips | 4.2 | Listed in CNAS and CMA; no limitation stated |
| Adjustment device | 4.3 | Listed in CNAS and CMA; no limitation stated |
| Materials | 4.4 | CNAS and CMA both state "not tested: biocompatibility" |
| Finished product | 4.5 | Listed in CNAS and CMA; no limitation stated |
| Stability | 4.6 | Listed in CNAS and CMA; no limitation stated |
| Mechanical strength and durability | 4.7 | Listed in CNAS and CMA; no limitation stated |
Table 4 Walking sticks with three or more legs: ISO 11334-4:2024
| Item | Clause | Notes / limitations |
|---|---|---|
| User mass / maximum load | 6.2 | CNAS; no limitation stated |
| Handle | 6.3.1 | CNAS; no limitation stated |
| Adjustment mechanism | 6.3.2 | CNAS; no limitation stated |
| Legs and tips | 6.3.3 | CNAS; no limitation stated |
| Distance from the stick legs to the ground, for sticks used outdoors | 6.3.4 | CNAS; no limitation stated |
| Distance of the shaft from the user | 6.3.5 | CNAS; no limitation stated |
| Infection and microbiological contamination | 7.3 | CNAS; no limitation stated |
| Corrosion resistance | 7.4 | CNAS; no limitation stated |
| Temperature of parts in contact with the body | 8 | CNAS; no limitation stated |
| Prevention of trapping of body parts | 9 | CNAS; no limitation stated |
| Surfaces, corners and edges | 10 | CNAS; no limitation stated |
| Static stability | 11 | CNAS; no limitation stated |
| Static strength | 12 | CNAS; no limitation stated |
| Durability | 13 | CNAS; no limitation stated |
| Information supplied by the manufacturer | 14 | CNAS; no limitation stated |
ISO 11334-4:2024 is not in the Hefei CMA scope, and CNAS accreditation covers only the clauses listed above.
IAS accreditation scope (TL-1119)
The Hefei IAS scope lists crutch and walking stick standards differently from CNAS and CMA: it gives the standard number only, with no edition year and no item-by-item list. The standard numbers and limitations as listed are:
- GB/T 19545.1: no exclusion stated
- GB/T 19545.2: no exclusion stated
- GB/T 19545.4: except for 4.4 Materials
- ISO 11334-1: no exclusion stated
- ISO 11334-4: except for 4.4 Materials
The IAS scope does not state which edition applies, so it should not be read as matching the CNAS and CMA editions in Tables 1 to 4 one for one. If you need an IAS report, confirm the standard edition and applicable clauses with us before ordering.
Materials and biocompatibility
Clause 4.4 (Materials) of GB/T 19545.4-2008 is marked "not tested: biocompatibility" in the CNAS and CMA scopes. The IAS scope lists GB/T 19545.4 and ISO 11334-4 "except for 4.4 Materials", which excludes that clause as a whole, not just its biocompatibility part. Whatever the standard, if the client needs biological tests on materials (cytotoxicity, sensitization, irritation and so on), SUNGO subcontracts them to a laboratory with the appropriate qualifications. Under accreditation rules, the client's consent is obtained in advance, and the report identifies the subcontracted items and the subcontractor.
Where the testing is done and under which accreditation
Crutch and walking stick testing takes place at the Hefei laboratory in Zipeng Town, Feixi County, Hefei, Anhui Province. The legal entity is Hefei SUNGO Medical Technology Co., Ltd., an independent company rather than a branch of the Shanghai company. Its certificates are CNAS L24279, CMA 260015342945 and IAS TL-1119.
Shanghai SUNGO Medical Technology Co., Ltd. (laboratory at 958 Kangqiao East Road, Pudong, Shanghai; CNAS L22083, CMA 240015340087, IAS TL-1019) is a separate legal entity, and its scope does not include crutch or walking stick standards.
| Standard (edition listed by CNAS and CMA) | CNAS L24279 | CMA 260015342945 |
|---|---|---|
| ISO 11334-1:2007 | 6 items in Table 1 | Not covered |
| GB/T 19545.1-2012 | 6 items in Table 1 | Not covered |
| GB/T 19545.2-2009 | 6 items in Table 2 | 6 items in Table 2 |
| GB/T 19545.4-2008 | 7 items in Table 3 (4.4: biocompatibility not tested) | 7 items in Table 3 (4.4: biocompatibility not tested) |
| ISO 11334-4:2024 | 15 items in Table 4 | Not covered |
The IAS TL-1119 scope gives no edition years and is not listed by edition; see "IAS accreditation scope" above.
Three things to keep in mind when choosing the report type:
- The CMA mark can be used only for items in the CMA schedule, and the certificate states that it is valid within the People's Republic of China. ISO 11334-1, ISO 11334-4 and GB/T 19545.1 are not in the Hefei CMA scope.
- The CNAS certificate states that CNAS is a signatory to the ILAC and APAC mutual recognition arrangements, and the IAS certificate carries the ilac-MRA mark. Whether a particular overseas regulator or buyer accepts a given report is for that regulator or buyer to decide.
- The accreditation mark a report can carry depends on whether the chosen standard, edition and clauses are within that certificate's scope. Clauses outside the scope cannot be reported under the accreditation.
Preparing samples and documents
- Model list: list every model to be tested and explain how they differ in materials, construction, height adjustment range and number of legs, so that representative samples can be agreed.
- Maximum user mass: the requirements and tests in ISO 11334-1 and ISO 11334-4 are based on the maximum user mass specified by the manufacturer. Make sure the value is the same on the label, in the instructions for use and in the technical file.
- Configuration: ISO 11334-1 addresses elbow crutches fully equipped with handgrip and tip, so samples should be complete. ISO 11334-4 tests sticks without accessories unless the particular test procedure says otherwise. List any optional accessories separately.
- Instructions for use and labels: both ISO standards set requirements for information supplied by the manufacturer, including marking and labelling, and clause 14 of ISO 11334-4:2024 in the scope is "Information supplied by the manufacturer". Provide instructions and label artwork that match the marketed product.
- Intended environment: if the product is claimed for outdoor use, say so when ordering. Clause 6.3.4 of ISO 11334-4:2024 in the scope concerns the distance from the stick legs to the ground for sticks used outdoors.
- Sample condition: samples should match the production or submitted configuration, with the main materials and surface finishes stated. The number of samples depends on the standards and items chosen and is confirmed at the quotation stage.
- Standard edition and report type: state the target market, the specified standard and edition (for example GB/T 19545.4-2008 or ISO 11334-4:2024, and which edition of GB/T 19545.2), and whether a CNAS, CMA or IAS report is needed.
- Biological testing: if biocompatibility tests on materials are needed, raise this when ordering so that the subcontracting arrangement can be agreed in advance.
Frequently asked questions
Which parts of ISO 11334 can SUNGO test?
SUNGO's scope contains only Part 1 (elbow crutches) and Part 4 (walking sticks with three or more legs) of ISO 11334. The CNAS scope lists them as ISO 11334-1:2007 and ISO 11334-4:2024, and both are tested at the Hefei laboratory. For axillary crutches, the scope contains only the Chinese national standard GB/T 19545.2.
Which standard applies to axillary crutches?
The scope covers axillary crutches through the Chinese national standard only: CNAS and CMA list GB/T 19545.2-2009, and the IAS scope lists GB/T 19545.2 without an edition year. The 2009 edition was withdrawn on 2026-08-01 and fully replaced by GB/T 19545.2-2026. The new edition is not among the editions listed in the CNAS and CMA scopes, so confirm the edition you need before ordering.
Are GB/T 19545.4-2008 and ISO 11334-4:2024 interchangeable?
No. GB/T 19545.4-2008 is an identical adoption of ISO 11334-4:1999, while ISO 11334-4:2024 is the second edition that replaced the 1999 version, and their clause numbers in the scope differ. Which one to use depends on the target market or the standard and edition the customer specifies.
Can crutch testing be reported with the CMA mark?
Only GB/T 19545.2-2009 (axillary crutches) and GB/T 19545.4-2008 (walking sticks with three or more legs) are in the Hefei CMA scope. ISO 11334-1, ISO 11334-4 and GB/T 19545.1 are not, and the CMA certificate is valid only within China.
How is biocompatibility of crutch materials handled?
Biological testing of crutch materials is outside SUNGO's accredited scope: clause 4.4 of GB/T 19545.4-2008 is marked "not tested: biocompatibility" in CNAS and CMA, and the IAS scope lists both GB/T 19545.4 and ISO 11334-4 "except for 4.4 Materials". When needed, SUNGO subcontracts the tests to a laboratory with the appropriate qualifications, with the client's prior consent, and the report identifies the subcontracted items and the subcontractor.
Requesting a quote
For crutch or walking stick testing, see the wheelchair and walking aid testing service page, then send your model list, target market, specified standards and editions, and the report type you need through the contact page. We will confirm which report types the Hefei laboratory's scope supports and which items would need to be subcontracted.