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Walking Aid Testing to ISO 11199-1/-2/-3 and GB/T 14728: Items and Scope

Walking Aid Testing to ISO 11199-1/-2/-3 and GB/T 14728: Items and Scope

Before you test a walking frame, a rollator or a walking table, three questions need answers: which part of ISO 11199 (or its Chinese counterpart, GB/T 14728) applies, which edition to test against, and which accreditation can appear on the report. This guide answers all three using the current CNAS, CMA and IAS scopes of SUNGO's Hefei laboratory. It lists every accredited test item by clause for all three parts, flags the clauses that fall outside the scope and explains how they are handled, and ends with a checklist of what to prepare before you ship samples.

Key points

  • Walking aid testing is carried out by Hefei SUNGO Medical Technology Co., Ltd. (the Hefei laboratory). The accreditation scopes of Shanghai SUNGO Medical Technology Co., Ltd. do not include any walking aid standard.
  • GB/T 14728.1-2024 and ISO 11199-1:2021 (walking frames), GB/T 14728.2-2024 and ISO 11199-2:2021/Amd 1:2024 (rollators), and GB/T 14728.3-2008 and ISO 11199-3:2005 (walking tables) are all within the Hefei laboratory's CNAS scope (L24279). All three parts, in both their ISO and GB/T forms, are also within its IAS scope (TL-1119), except clause 7.3 in Parts 1 and 2 and the whole of clause 4.9 (materials and finish) in Part 3.
  • CMA (260015342945) covers GB/T 14728.3-2008 only. It does not cover Parts 1 and 2 of GB/T 14728, and it does not cover any part of ISO 11199.
  • The biocompatibility clauses of the walking aid standards are outside SUNGO's accreditation scope: clause 7.3 of Parts 1 and 2 (biocompatibility and toxicity), and the biocompatibility content of clause 4.9 in Part 3. Where it is needed, SUNGO subcontracts the work to a laboratory with the appropriate qualifications. Under accreditation rules, the client's consent is obtained before subcontracting, and the report identifies the subcontracted items and the subcontractor.
  • Each GB/T part is an identical adoption of the corresponding ISO part (for Part 2, the Chinese platform lists ISO 11199-2:2021 with no amendment), and in the Hefei CNAS scope the two list exactly the same items and clause numbers. Even so, state the edition you need when you place the order, especially for rollators, where an ISO amendment exists.

Standards and scope

Which part covers which product

PartISO standardChinese national standardProduct type
Part 1ISO 11199-1:2021GB/T 14728.1-2024Walking frames
Part 2ISO 11199-2:2021, amended by ISO 11199-2:2021/Amd 1:2024GB/T 14728.2-2024Rollators
Part 3ISO 11199-3:2005GB/T 14728.3-2008Walking tables

The ISO abstracts describe each part's scope as follows (summarized here; the text of the standard governs):

  • ISO 11199-1:2021 specifies requirements and test methods for walking frames manipulated by both arms, tested without accessories unless the particular test procedure says otherwise. It also sets requirements for safety, ergonomics, performance and information supplied by the manufacturer, including marking and labelling.
  • ISO 11199-2:2021 does the same for rollators, that is, wheeled walking aids manipulated by both arms, again without accessories unless a test procedure specifies them. Its abstract states that it does not apply to rollators with horizontal forearm supports; those are classified as walking tables, and ISO 11199-3 applies.
  • ISO 11199-3:2005 specifies requirements and test methods for the static stability, braking capabilities, static strength and fatigue of walking tables, plus requirements for safety, ergonomics, performance, marking, labelling and information supplied by the manufacturer. It covers walking tables with three or more wheels or tips in contact with the walking surface and with arm supports in the form of a horizontal supporting table or two horizontal forearm supports.

In all three parts, the requirements and tests are based on everyday use as a walking aid, up to the maximum user mass specified by the manufacturer, and the ISO abstracts state that the standards cover products specified for a user mass of not less than 35 kg. Settle the maximum user mass and put it in your documentation before testing starts.

A common classification trap

A wheeled walker with forearm rests looks like a rollator. If the forearm supports are horizontal, however, the scope statement in ISO 11199-2:2021 places it among walking tables, so Part 3 applies. For other designs that sit between categories, rely on the terms and definitions in the standard itself. Getting the part wrong changes the whole item list: in the Hefei CNAS schedule, Parts 1 and 2 run from clause 6.2 to clause 20, while Part 3 sits entirely in clauses 4.1 to 4.10. A report against one part cannot stand in for another.

Editions and the GB/T–ISO relationship

According to China's National Public Service Platform for Standards Information:

  • GB/T 14728.1-2024 (Part 1: Walking frames) was published on 2024-09-29 and took effect on 2025-10-01. It fully replaces GB/T 14728.1-2006 and is an identical adoption of ISO 11199-1:2021.
  • GB/T 14728.2-2024 (Part 2: Rollators) has the same publication and effective dates. It fully replaces GB/T 14728.2-2008 and is an identical adoption of ISO 11199-2:2021.
  • GB/T 14728.3-2008 (Part 3: Walking tables) was published on 2008-12-31 and took effect on 2009-09-01. Its most recent review, on 2025-09-05, concluded that it remains valid. It is an identical adoption of ISO 11199-3:2005.

All three are recommended national standards (the "/T" in GB/T), under national technical committee TC148. On the ISO side, ISO 11199-1:2021 is the second edition (May 2021) and ISO 11199-2:2021 is the third edition (July 2021). With the 2021 editions, the title changed from "Walking aids manipulated by both arms" to "Assistive products for walking manipulated by both arms". ISO 11199-3 is still the first edition of 2005, which the ISO website shows as confirmed after review.

Rollators need a closer look. In November 2024, ISO published ISO 11199-2:2021/Amd 1:2024, titled "Removal of brake requirements". The Hefei laboratory's CNAS scope lists the ISO edition as ISO 11199-2:2021/Amd 1:2024, while the Chinese standards platform shows GB/T 14728.2-2024 as an identical adoption of ISO 11199-2:2021. Refer to the ISO text for exactly what the amendment changes. If you want testing to ISO 11199-2:2021 without the amendment, note that this edition is not the one listed in the CNAS scope; confirm at the quotation stage which accreditation the report can carry. State on your application whether the report should follow the ISO edition or the GB/T edition.

Test items (from the Hefei laboratory's accreditation scope)

The three tables below follow the CNAS scope schedule of Hefei SUNGO Medical Technology Co., Ltd. (L24279). In that schedule, the GB/T standard and the ISO standard for each part list identical items and clause numbers, so each part has a single table. The schedule is written in Chinese; the item names below are English translations, so refer to the standard for the official clause titles. The "Notes / limitations" column gives the limitation stated in the CNAS schedule, with CMA and IAS added for clause 4.9 in Part 3; "—" means the CNAS schedule states no limitation for that row.

Walking frames: GB/T 14728.1-2024 and ISO 11199-1:2021

Accreditation: both standards are within the CNAS scope (the schedule does not list 7.3); IAS covers GB/T 14728.1 and ISO 11199-1 except clause 7.3; neither is within the CMA scope.

ItemClauseNotes / limitations
Dismountable walking frames6.2—
Fasteners6.3—
User mass / maximum load6.4—
Structural requirements6.5—
Brakes6.6—
Hand grips6.7—
Legs and tips6.8—
Flammability7.2—
Infection and microbiological contamination7.4—
Resistance to corrosion7.5—
Ingress of liquids8—
Temperature of parts in contact with the human body9—
Safety of moving parts10—
Prevention of traps for parts of the human body11—
Folding, adjusting and locking mechanisms12—
Lifting and carrying handles13—
Surfaces, corners and edges14—
Static stability15—
Static strength16—
Durability17—
Ergonomic principles18—
Packaging19—
Information supplied by the manufacturer20—

Rollators: GB/T 14728.2-2024 and ISO 11199-2:2021/Amd 1:2024

Accreditation: both standards are within the CNAS scope (the schedule does not list 7.3); IAS covers GB/T 14728.2 and ISO 11199-2 except clause 7.3; neither is within the CMA scope. Compared with walking frames, the rollator schedule has no "legs and tips" item, and its clause 13 item is "carrying handles".

ItemClauseNotes / limitations
Dismountable rollators6.2—
Fasteners6.3—
User mass / maximum load6.4—
Structural requirements6.5—
Brakes6.6—
Hand grips6.7—
Flammability7.2—
Infection and microbiological contamination7.4—
Resistance to corrosion7.5—
Ingress of liquids8—
Temperature of parts in contact with the human body9—
Safety of moving parts10—
Prevention of traps for parts of the human body11—
Folding, adjusting and locking mechanisms12—
Carrying handles13—
Surfaces, corners and edges14—
Static stability15—
Static strength16—
Durability17—
Ergonomic principles18—
Packaging19—
Information supplied by the manufacturer20—

Walking tables: GB/T 14728.3-2008 and ISO 11199-3:2005

Accreditation: both standards are within the CNAS scope. CMA covers GB/T 14728.3-2008 only; its schedule lists the same 10 items by name (the CMA schedule does not give clause numbers), with the same "biocompatibility not tested" limitation on materials and finish. IAS covers GB/T 14728.3 and ISO 11199-3 except the whole of clause 4.9.

ItemClauseNotes / limitations
Stability4.1—
Braking devices4.2—
Mechanical durability4.3—
Wheels4.4—
Hand grips4.5—
Legs and tips4.6—
Adjustment devices4.7—
Seat4.8—
Materials and finish4.9CNAS: biocompatibility not tested (certificate text: 不测:生物相容性); CMA, for GB/T 14728.3-2008 only: same limitation; IAS: whole clause excluded (except for 4.9 Materials and finish)
Marking and labelling4.10—

What falls outside the scope

  • Clause 7.3 in Parts 1 and 2. Under clause 7, the CNAS schedule lists only 7.2, 7.4 and 7.5, not 7.3. The IAS scope states "except for 7.3 Biocompatibility and toxicity" for ISO 11199-1 and ISO 11199-2, and "except for 7.3" for GB/T 14728.1 and GB/T 14728.2.
  • Clause 4.9 in Part 3. CNAS and CMA cover 4.9 (materials and finish) with the limitation that biocompatibility is not tested. IAS excludes clause 4.9 entirely for ISO 11199-3 and GB/T 14728.3. In practice, the non-biocompatibility content of 4.9 can appear on a CNAS report (and, for the GB/T edition, a CMA report), but not on an IAS report.
  • Clauses not listed in the schedule. CNAS accreditation covers the items and clauses listed in the schedule. Clauses that are not listed are not CNAS-accredited items.

If you need data for clause 7.3 (biocompatibility and toxicity) or for the biocompatibility content of clause 4.9, SUNGO subcontracts the work to a laboratory with the appropriate qualifications. Under accreditation rules, the client's consent is obtained before subcontracting, and the report identifies the subcontracted items and the subcontractor.

Where the testing is done and under which accreditation

Walking aid testing takes place at Hefei SUNGO Medical Technology Co., Ltd., whose laboratory is in Zipeng Town, Feixi County, Hefei, Anhui Province, China. The Hefei company is an independent legal entity, not a branch of the Shanghai company, and it holds the following accreditations:

  • CNAS laboratory accreditation: L24279
  • CMA (China's qualification for inspection and testing bodies): 260015342945
  • IAS accreditation: TL-1119
StandardCNAS (L24279)CMA (260015342945)IAS (TL-1119)
GB/T 14728.1-2024In scope (schedule does not list 7.3)Not in scopeGB/T 14728.1, except 7.3
ISO 11199-1:2021In scope (schedule does not list 7.3)Not in scopeISO 11199-1, except 7.3
GB/T 14728.2-2024In scope (schedule does not list 7.3)Not in scopeGB/T 14728.2, except 7.3
ISO 11199-2:2021/Amd 1:2024In scope (schedule does not list 7.3)Not in scopeISO 11199-2, except 7.3
GB/T 14728.3-2008In scope (4.9: biocompatibility not tested)In scope (materials and finish: biocompatibility not tested)GB/T 14728.3, except 4.9
ISO 11199-3:2005In scope (4.9: biocompatibility not tested)Not in scopeISO 11199-3, except 4.9

Three things to keep in mind when choosing the report type:

  • The CMA mark can only be used for items in the CMA schedule, and the CMA certificate states that it is valid within the People's Republic of China. Of the three walking aid parts, only GB/T 14728.3-2008 can be reported under CMA.
  • The CNAS certificate states that CNAS is a member of 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 accreditation is something to confirm with them in advance.
  • The IAS scope lists standard numbers without years. Specify the edition you need when you place the order.

The accreditation scopes of Shanghai SUNGO Medical Technology Co., Ltd. (CNAS L22083, CMA 240015340087, IAS TL-1019; laboratory at 958 Kangqiao East Road, Pudong, Shanghai) do not include ISO 11199 or GB/T 14728. Please send walking aid samples to the Hefei laboratory.

Preparing your samples and documents

  1. Product category. State whether the product is a walking frame, a rollator or a walking table, with photos or a structural drawing. For products with forearm supports, describe the type of support.
  2. Model and size list. List every model and size to be covered and explain how they differ in dimensions, materials, construction and wheel or tip type. Include the maximum user mass specified by the manufacturer.
  3. Configuration. Tests are generally run without accessories unless a particular test procedure says otherwise. List standard and optional accessories (for example a seat, basket or tray) and state the configuration of the samples you send.
  4. Instructions for use and labels. "Information supplied by the manufacturer" (clause 20 in Parts 1 and 2) and "marking and labelling" (clause 4.10 in Part 3) are test items in their own right. Provide the instructions, labels and nameplates you intend to put on the market, in the language of the target market.
  5. Packaging. Clause 19, "packaging", is a test item in Parts 1 and 2, so ideally ship samples in their sales packaging.
  6. Sample condition. Send production units, or units equivalent to production, complete and unmodified. Folding and adjustable parts should work normally; state the adjustment ranges. The number of samples and the test sequence follow the standard and the test plan, and are confirmed at the quotation stage.
  7. Edition and report type. State whether you need the GB/T or the ISO standard, the exact edition and the accreditation you need on the report (CNAS, CMA or IAS). For rollators, the ISO edition listed in the Hefei CNAS scope is ISO 11199-2:2021/Amd 1:2024. ISO 11199-2:2021 without the amendment is not a listed CNAS edition, so confirm at the quotation stage which accreditation the report can carry.
  8. Biocompatibility. If you need clause 7.3 (biocompatibility and toxicity) or the biocompatibility content of clause 4.9, provide a list of the materials in parts that contact the user, and the subcontracting arrangement will be confirmed separately.

FAQ

Which standard applies to walking frames, rollators and walking tables?

Walking frames fall under ISO 11199-1 / GB/T 14728.1, rollators under ISO 11199-2 / GB/T 14728.2, and walking tables under ISO 11199-3 / GB/T 14728.3. According to the scope of ISO 11199-2:2021, a rollator with horizontal forearm supports is classified as a walking table, so Part 3 applies.

How does GB/T 14728 relate to ISO 11199?

According to China's National Public Service Platform for Standards Information, GB/T 14728.1-2024 and GB/T 14728.2-2024 are identical adoptions of ISO 11199-1:2021 and ISO 11199-2:2021, and GB/T 14728.3-2008 is an identical adoption of ISO 11199-3:2005. In the Hefei laboratory's CNAS scope, each GB/T part and its ISO counterpart list the same items and clauses.

Can a walking aid test report carry the CMA mark?

Only GB/T 14728.3-2008 (walking tables) is within the Hefei laboratory's CMA scope. GB/T 14728.1-2024, GB/T 14728.2-2024 and the ISO 11199 series are not; they can be reported under CNAS or IAS, each within its own scope.

Does SUNGO perform biocompatibility testing for walking aids?

The biocompatibility clauses of the walking aid standards are outside SUNGO's accreditation scope: clause 7.3 of Parts 1 and 2 (biocompatibility and toxicity), and the biocompatibility content of clause 4.9 in Part 3. Where needed, SUNGO subcontracts the work to a laboratory with the appropriate qualifications; under accreditation rules, the client's consent is obtained before subcontracting, and the report identifies the subcontracted items and the subcontractor.

Can the Shanghai laboratory test walking aids?

No. The accreditation scopes of Shanghai SUNGO Medical Technology Co., Ltd. do not include ISO 11199 or GB/T 14728; walking aid testing is handled by Hefei SUNGO Medical Technology Co., Ltd.

Requesting a quote

When you ask for a quote, please include the product type (walking frame, rollator or walking table), the model list, the manufacturer's maximum user mass, the standard edition and accreditation you need, and whether you need biocompatibility. Our service overview is on the wheelchair and walking aid testing page, and you can send your request through the contact page.