YY/T 0331-2024 Absorbent Cotton Gauze: What Changed from the 2006 Edition

YY/T 0331, the Chinese industry standard Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze, has a new edition: YY/T 0331-2024 replaces the 2006 edition in full and took effect on 1 March 2025. Regulatory, quality and sourcing teams generally need to settle three things: which test items changed, how to order testing when the product technical requirement still cites the 2006 edition, and which accreditation mark the report can carry. This article compares the two editions using the 2024 table of contents, foreword and introduction, then maps each item to the CNAS, CMA and IAS scopes of Shanghai SUNGO Medical Technology Co., Ltd.

Key points

• Edition and dates. YY/T 0331-2024 is a recommended (non-mandatory) pharmaceutical industry standard, published on 7 February 2024 and implemented on 1 March 2025. It replaces YY/T 0331-2006 in full. China's national standards information platform shows the 2006 edition as abolished on 1 March 2025.
• Seven main technical changes. The foreword lists a changed requirement for surface active substances; new requirements and test methods for ethylene oxide (EO) residue and bioburden; a new sterility requirement; changed test methods for extractable colouring matter and loss on drying; and new packaging and storage requirements.
• Four items were not deleted. Ether-soluble substances, water-soluble substances, loss on drying and sulphated ash are still in the 2024 edition (requirements 4.9, 4.11, 4.14, 4.15; test methods 5.10, 5.12, 5.15, 5.16). They are simply not among the 2024-edition rows in SUNGO's CNAS and CMA scopes.
• SUNGO Shanghai's coverage. CNAS (L22083) accredits 12 items of the 2024 edition, including Annex C bioburden, plus EO residue to GB/T 14233.1-2022 clause 9.4. The CMA schedule (240015340087) lists 11 items of the 2024 edition (no bioburden), EO residue to GB/T 14233.1-2022, and 15 items of the 2006 edition. IAS (TL-1019) lists YY/T 0331 as a whole standard with no edition year.
• Report marks depend on the edition. For the 2024 edition, the 11 physical and chemical items can carry the CNAS or CMA mark; bioburden is CNAS-accredited but cannot carry the CMA mark. For the 2006 edition, the CMA schedule lists 15 items. The IAS scope gives no edition year, so confirm the edition with the laboratory before any IAS report.

The standard and its scope

Sources: the standard's record on China's national standards information platform, the information table of NMPA Announcement No. 16 of 2024, and the public preview of the standard's cover, contents and foreword, all checked on 22 October 2026.

YY/T 0331-2024

• Status: recommended pharmaceutical industry standard (YY/T). The responsible authority is the National Medical Products Administration (NMPA); the technical owner is the Shandong Institute of Medical Device and Pharmaceutical Packaging Inspection.
• Dates: the cover gives 7 February 2024 (published) and 1 March 2025 (implemented), matching the platform record. NMPA issued it in Announcement No. 16 of 2024, signed on 7 February 2024, as a revision replacing YY/T 0331-2006.
• Scope: performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze. It does not apply to gauze whose yarn is made entirely of viscose fibre, or to gauze containing drugs.
• Definition: absorbent cotton gauze is a continuous woven fabric made from cotton yarn and then scoured, bleached or dyed, and purified.

YY/T 0331-2006

Published on 19 April 2006, implemented on 1 April 2007, replacing YY 0331-2002, and abolished on 1 March 2025. SUNGO's CMA schedule lists 15 items for it: the 11 physical and chemical items it also lists for 2024, plus ether-soluble substances, water-soluble substances, loss on drying and sulphated ash.

Documents referenced by the 2024 edition

Clause 2 lists GB/T 14233.1 (chemical analysis methods), GB/T 19633.1 (packaging for terminally sterilized medical devices, Part 1), GB/T 19973.1 (population of microorganisms on products), YY/T 0615.1 (requirements for medical devices to be designated "sterile", Part 1: requirements for terminally sterilized medical devices) and the Chinese Pharmacopoeia, 2020 edition, Volume II. Only the pharmacopoeia is dated; for undated references the latest edition applies, including all amendments.

The introduction adds that surgical gauze dressings made mainly from gauze meeting this standard are covered by YY 0594, General requirements for surgical gauze dressings. YY/T 0331 covers the gauze fabric; the finished dressing has its own standard.

What changed in 2024: the seven items in the foreword

Apart from editorial changes, the foreword lists these main technical changes from the 2006 edition.

Four items remain in the standard but not in the accredited rows

Compared with the 2006 edition in SUNGO's CMA schedule, the 2024-edition rows lack ether-soluble substances, water-soluble substances, loss on drying and sulphated ash. That does not mean the new edition dropped them: the 2024 table of contents still lists their requirements (4.9, 4.11, 4.14, 4.15) and test methods (5.10, 5.12, 5.15, 5.16), and the foreword lists no deletions. If your technical requirement includes them, confirm with the laboratory before ordering which type of report can be issued.

Three points in the introduction

• Whiteness is not specified. If a buyer needs it, the method and criteria can be agreed in the quality agreement. Whiteness is not among SUNGO's accredited rows for this standard.
• EO sterilization is not recommended. Gauze is supplied sterile or non-sterile. Because it is highly absorbent, EO taken up by the gauze can pose a high hazard to patients and medical staff, so the standard does not recommend EO sterilization.
• What bioburden data are for. For gauze supplied non-sterile, the manufacturer's bioburden data can serve as the basis for hospitals to set sterilization parameters.

The key test items

Thread count and mass per square metre

As the names suggest, thread count relates to the yarn density of the gauze and mass per square metre is the mass per unit area; for the exact definitions and counting method, refer to clauses 4.5 and 5.6 of the standard. The requirements are in 2024 clauses 4.5 and 4.6 and the test methods in 5.6 and 5.7. SUNGO's CNAS scope covers them at 2024 clauses 5.6 and 5.7, and the CMA schedule lists both for the 2024 and 2006 editions. Send any nominal values and tolerances from your technical requirement with the samples, so the report can give a verdict, not just measured values.

Minimum breaking force

As the name suggests, this item looks at the force the gauze withstands when pulled until it breaks, which relates to its resistance to tearing in use. The requirement is in 2024 clause 4.7 and the test method in 5.8; SUNGO's CNAS scope covers it at 2024 clause 5.8. Once gauze is made into a surgical gauze dressing, YY 0594-2006 has its own minimum breaking force clause (SUNGO's CNAS scope covers 5.4.3). State on the order whether you want the gauze or the finished dressing tested.

Sinking time

As the name suggests, sinking time looks at how long the gauze takes to sink once placed in water, as an indication of how quickly it absorbs. The requirement is in 2024 clause 4.8 and the test method in 5.9; SUNGO's CNAS scope covers it at 2024 clause 5.9, and the CMA schedule lists it for the 2024 and 2006 editions. Keep samples dry, free of oil and uncrushed during shipping and storage, so that absorbency results are not affected.

Bioburden: new, and not in the CMA schedule

The 2024 edition adds a bioburden requirement (4.17) and test method (5.18), with an informative Annex C, Bioburden test method, covering principle, apparatus and reagents, procedure, notes on the method, and test report. Clause 2 also references GB/T 19973.1. For the exact requirement in 4.17 and how 5.18, Annex C and GB/T 19973.1 fit together, refer to the standard text.

SUNGO Shanghai's CNAS scope covers bioburden to YY/T 0331-2024 Annex C. Bioburden is not in the CMA schedule, so it cannot be reported under the CMA mark. For an IAS report, confirm the edition with the laboratory first. See also our sterility and microbiology testing services; note that EO sterilization process validation is outside SUNGO's accreditation scope.

EO residue: the accredited row cites GB/T 14233.1-2022

The 2024 edition adds an EO residue requirement (4.16) and test method (5.17). Read with the introduction, which does not recommend EO sterilization of gauze, this item mainly concerns products that are in fact EO-sterilized; for the exact conditions and requirement in 4.16, refer to the standard text.

SUNGO Shanghai's accredited rows cite GB/T 14233.1-2022 rather than clause 5.17 of YY/T 0331-2024: clause 9.4 in the CNAS scope, and no clause in the CMA schedule. GB/T 14233.1-2022 was published on 12 October 2022, took effect on 1 November 2023, and replaces the 2008 edition in full; YY/T 0331-2024 references it without a date. SUNGO's IAS scope also lists GB/T 14233.1 (no edition year) clause 9, which the certificate describes as EO residue by gas chromatography ("EO residue-GC"). If you need this item, give the sterilization date on the order and send the samples sealed.

Other physical and chemical items

Fibre identification (5.2), acidity or alkalinity (5.3), foreign fibres (5.4), fluorescence (5.5), surface active substances (5.11), starch and dextrin (5.13) and extractable colouring matter (5.14) are in SUNGO's 2024-edition CNAS and CMA rows. Two normative annexes support these tests: Annex A, solutions for determining the colour of liquids, and Annex B, preparation of test solution S. As the surface active substances requirement and the extractable colouring matter method changed, take care when comparing new results with 2006-edition data.

Accreditation scope table

Each row comes from the CNAS (L22083) scope and CMA (240015340087) schedule of Shanghai SUNGO Medical Technology Co., Ltd. The test object in the CNAS scope is absorbent cotton gauze; in the CMA schedule it is gauze for the 2024 edition and absorbent cotton gauze for the 2006 edition. The CMA rows give no clause numbers, and the limitation field is blank in every original row.

The IAS scope (TL-1019) also lists YY/T 0331 as a whole standard (no edition year) and GB/T 14233.1 clause 9 (no edition year). Before an IAS report is issued to a particular edition, confirm the edition with the laboratory.

Where the testing is done and under which accreditation

Gauze items within SUNGO's accreditation scope are tested at Shanghai SUNGO Medical Technology Co., Ltd., No. 958 Kangqiao East Road, Pudong New Area, Shanghai. Hefei SUNGO Medical Technology Co., Ltd. is a separate legal entity whose certificates do not cover gauze. See our mask, glove, dressing and gauze testing services.

Testing to the 2024 edition

The 11 physical and chemical items for the 2024 edition can be reported under the CNAS or CMA mark. Bioburden (Annex C) is in the CNAS scope; it is not in the CMA schedule and cannot be reported under the CMA mark. EO residue is reported to GB/T 14233.1-2022. The CMA mark applies only to items in the CMA schedule, and the certificate states that it is valid within the People's Republic of China.

When the technical requirement still cites the 2006 edition

Article 30 of China's Provisions for Medical Device Registration and Filing requires testing for registration or filing to follow the product technical requirement, so the edition on your order should match it. SUNGO's CNAS scope does not include the 2006 edition. The CMA schedule lists 15 items of the 2006 edition, which can be reported under the CMA mark. For an IAS report to the 2006 edition, confirm with the laboratory in advance. The 2006 edition also has no EO residue, bioburden or sterility requirements; these were added in 2024.

IAS reports and overseas use

The IAS scope lists YY/T 0331 with no edition year, so confirm the edition with the laboratory before an IAS report to either the 2024 or the 2006 edition. 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 depends on that party's own requirements. For what each mark on a report shows and how to check it against a scope, see How to Check an Accreditation Scope and Read the Mark on a Report.

Biological tests

The YY/T 0331-2024 table of contents lists no biological tests. If registration needs tests such as cytotoxicity, sensitization or irritation, SUNGO subcontracts them to a laboratory with the relevant qualifications. Under the accreditation rules, the client's agreement is obtained in advance, and the report identifies the subcontracted items and the subcontractor.

Preparing your samples

• Standard and edition. Write YY/T 0331-2024 or YY/T 0331-2006 on the order with the clauses or items you need, and attach the product technical requirement.
• Fibre type. Absorbent cotton gauze or absorbent cotton and viscose gauze. The test object in the CNAS scope is absorbent cotton gauze; confirm with the laboratory before ordering whether cotton and viscose gauze can be reported within scope. All-viscose gauze and gauze containing drugs are outside the standard's scope.
• Supply condition and sterilization. Sterile or non-sterile supply. For EO-sterilized products, give the sterilization date and aeration conditions and keep samples sealed.
• Bioburden samples. Representative of normal production, in original unopened packaging, with the delivery date agreed in advance.
• Nominal values. Nominal values and tolerances from your technical requirement, so a verdict can be given.
• Report purpose. Domestic registration, export or buyer inspection, and whether you need the CNAS, CMA or IAS mark.
• Sample quantities. These differ by item; the laboratory will advise based on the standard and your item list.

FAQ

Did the 2024 edition delete ether-soluble substances, water-soluble substances, loss on drying and sulphated ash?

No. The 2024 table of contents still lists all four, and the loss-on-drying method was revised. They are just not among SUNGO's 2024-edition CNAS and CMA rows.

The 2006 edition is abolished. Can we still test to it?

Yes, if your technical requirement still cites it. SUNGO's CMA schedule lists 15 items of the 2006 edition (CMA mark, valid only within China); the CNAS scope does not include it. For an IAS report, confirm the edition first. Updating the technical requirement is for the registrant to assess.

Can bioburden be reported under the CMA mark?

No. Bioburden is not in SUNGO's CMA schedule, so it cannot be reported under the CMA mark; the CNAS scope covers it to YY/T 0331-2024 Annex C. For other report types, check with the laboratory before ordering.

How should the new sterility requirement be handled?

The 2024 edition adds sterility in 4.18, and no separate sterility test method appears in the clause 5 contents; for the exact requirement in 4.18 and how conformity is shown, refer to the standard text. Sterility is not among SUNGO's YY/T 0331-2024 rows; mention it in your enquiry and the laboratory will confirm.

Which standard should an export gauze report follow?

Start from the standard your target market or buyer asks for. For an IAS report to YY/T 0331, confirm the edition first.

When you request a quotation, give the standard and edition, the item list or technical requirement, the fibre type, the supply condition and sterilization method, and the report purpose and mark you need. Send these through our contact page, and the laboratory will reply item by item with the report types it can issue under its accreditation scope. Separate articles will cover YY/T 0330 medical absorbent cotton, YY 0594 surgical gauze dressings and EN 14079.