If you handle registration, quality, R&D or sourcing for single-use venous blood collection containers (usually called blood collection tubes, evacuated or non-evacuated), this article answers four questions: what YY/T 0314-2021 and ISO 6710:2017 cover and how they relate; which test items and clauses SUNGO's accreditation scopes include; whether the report can carry the CNAS or the CMA mark; and what to prepare before shipping samples. Anything about SUNGO's capability is taken from the scope schedules attached to our certificates. Standard titles, editions and scopes come from China's national standards information platform (std.samr.gov.cn), the National Library of Standards (ndls.org.cn) and the ISO website; the US section is based on the FDA Recognized Consensus Standards database.
Key points
- Where: the Shanghai laboratory. Reports are issued by Shanghai SUNGO Medical Technology Co., Ltd.; the laboratory is at No. 958 Kangqiao East Road, Pudong New Area, Shanghai.
- Which items: under YY/T 0314-2021 and ISO 6710:2017 the scope lists five items: materials (4.1, 4.3), draw volume (clause 5, Annex A, Annex B), design (clause 6), construction (clause 7), and marking and labelling (clause 10).
- Which accreditation: all five items appear in both the Shanghai CNAS scope (L22083) and the Shanghai CMA scope (240015340087), for both standards. ISO 6710:2017 is an international standard, yet it is also on the Shanghai CMA schedule.
- No IAS: the Shanghai IAS scope (TL-1019) does not include either standard, so no IAS report is issued for these items.
- Edition: the scope lists YY/T 0314-2021 only. The 2021 edition took effect on 2022-09-01 and fully replaces YY/T 0314-2007.
- Out of scope: clauses not listed in the scope, additive content testing (the YY/T 1416 series), capillary blood collection containers (YY/T 0617-2021) and venous blood collection needles (YY/T 1618-2018) are not covered by SUNGO's certificates.
The standards and what they apply to
YY/T 0314-2021, Single-use containers for human venous blood specimen collection
YY/T 0314-2021 is a recommended (non-mandatory) Chinese pharmaceutical industry standard. The competent authority is the National Medical Products Administration (NMPA), and the responsible committee is SAC/TC 106, the national technical committee for medical infusion devices. According to the national standards information platform, it was published on 2021-09-06, took effect on 2022-09-01, fully replaces YY/T 0314-2007, and is listed as current.
Scope: the standard specifies requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers and applies to both types. It does not cover requirements for collection needles or needle holders, and it does not apply to blood culture bottles or to "arterial" blood gas collection devices that can be used for venous blood.
ISO 6710:2017, Single-use containers for human venous blood specimen collection
ISO 6710:2017 belongs to ISO/TC 76. It is the second edition, published in July 2017, and replaces ISO 6710:1995, which has been withdrawn. The ISO website states that this edition was last reviewed and confirmed in 2023 and therefore remains current.
Its scope is essentially the same as that of YY/T 0314-2021: requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers, with no requirements for blood collection needles, needle holders, blood culture receptacles, or "arterial" blood gas collection devices that can be used for venous blood.
How the two standards relate, and which one goes on the report
The two standards share the same English title and essentially the same scope. SUNGO's CNAS schedule lists identical items and identical clause numbers for both (see the table below). Whether YY/T 0314-2021 adopts ISO 6710:2017 identically or with modifications is not something this article decides; the foreword of YY/T 0314-2021 is the authority on that point.
The client chooses the test basis. For a report used in a Chinese submission, order the test against the standard and edition named in your product technical requirements. For export, or for an audit by an overseas customer, follow the standard named by the target market or by the customer's documents. If you need both standards, list both on the same test request; each item is then checked against the scope.
Neighbouring products and methods have their own standards, outside SUNGO's scope
Based on the scope statements of the two standards and the related standards listed on the national standards information platform, the products and methods below have their own standards, and none of those standards is on SUNGO's certificates:
- Venous blood collection needles: covered by YY/T 1618-2018, Single-use needles for human venous blood specimen collection.
- Capillary blood collection containers: covered by YY/T 0617-2021, Single-use containers for human capillary blood specimen collection, which states that it does not apply to venous blood specimen containers.
- Blood culture bottles and arterial blood gas collection devices that can be used for venous blood: explicitly excluded by the scopes of both YY/T 0314-2021 and ISO 6710:2017.
- Measurement of additive content in the container: covered by the separate YY/T 1416 test-method series. The parts listed on the platform cover EDTA salts, sodium citrate, heparin, fluoride, glycine and imidazolidinyl urea.
One thing to check if you export to the United States
A search of the FDA Recognized Consensus Standards database for the title keyword "venous" on 22 October 2026 did not return ISO 6710:2017. It did return CLSI GP39-A6, Tubes and Additives for Venous Blood Specimen Collection, recognition number 7-221, recognized as a complete standard; the page lists 21 CFR 862.1675 and product codes GIM and JKA (Class II) as examples, noting that others may apply. CLSI GP39 is not in SUNGO's scope. How an ISO 6710 report can be used in a US submission depends on FDA requirements and your own submission strategy.
Test items
The table below is taken from the Shanghai CNAS schedule (test object: single-use containers for human venous blood specimen collection) and the Shanghai CMA schedule. Item names are translated from the Chinese schedule and clause numbers are copied as listed. Neither schedule records a limitation for these items.
| Item | Clause | Notes / limitations |
|---|---|---|
| Materials | YY/T 0314-2021 4.1, 4.3; ISO 6710:2017 4.1, 4.3 | Listed under both CNAS and CMA; no limitation recorded. Only 4.1 and 4.3 of clause 4 are listed; clauses not listed are outside the scope |
| Draw volume | YY/T 0314-2021 clause 5, Annex A, Annex B; ISO 6710:2017 clause 5, Annex A, Annex B | Listed under both CNAS and CMA; no limitation recorded |
| Design | YY/T 0314-2021 clause 6; ISO 6710:2017 clause 6 | Listed under both CNAS and CMA; no limitation recorded |
| Construction | YY/T 0314-2021 clause 7; ISO 6710:2017 clause 7 | Listed under both CNAS and CMA; no limitation recorded |
| Marking and labelling | YY/T 0314-2021 clause 10; ISO 6710:2017 clause 10 | Listed under both CNAS and CMA; no limitation recorded |
Three notes on reading the table:
- Clause numbers come from the CNAS schedule. The CMA schedule lists only the standard titles and numbers, without clause numbers; its item names match the CNAS schedule.
- The scope is limited to the clauses in the table. For materials, only 4.1 and 4.3 are listed. Any other clause of either standard that the schedules do not list is outside the accredited scope.
- The effective date of these items is 2026-03-09 on the CNAS schedule and 2026-02-14 on the CMA schedule.
If your product technical requirements or your customer's checklist include items beyond this table, send the standard and clause numbers with your enquiry and we will check them against the scope one by one. Any item outside the scope will be identified as such when we check your list. If your submission also involves biological tests, that work is subcontracted by SUNGO to a laboratory with the relevant qualifications; under accreditation rules, subcontracting requires the client's prior consent, and the report identifies the subcontracted items and the subcontractor.
Where the testing is done and under which accreditation
- Site: the Shanghai laboratory, No. 958 Kangqiao East Road, Pudong New Area, Shanghai.
- Legal entity issuing the report: Shanghai SUNGO Medical Technology Co., Ltd. SUNGO also operates Hefei SUNGO Medical Technology Co., Ltd.; the two companies are separate legal entities. The certificates of the Hefei laboratory (Zipeng Town, Feixi County, Hefei) do not include these two standards, so these samples are tested in Shanghai.
- CNAS (L22083): all five items in the table, for both standards, are within the accredited scope. The CNAS certificate states that CNAS is a signatory to the ILAC and APAC mutual recognition arrangements.
- CMA (240015340087): all five items in the table, for both standards, are on the CMA schedule. CMA covers only the items on its schedule, and the certificate states that it is valid within the People's Republic of China.
- IAS (TL-1019): the Shanghai IAS scope does not include YY/T 0314 or ISO 6710, so no IAS report is issued for these items.
Choosing the mark: for a report used in China, confirm that every item you need is on the CMA schedule. CMA is valid only within China, so for use outside China you can ask for the CNAS mark. Whether a particular overseas regulator or customer accepts the report is for that regulator or customer to decide. Within one report, an accreditation mark applies only to the items on the corresponding schedule.
Preparing your samples
The points below are general; the details follow the items confirmed at the quotation stage.
- Test basis and purpose: state YY/T 0314-2021, ISO 6710:2017 or both, and list the items and clauses you need. Say what the report is for (Chinese submission, export, customer audit) and whether you need the CNAS or the CMA mark.
- Model and specification list: for each model submitted, give the name, specification (nominal volume), evacuated or non-evacuated, type of additive, and how the cap or label identifies the tube.
- Configuration description: the components (tube, stopper, cap and so on) and their materials; if the tube contains additives, separator gel or other contents, name them.
- Instructions for use, labels and packaging marks: marking and labelling is checked item by item, so provide the versions that match the samples.
- Product technical requirements: for a report used in a Chinese submission, include them so the cited editions and clauses can be checked.
- Sample condition: preferably from a single lot, in intact packaging and within the expiry date. State the lot number, manufacturing date, whether the samples are sterilized, and the storage conditions; keep them as the instructions require during shipping.
- Accessories: if the tests need blood collection needles, needle holders or other accessories, agree at the quotation stage who supplies them and which model is used.
- Client details: the client name, manufacturer name and address, product name and model should match your registration file or customer documents; the report uses the details on the test request.
- Sample quantity: depends on the standard and items chosen; we give it clause by clause at the quotation stage.
Frequently asked questions
How does YY/T 0314-2021 relate to ISO 6710:2017?
They share the same English title, both apply to evacuated and non-evacuated single-use venous blood specimen containers, and both exclude needles, needle holders, blood culture bottles and arterial blood gas devices. SUNGO's scope lists the same items and clause numbers for both; the degree of adoption is stated in the foreword of YY/T 0314-2021.
Which accreditation marks can SUNGO's blood collection tube report carry?
The report is issued by Shanghai SUNGO Medical Technology Co., Ltd. Under YY/T 0314-2021 and ISO 6710:2017, five items are within the Shanghai CNAS (L22083) and CMA (240015340087) scopes: materials, draw volume, design, construction, and marking and labelling; the CNAS schedule lists clauses 4.1 and 4.3, clause 5 with Annexes A and B, and clauses 6, 7 and 10, and no other clause is in scope. The Shanghai IAS scope (TL-1019) does not include either standard, so no IAS report is issued.
Can you still test to YY/T 0314-2007?
SUNGO's scope lists YY/T 0314-2021 only. The 2021 edition has applied since 2022-09-01 and fully replaces the 2007 edition, so testing to the 2007 edition is outside the scope.
Can you measure EDTA, sodium citrate, heparin or other additive content?
Additive content is measured under the separate YY/T 1416 test-method series, and that series is not in SUNGO's scope.
Can capillary blood tubes or blood collection needles be tested together with the venous tubes?
Capillary blood specimen containers fall under YY/T 0617-2021 and venous blood collection needles under YY/T 1618-2018. Neither standard is in SUNGO's scope.
Requesting a quotation
To have blood collection tubes tested to YY/T 0314-2021 or ISO 6710:2017, see our other medical device testing service, then use the contact page to send your model and specification list, the standards and items you need, and what the report is for. We first confirm the scope item by item against the Shanghai CNAS and CMA schedules, then reply with a quotation and sample requirements.