YY/T 1756-2021Dentistry—Reprocessable cartridge syringes for intraligamentary injections (English PDF)
牙科学 可重复使用牙周膜注射架
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 9, 2021
Implementation date
April 1, 2022
Scope
YY/T 1756-2021 is the English-translated version of 牙科学 可重复使用牙周膜注射架.
YY/T 1756-2021 is the Chinese pharmaceutical industry standard for reprocessable cartridge syringes used for intraligamentary anaesthesia in dentistry, the injectors that deliver anaesthetic into the periodontal ligament.
It sets the requirements, the test methods, the instructions and the markings, covering the dose delivered at each actuation and its accuracy, the force needed to operate the syringe, the fit of the cartridge and of the needle with its metric thread, the materials and their corrosion resistance and the ability of the instrument to be cleaned and sterilized repeatedly.
Syringes with inch thread sizes may use it as a reference. Issued on 9 March 2021, it has applied since 1 April 2022.
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Document preview — YY/T 1756-2021
National Standard of the People's Republic of China
- Classification
- C 33
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard uses the redrafting method to amend and adopt ISO 21533:2018 "Dental Reusable Periodontal Injection Holder".
The technical differences between this standard and ISO 21533:2018 and the reasons are as follows.
---Regarding normative references, this standard has made adjustments with technical differences to adapt to my country's technical conditions and adjustments.
The situation is collectively reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows.
- Replace ISO 1942 (see Chapter 3) with GB/T 9937 modified to adopt international standards;
- Replace ISO 7885 (see 5.2) with YY/T 0587 modified to adopt international standards;
- Replace ISO 9997 with YY/T 0820 which is equivalent to the international standard (see 4.2.1, 4.3, 4.4).
--- Increased the index of the lateral displacement of the piston rod to improve the enforceability of this requirement (see 4.4).
--- The test method for the lateral displacement of the piston rod has been added to correspond to the requirements of 4.4 piston rod (see 5.5).
1 Scope
This standard specifies the requirements, test methods, instructions and markings for reusable oral anesthesia injection racks for periodontal ligament anesthesia.
This standard applies to oral anesthesia injection racks with metric thread sizes and only used for periodontal ligament injections. Each of the inch thread sizes This kind of injection rack (see Appendix A) can be used as a reference.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 9937 Dental Terminology (GB/T 9937-2020, ISO 1942:2009, MOD)
YY/T 0587 Sterile dental injection needles for single use (YY/T 0587-2018, ISO 7885:2010, MOD)
YY/T 0820 Dental barrel syringe (YY/T 0820-2010, ISO 9997:1999, IDT)
ISO 11499 Dental disposable oral anesthesia injection (Dentistry-Single-usecartridgesforlocalan- aesthetics)
3 Terms and definitions
The following terms and definitions defined in GB/T 9937 apply to this document.
3.1 Periodontal ligament injection
Anesthesia injection through the periodontal ligament.
3.2 Reusable periodontal ligament injection rack
It can be used repeatedly and used with oral anesthetics. It is an injection stand designed for periodontal ligament anesthesia injection.
3.3 Piston rod
A rigid part that provides thrust for the cylinder piston.
3.4 Lever
The part that transmits force to the piston rod.
3.5 Dosagewheel
Part of the injection rack, the injection dose can be controlled by the roller.
3.6 Dosage-wheeldesign
The injection rack of the piston rod is pushed through the dose wheel.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 9937.2-2008 — Dental vocabulary -- Part 2: Dental materials
GB/T 9937-2020 — Dentistry - Vocabulary
GB/T 9937.5-2008 — Dental vocabulary -- Part 5: Terms associated with testing
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YY/T 1756-2021
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