YY/T 0907-2013
Needle-free injectors for medical use.Requirements and test methods (English Version)

Standard No.

YY/T 0907-2013

Language

Chinese, Available in English version

Release Date

2013

Published By

Professional Standard - Medicine

Status

Be replaced 2024-07

Replace By

YY/T 0907-2023

Latest

YY/T 0907-2023

Scope

This standard applies to the safety, performance and testing requirements for single- or multiple-use needleless syringes for personal use by patients in clinical and related healthcare settings. The dosing chamber of a syringe is usually disposable and is replaced after a single use or a limited number of uses. Sometimes it is separate from the injection mechanism and is often referred to as a "cartridge", "ampule", "syringe", "capsule" or "disc". Conversely, the dose chamber can also be a permanent lumen whose performance remains effective during the expiry date. What does not apply to this standard is the method of drug administration: 　——puncture of a part of the needle-free injection device itself into or through the skin or mucous membrane (such as needles, tips, microneedles, implantable slow-release drug devices) ; 　——Produces aerosols, droplets, powders or other forms for inhalation, blowing, nasal or oral deposition (such as sprays, inhalers, microdevices); 　——Deposits on skin or mucous membrane surfaces, liquids, powders or other Substances passively diffused or ingested by the body (such as transdermal absorption patches, droplets); 　——Applied to acoustic energy or electromagnetic energy (such as ultrasound or iontophoresis devices); 　——Applied to accumulation or measurement into or through artificial A drug infusion system with tubing, catheters, and/or needles that themselves enter the body.

YY/T 0907-2013 Referenced Document

• GB 9706.1-2007 Medical electrical equipment.Part 1:General requirements for safety
• GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
• GB/T 16886.10 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization*， 2017-12-29 Update
• GB/T 16886.11 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity*， 2021-11-26 Update
• GB/T 16886.12 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials*， 2023-11-27 Update
• GB/T 16886.13 Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices*， 2017-12-29 Update
• GB/T 16886.14 Biological evaluation of medical devices--Part 14: Identification and quantification of degradation products from ceramics
• GB/T 16886.15 Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys*， 2022-12-30 Update
• GB/T 16886.16 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables*， 2021-11-26 Update
• GB/T 16886.17 Biological evaluation of medical devices.Part 17:Establishment of allowable limits for leachable substances
• GB/T 16886.18 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process*， 2022-12-30 Update
• GB/T 16886.19 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials*， 2022-12-30 Update
• GB/T 16886.2 Biological evaluation of medical devices.Part 2: Animal welfare requirements
• GB/T 16886.20 Biological evaluation of medical devices.Part 20:Principles and methods for immunotoxicology testing of medical devices*， 2015-12-10 Update
• GB/T 16886.3 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity*， 2019-06-04 Update
• GB/T 16886.4 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood*， 2022-04-15 Update
• GB/T 16886.5 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests*， 2018-07-01 Update
• GB/T 16886.6 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation*， 2022-04-15 Update
• GB/T 16886.7 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals*， 2015-12-10 Update
• GB/T 16886.9 Biological Evaluation of Medical Devices Part 9: Qualitative and Quantitative Framework for Potential Degradation Products*， 2022-12-30 Update
• GB/T 17248.2-1999 Acoustics--Noise emitted by machinery and equipment--Measurement of emission sound pressure levels at a work station and at other specified positions--Engineering method in an essentially free field over a reflecting plane
• GB/T 17248.3-1999 Acoustics--Noise emitted by machinery and equipment--Measurement of emission sound pressure levels at a work station and at other specified positions--Survey method in situ
• GB/T 17248.5-1999 Acoustics--Noise emitted by machinery and equipment--Measurement of emission sound pressure levels at a work station and at other specified positions--Method requiring environmental corrections
• GB/T 17626.1 Electromagnetic compatibility Testing and measurement techniques Overview of immunity test
• GB/T 17626.10 Electromagnetic compatibility—Testing and measurement techniques—Damped oscillatory magnetic field immunity test*， 2017-12-29 Update
• GB/T 17626.11 Electromagnetic Compatibility Testing and Measurement Techniques Part 11: Voltage Dips, Short Interruptions and Voltage Variation Immunity Tests for Equipment with Input Current Less than or Equal to 16 A per Phase*， 2023-05-23 Update
• GB/T 17626.12 Electromagnetic Compatibility Testing and Measurement Techniques Part 12: Ringing Wave Immunity Test*， 2023-03-17 Update
• GB/T 17626.13 Electromagnetic compatibility Testing and measurement techniques Harmonics and interharmonics including mains signalling at a.c. power port, low frequency immunity test
• GB/T 17626.14 Electromagnetic compatibility Testing and measurement techniques Voltage fluctuation immunity test
• GB/T 17626.15 Electromagnetic compatibility.Testing and measurement techniques .Flickermeter.Functional and design specifications
• GB/T 17626.16 Electromagnetic compatibility Testing and measurement techniques Test for immunity to conducted, common mode disturbances in the frequency range 0 Hz to 150 kHz
• GB/T 17626.17 Electromagnetic compatibility Testing and measurement techniques Ripple on d.c.input power port immunity test
• GB/T 17626.18 Electromagnetic compatibility—Testing and measurement techniques—Damped oscillatory wave immunity test*， 2016-12-13 Update
• GB/T 17626.19 Electromagnetic compatibility—Testing and measurement techniques—Part 19: Test for immunity to conducted, differential mode disturbances and signalling in the frequency range 2 kHz to 150 kHz at a.c.*， 2022-12-30 Update
• GB/T 17626.2 Electromagnetic compatibility.Testing and measurement techniques.Electrostatic discharge immunity test*， 2018-06-07 Update
• GB/T 17626.2-2006 Electromagnetic compatibility Testing and measurement techniques Electrostatic discharge immunity test
• GB/T 17626.20 Electromagnetic compatibility.Testing and measurement techniques.Emission and immunity testing in transverse electromagnetic (TEM) waveguide*， 2014-12-22 Update
• GB/T 17626.21 Electromagnetic compatibility.Testing and measurement techniques.Reverberation chamber test methods*， 2014-12-22 Update
• GB/T 17626.22 Electromagnetic compatibility (EMC)—Testing and measurement techniques—Radiated emissions and immunity measurements in fully anechoic rooms（FARs）*， 2017-12-29 Update
• GB/T 17626.24 Electromagnetic compatibility.Testing and measurement techniques.Test methods for protective devices for HEMP conducted disturbance
• GB/T 17626.27 Electromagnetic compatibility Testing and measurement techniques Unbalance immunity test
• GB/T 17626.28 Electromagnetic compatibility Testing and measurement techniques Variation of power frequency, immunity test
• GB/T 17626.29 Electromagnetic compatibility Testing and measurement techniques Voltage dips， short interruptions and voltage variations on d.c.input power port immunity tests
• GB/T 17626.3 Electromagnetic compatibility test and measurement technology Part 3: Radio frequency electromagnetic field radiation immunity test*， 2023-12-28 Update
• GB/T 17626.30 Electromagnetic compatibility test and measurement technology Part 30: Power quality measurement methods*， 2023-12-28 Update
• GB/T 17626.31 Electromagnetic compatibility—Testing and measurement techniques—Part 31：AC mains ports broadband conducted disturbance immunity test*， 2021-12-31 Update
• GB/T 17626.34 Electromagnetic compatibility.Testing and measurement techniques.Voltage dips,short interruptions and voltage variations immunity tests for equipment with mains current more than 16A per phase
• GB/T 17626.4 Electromagnetic compatibility－Testing and measurement techniques－Electrical fast transient/burst immunity test*， 2018-06-07 Update
• GB/T 17626.5 Electromagnetic compatibility—Testing and measurement techniques－Surge immunity test*， 2019-06-04 Update
• GB/T 17626.6 Electromagnetic compatibility—Testing and measurement techniques—Immunity to conducted disturbances,induced by radio-frequency fields*， 2017-12-29 Update
• GB/T 17626.7 Electromagnetic compatibility—Testing and measurement techniques—General guide on harmonics and interharmonics measurements and instrumentation, for power supply systems and equipment connected thereto*， 2017-07-12 Update
• GB/T 17626.8 Electromagnetic compatibility Testing and measurement techniques Power frequency magnetic field immunity test
• GB/T 17626.9 Electromagnetic compatibility. Testing and measurement techniques. Pulse magnetic field immunity test
• GB/T 18779.1-2002 Geometrical product specifications (GPS)-Inspection by measurement of workpieces and measuring equipment--Part 1:Decision rules for proving conformance or non-conformance with specifications
• GB/T 2423.4-2008 Environmental testing for electrical and electronic products - Part 2: Test method Test Db alternating damp heat (12h + 12h cycle)
• GB/T 2423.5-1995 Environmental testing for electric and electronic products. Part 2: Test methods. Test Ea and guidance: Shock
• GB/T 2423.56-2006 Environmental testing for electric and electronic products-Part 2:Test methods-Test Fh:Vibration,broad-band random(digital control) and guidance
• GB/T 2423.8-1995 Environmental testing for electric and electronic products. Parts 2: Test methods. Test Ed: Free fall
• GB/T 3768-1996 Acoustics--Determination of sound power levels of noise sources using sound pressure--Survey method using an enveloping measurement surface over a reflecting plane
• GB/T 4798.7-2007 Environmental conditions existing in the application of electric and electronic products.Part 7: Portable and non-stationary use
• ISO 3207:1975 Statistical interpretation of data; Determination of a statistical tolerance interval

YY/T 0907-2013 history

• 2024 YY/T 0907-2023 Requirements and test methods for medical needle-free syringes
• 2013 YY/T 0907-2013 Needle-free injectors for medical use.Requirements and test methods