YY/T 1768.1-2021 Translated English of Chinese Standard (YY/T 1768.1-2021, YYT1768.1-2021): Needle-based injection systems for medical use -- Requirements and test methods -- Part 1: Needle-based injection systems [Buy--download True-PDF in 3-second: https://play.google.com/books > Sign in > This BOOK > "3-dots" > Export > Save as "*.pdf"]This Part of YY/T 1768 specifies the requirements and test methods for needle-based injection systems. This Part applies to needle-based injection systems intended for use with needles and containers, such as pen injectors. The containers described in this Part include single-dose, multi-dose syringe systems and cartridge systems filled by the manufacturer or end user. This Part does not apply to needleless syringes. This Part does not address requirements and related methods for filling containers and appliances by the end user. |
Contents
| 4 | |
Annex A normative Test instruments | 26 |
Annex B normative Test method for dose accuracy Annex C normative Visual inspection and container inspection Annex D informative Dose combi... | 39 |
Annex F informative Illustration Annex G normative Unilateral and bilateral tolerance factor k Bibliography | 41 |
Common terms and phrases
adjustable dose syringes applicable Not applicable B1 and D1 Bilateral classified as B1 confidence level container is completely Damp heat deliverable volume designed distraction-free dose accuracy limits dose combination dose delivered dose delivery efficiency dose setting Dry heat easily find Electromagnetic compatibility electronic Electrostatic discharge evaluate final dose accuracy final dose error fixed dose Free fall test Gauge R&R given Vset humidity Kactual lower limit manufacturer manufacturer-filled medical devices milliliters minimum deliverable dose minimum dose Needle syringe Needle-based injection systems NISs number of measurements Pretreatment Probability component radio frequency relative error Requirements and test residual volume risk assessment risk management sample specific test standard conditions standard deviation statistical tolerance interval systems classified systems for medical Table G.1 continued target k value technical specification temperature test methods tolerance coefficient Unilateral user can easily user packaging verify visual inspection Vmax Vmid Vmin Vset is equal YY/T