YY/T 1768.2-2021 Translated English of Chinese Standard (YY/T 1768.2-2021, YYT1768.2-2021): Needle-based injection systems for medical use -- Requirements and test methods -- Part 2: Needles [Buy--download True-PDF in 3-second: https://play.google.com/books > Sign in > This BOOK > "3-dots" > Export > Save as "*.pdf"]https://www.chinesestandard.net, 2022 M10 31 - 26 pages This Part of YY/T 1768 specifies the requirements and test methods for single-use double-ended sterile needles. This Part applies to needles used in conjunction with the needle-based injection system (NIS) of YY/T 1768.1. This Part does not apply to dental needles, prefilled injection needles, needles pre-assembled by the manufacturer, and needles that do not require assembly or connection to the NIS. |
Contents
| 4 | |
1 Scope | 5 |
3 Terms and definitions | 6 |
4 Material requirements | 7 |
6 Chemical requirements | 10 |
8 Packaging | 11 |
Annex A normative Standard atmosphere and test apparatus | 15 |
Annex B normative Pretreatment of needles | 17 |
Annex C normative Radial runout determination method at patient end measurement point | 18 |
Annex D normative Determination of the flow through the needle | 20 |
Annex E normative Method for determination of connection between needle seat and needle tube | 22 |
Annex F normative Test method for confirming the suitability of needles and injection systems | 23 |
Bibliography | 26 |
Common terms and phrases
according to Annex Annex E normative Annex F apparatus that complies apply assembly torque atmospheric environment Batch code batch number Biocompatibility biological evaluation cartridge end code or batch complies with A.1 connection between needle disassembly torque dose test double-ended sterile needle endotoxin evaluation procedure Expiration date Figure C.2 flow following information/content functionally compatible Gauge R&R least the following manufacturer mark measurement point Measurement uncertainty medical devices meet the requirements method specified milliliters needle assembly needle container needle is intended Needle seat removal needle tip needle tube Needle-based injection systems Nominal outer diameter NOTE production Put the needles Record the peak Requirements and test requirements of GB/T seat and needle seat removal torque Shanghai specified in A.2 specified in GB/T standard atmosphere specified standard deviation syringe systems for medical target dose test apparatus test chamber test fixture test needle tested according torque tester unit packaging user packaging x-axis