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What is the self-destruct performance of medical devices? For injection products designed as self-destruct, the self-destruct performance should be verified
.
The effective time of self-destruct performance can vary depending on the design, mainly in the following cases: (1) from the beginning of the injection, the self-destruct characteristic automatically takes effect and remains effective; (2) When the conveying process, the self-destruction characteristic automatically takes effect and remains valid; (3) When the predetermined fixed dose is delivered, the self-destruction characteristic automatically takes effect
.
In all cases, once the self-destruct feature is in effect, syringes and needles cannot be reused
.
What are the instruments to test the self-destruct performance of syringes? General disposable sterile syringe self-destruct performance testing instrument: HT0573-C prevents reuse of the thrust tester
.
Test Standard: YY/T 0573.
4-2020 Disposable sterile syringe Part 4: Prevent reuse of syringe
.
Self-destruct fixed-dose vaccine syringe self-destruct performance testing instrument: ZS0573-C self-destruct characteristic self-locking force tester, YL0573-C self-destruct characteristic pressure tester, test standard: YY/T 0573.
3-2019 Disposable sterile syringe Part 3: self-destruct fixed-dose vaccine syringe
。 Safety syringe self-destruct performance testing instruments: AZC-C safety syringe self-destruct test removal tester, AZBY-C safety syringe self-destruction test back pressure test, AKZ-C safety syringe anti-needle force tester, in line with ISO7886-4 standard appendix B.
1 requirements
.