DIN EN ISO 8537:2025-12
Sterile single-use syringes, with or without needle, for insulin (ISO/DIS 8537:2025); German and English version prEN ISO 8537:2025 / Note: Date of issue 2025-11-14*Intended as replacement for DIN EN ISO 8537 (2016-11).
| Fecha edición: |
2025-12-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | ISO 8537:2016 specifies requirements and test methods for empty, sterile, single-use syringes, with or without needles, made of plastic materials and intended solely for the injection of insulin, with which the syringes are filled by the end user. This International Standard covers syringes intended for single-use only in humans and with insulins of various concentrations. The insulin syringes specified in this International Standard are intended for use (i.e. insulin injection) immediately after filling and are not intended to contain insulin for extended periods of time. ISO 8537:2016 excludes single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes that are pre-filled by the manufacturer, and syringes intended to be stored after filling (e. g. in a kit intended for filling by a pharmacist). |
| Keywords: | Cannulas|Cylinders|Definitions|Disposable|Disposables|Equipment for single use|Flasks|Hypodermic needles|Injection instruments|Injection syringes|Injections|Insulin|Limits (mathematics)|Marking|Medical devices|Medical equipment|Medical instruments|Medical products|Medical sciences|Medical technology|Packages|Scales|Single use syringes|Specification|Specification (approval)|Sterile|Sterile equipment|Sterilization (birth control)|Syringes|Testing |
| ICS: | 11.040.25 - Jeringuillas, agujas y catéteres |
| CTN: |
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