ISO 8537 Sterile single-use syringes, with or without needle, for insulin - Third Edition
Данный раздел/документ содержится в продуктах:
- Техэксперт: Машиностроительный комплекс
- Картотека зарубежных и международных стандартов
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- 59
- CEN EN 13855-1 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 1: Test method by rotation
- 59.040
- CEN EN 13855-1 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 1: Test method by rotation
- CEN EN 13855-2 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 2: Test method by oscillation
- 97
- CEN EN 13855-1 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 1: Test method by rotation
- 97.140
- CEN EN 13855-1 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 1: Test method by rotation
- CEN EN 13855-2 Manufactured articles solely filled with feathers and down - Measurement of thickness and compressibility of cushions - Part 2: Test method by oscillation
- CEI EN 61496-2 Safety of machinery - Electro-sensitive protective equipment Part 2: Particular requirements for equipment using active opto-electronic protective devices (AOPDs)
- ISO 16142-1 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non?IVD medical devices and guidance on the selection of standards - First Edition
- Картотека зарубежных и международных стандартов
International Organization for Standardization
Sterile single-use syringes, with or without needle, for insulin - Third Edition
N 8537
Annotation
This International Standard 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.
This International Standard excludes single-use syringes made of glass, syringes for use with powerdriven 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).
Автоматический перевод:
Стерильные сиринксы единственного использования, с или без иглы, для инсулина - Третий Выпуск
Этот Международный стандарт указывает требования и методы тестирования для пустого, стерильного, сиринксов единственного использования, с или без игл, сделанных из пластмассовых материалов и предназначенных только для инжекции инсулина, которым сиринксы заполнены конечным пользователем. Этот Международный стандарт покрывает сиринксы, предназначенные для единственного использования только в людях и с инсулинами различных концентраций.
