SIST EN ISO 7864:2016
Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 35
- Дата публикации:
- 18 октября 2016 г.
- ICS:
- 11.040.25
- Технический комитет:
- VAZ - Healthcare
ISO 7864:2016 specifies requirements for sterile hypodermic needles for single use of designated metric sizes 0,18 mm to 1,2 mm. It does not apply to those devices that are covered by their own standard such as dental needles and pen needles.
Abstract
Overview
specifies international requirements and test methods for sterile hypodermic needles intended for single use, covering metric sizes from 0.18 mm to 1.2 mm. This standard ensures that hypodermic needles used in medical and pharmaceutical settings meet strict quality, safety, and performance criteria. Notably, it does not apply to dental needles or pen needles, which are governed by separate standards. The document supports harmonized market access in compliance with EU Directives for medical devices, making it essential for manufacturers, healthcare providers, and regulatory bodies involved in the supply and use of hypodermic needles.
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