Описание на русском · Доступен перевод
GB18671-2009
Intravenous needles for single use
一次性使用静脉输液针
GB 18671-2009 — действующий обязательный национальный стандарт Китая: Intravenous needles for single use. Отрасль: Пищевая. Тема: Безопасность продукции. Дата вступления в силу: 1 мар. 2010 г..
Применимость зависит от продукции, схемы сертификации, уведомлений компетентных органов и переходных правил. Закажите перевод или проверьте источник, прежде чем использовать эту запись в решениях по соответствию.
Обзор требований
Этот обзор пока доступен только на английском языке.
Область применения
GB 18671-2009 applies to single-use intravenous needles with nominal outer diameters ranging from 0.36mm to 1.2mm, designed for use with gravity infusion sets, pressure infusion equipment, and blood transfusion sets. This standard is mandatory for all manufacturers of intravenous needles intended for the Chinese market. It also provides quality guidelines for materials used in these needles. Note that for needles supplied as配套 (matched) with infusion or transfusion sets, the sterility, packaging, and labeling requirements in certain chapters do not apply.
Технические требования
The standard specifies comprehensive physical requirements including color coding per YY/T 0296, particulate contamination limits, connection strength under axial tensile loads, leakage performance, and flow rate minimums at 20kPa pressure. Needle tube length tolerances and needle tip sharpness (free of burrs, hooks, and rough edges) are also defined. The connection hub must comply with GB/T 1962.1 or GB/T 1962.2 (Luer taper), and needles used with pressure infusion equipment must feature locking-type connectors. Compliance with all physical parameters is mandatory for market access. Chemical requirements cover reducing substances, metal ion limits (barium, chromium, copper, lead, and tin — per the 2023 amendment replacing cadmium with tin in the total content list), acidity/alkalinity, evaporation residue, and UV absorbance of test solutions. These ensure that no harmful substances leach from the needle materials into the fluid path. Biological requirements mandate biocompatibility evaluation per GB/T 16886.1, confirming non-toxicity. Needles must be sterile via a validated sterilization process, and bacterial endotoxin limits must not exceed 0.5 EU/mL. If ethylene oxide sterilization is used, the primary packaging must employ dialysis materials to allow gas dissipation.
Методы испытаний
Physical testing includes particulate contamination evaluation (flushing method per GB 8368), leakage testing (50kPa air pressure immersion), and flow rate measurement at 20kPa using a dedicated test apparatus. Chemical analysis follows methods in GB/T 14233.1-2008, covering titration for reducing substances, atomic absorption spectrophotometry (AAS) for metal ions, and UV spectrophotometry for absorbance. Biological testing references GB/T 14233.2 for sterility and bacterial endotoxin methods. Needle tip penetration performance can be optionally evaluated using a polyurethane membrane puncture test as described in the informative Annex D.
Частые вопросы
What products are regulated under GB 18671-2009?
GB 18671-2009 regulates single-use intravenous needles with nominal outer diameters from 0.36mm to 1.2mm, intended for use with gravity infusion sets, pressure infusion equipment, and blood transfusion sets. It covers both independently sold needles and those supplied as matched accessories with infusion or transfusion sets.
Are there any updates from the previous version of GB 18671-2009?
Yes. Compared to GB 18671-2002, the 2009 version expanded the scope to include needles for pressure infusion equipment, added the 0.36mm gauge size, made connection hub requirements mandatory, changed the acidity test method to titration, and removed ethylene oxide residual limits while requiring dialysis packaging materials for EO-sterilized products. Additionally, a 2023 amendment (effective June 1, 2025) changed the metal ion requirement from cadmium to tin in the total content list.
How does GB 18671-2009 relate to international standards?
The standard references several international standards, including ISO 594-1 and ISO 594-2 (via GB/T 1962.1 and 1962.2) for Luer connectors, ISO 9626 (via GB 18457) for stainless steel needle tubing, and ISO 6009 (via YY/T 0296) for color coding. However, GB 18671-2009 is a standalone mandatory Chinese national standard with its own specific test methods and limit values that may differ from ISO requirements.
The summary above provides a high-level overview of GB 18671-2009. To ensure complete compliance for your intravenous needle products entering the Chinese market, a precise and professional translation of the full technical specifications is essential. Purchase our high-quality English translation of GB 18671-2009 today to access all detailed parameters, tables, testing procedures, and the 2023 amendment content.
Подсказки по применимости
- Тип
- Продукция
- CCS
- C31
- ICS
- 11.040.20
- Компетентное ведомство
- National Medical Products Administration
- Технический комитет
- National Technical Committee on Medical Infusion Devices of Standardization Administration of China
Связи
Заменяет:GB 18671-2002