ISO 7864 is the core international standard governing sterile hypodermic needles for single use. It defines both performance requirements and verified test methods to ensure safety, consistency, and functionality in clinical use. From a quality and regulatory perspective, ISO 7864 connects product design, material selection, and mechanical performance through objective testing.
For manufacturers, medical device laboratories, and inspection agencies, ISO 7864 provides a structured framework to evaluate needle strength, penetration behavior, bonding reliability, and fluid delivery performance. These parameters directly affect user safety, patient comfort, and compliance with global regulatory expectations.
Within hypodermic needle testing, ISO 7864 emphasizes mechanical integrity and functional performance. The standard addresses how a needle penetrates tissue-like substrates, how securely it bonds to the hub, and how effectively it delivers fluids. Each test targets a specific risk associated with needle use, such as excessive insertion pain, detachment from the hub, or restricted flow.
Testing according to ISO 7864 ensures that hypodermic needles perform consistently across batches and manufacturing sites, which is especially important for high-volume disposable medical devices.
One of the most critical procedures described in ISO 7864 is the needle penetration test. This method measures the force required for a needle to enter a standardized substrate at a constant speed. The resulting force–displacement curve provides two key indicators:
최대 침투력, representing the maximum resistance during initial entry
드래그 힘, reflecting friction as the needle continues through the substrate
Controlled measurement of 침투력 helps manufacturers optimize needle geometry, tip sharpness, and surface finish. Excessive penetration force may increase patient discomfort, while insufficient force consistency may indicate variability in grinding or polishing processes.
A dedicated Strength Tester equipped with a high-resolution load cell ensures reliable force measurement and repeatable results. Modern systems allow precise speed control and continuous force recording, which supports both development and routine quality control.
그리고 fragmentation test for medical needles focuses on structural safety. During insertion and withdrawal, a needle must remain intact without shedding fragments that could remain in tissue. ISO 7864 includes requirements to verify that the needle maintains its integrity under defined mechanical conditions.
This test supports risk reduction in clinical use and confirms that material quality, heat treatment, and manufacturing processes meet the expected safety threshold. Fragmentation results also provide valuable feedback during supplier qualification and process validation.
Needle Bond strength represents the mechanical connection between the needle tube and the hub. ISO 7864 specifies a tensile test method to confirm that this bond withstands defined loads without separation or failure.
Using a calibrated tensile Strength Tester, the needle is pulled axially at a controlled speed until separation occurs or a maximum force is reached. The recorded value reflects the bonding strength and indicates whether the selected adhesive or bonding process is suitable for the needle size and application.
Reliable needle bond performance is essential for preventing accidental detachment during injection, which could cause serious safety incidents.
이 기기는 시린지에 제어된 진공을 정밀하게 적용하여 압력 변화와 플런저 무결성을 정확하게 모니터링할 수 있습니다. ISO 80369-7 호환 연결부와 안전한 클램핑 메커니즘으로 설계된 SLT-01은 기밀성과 플런저 스토퍼 고정력을 모두 철저히 평가할 수 있습니다.
고정밀 기계 시스템을 활용하여 유체 배출 중 브레이크 풀림과 활공력을 측정합니다. MST-01을 통해 제조업체는 시작 및 이동 저항을 정량화하여 안전하고 편안한 플런저 동작에 중요한 부드럽고 일관된 플런저 동작을 보장하는 데 필수적인 데이터를 제공할 수 있습니다.
이 장치는 플런저에 횡방향 및 축방향 하중을 가하면서 주사기 배럴 내부의 압력을 시뮬레이션하여 임상 사용 조건을 면밀히 재현합니다. SSPT-01은 미세한 밀봉 결함까지 감지하도록 설계되어 제조업체가 제품의 신뢰성과 엄격한 안전 표준 준수 여부를 검증할 수 있도록 지원합니다.
In addition to mechanical strength, ISO 7864 addresses functional performance through the flow rate through the needle test. This evaluation confirms that the internal lumen allows fluids to pass at an expected rate under defined conditions.
Flow rate results relate closely to inner diameter consistency, surface finish, and cleanliness. A stable and predictable flow rate ensures accurate dosing and smooth injection, particularly in applications involving viscous pharmaceutical formulations.
To meet ISO 7864 efficiently, laboratories increasingly rely on integrated testing platforms. A modern Needle Penetration and Drag Force Tester from 셀 기기 combines penetration force measurement, drag force analysis, and flexible fixture design in a single system. Such solutions support standardized testing while allowing customization for specific needle types or customer requirements.
Automation options further improve repeatability, reduce operator influence, and support high-throughput testing environments. These advantages align well with ISO 7864 objectives and modern quality management systems.
ISO 7864 establishes a comprehensive technical foundation for evaluating sterile hypodermic needles. Through structured hypodermic needle testing, including needle penetration test procedures, penetration force analysis, Needle Bond strength verification, fragmentation test for medical needles, and flow rate through the needle test, manufacturers can ensure safety, performance, and regulatory compliance.
By adopting advanced testing solutions such as the 셀 기기 Needle Penetration and Drag Force Tester, organizations can improve data reliability, streamline quality control, and confidently meet ISO 7864 requirements across the full product lifecycle.
KO 
EN 
AR 
BG 
CS 
DA 
DE 
EL 
ES 
ET 
FI 
FR 
HU 
ID 
IT 
JA 
LT 
LV 
NB 
NL 
PL 
PT 
RO 
RU 
SK 
SL 
SV 
TR 
UK