EN ISO 21649:2023 PDF
Needle-free injection systems for medical use - Requirements and test methods (ISO 21649:2023)
Needle-free injection systems for medical use - Requirements and test methods (ISO 21649:2023)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 46
- Дата публикации:
- 8 февраля 2023 г.
- Издание:
- CEN EN 21649 edition 2 version 1
- ICS:
- 11.040.20
This document applies to safety and performance and testing requirements for single-use and multiple-use Needle-Free Injection Systems (NFISs) intended for human use in clinics and other medical settings and for personal use by patients. The dose chamber of the NFIS is often disposable and intended to be replaced after either a single use or a limited number of uses. It is sometimes separable from the injection mechanism and often termed a “cartridge”, “ampoule”, “syringe”, “capsule” or “disc”. In contrast, the dose chamber can also incorporate a permanent internal chamber designed to last through the claimed life of the device, and an additional member or members which eliminate the risk of cross-contamination. Excluded from this document are drug delivery methods which: — involve penetration of a part of the device itself into or through skin or mucous membranes (such as needles, tines, micro-needles, implantable slow-release drug devices); — generate aerosols, droplets, powders or other formulations for inhalation, insufflation, intranasal or oral deposition (such as sprays, inhalers, misters); — deposit liquids, powders, or other substances on the surface of skin or mucosal surfaces for passive diffusion or ingestion into the body (such as transdermal patches, liquid drops); — apply sonic or electromagnetic energy (such as ultrasonic or iontophoretic devices); — infusion systems for adding or metering medication into or through systems of artificial tubes, catheters, and/or needles which themselves enter the body.
Abstract
Overview
EN ISO 21649:2023 (ISO 21649:2023) specifies requirements and test methods for needle-free injection systems (NFIS) intended for human medical use in clinics, other medical settings, and for personal patient use. It covers both single‑use and multiple‑use NFISs, including devices with disposable dose chambers (cartridges, ampoules, capsules, discs) and devices with permanent internal chambers designed to avoid cross‑contamination. The standard does not cover needle-based delivery, aerosol/inhalation devices, topical deposition (patches, drops), sonic/electromagnetic delivery, or infusion systems using catheters/needles.
Key Topics
The standard defines technical and usability requirements and lays out test methods across many functional areas:
- Performance and dose accuracy: requirements and statistical methods for verifying delivered dose and accuracy.
- Risk‑based approach: specifications and testing guided by risk analysis and uncertainty of measurement.
- Usability engineering: human factors and instructions for safe operation in clinical and personal settings.
- Environmental and lifecycle testing: preconditioning and tests for standard, hot/cold, dry/damp heat, cyclical atmospheres, transport, free‑fall, vibration and shock to simulate in‑use and storage conditions.
- Robustness and longevity: tests for claimed lifetime and repetitive use (important for multi‑use NFISs and mass vaccination scenarios).
- Safety features: requirements and test methods for auto‑disable / re‑use prevention and measures to eliminate cross‑contamination between patients.
- Electromagnetic compatibility (EMC) for NFISs with electrical components.
- Noise, water and dust resistance: tests to assess operational noise and ingress protection.
- Documentation: marking, instructions for use (IFU), labelling, and reporting of test results.
Applications
EN ISO 21649:2023 is used for:
- Manufacturers designing and verifying NFIS performance, safety, and compliance for market access.
- Test laboratories performing environmental, mechanical, EMC and dose‑accuracy testing according to standardized methods.
- Regulators and notified bodies assessing conformity and clinical safety for approval and post‑market surveillance.
- Procurement teams and healthcare providers specifying devices for clinics, immunization campaigns, and home use.
- Public health programs and mass vaccination planners who require devices with cross‑contamination prevention and durability in harsh environments.
Related Standards
- ISO 11608 series (requirements and testing approaches for needle‑based injection systems) - referenced for harmonized testing philosophy and statistical approaches.
- Prepared by ISO/TC 84 (Devices for administration of medicinal products and catheters) and adopted by CEN as EN ISO 21649:2023.
Keywords: needle-free injection systems, NFIS, ISO 21649, EN ISO 21649:2023, test methods, dose accuracy, auto‑disable, water and dust resistance, EMC, medical devices.
Технические детали
- Технический комитет
- CEN/SS S03 - Syringes
- SKU
- EN ISO 21649:2023
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