ISO 21649-2023 PDF

Full title and description

ST ISO 21649-2023 — Needle-free injection systems for medical use — Requirements and test methods. This international standard specifies safety, performance and testing requirements for single‑use and multiple‑use needle‑free injection systems (NFIS) intended for human medical use in clinical settings and for personal use by patients. It covers the design, performance characteristics and test methods needed to demonstrate compliance with claimed safety and performance requirements.

Abstract

ISO 21649:2023 (Edition 2) defines requirements and test methods for needle‑free injection systems (NFIS) including devices with disposable or permanent dose chambers (often called cartridges, ampoules, syringes, capsules or discs). The standard addresses dose accuracy, delivery performance, safety (including cross‑contamination control), mechanical and functional durability, and relevant labeling and information for users. It also lists exclusions, for example devices that penetrate skin (needles, micro‑needles), devices that generate aerosols for inhalation, topical deposition devices (patches), and devices that apply sonic/electromagnetic energy or are infusion systems that rely on catheters/needles entering the body.

General information

• Status: Published (active)
• Publication date: 24 January 2023
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.040.20 (Transfusion, infusion and injection equipment)
• Edition / version: Edition 2 (2023)
• Number of pages: 36

Scope

This standard applies to safety, performance and testing of needle‑free injection systems intended for human medical use, including both single‑use and multiple‑use devices and their dose chambers (disposable or permanent). It specifies test methods to assess dose delivery, accuracy, leakage, backflow, durability, microbiological safety and aspects of user information and labeling. Exclusions include devices that physically penetrate skin or mucous membranes (needles, micro‑needles, implantable devices), devices that deliver substances by inhalation or nasal/oral deposition, transdermal patches, devices using sonic or electromagnetic delivery methods, and infusion systems that rely on catheters or needles entering the body.

Key topics and requirements

• Definitions and classification of NFIS types (single‑use, multiple‑use, dose chamber variations).
• Performance requirements: dose volume accuracy, repeatability and delivery velocity.
• Safety requirements: prevention of cross‑contamination, containment of biological material, mechanical safety features.
• Design and construction: materials, compatibility with intended medicinal products, sealing and integrity of dose chambers.
• Test methods: bench tests for dose accuracy, leak testing, durability/cycling, sterility/bioburden considerations, and device‑specific functional tests.
• Labeling and packaging requirements: user instructions, safe use, contraindications, disposal or reprocessing instructions for reusable parts.
• Risk management and documentation: demonstration of conformity, validation of cleaning/reprocessing (if applicable), and clinical/performance evidence where required.

Typical use and users

Manufacturers and designers of needle‑free injection systems use this standard to design, test and demonstrate conformity of devices. Notified bodies, regulatory authorities and conformity assessment laboratories rely on it for premarket evaluation and testing. Hospitals, clinics, healthcare procurement teams and quality/sterility testing laboratories reference the standard when selecting, validating or auditing NFIS products and associated processes.

Related standards

Commonly referenced and related standards include ISO 13485 (medical device quality management systems), ISO 14971 (risk management for medical devices), ISO 10993 series (biocompatibility), applicable national adaptations (EN/ISO harmonized versions), and earlier edition ISO 21649:2006 (withdrawn and replaced by the 2023 edition). Other device‑specific or general medical device standards may apply depending on device features and region.

Keywords

needle‑free injection system, NFIS, needleless injector, dose chamber, cartridge, requirements, test methods, performance, safety, ISO 21649, medical device

FAQ

Q: What is this standard?

A: ISO 21649:2023 is an international standard that sets out safety, performance and test method requirements for needle‑free injection systems intended for human medical use.

Q: What does it cover?

A: It covers definitions, performance requirements (dose accuracy, delivery performance), safety and cross‑contamination controls, design and materials considerations, and specific laboratory test methods to demonstrate compliance. It excludes needle‑penetrating devices, inhalation or topical delivery devices, and certain infusion/catheter systems.

Q: Who typically uses it?

A: Device manufacturers, regulatory bodies, conformity assessment and test laboratories, healthcare procurement teams and clinical engineers use the standard to design, assess, certify and procure NFIS devices.

Q: Is it current or superseded?

A: ISO 21649:2023 (published 24 January 2023) is the current edition and replaces the earlier ISO 21649:2006 edition. The 2023 edition is active as of 28 February 2026.

Q: Is it part of a series?

A: It belongs to the body of ISO standards for medical devices under ICS 11.040.20 and is associated with broader medical device quality and safety standards (for example ISO 13485, ISO 14971 and ISO 10993 series). Regional/adapted versions (EN/ISO or national adoptions) may exist.

Q: What are the key keywords?

A: Needle‑free injection system, NFIS, needleless injector, dose chamber, cartridge, requirements, test methods, performance, safety, biocompatibility.