DIN EN ISO 21649 2010-01 PDF

Full title and description

STB DIN EN ISO 21649 2010-01 — Needle-free injectors for medical use — Requirements and test methods. This document is the German/EN adoption of ISO 21649 (original edition published 2006) as released in the 2010 EN/DIN catalog and covers safety, performance and test methods for single‑use and multiple‑use needle‑free injection systems (NFIS).

Abstract

This standard sets out requirements and laboratory test methods to assess the safety and performance of needle‑free injection systems intended for human medical use. It addresses system design (including dose chambers/cartridges), dose specification and accuracy, performance profiling, noise and measurement uncertainty, and the tests needed to demonstrate conformity with those requirements. The original ISO document (2006 edition) has since been revised and replaced by ISO 21649:2023; the 2010 national/EN adoption is therefore superseded.

General information

• Status: Superseded / withdrawn (DIN EN ISO 21649:2010-01 has been superseded by the 2023 edition).
• Publication date: January 2010 (designation DIN EN ISO 21649:2010-01 as the EN/DIN adoption).
• Publisher: Deutsches Institut für Normung (DIN) — published as DIN EN ISO 21649 (EN adoption of ISO 21649).
• ICS / categories: 11.040.20 (Medical equipment; injection systems).
• Edition / version: EN/DIN adoption of ISO 21649 (2010 adoption of ISO 21649:2006).
• Number of pages: Approximately 40 pages (catalog listings for the DIN/EN adoption indicate ~40–41 pages).

Scope

The standard applies to needle‑free injection systems intended for human medical use in clinical and personal settings. It covers safety and performance requirements and the tests necessary to demonstrate conformity for both single‑use and multiple‑use NFIS, including requirements related to the dose chamber (disposable or permanent), dose delivery characteristics, and system performance under expected environmental and use conditions. Methods and device types that penetrate skin (for example needles or microneedles) are excluded. Note that the 2006/2010 text has been revised in the 2023 edition to include updated risk‑based approaches and additional tests relevant to modern use cases.

Key topics and requirements

• Safety and performance requirements for single‑use and multiple‑use NFIS (design, intended life, and user/patient contact parts).
• Dose specification, accuracy and performance profiling (including uncertainty of measurements and conformance testing).
• Noise requirements and other user‑impact performance characteristics.
• Test methods for functional performance, durability and environmental exposure (transport, moisture/heat tests in later revisions).
• Requirements intended to mitigate cross‑contamination risk and to address re‑use prevention in multi‑use designs (strengthened in the 2023 revision).

Typical use and users

Manufacturers and designers of needle‑free injection systems use this standard to define product requirements and to design validation and test programs. Regulatory affairs teams and notified/competent bodies refer to it when assessing conformity. Test laboratories rely on the specified test methods to perform bench testing. Healthcare organizations and procurement specialists may use the standard to evaluate device performance and suitability for clinical or mass‑immunization programs. (For current design and regulatory expectations, refer to the 2023 edition.)

Related standards

ISO 21649 sits alongside other medical device standards addressing injection systems and device safety. The 2023 revision explicitly aligned aspects of the document with the approach and requirements of the ISO 11608 series (injectors/pen systems) and references general medical device standards (for example risk management and biocompatibility standards) as appropriate. Users should consider ISO 10993 for biocompatibility, ISO 14971 for risk management, and the ISO 11608 series when comparing requirements across injection system types.

Keywords

needle‑free injectors; NFIS; injection systems; dose chamber; dose accuracy; performance testing; test methods; single‑use; multiple‑use; cross‑contamination; DIN EN ISO 21649; medical devices.

FAQ

Q: What is this standard?

A: It is the DIN/EN adoption (2010) of ISO 21649, titled "Needle‑free injectors for medical use — Requirements and test methods," specifying safety, performance and test methods for NFIS.

Q: What does it cover?

A: It covers requirements and laboratory test methods for single‑use and multiple‑use needle‑free injection systems, including dose specification, performance profiling, test methods for functional performance, and other device characteristics. It excludes drug‑delivery methods that penetrate skin (needles, microneedles, implantable devices).

Q: Who typically uses it?

A: Device manufacturers, test laboratories, regulatory reviewers / notified bodies, clinical engineers, and procurement specialists use the standard to design, test and assess needle‑free injection systems.

Q: Is it current or superseded?

A: The DIN EN ISO 21649:2010-01 adoption is superseded/withdrawn and has been replaced by DIN EN ISO 21649:2023 (ISO 21649:2023, published January 2023 / adopted at DIN in mid‑2023). For current requirements and tests use the 2023 edition.

Q: Is it part of a series?

A: ISO 21649 is a standalone standard for needle‑free systems but the 2023 revision aligns its approach with the broader ISO 11608 series and references other general medical device standards (eg, risk management and biocompatibility standards).

Q: What are the key keywords?

A: Needle‑free injectors, NFIS, dose chamber, dose accuracy, performance testing, single‑use, multiple‑use, test methods, DIN EN ISO 21649.