ISO 11608-2-2022 PDF

Full title and description

Needle-based injection systems for medical use — Requirements and test methods — Part 2: Double-ended pen needles. This International Standard specifies requirements and test methods for single-use, double-ended, sterile needles intended to be used with needle-based injection systems (NISs) that use a non-integrated double-ended needle in accordance with ISO 11608-1.

Abstract

ISO 11608-2:2022 defines design, performance and testing requirements for disposable double-ended pen needles (single‑use, sterile) used with certain pen-type injection systems. It includes requirements for sterility, dimensional and mechanical characteristics, compatibility with NIS containers and hubs, and excludes products such as dental needles, pre-attached syringe needles, hypodermic needles intended for other routes of administration and primary container contact materials — while noting that some tests may be useful for related products.

General information

• Status: Published.
• Publication date: April 7, 2022 (ISO publication).
• Publisher: International Organization for Standardization (ISO), Technical Committee ISO/TC 84.
• ICS / categories: 11.040.25 (Syringes, needles and catheters).
• Edition / version: Edition 3 (2022).
• Number of pages: 30 pages.

Scope

ISO 11608-2:2022 applies to single-use, double-ended, sterile needles intended for use with certain needle-based injection systems that employ non-integrated double-ended needles (as referenced by ISO 11608-1). It is not intended to apply directly to needles for dental use, pre-attached syringe needles, hypodermic needles intended for other routes (e.g., intravenous, intrathecal, intraocular), or to materials forming the medicinal-product-contact surfaces of primary container closures; however, some requirements and test methods in the standard can be used to inform the design and evaluation of such products. The document also clarifies that needles integrated into the fluid path or container are covered by ISO 11608-3 and that hypodermic needles provided separately are covered by ISO 7864.

Key topics and requirements

• Design and dimensional tolerances for double-ended pen needles (geometry, hub/needle fit and compatibility with pen injectors).
• Sterility and packaging requirements for single‑use needles.
• Mechanical tests: bond strength between hub and needle tube, ease of assembly, insertion/retraction forces, and resistance to mechanical stress.
• Functional and performance tests: flow rate through the needle, life‑cycle and last‑dose accuracy considerations where applicable, and automated function interfaces when used with automated systems.
• Environmental and conditioning tests: cold, standard, warm atmospheres, damp‑heat, vibration and drop/free‑fall testing relevant to packaging and device integrity.
• Labelling, instructions for use and traceability expected for safe selection and use of the needle with compatible NIS.

Typical use and users

Primary users and stakeholders include pen needle and injector manufacturers, medical device test laboratories, quality and regulatory teams, clinical engineers, procurement specialists for healthcare providers, and conformity assessment bodies. The standard is used to guide product design, verification testing, regulatory submissions, and routine quality assurance. Testing laboratories frequently reference the standard’s test methods when performing function, mechanical and environmental challenge testing.

Related standards

ISO 11608-2:2022 is part of the ISO 11608 series on needle-based injection systems. Closely related documents include ISO 11608-1 (general requirements and test methods for needle-based injection systems), ISO 11608-3 (requirements for containers and integrated fluid paths), ISO 11608-5 (automated functions) and ISO 11608-6 (on‑body delivery systems). Hypodermic needles provided separately are covered by ISO 7864; other applicable standards for related device functions or environmental testing (e.g., IEC standards) may be referenced within the ISO 11608 series.

Keywords

double-ended pen needle; pen needle; needle-based injection system; NIS; sterile needle; mechanical testing; flow rate; hub bond strength; packaging; ISO 11608 series; medical device standard.

FAQ

Q: What is this standard?

A: ISO 11608-2:2022 is an International Standard that specifies requirements and test methods for single-use, double-ended, sterile needles intended for use with certain needle-based injection systems (double-ended pen needles).

Q: What does it cover?

A: It covers design, performance and test methods specific to double-ended pen needles — including sterility, dimensional and mechanical requirements, functional tests (e.g., flow), environmental conditioning and packaging/labeling expectations — and lists explicit exclusions where other standards apply.

Q: Who typically uses it?

A: Manufacturers of pen needles and injection systems, test laboratories performing conformity and verification testing, regulatory and quality teams, conformity assessment bodies, and procurement or clinical engineering groups in healthcare organizations.

Q: Is it current or superseded?

A: Current. ISO 11608-2:2022 (edition 3, published April 7, 2022) replaced and supersedes the withdrawn ISO 11608-2:2012 edition.

Q: Is it part of a series?

A: Yes — it is part of the ISO 11608 series (needle-based injection systems). Other parts address general system requirements (ISO 11608-1), containers and fluid paths (ISO 11608-3), automated functions (ISO 11608-5), on‑body delivery systems (ISO 11608-6), and additional parts as published.

Q: What are the key keywords?

A: Double-ended pen needle, pen needle, needle-based injection system, sterile needle, mechanical testing, flow rate, hub bond strength, ISO 11608.