EN ISO 11608-2:2022 PDF

Overview

EN ISO 11608-2:2022 - "Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles" is the CEN-adopted European version of ISO 11608-2:2022. It specifies requirements and test methods for single-use, sterile double-ended pen needles intended for use with certain needle-based injection systems (NISs) that use a non-integrated double-ended needle. The standard excludes dental needles, pre-attached syringe needles, hypodermic needles for other routes (e.g., intravenous, intrathecal, intraocular), and primary container contact materials - though many of its tests and design criteria can inform those products.

Key topics and technical requirements

This document defines technical requirements and standardized test methods for double-ended pen needles, covering:

• Needle tube materials and tubing characteristics - material selection and dimensional expectations for needle tubes.
• Double-ended pen needle assembly requirements - hub geometry, dimensions, and freedom from defects.
• Needle points and flow rate - needle tip characteristics and methods to determine fluid flow rate through the needle (see Annex A).
• Bonding strength and hub integrity - tests for the bond between hub and needle tube (normative and informative test methods).
• Functional compatibility with NISs - dose delivery accuracy, needle removal torque, and compatibility test procedures with pen injectors.
• Biocompatibility, sterility and pyrogenicity - requirements to ensure safety of single-use, sterile needles.
• Preconditioning, sampling and standard test atmosphere - conditions for preconditioning samples (dry heat, cold, damp heat, cyclic atmospheres) and standard laboratory atmosphere for testing.
• Packaging, labeling and instructions for use - marking requirements and user information to support safe use.
• Test apparatus and methods - standardized gauges and apparatus descriptions, plus sampling plans.

Practical applications and users

EN ISO 11608-2:2022 is essential for:

• Manufacturers of double-ended pen needles and pen injectors - for product design, verification and conformity.
• Medical device test laboratories - for performing required bond, flow, dose delivery and compatibility tests.
• Regulatory and quality assurance teams - to demonstrate compliance with recognized test methods and requirements.
• Procurement and clinical engineers - to specify devices that meet standardized performance and safety criteria.

Using this standard helps ensure consistent product safety, performance, sterility and user information for needle-based injection systems.

Related standards

• ISO 11608-1 - general requirements and test methods for needle-based injection systems (referenced for alignment of sample sizes and test frameworks).
• ISO 11608-3 - needles integrated into the fluid path or container.
• ISO 7864 - separately supplied hypodermic needles.

Keywords: EN ISO 11608-2:2022, double-ended pen needles, needle-based injection systems, NIS, pen needle testing, sterile needles, flow rate, biocompatibility, medical device standards.