ISO 11608 – Testing Protocols for Needle Based Injection Systems (NISs)

ISO 11608-1: An Introduction

ISO 11608-1: is a standard that puts forward the requirements and testing methods concerning single–patient use of NIS (Needle-Based Injection System) for delivering a bolus of a medicinal product. The bolus can be delivered via needles or soft cannulas through intradermal, subcutaneous, or intramuscular routes. Additionally, these NISs can incorporate pre-filled or user-filled replaceable or non-replaceable containers.

Details of the Revised Version of ISO 11608

The current version of ISO 11608-1: 2022 – Needle-based injection systems for medical use – Requirements and test methods – Part 1: Needle-based injection systems is a recent update in the standard. This update will work to bring all the potential NISs and their parts together while ensuring their proper integration. Part 1 (ISO 11608-1) of this standard explains the requirements and test methods for such NIS.

In its revised version, NIS offers the following concepts:

  • Primary functions, i.e., functions of the medical device allowing its safe and effective use
  • Functional stability, i.e., the expansion of testing regimens stimulating the whole-life testing for reusable devices

Apart from these concepts, it also contains

  • An introduction to a new class of medical devices, known as OBDS (On-Body Delivery Systems),
  • The consideration is that the NIS must be designed such that it can bear the medicinal product’s impact and requirements, and
  • An expansion of the guidance on risk-based design approaches

What Other Modifications are Included in the Revised Version?

The revised version of ISO 11608 contains the following minor modifications in its draft structure:

  • All the requirements regarding EMC testing and electronics have been moved to ISO 11608-4
  • A choking hazard warning concerning small parts has been added
  • A section dedicated to guidance on design verification w.r.t. ISO 13485 has also been included
ISO 11608 Tests
Testing Protocols for Needle-Based Injection Systems

What are the Implications of this System?

The implications of this ISO standard are as follows:

  • Medicinalsystems using needles
  • Medicinal systems using replaceable or non-replaceable containers

These containers can be single or multi-dose syringe-based or cartridge-based. They can either be filled by the user or the manufacturer.

What is not Included in this Standard’s Scope?

The following exclusions are linked with ISO 11608-1:2022:

  • Pre-filled syringes, as mentioned in ISO 11040-S
  • NIS that can provide continuous delivery and require a clinically-specific delivery rate in the medicinal product, such as insulin patch pumps designed to provide a continuous delivery of insulin, which is a medicinal product
  • NIS has containers that can be filled multiple times
  • NIS for dental use
  • NIS for different administration routes, such as intrathecal, intravenous, or intraocular
  • Requirements concerning methods or equipment concerned with user-filling of containers

What are the Testing Capabilities of ISO 11608-1?

The testing capabilities of this standard are as follows:

  • Accuracy of the last dose
  • Atmosphere testing in three modes, i.e., cool, standard, and warm
  • Automated functions of NIS, such as needle shielding, needle hiding, the distance of insertion, needle retraction, and minimum overriding forces
  • The bond between the needle tube and hub
  • Cold-storage and dry-heat testing
  • Cyclical testing
  • Damp-heat testing
  • Dose accuracy according to NISs’ specifications  
  • Ease of assembly of NIS in the presence of needles and containers
  • Free-fall testing
  • Inspection of the container and the NIS visually
  • Lifecycle testing
  • Preparation and operation of NIS
  • Rate of flow through the needle
  • Vibration testing

What are the Other Sections of ISO 11608 – 1:2022 Concerning NISs?

The first version of ISO 11608 was launched in 2000 as ISO 11608-1: Pen Injectors in Medical Use. Over 22 years, it has expanded greatly and now covers various aspects concerning requirements and testing methods for Needle-Based Injection Systems. The standards it presents in this regard are:

  • ISO 11608-2:2022 – Double-ended Pen Needles
  • ISO 11608-3:2022 – Containers and Integrated Fluid Paths
  • ISO 11608-4:2022 – Needle-based Injection Systems Containing Electronics  
  • ISO 11608-5:2022 – Automated Functions
  • ISO 11608-6:2022 – On-body Delivery Systems

ISO 11608-2:2022 Double-ended Pen Needles

Several modifications in ISO 11608-2 have been made this year. These include

  • Expansion of determination of flow rate to include suggested flow ranges, and
  • The compliance of sample sizes with ISO 11608-1

Furthermore, the revised version of ISO 11608-2 includes the testing requirements for confirming the compatibility between a needle and a specific NIS. Now, these requirements include needle hub removal force and dose delivery features. Moreover, the revised version also saw a reduction in the samples for functional compatibility along with requirements that guide the inner needle shield.

ISO 11608-3:2022 – Containers and Integrated Fluid Paths

Previously, ISO 116083 was limited to the definition of cartridge geometry and performance. Now, the revised version of the standard includes integrated fluid paths and NIS containers. The cause of these changes is the OBDS (On-Body Delivery Systems). Other modifications in the revised version include:

  • An increase in particle size for coring characterization from 50um to 150um or larger
  • General requirements for fluid line connections and soft cannulas
  • Reduction in resealing the cartridge from 1.5x of the intended use to at least 1.0x of the intended life, and
  • Shifting the definition of cartridge geometry to an information annex, implying that it is not mandatory now

ISO 11608-4:2022 – Needle-based Injection Systems Containing Electronics

The major recognizable changes made in ISO 11608-4 are:

  • The expansion of its scope is such that it now includes all the electronics on a NIS. Previously, it was limited only to those relating to the delivery of the drug product
  • Permission to deliver  the medicinal product while being connected to the mains power (for charging the battery)

Other minor changes include the following:

  • An increase in the minimum ingress protection from IP22 to IP52
  • Definition of allowable temperatures for skin contact
  • Definition of NIS in an oxygen-rich environment, and
  • Permission of failure evident to the user after a freefall preconditioning

ISO 11608-5:2022 Automated Functions

The revised version of ISO 11608-5 now directs the reads to ISO 11608-1 for the General Requirements. The main focus points of this standard are dose delivery and automated needle insertion. Other modifications in this revised version include:

  • Addition of requirements regarding fenestrated (holes in the side) needles
  • Exploration of non-perpendicular needles and cannula insertions
  • Modification of dose accuracy test for needles having automated insertion, and]

Moreover, the standard now requires the definition and measurement of dose delivery time.

ISO 11608-6:2022 – On-body Delivery Systems

This latest review of ISO 11608 includes an introduction to OBDS (On-body Delivery Systems) and defines its requirements. Moreover, many of the new concepts introduced in this standard are adopted into the following documents:

  • ISO 11608-1 (General Requirements)
  • ISO 11608-3:– Containers and Integrated Fluid Paths
  • ISO 11608-5:2022 – Automated Functions

The revised version also explains the differences between an OBDS and an infusion pump. As per the standard, the performance of an OBDS is defined by its dose accuracy for a fixed volume of a medicinal product. In contrast, an infusion pump is defined by the rate of delivering a medicinal product.

Another major difference between OBDS and other NIS is that OBDS deliver the medicinal product by being attached to the body. At the same time, traditional NISs must be held by the user during the complete course of delivery of the medicinal product.

How can you get your Copy of the standard?

If you are willing to learn more about the criteria and scope of these standards, you can purchase copies of these standards from ISO’s web store.

About the Author

Waqas Imam

S. M. Waqas Imam is associated with TS Quality as a Regional Partner. He is also an ambassador of Medical Device Community. He is an Industrial Engineer by qualification and served the manufacturing industry since 2011. He is also IRCA CQI Lead Auditor of ISO 9001 and other management system standards. He had served as Quality Assurance and Regulatory Affairs Manager in QSA Surgical Pvt. Ltd. and Ultimate Medical Products. He managed requirements of ISO 13485:2003, EU directives, CE marking and FDA. He also served as Expert Blog Writer for 13485Academy and wrote expert articles on various topics of ISO 13485:2016.