ISO 11608 Needle Injection Systems for Medical Use - Requirements and Test Methods

The “ISO 11608 Needle injection systems for medical use - Requirements and test methods” standard, published by the International Organization for Standardization (ISO), consists of the following sub-sections published under the same title:

• The ISO 11608-1 Part 1: Needle injection systems standard describes the requirements and test methods for needle-based injection systems designed for single-patient use, delivering specific volumes of medicinal product, using pre-filled or user-filled, replaceable or non-replaceable containers, and delivering via needles or soft cannulas for intradermal, subcutaneous, or intramuscular administration.

This standard applies where the needle-based injection system includes a pre-filled syringe. However, standalone pre-filled syringes, as defined by the ISO 11040-8 standard, are not covered by this standard.

Other functions and features of the pre-filled syringe, such as dose accuracy, are subject to the requirements of the ISO 11040-8 standard (delivered volume), provided that they do not affect the insertion function (e.g., a mechanism intended to restrict or stop piston movement and limit the delivered dose).

The following are excluded from the scope of this standard:

• Self-contained pre-filled syringes as defined by the ISO 11040-8 standard (with the exceptions noted above)
• Needle-based injection systems that provide continuous administration and require an administration rate that is clinically specified on the medical product label or determined by a physician based on clinical significance (i.e., drug efficacy) (such as insulin patch pumps or conventional infusion pumps)
• Needle-based injection systems with refillable containers.
• Requirements regarding methods or equipment for the user to fill containers, unless these are special accessories (whether included in the original kit product or not, a component necessary for the primary function)
• Needle-based injection systems designed for dental use.
• Needle-based injection systems designed for different routes of administration (e.g., intravenous, intrathecal, intraocular).

This standard does not apply to:

• Needles for dental use
• Pre-attached syringe needles
• Hypodermic needles
• Needles designed for different routes of administration (e.g., intravenous, intrathecal, intraocular)
• Materials forming the surfaces of the primary container lid that come into contact with the medicinal product.

However, while this standard is not designed to be applied directly to these needle products, it includes requirements and test methods that can be used to aid in their design and evaluation.

For needles supplied by the manufacturer integrated into the fluid pathway or container, ISO 11608-3 standards apply, while for hypodermic needles supplied separately, ISO 7864 standards apply.

• The standard “ISO 11608-3 Part 3: Containers and integrated fluid paths” describes the requirements and test methods for design verification of containers and integrated fluid paths used with needle-based injection systems, according to the ISO 11608-1 standard.

This standard applies to single and multi-dose containers (e.g., cartridges, syringes) filled by the manufacturer (primary container cap) or the end user (reservoir), and to fluid pathways integrated with needle-based injection systems at the point of manufacture.

This standard also applies to pre-filled syringes (ISO 11040-8) when used with a needle-based injection system.

This standard does not apply to the following products:

• Sterile hypodermic needles
• Sterile hypodermic syringes
• Sterile disposable syringes, with or without needles, for insulin.
• Containers that can be refilled multiple times.
• Containers designed for dental use.
• Catheters or infusion sets that are inserted or assembled separately by the user.

The electronic, needle-based injection system can be disposable or reusable and can be operated with or without electrical/conductive connections to other devices. The system is designed to administer medication to the patient either through self-administration or by another operator (e.g., caregiver or healthcare professional).

This standard applies to electronic accessories intended to be physically connected to needle-based injection systems containing electronics, according to their intended use.

This standard also applies to electronic accessories for needle-based injection systems containing electronics, which are intended to have electrical/conductive connections depending on their intended use.

This standard does not specify requirements for the software in these systems. Furthermore, this standard does not specify cybersecurity requirements.

• The ISO 11608-5 Part 5: Automated functions standard describes the requirements and test methods for automated functions in needle-based injection systems with automated functions.

General requirements have been met for all automated functions. In addition, specific requirements have been met for the following automated functions:

• Preparation of medicinal products (e.g., dilution)
• Needle preparation
• Needle concealment
• Preliminary
• Dose adjustment
• Needle placement
• Injection depth control
• Injection of the medical product
• Recording of device functions (this standard does not cover remote communication from needle-based injection systems with automated functions (it covers wired and wireless communication transmission)).
• Disabling needle-based injection systems with automated functions.
• Needle withdrawal
• Needle protection
• Needle removal

This standard does not apply to functions performed manually by the user.

• The ISO 11608-6 Part 6: Intravenous administration systems standard describes the requirements and test methods for needle injection systems designed for single-patient use, intended for the administration of a specific volume of medicinal product via subcutaneous, intramuscular, or intradermal routes, and containing pre-filled or user-filled, replaceable or non-replaceable containers.

Technically, a device using a soft cannula, although not needle-equipped, can be included in this classification if a needle is inserted into the soft cannula.

Infusion pumps designed for continuous administration at a specific rate required to achieve or maintain the desired plasma medicinal product concentration are excluded from this standard. However, while this standard is not intended to directly apply to these pump products, it includes requirements and test methods that can be used to aid in their design and evaluation.

If these are electronic, they fall under the scope of IEC 60601-2-24; if they are not electronic, they fall under the scope of ISO 28620 standard.

• ISO 11608-7 Part 7: Accessibility for the visually impaired standard describes specific requirements for making needle-based drug delivery systems or needle-based injection systems accessible to visually impaired individuals. This applies to devices designed for the administration of medical products to patients or caregivers.

This standard covers requirements for ensuring the safe and correct use of needle-based injection systems, including labeling, packaging, and instructions for use. It also includes requirements for training programs, where applicable.

This standard covers requirements for needle-based injection systems claimed to be suitable for use by visually impaired individuals. It does not address requirements relating to the use of cutting instrument containers by visually impaired individuals.

Although primarily intended for needle-based injection systems within the ISO 11608 series, the ISO 11608-7 standard can also be applied to needle-based injection systems outside the ISO 11608 series if they are suitable for use by visually impaired individuals.

This standard is designed to meet the needs of individuals with all levels of visual impairment, including mild, moderate, or severe visual impairment, legal, functional, or total blindness, and color vision impairment. Therefore, this standard includes the requirement to provide information in visual formats that can be perceived and understood by individuals with moderate visual impairment, and in non-visual formats (e.g., tactile or auditory) that can be perceived and understood by individuals with no visual impairment.

For simplicity, this range is defined as meeting the needs of individuals with moderate visual impairment or blindness according to this standard.

Needle-based injection systems that are not claimed to be suitable for use by people with visual impairments are not required to meet these requirements, but manufacturers are encouraged to consider them.

For many years, our organization, with its competent and experienced staff, has been understanding the needs of its clients, providing the advanced testing services they require, and assisting them in the establishment, implementation, and improvement of management systems. Within this framework, we also provide testing services compliant with the ISO 11608 standard.