ISO 11608-7:2016

Overview

ISO 11608-7:2016 - "Needle-based injection systems for medical use - Part 7: Accessibility for persons with visual impairment" - specifies requirements and test methods to make needle-based injection systems (NIS) accessible and safe for users with visual impairment. It applies to devices intended for patient or caregiver administration of medicinal products and covers device design, labelling, packaging, instructions for use, and training where applicable. The standard addresses a range of vision loss (moderate visual impairment through blindness) and requires information to be available in both enhanced visual formats and non‑visual formats (e.g., tactile, auditory).

Key Topics and Requirements

• Scope and applicability: Applies to NIS within the ISO 11608 series and can be adapted to other NIS intended for users with visual impairments. It intentionally excludes requirements for sharps container use.
• Risk analysis: Manufacturers must include users with visual impairment in ISO 14971 risk assessments, identify use scenarios that could lead to hazardous situations, and implement risk controls.
• Design considerations: Usability engineering and human factors (per IEC 62366-1) should inform NIS design to support safe handling by people with moderate to severe visual impairment.
• Information formats: Requires provision of information in perceivable formats:
  • Visual: high‑contrast, large‑print, colour‑considerate graphics for moderate impairment.
  • Non‑visual: tactile cues, auditory feedback, or other sensory channels for users with no useful vision (Braille may be used but should not be the only tactile format).
• Packaging, marking, and instructions for use: Specific requirements for tactile marking, electronic formats, and clear instructions designed for visually impaired users.
• Testing and validation: Verification testing, summative (validation) evaluations, and documented test reports are required to demonstrate accessibility claims.
• Annex guidance: Includes informative annexes on measuring visual impairment, developing accessible instructions, and establishing test specifications.

Practical Applications and Who Uses It

• Medical device manufacturers and product designers developing injectors, pen devices, and on‑body injectors who need to claim accessibility for visually impaired users.
• Human factors and usability engineers implementing IEC 62366‑1 processes with an accessibility focus.
• Regulatory, quality, and compliance teams preparing submissions and conformity evidence.
• Procurement and clinical stakeholders evaluating devices for patient populations with vision loss.
• Accessibility specialists and trainers creating training programs and instructions for use.

Adopting ISO 11608-7 supports a universal design approach that improves safety, broadens market access, and reduces risk for users with visual impairment.

Related Standards

• ISO 11608-1:2014 (NIS general requirements)
• ISO 14971 (risk management for medical devices)
• IEC 62366-1 (usability engineering for medical devices)