This part of ISO 11608 specifies requirements for needle-based drug delivery systems intended for use by persons with visual impairments. It applies to devices intended for patient or caregiver administration of human therapeutics.
This standard covers requirements to allow for safe and correct handling of the device, including labelling, packaging, and instructions for use. It also includes requirements for training programs, if applicable.
Devices that are claimed appropriate for use by persons with visual impairments shall meet the applicable requirements of this standard.
This Standard does not address requirements for use of Sharps Containers by persons with visual impairments.
Registration number (WIID)
58575
Scope
This part of ISO 11608 specifies requirements for needle-based drug delivery systems intended for use by persons with visual impairments. It applies to devices intended for patient or caregiver administration of human therapeutics.
This standard covers requirements to allow for safe and correct handling of the device, including labelling, packaging, and instructions for use. It also includes requirements for training programs, if applicable.
Devices that are claimed appropriate for use by persons with visual impairments shall meet the applicable requirements of this standard.
This Standard does not address requirements for use of Sharps Containers by persons with visual impairments.
