BS EN ISO 11608-7:2017规定了特殊要求，以使视觉障碍者能够使用针头给药系统或NIS（针头注射系统）。它适用于患者或护理者向人类服用药物的设备。ISO 11608的本部分涵盖了安全正确处理NIS的要求，包括标签、包装和使用说明。它还包括培训计划的要求（如适用）。ISO 11608的这一部分涵盖了NIS的要求，这些NIS声称适用于有视觉障碍的人。ISO 11608的本部分不涉及视觉障碍者使用锐器容器的要求。尽管专门用于ISO 11608系列内基于针头的注射系统，但ISO 11608的本部分也可适用于ISO 11608系列外的NIS，前提是这些NIS可能被视力障碍者使用。 ISO 11608的这一部分是为了满足各种程度的视觉限制，包括低、中、重度视觉障碍的人的需求而编写的；法律、功能或完全失明；以及色觉缺陷。因此，ISO 11608的这一部分要求以中度视觉障碍的人可以感知和理解的视觉格式以及没有有用视觉的人可以感知和理解的非视觉格式（例如触觉或听觉）提供信息。为简单起见，ISO 11608的本部分描述了该范围，以满足中度视力障碍或失明患者的需求。交叉引用:ISO 14971:2007IEC 62366-1:2015ISO 11608-1:2014 ED3ISO 24500:2010 Ed 1ISO 11156:2011ISO/TR 22411:2008 Ed 1ISO 24502:2010 Ed 1ISO/TR 19244:2014 ED1ISO/IEC 18004:2015ISO 11608-5:2012购买本文件时提供的所有当前修订版均包含在购买本文件中。

BS EN ISO 11608-7:2017 specifies particular requirements to make needle-based drug delivery systems or NIS (needle-based injection system) accessible for persons with visual impairments. It applies to devices intended for patient or caregiver administration of medicinal products to humans.This part of ISO 11608 covers requirements to allow for safe and correct handling of the NIS, including labelling, packaging, and instructions for use. It also includes requirements for training programs, if applicable.This part of ISO 11608 covers requirements for NIS that are claimed to be appropriate for use by persons with visual impairments.This part of ISO 11608 does not address requirements for use of sharps containers by persons with visual impairments.Although specifically intended to apply to needle-based injection systems within the ISO 11608 series, this part of ISO 11608 can be applied to NIS outside the ISO 11608 series as well, if they might be used by persons with visual impairments.This part of ISO 11608 is written to address the needs of persons with all levels of visual limitations, including low, moderate, or severe visual impairment; legal, functional, or total blindness; and colour vision deficiencies.Therefore, this part of ISO 11608 includes the requirement to provide information in visual formats that can be perceived and understood by people with moderate visual impairment and in non-visual formats (e.g. tactile or auditory) that can be perceived and understood by people with no useful vision.For simplicity's sake, this range is described in this part of ISO 11608 as addressing the needs of individuals with moderate visual impairment or blindness.Cross References:ISO 14971:2007IEC 62366-1:2015ISO 11608-1:2014 ED3ISO 24500:2010 Ed 1ISO 11156:2011ISO/TR 22411:2008 Ed 1ISO 24502:2010 Ed 1ISO/TR 19244:2014 ED1ISO/IEC 18004:2015ISO 11608-5:2012All current amendments available at time of purchase are included with the purchase of this document.