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现行 ISO 11608-7:2016
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Needle-based injection systems for medical use — Requirements and test methods — Part 7: Accessibility for persons with visual impairment 基于针头的医疗注射系统 - 要求和测试方法 - 第7部分:视力障碍者的辅助功能
发布日期: 2016-07-29
ISO 11608-7:2016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。 它涵盖了安全和正确处理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)。 它涵盖了声称适合视觉障碍者使用的NIS要求。 它不涉及视觉障碍者使用锐器容器的要求。 尽管ISO 11608-7:2016专门适用于ISO 11608系列内的针头注射系统,但ISO 11608-7:2016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。 本手册旨在满足具有各种程度视觉障碍的人的需求,包括低、中、重度视觉障碍;法律、功能或完全失明; 以及色觉缺陷。 因此,ISO 11608-7:2016包括以中度视觉障碍者可以感知和理解的视觉格式和非视觉格式(例如触觉或听觉)提供信息的要求,非视觉格式(例如触觉或听觉)可以被没有有用视觉的人感知和理解。 为简单起见,ISO 11608-7:2016将该范围描述为满足中度视力障碍或失明患者的需求。
ISO 11608-7:2016 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. It 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. It covers requirements for NIS that are claimed to be appropriate for use by persons with visual impairments. It 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, ISO 11608-7:2016 can be applied to NIS outside the ISO 11608 series as well, if they might be used by persons with visual impairments. It 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, ISO 11608-7:2016 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 ISO 11608-7:2016 as addressing the needs of individuals with moderate visual impairment or blindness.
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发布单位或类别: 国际组织-国际标准化组织
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归口单位: ISO/TC 84
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