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판매
ISO 11608-7:2016
Needle-based injection systems for medical use — Requirements and test methods — Part 7: Accessibility for persons with visual impairment- 발행일 : 2016-07-29
- 발행기관 : ISO
상세정보
| 분야 | ISO/TC 84 : Devices for administration of medicinal products and catheters |
|---|---|
| 적용범위 | 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. |
| 국제분류(ICS)코드 | 11.040.25 : 주사기, 바늘, 카테터 |
| 페이지수 | 19 |
| Edition | 1 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 11608-7:2016상세보기 | Needle-based injection systems for medical use — Requirements and test methods — Part 7: Accessibility for persons with visual impairment | 2016-07-29 | 표준 |
관련상품
- ISO/DIS 11608-6 - Needle-based injection systems for medical use — Requirements and test methods — Part 6: On-body delivery systems
- ISO/DIS 11608-4 - Needle-based injection systems for medical use - Requirements and test methods — Part 4: Needle-based injection systems containing electronics
- ISO 11608-4:2022 - Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics
- ISO 11608-5:2022 - Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions
- ISO 11608-3:2022 - Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths
다른 사람이 함께 구입한 상품
- ISO 11608-3:2012 - Needle-based injection systems for medical use — Requirements and test methods — Part 3: Finished containers
- ISO 13926-2:2017 - Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use
- ISO 13926-3:2019 - Pen systems — Part 3: Seals for pen-injectors for medical use
- ISO 11608-5:2012 - Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions
- ISO 11608-1:2014 - Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems
추천 상품
- IEC TS 63134:2020 - Active assisted living (AAL) use cases
- IEC 60034-5:2020 RLV - Rotating electrical machines - Part 5: Degrees of protection provided by the integral design of rotating electrical machines (IP code) - Classification
- KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs)
- KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs)
- KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스
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