관심표준 등록 : 표준업데이트 시 알림을 받을 수 있습니다.
PDF : 직접 파일 다운로드 및 인쇄 (마이페이지 확인)
PRINT : 인쇄본 우편발송, 2~3일 소요(PDF파일 미제공)
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 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
---|---|---|---|---|
1 | ISO 11608-7:2016 | Needle-based injection systems for medical use — Requirements and test methods — Part 7: Accessibility for persons with visual impairment | 2016-07-29 | 표준 |
ISO 11608-1:2022 - Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems 상세보기
ISO 11608-2:2022 - Needle-based injection systems for medical use — Requirements and test methods — Part 2: Double-ended pen needles 상세보기
ISO 11608-4:2022 - Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics 상세보기
ISO 11608-6:2022 - Needle-based injection systems for medical use — Requirements and test methods — Part 6: On-body delivery systems 상세보기
ISO 11608-3:2022 - Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths 상세보기
ISO 13926-2:2017 - Pen systems — Part 2: Plunger stoppers for pen-injectors for medical use 상세보기
ISO 11608-1:2014 - Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems 상세보기
ISO 11608-5:2012 - Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions 상세보기
ISO 11608-3:2012 - Needle-based injection systems for medical use — Requirements and test methods — Part 3: Finished containers 상세보기
ISO 11608-2:2012 - Needle-based injection systems for medical use — Requirements and test methods — Part 2: Needles 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
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 상세보기
KS B ISO TS 25740-1 - 에스컬레이터 및 무빙워크에 대한 안전요건 — 제1부: 세계공통 필수 안전요건(GESRs) 상세보기
KS B ISO TS 8100-21 - 승객 및 화물 운송용 엘리베이터 —제21부: 세계공통 필수안전요건(GESRs)을 충족하는 세계공통 안전 파라미터(GSPs) 상세보기
KS C IEC TS 62872 - 산업 시설과 스마트 그리드 사이의 산업 공정 측정, 제어 및 자동화 시스템 인터페이스 상세보기