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Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
| 분야 | ISO/TC 210 : Quality management and corresponding general aspects for medical devices |
|---|---|
| 적용범위 | ISO 15223-2:2010 specifies a process for developing, selecting and validating symbols for inclusion in ISO 15223-1. The purpose of ISO 15223-2:2010 is to ensure that symbols included in ISO 15223-1 are readily understood by the target group. If the symbol validation process detailed in ISO 15223-2:2010 has been complied with, then the residual risks, as defined in ISO 14971 and IEC 62366, associated with the usability of a medical device symbol are presumed to be acceptable, unless there is objective evidence to the contrary. ISO 15223-2:2010 is not restricted to symbols intended to meet regulatory requirements or specified in regulatory guidelines on labelling. |
| 국제분류(ICS)코드 |
11.040.01 : 일반 의료장비
01.080.20 : 특정 기기용 도표기호 |
| 페이지수 | 16 |
| Edition | 1 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 15223-2:2010 | Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation | 2010-01-15 | 표준 |
ISO 15223-1:2021/DAmd 1 - Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements — Amendment 1: Addition of defined term for authorized representative and Modified EC REP symbol to not be country or region specific 상세보기
ISO 15223-1:2021 - Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements 상세보기
IEC TR 62366-2:2016 - Medical devices - Part 2: Guidance on the application of usability engineering to medical devices 상세보기
ISO 15223-1:2021 - Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements 상세보기
ISO 14644-2:2015 - Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration 상세보기
ISO 13485:2016 - Medical devices — Quality management systems — Requirements for regulatory purposes 상세보기
ISO 20417:2021 - Medical devices — Information to be supplied by the manufacturer 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
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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
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