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판매
Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements
| 분야 | ISO/TC 210 : Quality management and corresponding general aspects for medical devices |
|---|---|
| 적용범위 | This document specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are available globally and need to meet different regulatory requirements. These symbols can be used on the medical device itself, on its packaging or in the accompanying information. The requirements of this document are not intended to apply to symbols specified in other standards. |
| 국제분류(ICS)코드 |
11.040.01 : 일반 의료장비
01.080.20 : 특정 기기용 도표기호 |
| 페이지수 | 36 |
| Edition | 4 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 15223-1:2021 | Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements | 2021-07-06 | 표준 |
| 2 | ISO 15223-1:2016 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements | 2016-11-02 | 구판 |
| 3 | ISO 15223-1:2012 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements | 2012-06-25 | 구판 |
| 4 | ISO 15223-1:2007/Amd 1:2008 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements — Amendment 1 | 2008-06-10 | 구판 |
| 5 | ISO 15223-1:2007 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements | 2007-04-04 | 구판 |
| 6 | 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 | 초안 |
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 15223-2:2010 - Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation 상세보기
ISO 20417:2021 - Medical devices — Information to be supplied by the manufacturer 상세보기
KS P ISO 14971 - 의료기기 ─ 의료기기에 대한 위험 관리의 적용 상세보기
KS P ISO 15223-1 - 의료기기 — 의료기기의 라벨, 라벨링 및제공해야 할 정보에 사용하는 기호 — 제1부: 일반 요구사항 상세보기
ISO 14971:2019 - Medical devices — Application of risk management to medical devices 상세보기
ISO 10993-12:2021 - Biological evaluation of medical devices — Part 12: Sample preparation and reference materials 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
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