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Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
| 분야 | ISO/TC 210 : Quality management and corresponding general aspects for medical devices |
|---|---|
| 적용범위 | ISO 15223-1:2016 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this document. ISO 15223-1:2016 is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements. These symbols may be used on the medical device itself, on its packaging or in the associated documentation. 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 | 25 |
| Edition | 3 |
| 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 15223-1:2021 - Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements 상세보기
ISO 14971:2019 - Medical devices — Application of risk management to medical devices 상세보기
ISO 11607-1:2019 - Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems 상세보기
ISO 11607-2:2019 - Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes 상세보기
ISO 10993-1:2018 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process 상세보기
BS EN 1041:2008+A1:2013 - Information supplied by the manufacturer of medical devices. 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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