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Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
| 분야 | ISO/TC 198 : Sterilization of health care products |
|---|---|
| 적용범위 | This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of non-critical medical devices not intended to be sterilized (i.e. a medical device that is intended to come into contact with intact skin only or a medical device not intended for direct patient contact). This includes information for processing prior to use or reuse of the medical device. Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable: a) preparation before processing; b) cleaning; c) disinfection; d) drying; e) inspection and maintenance; f) packaging; g) storage; h) transportation. This document excludes processing of: 1) critical and semi-critical medical devices; 2) medical devices intended to be sterilized; 3) textile medical devices used in patient draping systems or surgical clothing; 4) medical devices specified by the manufacturer for single use only and supplied ready for use. NOTE See Annex E for further guidance on the application of the ISO 17664 series to a medical device. |
| 국제분류(ICS)코드 | 11.080.01 : 일반 살균 및 소독 |
| 페이지수 | 24 |
| Edition | 1 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | CSA ISO 17664-2:23 | Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices (Adopted ISO 17664-2:2021, first edition, 2021-02) | 2023-01-01 | 표준 |
| 2 | ISO 17664-2:2021 | Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices | 2021-02-25 | 표준 |
ISO 17664-1:2021 - Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices 상세보기
CSA ISO 17664-2:23 - Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices (Adopted ISO 17664-2:2021, first edition, 2021-02) 상세보기
CSA ISO 17664-1:23 - Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices (Adopted ISO 17664-1:2021, first edition, 2021-07) 상세보기
ISO 17664-1:2021 - Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices 상세보기
ISO 20417:2021 - Medical devices — Information to be supplied by the manufacturer 상세보기
ISO 10993-12:2021 - Biological evaluation of medical devices — Part 12: Sample preparation and reference materials 상세보기
AAMI SW91(2018 Edition) - Classification of defects in health software 상세보기
AAMI SW96 2023 Edition, 2023 - Standard for medical device security—Security risk management for device manufacturers 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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