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 | This document specifies requirements and test methods for Needle-Based Injection Systems (NISs) for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, which can be delivered through needles or soft cannulas for intradermal, subcutaneous and/or intramuscular delivery, incorporating pre-filled or user-filled, replaceable or non-replaceable containers. This document applies in cases where the NIS incorporates a prefilled syringe. However, stand-alone prefilled syringes defined by ISO 11040-8 are not covered by this document (see exclusions below). It is important to note that other functions and characteristics of the prefilled syringe, such as dose accuracy, are subject to the requirements (delivered volume) in ISO 11040-8 and not this document, unless the addition impacts the delivery function (e.g. a mechanism that intends to restrict or stop the plunger movement, which would limit the dose delivered). In that case, the system is completely covered by this document and applicable requirements of the ISO 11608 series. Excluded from the scope are: — stand-alone prefilled syringes defined by ISO 11040-8 (with noted exceptions above); — NISs that provide continuous delivery and require a delivery rate clinically specified in the medicinal product labelling or determined by a physician based on clinical relevance (i.e. medication efficacy) as would be the case with insulin patch pumps or traditional infusion pumps (e.g. IEC 60601-2-24, ISO 28620) associated with continuous delivery of medicinal products (e.g. insulin); — NISs with containers that can be refilled multiple times; — requirements relating to methods or equipment associated with user filling of containers unless they are dedicated accessories (a component necessary for primary function, whether included in the original kitted product or not); — NISs intended for dental use; — NISs intended for different routes of administration (e.g. intravenous, intrathecal, intraocular). NOTE These products that are excluded might benefit from elements in this document but might not completely fulfil the basic safety and effectiveness of such products. |
국제분류(ICS)코드 | 11.040.25 : 주사기, 바늘, 카테터 |
페이지수 | 69 |
Edition | 4 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
---|---|---|---|---|
1 | ISO 11608-1:2022 | Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems | 2022-04-07 | 표준 |
2 | ISO 11608-1:2014 | Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems | 2014-12-16 | 구판 |
3 | ISO 11608-1:2012 | Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems | 2012-03-30 | 구판 |
4 | ISO 11608-1:2000 | Pen-injectors for medical use — Part 1: Pen-injectors — Requirements and test methods | 2000-12-21 | 구판 |
ISO 11608-7:2016 - Needle-based injection systems for medical use — Requirements and test methods — Part 7: Accessibility for persons with visual impairment 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
IEEE 2146.1-2022 - IEEE Standard for Entity-Based Risk Mutual Assistance Model through Blockchain Technology 상세보기
IEEE 2801-2022 - IEEE Recommended Practice for the Quality Management of Datasets for Medical Artificial Intelligence 상세보기
AAMI TIR68 : 18th Edition(2022) - Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces 상세보기
AAMI ST98 : 2022 Edition(2022) - Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices 상세보기
IEC 60793-1-30:2010 - Optical fibres - Part 1-30: Measurement methods and test procedures - Fibre proof test 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