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Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
| 분야 | ISO/TC 84 : Devices for administration of medicinal products and catheters |
|---|---|
| 적용범위 | ISO 7886-1:2017 specifies requirements and test methods for verifying the design of empty sterile single-use hypodermic syringes, with or without needle, made of plastic or other materials and intended for the aspiration and injection of fluids after filling by the end-users. This document does not provide requirements for lot release. The syringes are primarily for use in humans. Sterile syringes specified in this document are intended for use immediately after filling and are not intended to contain the medicament for extended periods of time. It excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit for filling by a pharmacist). Hypodermic syringes without a needle specified in this document are intended for use with hypodermic needles specified in ISO 7864. |
| 국제분류(ICS)코드 | 11.040.25 : 주사기, 바늘, 카테터 |
| 페이지수 | 28 |
| Edition | 2 |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ISO 7886-1:2017 | Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | 2017-05-03 | 표준 |
| 2 | ISO 7886-1:1993/Cor 1:1995 | 1995-10-26 | 구판 | |
| 3 | ISO 7886-1:1993 | Sterile hypodermic syringes for single use — Part 1: Syringes for manual use | 1993-09-16 | 구판 |
ISO 7886-4:2018 - Sterile hypodermic syringes for single use — Part 4: Syringes with re-use prevention feature 상세보기
ISO 7886-2:2020 - Sterile hypodermic syringes for single use — Part 2: Syringes for use with power-driven syringe pumps 상세보기
ISO 7886-3:2020 - Sterile hypodermic syringes for single use — Part 3: Auto-disabled syringes for fixed-dose immunization 상세보기
ASTM F1980-16 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices 상세보기
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ISO/TR 80002-2:2017 - Medical device software — Part 2: Validation of software for medical device quality systems 상세보기
BS EN ISO 15223-1:2016 - TC - Tracked Changes. Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements. 상세보기
IEC TS 63134:2020 - Active assisted living (AAL) use cases 상세보기
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