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DIN EN ISO 11608-3:2026-11
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022 + Amd 1:2026); German version EN ISO 11608-3:2022 + A1:2026- 발행일 : 2026-11-01
- 발행기관 : DIN
상세정보
| 분야 | |
|---|---|
| 적용범위 | This part of ISO 11608 specifies the requirements and test methods for the design verification of containers and integrated fluid pathways for use with needle-based injection systems (NIS) that meet the specifications of ISO 11608-1. The containers covered by this standard include single-dose and multiple-dose containers (filled by the manufacturer or the end user) that can be provided to the end user already integrated into the NIS or for insertion into the NIS at the time of use. Excluded from the scope of application are - sterile hypodermic needles; - sterile hypodermic syringes; - sterile disposable syringes, with or without needle, for insulin; - Containers that can be refilled several times; - Containers for dental use; - Catheters or infusion sets that are attached or assembled separately by the user. This document was prepared by Technical Committee ISO/TC 84 "Devices for administration of medicinal products and catheters" in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices" (secretariat: DIN) and with the participation of German experts. The working committee NA 176-04-02 AA "Injection systems" in the Health Technologies Standards Committee (NAGesuTech) of the DIN German Institute for Standardization is responsible. * keyword : Carpules*Containers*Cylinders*Data of the manufacturer*Definitions*Design*Designations*Dimensions*Dosage*Drug administration*Injection instruments*Injection syringes*Injectors*Insulin*Liquids*Marking*Mathematical calculations*Medical devices*Medical equipment*Medical products*Medical technology*Medicine*Pen-injectors*Precision*Replaceability*Specification (approval)*Storetanks*Technical data sheets*Testing*User information |
| 국제분류(ICS)코드 | 11.040.25 : 주사기, 바늘, 카테터 |
| 페이지수 | 41 |
| Edition |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | DIN EN ISO 11608-3:2026-11상세보기 | Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022 + Amd 1:2026); German version EN ISO 11608-3:2022 + A1:2026 | 2026-11-01 | 표준 |
| 2 | DIN EN ISO 11608-3:2026-11상세보기 | Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022 + Amd 1:2026) (includes Amendment A1:2026) | 2026-11-01 | 표준 |
| 3 | DIN EN ISO 11608-3:2024-01상세보기 | Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022, Corrected version 2023-01); German version EN ISO 11608-3:2022 | 2024-01-01 | 구판 |
| 4 | DIN EN ISO 11608-3:2024-01상세보기 | Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022, Corrected version 2023-01) | 2024-01-01 | 표준 |
| 5 | DIN EN ISO 11608-3:2022-09상세보기 | Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022)- German version EN ISO 11608-3:2022 | 2022-09-01 | 구판 |
| 6 | DIN EN ISO 11608-3:2022-09상세보기 | Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022) | 2022-09-01 | 표준 |
| 7 | DIN EN ISO 11608-3:2020-05상세보기 | Needle-based injection systems for medical use - Requirements and test methods - Part 3: NIS containers and integrated fluid paths (ISO/DIS 11608-3:2020)- German and English version prEN ISO 11608-3:2020 | 2020-05-01 | 구판 |
| 8 | DIN EN ISO 11608-3:2013-01상세보기 | Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012)- German version EN ISO 11608-3:2012 | 2013-01-01 | 구판 |
| 9 | DIN EN ISO 11608-3:2013-01상세보기 | Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012) | 2013-01-01 | 구판 |
| 10 | DIN EN ISO 11608-3:2011-01상세보기 | Needle-based injection systems - Requirements and test methods - Part 3: Finished containers (ISO/DIS 11608-3:2010)- German version prEN ISO 11608-3:2010 | 2011-01-01 | 구판 |
| 11 | DIN EN ISO 11608-3:2001-05상세보기 | Pen-injectors for medical use - Part 3: Finished cartridges- Requirements and test methods (ISO 11608-3:2000)- German version EN ISO 11608-3:2000 | 2001-05-01 | 구판 |
| 12 | DIN EN ISO 11608-3:2001-05상세보기 | Pen-injectors for medical use - Part 3: Finished cartridges- Requirements and test methods (ISO 11608-3:2000)- English version of DIN EN ISO 11608-3 | 2001-05-01 | 구판 |
| 13 | DIN EN ISO 11608-3:1997-10상세보기 | Pen-injectors for medical use - Part 3: Finished cartridges- requirements and test methods (ISO/DIS 11608-3:1997)- German version prEN ISO 11608-3:1997 | 1997-10-01 | 구판 |
관련상품
- DIN EN ISO 11608-7:2017-10 - Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016)
- DIN EN ISO 11608-7:2017-10 - Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016); German version EN ISO 11608-7:2017
- DIN EN ISO 11608-2:2022-09 - Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles (ISO 11608-2:2022); German version EN ISO 11608-2:2022
- DIN EN ISO 11608-4:2022-09 - Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics (ISO 11608-4:2022); German version EN ISO 11608-4:2022
- DIN EN ISO 11608-3:2022-09 - Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths (ISO 11608-3:2022)
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