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표준
판매
Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods.
| 분야 | |
|---|---|
| 적용범위 | Sterilization (hygiene), Strength of materials, Joints, Medical equipment, Paper, Heat-sealing, Composite materials, Performance, Medical instruments, Sterile equipment, Marking, Performance testing, Visual inspection (testing), Packaging materials, Plastic films, Holes, Mechanical testing, Containers, Plastics, Peeling tests, Paper products, Stain tests, Fibres, Packaging, Drums (materials handling equipment) |
| 국제분류(ICS)코드 |
11.080.30 : 멸균 포장
55.080 : 주머니. 자루 55.040 : 포장 자재 및 부속품 |
| 페이지수 | 24 |
| Edition |
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | BS EN 868-5:2018 - TC | Tracked Changes. Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods. | 2019-08-01 | 표준 |
| 2 | BS EN 868-5:2018 | Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods. | 2019-01-07 | 표준 |
| 3 | BS EN 868-5:2009 | Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous and plastic film construction. Requirements and test methods. | 2009-10-31 | 폐지 |
| 4 | BS EN 868-5:1999 | Packaging materials and systems for medical devices which are to be sterilized. Heat and self-sealable pouches and reels of paper and plastic film construction. Requirements and test methods. | 2003-01-15 | 폐지 |
BS EN 868-1:1997 - Packaging materials and systems for medical devices which are to be sterilized. General requirements and test methods. 상세보기
BS EN 868-8:1999 - Packaging materials and systems for medical devices which are to be sterilized. Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods. 상세보기
BS EN 868-7:1999 - Packaging materials and systems for medical devices which are to be sterilized. Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation. Requirements and test methods. 상세보기
BS EN 868-6:1999 - Packaging materials and systems for medical devices which are to be sterilized. Paper for the manufacture of packs for medical use for sterilization by ethylene oxide or irradiation. Requirements and test methods. 상세보기
BS EN 868-4:1999 - Packaging materials and systems for medical devices which are to be sterilized. Paper bags. Requirements and test methods. 상세보기
ISO 10993-1:2018 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process 상세보기
BS EN 556-1:2024 - Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices. 상세보기
BS EN ISO 14607:2018 - Non-active surgical implants. Mammary implants. Particular requirements. 상세보기
BS EN ISO 10993-11:2018 - Biological evaluation of medical devices. Tests for systemic toxicity. 상세보기
ASTM F88/F88M-15 REDLINE - Standard Test Method for Seal Strength of Flexible Barrier Materials 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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