|
|
|
Standard Detayı
|
TÜRK STANDARDI
|
|
TS No :
|
TS EN ISO 11607-1
|
|
|
Kabul Tarihi :
|
9.11.2020
|
|
Hazırlık Grubu :
|
Teknik Kurul |
|
Doküman Tipi :
|
|
|
Yürürlük Durumu :
|
U (Yürürlükteki Standard/Standard) |
|
Başlık :
|
Nihai olarak steril edilmiş tıbbi cihazlar için ambalajlama - Bölüm 1: Malzemeler, steril bariyer sistemleri ve ambalajlama sistemleri için kurallar |
|
Başlık (İng) :
|
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
|
Kapsam :
|
- |
|
Kapsam (İng) :
|
This document specifies requirements and test methods for materials, preformed sterile barrier
systems, sterile barrier systems and packaging systems that are intended to maintain sterility of
terminally sterilized medical devices until the point of use.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile
barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical
devices that are manufactured aseptically. Additional requirements can be necessary for drug/device
combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device
during transportation of the item to the site of reprocessing or disposal. |
|
Yerini Aldığı :
|
TS EN ISO 11607-1 :2017; |
|
Tadil Eden :
|
TS EN ISO 11607-1/A11 :2022; TS EN ISO 11607-1/A1 :2023; |
|
Yararlanılan Kaynak :
|
EN ISO 11607-1:2020 |
|
Uluslararası Karşılıklar :
|
EN ISO 11607-1-EQV; ISO 11607-1-EQV |
|
ICS Kodu :
|
11.080.30 Steril Ambalajlama |
|
Cen/Cenelec :
|
CEN/ISO |
|
Dili :
|
en |
|
Renk Durumu :
|
Siyah-Beyaz |
|
Uygulama Durumu :
|
Yürürlükte |
|
Sayfa Sayısı :
|
58 |
|
Fiyatı :
|
94,00 EURO (3.258,95 TL + %10 Kdv) |
| Çakışan Standart Varsa İptal Tarihi (DOW) | - |
|