DPS
Drejtoria e Përgjithshme e Standardizimit
Tel/Cel: +355 4 222 62 55
E-mail: info@dps.gov.al
Adresa: Rr.: "Reshit Collaku", (pranë ILDKPKI, kati VI), Kutia Postare 98, Tiranë - Shqipëri
Main menu

SSH EN ISO 11607-2:2020

Ambalazhimi për pajisje mjekësore të sterilizuara në fazën përfundimtare - Pjesa 2: Kërkesat e miratimit për proceset e formimit, hermetizimit dhe montimit (ISO 11607-2:2019)

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
14 gush 2024

General information

60.60     14 gush 2024

DPS

DPS/KT 206

European Norm

11.080.30  

anglisht  

Buying

Publikuar

Language in which you want to receive the document.

Scope

This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

Related directives

Directives related to this standards.

90/385/EEC

Pajisjet mjekësore aktive transplatuese

Të harmonizuara
93/42/EEC

Pajisje Mjekësore

Të harmonizuara
98/79/EC

Pajisje mjekësore të diagnostikimit "in-vitro"

Të harmonizuara
2017/745

Të harmonizuara
2017/746

Të harmonizuara

Life cycle

NOW

PUBLISHED
SSH EN ISO 11607-2:2020
60.60 Standard published
14 gush 2024

CORRIGENDA / AMENDMENTS

PUBLISHED
SSH EN ISO 11607-2:2020/A1:2023

Related project

Adopted from EN ISO 11607-2:2020