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Drejtoria e Përgjithshme e Standardizimit

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prSSH EN 556-2:2024

Sterilizimi i pajisjeve mjekësore - Kërkesat për pajisjet mjekësore të shënuara " STERILE " - Pjesa 2: Kërkesat për pajisjet mjekësore të trajtuara për sterilitet

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

General information

Current stage: 40.60 Effective date: 7 maj 2025

Next stage: 50.99 Next stage date: 28 tet 2025

Originator: DPS

Owner: DPS/KT 316

Type: European Norm

Scope

This document specifies the requirements for an aseptically processed medical device to be designated “STERILE”.

Related directives

Directives related to this standards.

2017/746

Directive 2017/746

2017/745

Directive 2017/745

Life cycle

PREVIOUSLY

PUBLISHED
SSH EN 556-2:2015

NOW

IN_DEVELOPMENT
prSSH EN 556-2:2024
40.60 Close of voting
7 maj 2025

Related project

Adopted from EN 556-2:2024 IDENTICAL