DPS
Drejtoria e Përgjithshme e Standardizimit
0 Items
My account
E-albania
Phone: +355 4 222 62 55
E-mail: info@dps.gov.al
Address: Address: "Reshit Collaku" Str., (nearby ILDKPKI, VI floor), Po.Box 98, Tiranë - Albania
Main menu

SSH EN ISO 11737-2:2009

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)

Mar 26, 2012
95.99 Withdrawal of Standard   Dec 11, 2020

General information

95.99     Dec 11, 2020

DPS

DPS/KT 316

European Norm

07.100.10     11.080.01  

English  

Buying

Withdrawn

Language in which you want to receive the document.

Scope

ISO 11737-2:2009 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.

Related directives

Directives related to this standards.

90/385/EEC

Active implantable medical devices

Harmonized
Directive 90/385/EEC
93/42/EEC

Medical devices

Harmonized
Directive 93/42/EEC
98/79/EC

In vitro diagnostic medical devices

Harmonized
Directive 98/79/EC
2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Directive 2007/47/EC

Life cycle

PREVIOUSLY

WITHDRAWN
SSH EN ISO 11737-2:2003

NOW

WITHDRAWN
SSH EN ISO 11737-2:2009
95.99 Withdrawal of Standard
Dec 11, 2020

REVISED BY

PUBLISHED
SSH EN ISO 11737-2:2020

Related project

Adopted from EN ISO 11737-2:2009