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 11137-2:2015

Sterilizimi i produkteve të kujdesit shëndetësor - Rrezatimi - Pjesa 2: Vendosja e dozës së sterilizimit (ISO 11137-2:2013)

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
29 mar 2016

General information

60.60     29 mar 2016

DPS

DPS/KT 316

European Norm

11.080.01  

anglisht  

Buying

Publikuar

Language in which you want to receive the document.

Scope

ISO 11137-2:2013 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. ISO 11137-2:2013 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.
ISO 11137-2:2013 defines product families for sterilization dose establishment and sterilization dose audit.

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

PREVIOUSLY

WITHDRAWN
SSH EN ISO 11137-2:2013

NOW

PUBLISHED
SSH EN ISO 11137-2:2015
60.60 Standard published
29 mar 2016

Related project

Adopted from EN ISO 11137-2:2015