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)

Publication date: 29 mar 2016

General information

Current stage: 60.60 Effective date: 29 mar 2016

Originator: DPS

Owner: DPS/KT 316

Type: European Norm

ICS: 11.080.01

Gjuha: anglisht

Buying

Statusi: Publikuar

PDF - 1 963 Lekë

Paper - 1 963 Lekë

CD - 1 963 Lekë

PDF and Paper - 3 926 Lekë

Language

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

më tepër

93/42/EEC

Pajisje Mjekësore

Të harmonizuara

më tepër

98/79/EC

Pajisje mjekësore të diagnostikimit "in-vitro"

Të harmonizuara

më tepër

2017/745

Të harmonizuara

më tepër

2017/746

Të harmonizuara

më tepër

Life cycle

PREVIOUSLY

Replaces
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

Preview

Only informative sections of projects are publicly available. To view the full content, you will need to members of the committee. If you are a member, please log in to your account by clicking on the "Log in" button.