Phone: (011) 7541-421, 3409-301, 3409-335, 6547-293, 3409-310
E-mail: Standards sales: prodaja@iss.rs Education: iss-edukacija@iss.rs Information about standards: infocentar@iss.rs
Stevana Brakusa 2, 11030 Beograd
Main menu

naSRPS EN ISO 11137-2:2024

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO/DIS 11137‑2:2026)

General information

40.20     Aug 13, 2026

40.60    Oct 16, 2026

ISS

Z076

European Norm

11.080.01  

English  

Buying

Уколико желите да набавите овај документ обратите се на следећу адресу: prodaja@iss.rs

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

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

2017/746

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Life cycle

NOW

PROJECT
naSRPS EN ISO 11137-2:2024
40.20 DIS ballot initiated: 12 weeks
Aug 13, 2026

Related project

Adopted from prEN ISO 11137-2 IDENTICAL

Adopted from ISO/DIS 11137-2 IDENTICAL

Preview

To view the full content, you need to register or to log in to your account by clicking on the "Log in" button

Login