Instituti për standardizim i Republikës së Maqedonisë së Veriut

0 Items

Certified by ISO 9001:2015

MK AL EN

Phone: +389 02 3247 150, +389 02 3247 159, +389 75 444 627,+389 76 448 791
E-mail: isrsm@isrsm.gov.mk
Yuri Gagarin 15, 3-rd floor, 1000 Skopje

Main menu

prМКС EN 553:2017

*

Sterilization of medical devices - Method for validation and routine control of sterilization by irradiation - Guidance

General informations

Current stage: 40.98 Effective date: 15 qer 2023

Originator: ISRSM

Technical committee: ИСРСМ Совет

Type: European Norm

Scope

This European standard provides guidance and advice on methods and procedures which may be used to ensure compliance with the requirements specified in EN 552. This standard does not include advice on irradiator design, operator training and radiation safety.

prМКС EN 553:2017

*

Sterilization of medical devices - Method for validation and routine control of sterilization by irradiation - Guidance

General informations

Scope

Life cycle

NOW

Related projects/standards

Adopted from prEN 553 IDENTICAL