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SR EN 552:2001

Sterilization of medical devices - Validation and routine control of sterilization by irradiation

1.1 This European Standard specifies requirements for the validation, process control and monitoring of the radiation sterilization of medical devices. It is applicable to continuous and batch type gamma irradiators using the radionuclides 60Co or 137Cs and to irradiators using electrons, at or below an energy level of 10 MeV, generated from machine sources. 1.2 This European Standard specifies the requirements which ensure that a predetermined dose is consistently absorbed by product presented to the sterilization process. 1.3 This European Standard does not describe a quality assurance system for control of all stages of manufacture. Note: Attention is drawn to the standards for quality systems (see EN 46001 or EN 46002) which control all stages of manufacture including the sterilization process. It is not a requirement of this standard to have a complete quality stystem during manufacture but certain elements of such a system are required and these are normatively referenced at appropriate places in the text. 1.4 This European Standard covers the determination of the ma

Status : Withdrawn
Approval date : 11/29/2001
Publish date : 11/30/2001
Withdrawal date : 10/30/2006
Number of pages : 34
ICS : 11.080.01 Sterilization and desinfectation
Technical Committee : 377 - Medical devices

Relations with other standards: