Norm

NEN-EN-ISO 11137-2:2004 Ontw. en

Sterilisatie van producten voor de gezondheidszorg - Radiatie - Deel 2: Vaststellen van de sterilisatiedosering

  • Deze norm is ingetrokken sinds 15-05-2006

44,69

Over deze norm

Status Ingetrokken
Aantal pagina's 67
Gepubliceerd op 01-05-2004
Taal Engels
This International Standard describes methods of 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. This International Standard also describes methods of dose auditing to demonstrate the continued effectiveness of the sterilization dose. While the dose setting and dose substantiation methods described in this International Standard meet the requirements specified in 8.2 of the International Standard 11137-1, other methods that also meet these requirements may be used. For this reason, International Standard 11137-2 is considered "informative." The use of the terms "shall", "should", etc. should be considered within the context of this Standard only; that is, if the decision is made to use one of the methods, then the method has to be followed in its entirety in adherence with the requirements ("shall") and with due consideration of the recommendations ("should") as set forth in this International Standard.

Details

ICS-code 11.080.01
Nederlandse titel Sterilisatie van producten voor de gezondheidszorg - Radiatie - Deel 2: Vaststellen van de sterilisatiedosering
Engelse titel Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
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Normatieve verwijzingen
  • 98/79/EG, In vitro diagnostica

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