ISO 11135:2014/Amd 1:2018

Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Annex E, Single batch release

Stérilisation des produits de santé — Oxyde d'éthylène — Exigences de développement, de validation et de contrôle de routine d'un processus de stérilisation pour des dispositifs médicaux — Amendement 1: Révision de l'Annexe E, Libération d'un lot unique

Date:

2018-10-15 / Published

ICS:

11.080.01 - Sterilization and disinfection in general. Including sterilization methods, air quality of surgery rooms, etc.

Committee:

ISO/TC 198 - Sterilization of health care products

Relación con otras normas ISO:

Modifica a: ISO 11135:2014

Es anulada por: ISO/DIS 11135

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