ISO 11135:1994

Medical devices — Validation and routine control of ethylene oxide sterilization

Датум објављивања: 27. 1. 1994.

95.99 Повучен 17. 7. 2008.

Опште информације

Тренутна фаза: 95.99 Effective date: 17. 7. 2008.

Иницијатор: ISO

Припада: ISO/TC 198

Врста: Међународни стандард

ICS: 11.080.01

Језик: француски енглески

Куповина

Статус: Повучен

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Апстракт

Establishes requirements and guidance. Particular attention is drawn to the need for specific testing for safety, quality and efficacy, possibly exceeding the general requirements, which may be necessary for a specific product. Attention is drawn to the existence in some countries of regulations laying down safety requirements for handling ethylene oxide and for premises in which it is used as well as of regulations laying down limits for the level of ethylene oxide residues within medical devices and products.