ISO 11135:1994

Medical devices — Validation and routine control of ethylene oxide sterilization

Datum objavljivanja: 27. 1. 1994.

95.99 Povučen 17. 7. 2008.

Опште информације

Trenutna faza: 95.99 Effective date: 17. 7. 2008.

Inicijator: ISO

Pripada: ISO/TC 198

Vrsta: Međunarodni standard

ICS: 11.080.01

Jezik: francuski engleski

Kupovina

Status: Povučen

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Apstrakt

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.