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SRPS ISO 11135:1998

Medical devices — Validation and routine control of ethylene oxide sterilization

Mar 17, 1998
Mar 17, 1998
95.99   Withdrawal of Standard   Jan 31, 2019

General information

95.99     Jan 31, 2019

ISS

Z076

International Standard

11.080.01  

Serbian  

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Scope

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.

Life cycle

NOW

WITHDRAWN
SRPS ISO 11135:1998
95.99 Withdrawal of Standard
Jan 31, 2019

REVISED BY

PUBLISHED
SRPS EN ISO 11135:2015

Related project

Adopted from ISO 11135:1994