logo

Standards Manage Your Business

We Manage Your Standards

ISO

ISO 11135:1994

Medical devices — Validation and routine control of ethylene oxide sterilization

Standard Details

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.

General Information

Status : WITHDRAWN
Standard Type: Main
Document No: ISO 11135:1994
Document Year: 1994
Pages: 24
Edition: 1
  • Section Volume:
  • ISO/TC 198. Sterilization of health care products
  • ICS:
  • 11.080.01 Sterilization and disinfection in general

Life Cycle

Published

Currently Viewing

WITHDRAWN
ISO 11135:1994
Knowledge Corner

Expand Your Knowledge and Unlock Your Learning Potential - Your One-Stop Source for Information!

© Copyright 2024 BSB Edge Private Limited.

Enquire now +