CSA ISO 11135 : 1998:R2003

Superseded

MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION

Available format(s)

Hardcopy , PDF

Superseded date

01-03-2009

Language(s)

French

Published date

01-01-2003

Publisher

Canadian Standards Association

1 Scope
2 Normative references
3 Definitions
4 General
   4.1 Personnel
   4.2 Process development and product compatibility
   4.3 Sterilization process
   4.4 Equipment
   4.5 Calibration
   4.6 Maintenance
5 Validation
   5.1 General
   5.2 Commissioning
   5.3 Performance qualification - physical
   5.4 Performance qualification - microbiological
   5.5 Certification of validation
   5.6 Revalidation
6 Process control and monitoring
7 Product release
   7.1 Conventional product release
   7.2 Parametric release
Annexes
A General aspects of sterilization
B Validation
C Process control and monitoring [6]
D Product release [7]

Specifies guidance and requirements for routine control and validation of ethylene oxide sterilization processes for medical devices.

DevelopmentNote	Supersedes CSA Z314.5 (06/2006)
DocumentType	Standard
Pages	41
PublisherName	Canadian Standards Association
Status	Superseded
Supersedes	CSA Z314.5 : 0 CSA ISO 11135 : 1998

Standards	Relationship
ISO 11135:2014	Identical

CSA Z10651-5 : 2008 : R2013	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS
CSA Z10651-5 : 2008 : INC : UPD 1 : 2011	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS
CSA Z8638 : 2008	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - EXTRACORPOREAL BLOOD CIRCUIT FOR HAEMODIALYSERS, HAEMODIAFILTERS AND HAEMOFILTERS
CSA Z10651-5 : 2008	LUNG VENTILATORS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - PART 5: GAS-POWERED EMERGENCY RESUSCITATORS
CSA Z10651-5 : 2008 : R2018	Lung Ventilators for Medical Use - Particular Requirements for Basic Safety and Essential Performance - Part 5: Gas-Powered Emergency Resuscitators
CSA Z8637 : 2008	CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HAEMODIALYSERS, HAEMODIAFILTERS, HAEMOFILTERS AND HAEMOCONCENTRATORS

ISO 9002:1994	Quality systems — Model for quality assurance in production, installation and servicing
ISO 9004:2009	Managing for the sustained success of an organization A quality management approach
ISO 10993-7:2008	Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
ISO 9001:2015	Quality management systems — Requirements
ISO 11138-1:2017	Sterilization of health care products — Biological indicators — Part 1: General requirements

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CSA ISO 11135 : 1998:R2003

Superseded

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referenced By This Book

Standards Referencing This Book

Category

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