• There are no items in your cart

CSA Z11140.1 : 2007

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
Available format(s)

Hardcopy , PDF

Superseded date

07-14-2021

Language(s)

English

Published date

01-01-2012

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 General requirements
6 Performance requirements
7 Test methods
8 Additional requirements for process (Class 1) indicators
9 Additional requirements for single variable (Class 3)
   indicators
10 Additional requirements for multi-variable (Class 4)
   indicators
11 Additional requirements for steam integrating (Class 5)
   indicators
12 Additional requirements for dry heat integrating
   (Class 5) indicators
13 Additional requirements for ethylene oxide integrating
   (Class 5) indicators
14 Additional requirements for emulating (Class 6) indicators
Annex A - (informative) Method for demonstrating shelf life
          of the product
Annex B - (informative) Examples of testing indicators
Annex C - (informative) Rationale for the requirements for
          integrating indicators and the link to the requirements
          for biological indicators (BIs) specified in ISO
          11138 and microbial inactivation
Annex D - (informative) Rationale for the liquid-phase test method
          for steam-formaldehyde indicators
Annex E - (informative) Relationship of indicator components
Bibliography

Describes general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the variables required for a sterilization process.

DocumentType
Standard
Pages
46
ProductNote
Reconfirmed EN
PublisherName
Canadian Standards Association
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 11140-1:2014 Identical

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
EN 45014 : 1998 GENERAL CRITERIA FOR SUPPLIER'S DECLARATION OF CONFORMITY
ISO 15882:2008 Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
EN 285:2015 Sterilization - Steam sterilizers - Large sterilizers
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
EN 14180:2014 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
ISO 9001:2015 Quality management systems — Requirements
ISO 11607:2003 Packaging for terminally sterilized medical devices
ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
EN 1422:2014 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO/IEC Guide 22:1996 General criteria for supplier's declaration of conformity

View more information

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.