Hello. Sign In
Standards Store
Look Inside

CSA Z11138-1

1st Edition, January 1, 2007

Complete Document

Sterilization of health care products - Biological indicators - Part 1: General requirements

Includes all amendments and changes through Reaffirmation Notice , 2016


Detail Summary

Superseded By: CSA ISO 11138-1

EN
Additional Comments:
W/D S/S BY CSA ISO 11138-1
Format
Details
Price (USD)
Secure PDF
Single User
$294.00
Print
In Stock
$294.00
Add to Cart

Product Details:

  • Revision: 1st Edition, January 1, 2007
  • Published Date: January 2016
  • Status: Superseded By:
  • Superseded By: CSA ISO 11138-1
  • Document Language: English
  • Published By: CSA Group (CSA)
  • Page Count: 56
  • ANSI Approved: No
  • DoD Adopted: No

Description / Abstract:

General 

This part of ISO 11138 provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes. 

This part of ISO 11138 specifies basic and common requirements that are applicable to all subsequent parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of ISO 11138. If no specific subsequent part is provided, this part applies.

NOTE National or regional regulations may apply.
CSA B51