Logo
Login Sign Up
Current Reaffirmation

CSA CAN/CSA-ISO 11138-1:17 (R2022)

Sterilization of health care products — Biological indicators — Part 1: General requirements (Adopted ISO 11138-1:2017, third edition, 2017-03)
Best Price Guarantee
Instant

$189.00

5-10 Days

$189.00

SAVE 10%

$340.20


Sub Total (1 Item(s))

$ 0.00

Estimated Shipping

$ 0.00

Total (Pre-Tax)

$ 0.00


View in Library
or
...
Sterilization of health care products — Biological indicators — Part 1: General requirements (Adopted ISO 11138-1:2017, third edition, 2017-03)
Scope

This document specifies 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 document specifies basic and common requirements that are applicable to all parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138. If no specific subsequent part is provided, this document applies. NOTE National or regional regulations can apply. This document does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.

SDO CSA: Canadian Standards Association
Document Number
Publication Date Jan. 1, 2017
Language en - English
Page Count 61
Revision Level
Supercedes
Committee
Loading...

Failed to load document history.

Publish Date Document Id Type View