Standards Worldwide
Standards Worldwide
Phone +49 30 58885700-07

Standard [CURRENT]

DIN EN ISO 11138-1:2017-07

Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017); German version EN ISO 11138-1:2017

German title
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 1: Allgemeine Anforderungen (ISO 11138-1:2017); Deutsche Fassung EN ISO 11138-1:2017
Publication date
2017-07
Original language
German
Pages
52

from 129.30 EUR VAT included

from 120.84 EUR VAT excluded

Format and language options

PDF download
  • 129.30 EUR

  • 155.30 EUR

  • 161.50 EUR

Shipment (3-5 working days)
  • 156.30 EUR

  • 195.10 EUR

Monitor with the Standards Ticker

This option is only available after login.
Easily subscribe: Save time and money now!

You can also subscribe to this document - together with other important standards in your industry. This makes your work easier and pays for itself after a short time.

Sparschwein_data
Subscription advantages
Sparschwein Vorteil 1_data

Important standards for your industry, regularly updated

Sparschwein Vorteil 2_data

Much cheaper than buying individually

Sparschwein Vorteil 3_data

Useful functions: Filters, version comparison and more

Publication date
2017-07
Original language
German
Pages
52
DOI
https://dx.doi.org/10.31030/2576964

Quick delivery via download or delivery service

Buy securely with a credit card or pay upon receipt of invoice

All transactions are encrypted

Overview

Biological indicator systems are used for testing sterilizers and for assessing the performance of sterilization processes. Part 1 of the DIN EN ISO 11138 series of standards specifies the general requirements for the manufacture and performance of biological indicator systems. The requirements are supplemented by test methods for determining the resistance of biological indicator systems. These include test methods for determining the live germ count, the D-value and the growth inhibition by germ carriers and packaging. For the determination of the D-value, procedures according to the fraction-negative method (Holcomb-Spearman-Karber, Stumbo-Murphy-Cochran, limited Stumbo-Murphy-Cochran method), procedures according to the survival curve and for the determination of the survival/kill range have been included. At least two of these methods shall be used. In addition, the standard contains specifications for the information to be provided by the manufacturer. Specific requirements for biological indicator systems for use in certain sterilization processes can be found in the other parts of this series of standards. These include - sterilization processes using ethylene oxide, in which ethylene oxide is used both as a pure gas and in mixtures with other gases; - sterilization processes with moist heat (saturated steam process); - sterilization process with dry heat; - sterilization process with low temperature steam and formaldehyde. The test germs to be used for the respective sterilization methods, the specific requirements for the suspensions, the germ carriers, the primary packaging for the biological indicators and for resistance are specified. The specific conditions for the test procedure to determine resistance have also been specified. The resistometers to be used for carrying out these test methods are specified in ISO 18472. The International Standard has been prepared by ISO/TC 198 "Sterilization of health care products" in collaboration with CEN/TC 102 "Sterilizers for medical purposes" (secretariat: DIN). The responsible German committee is Working Committee NA 063-04-08 AA "Indikatoren" ("Indicators") at DIN Standards Committee Medicine (NAMed).

Content
ICS
11.080.20
DOI
https://dx.doi.org/10.31030/2576964
Replacement amendments

Cooperation at DIN

Also available in
Loading recommended items...
Loading recommended items...
Loading recommended items...
Loading recommended items...