Back

EVS-EN ISO 11138-4:2017

Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)

General information
Valid from 18.04.2017
Base Documents
EN ISO 11138-4:2017; ISO 11138-4:2017
ICS Groups
11.080.01 Sterilization and disinfection in general
Directives or regulations
None

Standard history

Status
Date
Type
Name
18.04.2017
Main
EVS-EN ISO 11138-4:2017
07.09.2006
Main
EVS-EN ISO 11138-4:2006
This document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C.
NOTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 20857.
NOTE 2 Requirements for work place safety can be provided by national or regional regulations.
*
*
*
PDF
15.86 € incl tax
Paper
15.86 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring
English

Related products

Main

EVS-EN ISO 11737-2:2020

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
Newest version Valid from 02.06.2020
Main

EVS-EN 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 (ISO 11135:2014)
Newest version Valid from 04.08.2014
Amendment

EVS-EN ISO 11135:2014/A1:2019

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
Newest version Valid from 02.12.2019
Main

EVS-EN ISO 17664-1:2021

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
Newest version Valid from 16.09.2021

Customers who bought this item also bought

Main

EVS-EN ISO 11138-3:2017

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017)
Newest version Valid from 18.04.2017
Main

EVS-EN ISO 11138-2:2017

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2017)
Newest version Valid from 18.04.2017
Main

EVS-EN ISO 11138-1:2017

Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2017)
Newest version Valid from 18.04.2017
Main

EVS-EN ISO 11138-5:2017

Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017)
Newest version Valid from 18.04.2017

Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English

Contact

standard@evs.ee
+372 605 5060
Akadeemia tee 21/6, Tallinn, 12618, Estonia
Reg. code 80120020
Eesti Standardimis- ja Akrediteerimiskeskus MTÜ
E-N 8:30-17:00 R 8:30-16:00

Assistance in ordering

Direct links

Mastercard
Visa
Paypal
Swedbank
SEB
Luminor
LHV
Copyright © 2024 EVS. All rights reserved.