iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
SIST

SIST EN ISO 11140-3:2007/AC:2008

(Corrigendum)

Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007)

Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007)

Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Teil 3: Indikatorsysteme der Klasse 2 zur Verwendung im Bowie-Dick-Dampfdurchdringungstest (ISO 11140-3:2007)

Stérilisation des produits de santé - Indicateurs chimiques - Partie 3: Systèmes d'indicateurs de Classe 2 pour utilisation lors de l'essai de Bowie et Dick de pénétration de la vapeur (ISO 11140-3:2007)

Sterilizacija izdelkov za zdravstveno nego - Kemijski indikatorji - 3. del: Sistemi indikatorjev razreda 2 za uporabo pri Bowie-Dickovem preskusu prodiranja pare (ISO 11140-3:2007) - Popravek AC

General Information

Status
Withdrawn
Publication Date
07-Oct-2008
Withdrawal Date
14-May-2009
ICS
11.080.01 - Sterilization and disinfection in general
Technical Committee
VAZ - Healthcare
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
15-May-2009
Due Date
07-Jun-2009
Completion Date
15-May-2009
Ref Project
EN ISO 11140-3:2007/AC:2008 - Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007)

Relations

Replaced By
SIST EN ISO 11140-3:2009 - Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007)
Effective Date
01-Jul-2009
Corrects
SIST EN ISO 11140-3:2007 - Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007)
Effective Date
01-Nov-2008
Corrects
SIST EN ISO 11140-3:2007 - Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007)
Effective Date
08-Jun-2022

Buy Standard

EN ISO 11140-3:2007/AC:2008EN ISO 11140-3:2007/AC:2008
PreviousNext
Corrigendum
EN ISO 11140-3:2007/AC:2008
English language
3 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sterilizacija izdelkov za zdravstveno nego - Kemijski indikatorji - 3. del: Sistemi indikatorjev razreda 2 za uporabo pri Bowie-Dickovem preskusu prodiranja pare (ISO 11140-3:2007) - Popravek ACSterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Teil 3: Indikatorsysteme der Klasse 2 zur Verwendung im Bowie-Dick-Dampfdurchdringungstest (ISO 11140-3:2007)Stérilisation des produits de santé - Indicateurs chimiques - Partie 3: Systèmes d'indicateurs de Classe 2 pour utilisation lors de l'essai de Bowie et Dick de pénétration de la vapeur (ISO 11140-3:2007)Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007)11.080.01Sterilizacija in dezinfekcija na splošnoSterilization and disinfection in generalICS:Ta slovenski standard je istoveten z:EN ISO 11140-3:2007/AC:2008SIST EN ISO 11140-3:2007/AC:2008en01-november-2008SIST EN ISO 11140-3:2007/AC:2008SLOVENSKI
STANDARD



SIST EN ISO 11140-3:2007/AC:2008



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 11140-3:2007/ACSeptember 2008Septembre 2008September 2008ICS 11.080.01English versionVersion FrançaiseDeutsche FassungSterilization of health care products - Chemical indicators - Part 3: Class 2indicator systems for use in the Bowie and Dick-type steam penetration test(ISO 11140-3:2007)Stérilisation des produits de santé -Indicateurs chimiques - Partie 3: Systèmesd'indicateurs de Classe 2 pour utilisationlors de l'essai de Bowie et Dick depénétration de la vapeur (ISO 11140-3:2007)Sterilisation von Produkten für dieGesundheitsfürsorge - ChemischeIndikatoren - Teil 3: Indikatorsysteme derKlasse 2 zur Verwendung im Bowie-Dick-Dampfdurchdringungstest (ISO 11140-3:2007)This corrigendum becomes effective on 17 September 2008 for incorporation in the three officiallanguage versions of the EN.Ce corrigendum prendra effet le 17 s
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

SIST
SIST-TS CEN ISO/TS 11137-4:2023(Main)
Sterilization of health care products - Radiation - Part 4: Guidance on process control (ISO/TS 11137-4:2020)
CEN ISO/TS 11137-4:2023

This document provides additional guidance to that given in ISO 11137‑3 on meeting the requirements specified in ISO 11137‑1, ISO 11137‑2 and ISO/TS 13004 for the establishment and control of a radiation sterilization process using gamma, electron beam, and Xirradiation.

  • Technical specification
    64 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    61 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 11137-2:2015/A1:2023(Amendment)
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - Amendment 1 (ISO 11137-2:2013/Amd 1:2022)
EN ISO 11137-2:2015/A1:2023

2022-06-21 - lack of compliance - publication on hold

  • Amendment
    13 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    14 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 13004:2023(Main)
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD (ISO 13004:2022)
EN ISO 13004:2023

Adoption of ISO 13004:2022 – This is currently in FDIS and will be publishing in October 2022.
This document describes a method for substantiating a selected sterilization dose of 17,5,
20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 10−6 or less for radiation
sterilization of health care products. This Technical Specification also specifies a method of sterilization
dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.
NOTE Selection and substantiation of the sterilization dose is used to meet the requirements for establishing
the sterilization dose within process definition in ISO 11137-1.

  • Standard
    63 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    60 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 11140-6:2023(Main)
Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers (ISO 11140-6:2022)
EN ISO 11140-6:2022

This International Standard specifies the performance requirements and test methods for chemical indicators and hollow devices and porous devices within which they are intended to function, to be used for testing the steam penetration performance of type B cycles of small steam sterilizers; small steam sterilizers are defined in EN 13060. The hollow and porous devices described in this standard do not substantiate their suitability as surrogate devices for lumened, hollow and porous medical devices used in health care facilities.
Chemical indicators used with a porous device specified in this standard are designed to demonstrate the adequacy of steam penetration into a porous device in small steam sterilizers (see EN 13060).
The relevant sections of this International Standard covering porous loads specify the requirements for
— a reference porous device to be used in the small load test for porous loads in small steam sterilizers and as a reference device by which alternative porous devices can be shown to be equivalent in performance according to this standard; ie, a textile test pack in which steam penetration is judged by thermometric means;
— an alternative porous device equivalent in performance to the reference porous device; ie, an alternative porous device, usually commercially manufactured, of any design.
Chemical indicator systems used with a hollow load device specified in this standard are designed to demonstrate the adequacy of steam penetration into a hollow device in small steam sterilizers (see EN 13060).
The relevant sections of this International Standard covering hollow loads specify the requirements for
— a reference hollow device used as a reference device in this standard; ie, a lumened device with attached capsule in which steam penetration is judged by inactivation or survival of a specified biological indicator;
— an alternative hollow device employing the same specific test load as defined for the reference hollow device and an indicator system designed specifically for use in the reference hollow test load; ie, a lumened device with an attached capsule in which steam penetration is judged by visual examination of an indicator system;
— an alternative hollow device equivalent in performance to the reference hollow device; ie, an alternative hollow device, usually commercially manufactured, of any design.

  • Standard
    48 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    47 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 25424:2020/A1:2022(Amendment)
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)
EN ISO 25424:2019/A1:2022

2022-01-13 - TC decision is missing to skip FV - publication on hold.

  • Amendment
    15 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    11 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 17664-1:2021(Main)
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)
EN ISO 17664-1:2021

This document specifies requirements for the information to be provided by the medical device
manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that
enters normally sterile parts of the human body or a medical device that comes into contact with
mucous membranes or non-intact skin) or medical devices that are intended to be sterilized.
This includes information for processing prior to use or reuse of the medical device.
Processing instructions are not defined in this document. Rather, this document specifies requirements
to assist manufacturers of medical devices in providing detailed processing instructions that consist of
the following activities, where applicable:
a) initial treatment at the point of use;
b) preparation before cleaning;
c) cleaning;
d) disinfection;
e) drying;
f) inspection and maintenance;
g) packaging;
h) sterilization;
i) storage;
j) transportation.
This document excludes processing of the following:
— non-critical medical devices unless they are intended to be sterilized;
— textile devices used in patient draping systems or surgical clothing;
— medical devices specified by the manufacturer for single use only and supplied ready for use.
NOTE See ISO 17664-2:2021, Annex E, for further guidance on the application of the ISO 17664 series to a
medical device

  • Standard
    34 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    29 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 11138-8:2021(Main)
Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021)
EN ISO 11138-8:2021

1.1 This document specifies the requirements for a test method to be utilized to establish or confirm a reduced incubation time (RIT) that is shorter than the 7 day reference incubation time specified in 7.3.22 of ISO 11138-1:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes.
1.2 This document is applicable to manufacturers of biological indicators and to end users of biological indicators who intend to, if required by their quality system, establish, validate or confirm an RIT.
1.3 This document is not applicable to biological indicators used to monitor dry heat, low temperature steam formaldehyde (LTSF) or vaporized hydrogen peroxide (VH2O2) sterilization processes.
NOTE 1 The method described in this document to establish an RIT for biological indicators used to monitor moist heat or EO sterilization processes has been used extensively for many years. However, there is limited experience in use of this method to establish an RIT for biological indicators used to monitor dry heat, low temperature steam formaldehyde or vaporized hydrogen peroxide sterilization processes. This document, therefore, does not include these sterilization processes.
NOTE 2 For EO as a sterilizing agent, the stated RIT will be applicable for any EO cycle type, i.e. 100% EO, EO blends, etc.

  • Standard
    15 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    12 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 11737-1:2018/A1:2021(Amendment)
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)
EN ISO 11737-1:2018/A1:2021
  • Amendment
    13 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    4 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 13408-6:2021(Main)
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
EN ISO 13408-6:2021

This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products.
This document does not specify requirements for restricted access barrier systems (RABS).
This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions.
This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application.
This document does not define biosafety containment requirements.

  • Standard
    39 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    44 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 11737-2:2020(Main)
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)
EN ISO 11737-2:2020

EN-ISO 11737-2 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent which has been reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process. This document is not applicable to: a) sterility testing for routine release of product that has been subjected to a sterilization process, b) performing a test for sterility. c) test of sterility or test for sterility for demonstration of product shelf life, stability and/or package integrity, and d) culturing of biological indicators or inoculated products.

  • Standard
    35 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    28 pages
    English language
    sale 10% off
    e-Library read for
    1 day