iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
SIST

SIST EN 866-5:2000

(Main)

Biological systems for testing sterilizers and sterilization processes - Part 5: Particular systems for use in low temperature steam and formaldehyde sterilizers

Biological systems for testing sterilizers and sterilization processes - Part 5: Particular systems for use in low temperature steam and formaldehyde sterilizers

This part of EN 866 specifies requirements for inoculated carriers and biological indicators intended for use in assessing the performance of sterilizers employing low temperature steam and formaldehyde as the sterilant over a sterilizing temperature range of 55° C to 80° C.

Biologische Systeme für die Prüfung von Sterilisatoren und Sterilisationsverfahren - Teil 5: Spezielle Systeme für den Gebrauch in Sterilisatoren mit Niedertemperatur-Dampf und Formaldehyd

Dieser Teil von EN 866 legt die Anforderungen an beimpfte Keimträger und biologische Indikatoren fest, die für die Beurteilung der Leistungsfähigkeit von Sterilisatoren vorgesehen sind, die mit Niedertemperatur-Dampf und Formaldehyd als Sterilisiermittel bei Sterilisationstemperaturen zwischen 55° C und 80° c arbeiten.

Systemes biologiques pour l'essai des stérilisateurs et les procédés de stérilisation - Partie 5: Systemes particuliers destinés a etre utilisés dans des stérilisateurs a la vapeur d'eau et au formaldéhyde a basse température

La présente partie de la norme EN 866 spécifie les exigences pour les porte-germes inoculés et les indicateurs biologiques dont l'utilisation est prévue pour l'évaluation de la performance de stérilisateurs employant de la vapeur et du formaldéhyde a basse température comme agent de stérilisation sur une plage de température de stérilisation comprise entre 55° C et 80 °C.

Biološki sistemi za preskušanje sterilizatorjev in sterilizacijskih postopkov - 5. del: Posebni sistemi za uporabo sterilizacije s paro nizke temperature in s formaldehidom

General Information

Status
Withdrawn
Publication Date
30-Jun-2000
Withdrawal Date
31-Aug-2006
ICS
11.080.10 - Sterilizing equipment
Technical Committee
VAZ - Healthcare
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
01-Sep-2006
Due Date
01-Sep-2006
Completion Date
01-Sep-2006
Ref Project
EN 866-5:1999 - Biological systems for testing sterilizers and sterilization processes - Part 5: Particular systems for use in low temperature steam and formaldehyde sterilizers

Relations

Replaced By
SIST EN ISO 11138-5:2006 - Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2006)
Effective Date
01-Sep-2006

Buy Standard

EN 866-5:2000EN 866-5:2000
PreviousNext
Standard
EN 866-5:2000
English language
8 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 866-5:2000
01-julij-2000
Biološki sistemi za preskušanje sterilizatorjev in sterilizacijskih postopkov - 5. del:
Posebni sistemi za uporabo sterilizacije s paro nizke temperature in s
formaldehidom
Biological systems for testing sterilizers and sterilization processes - Part 5: Particular
systems for use in low temperature steam and formaldehyde sterilizers
Biologische Systeme für die Prüfung von Sterilisatoren und Sterilisationsverfahren - Teil
5: Spezielle Systeme für den Gebrauch in Sterilisatoren mit Niedertemperatur-Dampf
und Formaldehyd
Systemes biologiques pour l'essai des stérilisateurs et les procédés de stérilisation -
Partie 5: Systemes particuliers destinés a etre utilisés dans des stérilisateurs a la vapeur
d'eau et au formaldéhyde a basse température
Ta slovenski standard je istoveten z: EN 866-5:1999
ICS:
11.080.10 Sterilizacijska oprema Sterilizin
...

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 EN 285:2016+A1:2021(Main)
Sterilization - Steam sterilizers - Large sterilizers
EN 285:2015+A1:2021

This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads.
This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l.
Large steam sterilizers can also be used during the commercial production of medical devices.
This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues.
This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.
NOTE 1   Attention is drawn to the standards for quality management systems e.g. EN ISO 13485.
NOTE 2   Environmental aspects are addressed in Annex A.

  • Standard
    118 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 15883-5:2021(Main)
Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (ISO 15883-5:2021)
EN ISO 15883-5:2021

This document specifies procedures and test methods used to demonstrate the cleaning efficacy of
washer-disinfectors (WD) and their accessories intended to be used for cleaning of reusable medical
devices.
NOTE 1 The requirements can be used for washer-disinfectors intended for use with other articles used in the
context of medical, dental, laboratory, pharmaceutical and veterinary practice.
NOTE 2 This document does not apply to the activities to be performed by the manufacturers of reusable
medical devices.

  • Standard
    68 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    45 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 15883-4:2019(Main)
Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2018)
EN ISO 15883-4:2018

This document specifies the particular requirements, including performance criteria for washerdisinfectors
(WD) that are intended to be used for cleaning and chemical disinfection of thermolabile
endoscopes.
This document also specifies the performance requirements for the cleaning and disinfection of the
washer-disinfector and its components and accessories which can be required to achieve the necessary
performance criteria.
The methods, instrumentation and instructions required for type testing, works testing, validation
(installation, operational and performance qualification on first installation), routine control and
monitoring, and requalification of WD periodically and after essential repairs, are also specified.
NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of
activities covered by this document.
NOTE 2 WD complying with this document can also be used for cleaning and chemical disinfection of other
thermolabile re-usable medical devices for which the device manufacturer has recommended and validated this
method of disinfection.
WD complying with the requirements of this document are not intended for cleaning and disinfection
of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or
sterilized by thermal methods (see ISO 15883-1:2006+Amd 1:2014, 4.1.5).
The specified performance requirements of this document do not ensure the inactivation or removal of
the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
NOTE 3 If it is considered that prion protein might be present, particular care is needed in the choice of
cleaning agents and disinfectants to ensure that the chemicals used do not react with the prion protein and/or
other protein in a manner that can inhibit its removal or inactivation from the load or washer-disinfector.
NOTE 4 This document can be used by prospective purchasers and manufacturers as the basis of agreement
on the specification of the WD, manufacturers of endoscopes, cleaning products, and disinfecting products.

  • Standard
    95 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN 13060:2015+A1:2019(Main)
Small steam sterilizers
EN 13060:2014+A1:2018

This European Standard specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids.
This European Standard applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer.
This European Standard applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm).
The requirements concerning the quality management and risk management are addressed by other standards (e.g. EN ISO 13485, EN ISO 14971).
This European Standard does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products.
This European Standard does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases).
This European Standard does not specify requirements for the validation and routine control of sterilization by moist heat.
NOTE Requirements for the validation and routine control of sterilization by moist heat are given in EN ISO 17665-1.
This European Standard does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).

  • Standard
    84 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 15883-7:2016(Main)
Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment (ISO 15883-7:2016)
EN ISO 15883-7:2016

This part of ISO 15883 specifies the particular requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of re-usable items such as:
a) bedframes;
b) bedside tables;
c) transport carts;
d) containers;
e) surgical tables;
f) sterilization containers;
g) surgical clogs;
h) wheelchairs, aids for the disabled.
This Part of ISO 15883 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be necessary in order to achieve the required performance.
Devices identified within the Scopes of ISO 15883-2:2006, ISO 15883-3:2006, ISO I5883-4:2008, and ISO 15883-6:2011 do not fall within the scope of this part of ISO 15883.
In addition, the methods are specified as well as instrumentation and instructions required for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control and monitoring as well as re-validations required to be carried out periodically and after essential repairs.
NOTE WDs corresponding to this part of ISO 15883 can also be used for cleaning and chemical disinfection of other thermolabile and re-usable medical devices as recommended by the device manufacturer.
The performance requirements specified in this part of ISO 15883 may not ensure the inactivation or removal of the causative agent(s) (prion proteins) of Transmissible Spongiform Encephalopathies.

  • Standard
    47 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 15883-6:2015(Main)
Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment (ISO 15883-6:2011)
EN ISO 15883-6:2015

ISO 15883-6:2011 specifies particular requirements for washer-disinfectors (WDs) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which gives general requirements for WDs.
The range of products on which WDs of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces).

  • Standard
    22 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN 14180:2014(Main)
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
EN 14180:2014

EN 14180 specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only. These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities. This European Standard specifies minimum requirements: - for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; - for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.

  • Standard
    61 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 15883-1:2009/A1:2014(Amendment)
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006/Amd 1: 2014)
EN ISO 15883-1:2009/A1:2014

This part of ISO 15883 specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as for the accessories which can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs, are also specified. The requirements for washer-disinfectors intended to process specific loads are specified in subsequent parts of this standard. For washer-disinfectors intended to process loads of two or more different types the requirements of all relevant parts of this standard apply. This part of ISO 15883 does not specify requirements intended for machines for use for laundry or general catering purposes. This part of ISO 15883 does not include requirements for machines which are intended to sterilize the load, or which are designated as "sterilizers", these are specified in other standards e.g. EN 285. The specified performance requirements of this standard may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. This part of ISO 15883 may be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a WD. The test methods for demonstration of compliance with the requirements of this part of ISO 15883 may also be employed by users to demonstrate continued compliance of the installed WD throughout its working life. Guidance on a routine test programme is given in Annex A.

  • Amendment
    16 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN 1422:2014(Main)
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
EN 1422:2014

EN 1422 specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories. This European Standard specifies requirements for ethylene oxide sterilizers (EO-sterilizers) working at super or sub-atmospheric pressure for: - the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; - the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes. The test loads described in this European Standard are selected to represent a number of loads for the evaluation of the performance of EO sterilizers for medical devices. However, specific loads may require the use of other test loads.

  • Standard
    49 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 15883-3:2009(Main)
Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)
EN ISO 15883-3:2009

This part of ISO 15883 specifies particular requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, cleaning and thermal disinfection of containers used to hold human waste for disposal by one operating cycle. This part of ISO 15883 is to be applied in conjunction with ISO 15883-1.

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