iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CEN

EN 13060:2004/FprA2

(Amendment)

Small steam sterilizers

Small steam sterilizers

2009-08-04 EMA: Missing 3-year timeframe added.

Dampf-Klein-Sterilisatoren

Petits stérilisateurs à la vapeur d'eau

Mali parni sterilizatorji

General Information

Status
Not Published
ICS
11.080.10 - Sterilizing equipment
Technical Committee
CEN/TC 102 - Sterilizers for medical purposes
Drafting Committee
CEN/TC 102/WG 5 - Small sterilizers
Current Stage
5060 - Closure of Vote - Formal Approval
Start Date
05-Jan-2010
Due Date
16-Feb-2011
Completion Date
05-Jan-2010
Directive
2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN 13060:2005/kprA2:2010 - Small steam sterilizers

Relations

Merged Into
EN 13060:2004+A2:2010 - Small steam sterilizers
Effective Date
19-Jan-2023
Amends
EN 13060:2004+A1:2009 - Small steam sterilizers
Effective Date
21-Nov-2009
Amends
EN 13060:2004 - Small steam sterilizers
Effective Date
22-Dec-2008

Buy Standard

EN 13060:2005/oprA2:2009EN 13060:2005/oprA2:2009
PreviousNext
Draft
EN 13060:2005/oprA2:2009
English language
5 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)


SLOVENSKI STANDARD
SIST EN 13060:2005/oprA2:2009
01-april-2009
Mali parni sterilizatorji
Small steam sterilizers
Dampf-Klein-Sterilisatoren
Petits stérilisateurs à la vapeur d'eau
Ta slovenski standard je istoveten z: EN 13060:2004/prA2
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
SIST EN 13060:2005/oprA2:2009 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST EN 13060:2005/oprA2:2009
SIST EN 13060:2005/oprA2:2009
EUROPEAN STANDARD
DRAFT
EN 13060:2004
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA2
February 2009
ICS 11.080.10
English Version
Small steam sterilizers
Petits stérilisateurs à la vapeur d'eau Dampf-Klein-Sterilisatoren
This draft amendment is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 102.
This draft amendment A2, if approved, will modify the European Standard EN 13060:2004. If this draft becomes an amendment, CEN
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment
into the relevant national standard without any alteration.
This draft amendment was established by CEN in three official versions (English, French, German). A version in any other language made
by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13060:2004/prA2:2009: E
worldwide for CEN national Members.

SIST EN 13060:2005/oprA2:2009
EN 13060:2004/prA2:2009 (E)
Contents Page
Foreword .3
1 Addition in Foreword .4
2 Modification concerning the whole standard .4
3 Modification to clause 3 .
...

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

CEN
EN 285:2015+A1:2021(Main)
Sterilization - Steam sterilizers - Large sterilizers
SIST EN 285:2016+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
CEN
EN ISO 15883-5:2021(Main)
Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (ISO 15883-5:2021)
SIST 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
CEN
EN ISO 15883-4:2018(Main)
Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2018)
SIST EN ISO 15883-4:2019

This document specifies the particular requirements, including performance criteria for washer-disinfectors (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
CEN
EN 13060:2014+A1:2018(Main)
Small steam sterilizers
SIST EN 13060:2015+A1:2019

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
CEN
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)
SIST EN ISO 15883-7:2016

ISO 15883-7:2016 specifies the particular requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as the following:
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.
ISO 15883-7:2016 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, ISO 15883‑3, ISO I5883-4, and ISO 15883‑6 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 requalifications 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 reusable 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
CEN
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)
SIST 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
CEN
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)
SIST EN ISO 15883-1:2009/A1:2014

2013-08-02 EMA: Draft for // vote received in ISO/CS (see notification of 2013-08-02 in dataservice).
2012-02-14 EMA: WI allocated to WG 8 as per TC secretary request.
2012-01-06 EMA: Draft for // ENQ received in ISO/CS (see notification of 2011-12-06 in dataservice).

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

This European Standard 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
CEN
EN 1422:2014(Main)
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
SIST EN 1422:2014

This European Standard 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.
This European Standard does not specify those tests which are necessary to determine the probability of a processed product being sterile, nor the routine quality control tests required prior to release of sterile product. These topics are addressed in prEN ISO 11135:2012.
This European Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities.
NOTE 1   For further information on safety, see examples in the Bibliography. National or regional regulations can exist.
This European Standard does not cover sterilizers which employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber.
NOTE 2   See EN ISO 14937.
This European Standard is not intended as a checklist for suitability of an existing EO sterilizer when assessing compliance with prEN ISO 11135:2012. This standard is not intended to be applied retrospectively.
This European Standard does not cover analytical methods for determining levels of residual EO and/or its reaction products.
NOTE 3   For further information see ISO 10993 7.

  • Standard
    49 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
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)
SIST EN ISO 15883-3:2009

ISO 15883-3:2006 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.
ISO 15883-3:2006 is to be applied in conjunction with ISO 15883-1.

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