EN 13060:2014/prA1:2017

Small steam sterilizers

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).

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: 4060 - Closure of enquiry - Enquiry
• Start Date: 15-Feb-2018
• Due Date: 03-Apr-2018
• Completion Date: 15-Feb-2018
• Directive: 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 13060:2015/oprA1:2018 - Small steam sterilizers

Relations

• Merged Into: EN 13060:2014+A1:2018 - Small steam sterilizers
• Effective Date: 06-Jun-2018
• Amends: EN 13060:2014 - Small steam sterilizers
• Effective Date: 08-Mar-2017

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 13060:2015/oprA1:2018
01-januar-2018
Mali parni sterilizatorji
Small steam sterilizers
Dampf-Klein-Sterilisatoren
Petits stérilisateurs à la vapeur d'eau
Ta slovenski standard je istoveten z: EN 13060:2014/prA1:2017
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
SIST EN 13060:2015/oprA1:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 13060:2015/oprA1:2018

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SIST EN 13060:2015/oprA1:2018


DRAFT
EUROPEAN STANDARD
EN 13060:2014
NORME EUROPÉENNE

EUROPÄISCHE NORM
prA1
November 2017
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 A1, if approved, will modify the European Standard EN 13060:2014. 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-CENELEC
Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey 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.


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