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EN 285:2015/FprA1

(Amendment)

Sterilization - Steam sterilizers - Large sterilizers

Sterilization - Steam sterilizers - Large sterilizers

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.

Sterilisation - Dampf-Sterilisatoren - Groß-Sterilisatoren

No Scope available

Stérilisation - Stérilisateurs à la vapeur d'eau - Grands stérilisateurs

No scope available

Sterilizacija - Parni sterilizatorji - Veliki sterilizatorji

General Information

Status
Not Published
Publication Date
24-Oct-2021
Withdrawal Date
23-Jan-2022
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
22-Apr-2021
Completion Date
22-Apr-2021
Directive
2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
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
M/565 - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
Ref Project
SIST EN 285:2016/kprA1:2020 - Sterilization - Steam sterilizers - Large sterilizers

Relations

Merged Into
EN 285:2015+A1:2021 - Sterilization - Steam sterilizers - Large sterilizers
Effective Date
19-Jan-2023
Amends
EN 285:2015 - Sterilization - Steam sterilizers - Large sterilizers
Effective Date
02-May-2018

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EN 285:2016/oprA1:2018EN 285:2016/oprA1:2018
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EN 285:2016/oprA1:2018
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SLOVENSKI STANDARD
SIST EN 285:2016/oprA1:2018
01-december-2018
Sterilizacija - Parni sterilizatorji - Veliki sterilizatorji
Sterilization - Steam sterilizers - Large sterilizers
Sterilisation - Dampf-Sterilisatoren - Groß-Sterilisatoren
Stérilisation - Stérilisateurs à la vapeur d'eau - Grands stérilisateurs
Ta slovenski standard je istoveten z: EN 285:2015/prA1:2018
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
SIST EN 285:2016/oprA1:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST EN 285:2016/oprA1:2018
SIST EN 285:2016/oprA1:2018
DRAFT
EUROPEAN STANDARD
EN 285:2015
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
September 2018
ICS 11.080.10
English Version
Sterilization - Steam sterilizers - Large sterilizers
Stérilisation - Stérilisateurs à la vapeur d'eau - Grands Sterilisation - Dampf-Sterilisatoren - Groß-
stérilisateurs 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 285:2015. 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.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 285:2015/prA1:2018:2018 E
worldwide for CEN national Members.

SIST EN 285:2016/oprA1:2018
EN 285:2015/prA1:2018 (E)
Contents Page
European foreword . 3
1 Modification to Clause 3, Terms and definitions . 4
2 Modification to 6.2, Measuring system . 4
3 Modification to 6.4.4, Pressure measuring chains for cont
...

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