EN 285:2006/prA1

Sterilization - Steam sterilizers - Large sterilizers

This amendment specifies a test method to demonstrate that at the levels at which the controls are set, air dilution from within the test piece is sufficient to permit even steam penetration into it.

Sterilisation - Dampf-Sterilisatoren - Groß-Sterilisatoren

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

Sterilizacija – Parni sterilizatorji – Veliki 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 3 - Requirements
• Current Stage: 5060 - Closure of Vote - Formal Approval
• Start Date: 01-Jan-2008
• Due Date: 01-Mar-2008
• Completion Date: 01-Jan-2008
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN 285:2006/oprA1:2006 - Sterilization - Steam sterilizers - Large sterilizers

Relations

• Amends: EN 285:2006 - Sterilization - Steam sterilizers - Large sterilizers
• Effective Date: 22-Dec-2008
• Merged Into: EN 285:2006+A1:2008 - Sterilization - Steam sterilizers - Large sterilizers
• Effective Date: 18-Jan-2023

Standards Content (Sample)

SLOVENSKI SIST EN 285:2006/oprA1:2006

PREDSTANDARD
september 2006
Sterilizacija – Parni sterilizatorji – Veliki sterilizatorji
Sterilization - Steam sterilizers - Large sterilizers
ICS 11.080.10 Referenčna številka
SIST EN 285:2006/oprA1:2006(en)
©  Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno

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EUROPEAN STANDARD
DRAFT
EN 285:2006
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
July 2006
ICS

English Version
Sterilization - Steam sterilizers - Large sterilizers
Stérilisation - Stérilisateurs à la vapeur d'eau - Grands Sterilisation - Dampf-Sterilisatoren - Groß-Sterilisatoren
stérilisateurs
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 285:2006. 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 Management Centre has the same status
as the official versions.
CEN members are the national standards bodies of Austria, Belgium, 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.
: This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
Warning
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
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 285:2006/prA1:2006: E
worldwide for CEN national Members.

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EN 285:2006/prA1:2006 (E)
Contents Page
Foreword.3
Revised text.3
2 Clause.3
8.3.5 Hollow load test .3
15 Hollow load test .4
15.1 General.4
15.2 Apparatus.4
15.3 Procedure.4

2

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EN 285:2006/prA1:2006 (E)
Foreword
This document (EN 285:2006/prA1:2006) has been prepared by Technical Committee CEN/TC 102
“Sterilizers for medical purposes”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
Revised text
2 Clause
Add
EN 867-5, Non-biological systems for use in sterilizers – Part 5: Specification for indicator systems and
process challenge devices for use in performance testing for small sterilizers type B and type S
7.1.13
Delete at the end of the first sentence "(e.g. the sterilization of instruments, textiles, rubber)"
8.1.3
replace the text of "NOTE 2" by the following
...