EN 285:2006/prA2

Sterilization - Steam sterilizers - Large sterilizers

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: 04-Mar-2009
• Completion Date: 04-Mar-2009
• 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
• 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 285:2006/kprA2:2009 - Sterilization - Steam sterilizers - Large sterilizers

Relations

• Merged Into: EN 285:2006+A2:2009 - Sterilization - Steam sterilizers - Large sterilizers
• Effective Date: 19-Jan-2023
• Amends: EN 285:2006 - Sterilization - Steam sterilizers - Large sterilizers
• Effective Date: 22-Dec-2008

Overview

EN 285:2006/prA2 is a draft amendment to the European standard EN 285:2006, prepared by CEN/TC 102 for steam sterilizers - specifically large sterilizers used for medical purposes. This prA2 document (December 2008 draft) proposes targeted editorial and normative changes to the published standard and to its conformity mapping with European Directives. It is distributed for review under the CEN Unique Acceptance Procedure and is intended to support essential requirements of EC Directive(s).

Key topics and technical changes

• Scope: Amendment to EN 285:2006 addressing large steam sterilizers (sterilizing equipment for medical use).
• Document status: prA2 is a draft amendment (not yet a final European Standard until accepted).
• Table modifications:
  • Changes in Table A.1: specific replacements (e.g., references in column "stage A" and "stage C" where "Table D.1" is replaced by "Table E.1", and a reference changed from "5.2.4" to "5.2.2.2").
  • Changes in Table ZA.1: amendments to how Essential Requirements (ERs) are listed - for example, ER 12 is amended to exclude 12.1a), ER 13 is amended with an exception and a qualifying note that part of ER 13.3 a) is only partly addressed.
• Regulatory mapping:
  • Addition of entries to Table ZA.1 identifying which Essential Requirements of Directive 93/42/EEC are not or only partly addressed by the standard (e.g., 12.1a) and 13.6q) not addressed; 13.3 a) partly addressed).
  • Addition of Table ZA.2, which maps clauses of EN 285 to the Essential Health and Safety Requirements (EHSRs) of Directive 2006/42/EC (Machinery). Each row indicates whether the EHSR is addressed, partly addressed, or not addressed by the standard.

Practical applications and users

• Manufacturers of large steam sterilizers will use EN 285 (and its amendments) to align product design and documentation with European expectations for sterilization equipment.
• Regulatory and conformity assessment bodies rely on Table ZA mappings to evaluate compliance with Directive 93/42/EEC (medical devices) and to consider aspects relevant to Directive 2006/42/EC (machinery).
• Test laboratories, hospital engineering departments, and procurement teams use the standard and its amendments when validating equipment performance, specifying procurement requirements, or assessing conformity claims.

Related standards and references

• Directive 93/42/EEC (Medical Devices) - Essential Requirements mapping in Table ZA.1
• Directive 2006/42/EC (Machinery) - EHSR mapping added as Table ZA.2
• Prepared by CEN/TC 102 (Sterilizers for medical purposes)

Keywords: EN 285:2006/prA2, steam sterilizers, large sterilizers, CEN, medical device directive, machinery directive, essential requirements, sterilization standard, conformity mapping.

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2009
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 285:2006/prA2
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
FINAL DRAFT
EN 285:2006
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA2
December 2008
ICS 11.080.10
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 unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 102.
This draft amendment A2, 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 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.
: 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
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 285:2006/prA2:2008: E
worldwide for CEN national Members.

Contents Page
Foreword .3
1 Modifications to Table A.1 .4
2 Modifications to Table ZA.1 .4

Foreword
This document (EN 285:2006/prA2:2008) 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 Unique Acceptance Procedure.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive(s).
For relationship with EC Directive(s), see informative Annex ZA, which is an integral part of this document.
1 Modifications to Table A.1
In column "stage A", rows 1,2, 5 and 7, replace "Table D.1" with "Table E.1".
In column "stage C", row 4, replace "5.2.4" with "5.2.2.2".
In column "stage C", rows 5 and 7, replace "Table D.1" with "Table E.1".
2 Modifications to Table ZA.1
Where Essential Requirement 12 is listed, amend to read "12 [except, 12.1a)]".
Where Essential Requirement 13 is listed, amend to read "13 [except 13.6q)]" and add the following to column
"Qualifying remarks/Notes":
"the relevant Essential Requirement 13.3 a) is partly addressed".

Add the following rows to Table ZA.1:
"
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
- 12.1a) This relevant Essential
Requirement is not
addressed in this European
Standard
12.2, 26.3 g) 13.3 a) This relevant Essential
Requirement is partly
addressed in this Eu
...