EN ISO 8835-3:2009/A1:2010

Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007/AMD 1:2010)

2019-02-19 - JO - TC decision 17/2018  (BT N 11332 - BT C160/2018)  to remove this work item from the harmonisation process linked with the MDD (93/42/EEC) thereby removing the need for annex ZA and allowing the standard to be publish without change as EN ISO.
MINOR AMENDMENT!!!     MINOR AMENDMENT!!!     MINOR AMENDMENT!!!     MINOR AMENDMENT!!!
2010-05-10 EMA: Track changed into UAP as ISO decided to restart the process and to go directly to FDIS (see e-mail from Martine Gaillen-Guedy in WI folder).

Systeme für die Inhalationsanästhesie - Teil 3: Weiterleitungs- und Aufnahmesysteme von aktiven Anästhesiegas-Fortleitungssystemen (ISO 8835-3:2007/Amd.1:2010)

Systèmes d'anesthésie par inhalation - Partie 3: Systèmes de transfert et de réception des systèmes d'évacuation des gaz d'anesthésie (ISO 8835-3:2007/AMD 1:2010)

Inhalacijski anestezijski sistemi - 3. del: Sistemi za prenos in sprejem sistemov za odstranjevanje anestezijskih plinov (ISO 8835-3:2007/AMD 1:2010)

Amandma A1:2011 je dodatek k standardu SIST EN ISO 8835-3:2009
Ta del ISO 8835 določa zahteve za sisteme za prenos in sprejem sistemov za odstranjevanje anestezijskih plinov (AGSS), namenjene za zmanjšanje izpostavljenosti zdravstvenega osebja anestezijskim plinom in hlapom med tem, ko bolnikom nudijo varstvo (npr. pred prevelikim pretokom in pritiskom). Ta del ISO 8835 prav tako določa zahteve za sisteme za prenos in sprejem sistemov za odstranjevanje anestezijskih plinov, v katerih je napajalnik vgrajen v sistem za prenos in sprejem.

General Information

• Status: Withdrawn
• Publication Date: 14-Oct-2010
• Withdrawal Date: 11-Dec-2012
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 12-Dec-2012
• Completion Date: 12-Dec-2012
• 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 ISO 8835-3:2009/A1:2011 - Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007/AMD 1:2010)

Relations

• Replaced By: EN ISO 80601-2-13:2012 - Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
• Effective Date: 26-Dec-2012
• Amends: EN ISO 8835-3:2009 - Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)
• Effective Date: 27-Feb-2010

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8835-3:2009/kFprA1:2010
01-oktober-2010
Inhalacijski anestezijski sistemi - 3. del: Sistemi za prenos in sprejem sistemov za
odstranjevanje anestezijskih plinov (ISO 8835-3:2007/FDAM 1:2010)
Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active
anaesthetic gas scavenging systems (ISO 8835-3:2007/FDAM 1:2010)
Systeme für die Inhalationsanästhesie - Teil 3: Weiterleitungs- und Aufnahmesysteme
von aktiven Anästhesiegas-Fortleitungssystemen (ISO 8835-3:2007/FDAM 1:2010)
Systèmes d'anesthésie par inhalation - Partie 3: Systèmes de transfert et de réception
des systèmes d'évacuation des gaz d'anesthésie (ISO 8835-3:2007/FDAM 1:2010)
Ta slovenski standard je istoveten z: EN ISO 8835-3:2009/FprA1
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 8835-3:2009/kFprA1:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 8835-3:2009/kFprA1:2010

---------------------- Page: 2 ----------------------

SIST EN ISO 8835-3:2009/kFprA1:2010


EUROPEAN STANDARD
FINAL DRAFT
EN ISO 8835-3:2009
NORME EUROPÉENNE

EUROPÄISCHE NORM
FprA1
July 2010
ICS 11.040.10
English Version
Inhalational anaesthesia systems - Part 3: Transfer and
receiving systems of active anaesthetic gas scavenging systems
(ISO 8835-3:2007/FDAM 1:2010)
Systèmes d'anesthésie par inhalation - Partie 3: Systèmes Systeme für die Inhalationsanästhesie - Teil 3:
de transfert et de réception des systèmes d'évacuation des Weiterleitungs- und Aufnahmesysteme von aktiven
gaz d'anesthésie (ISO 8835-3:2007/FDAM 1:2010) Anästhesiegas-Fortleitungssystemen (ISO 8835-
3:2007/FDAM 1:2010)
This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 215.

This draft amendment A1, if approved, will modify the European Standard EN ISO 8835-3:2009. 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, Croatia, 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.



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: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8835-3:2009/FprA1:2010: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 8835-3:2009/kFprA1:2010
EN ISO 8835-3:2009/FprA1:2010 (E)
Contents Page
Foreword .3

2

---------------------- Page: 4 ----------------------

SIST EN ISO 8835-3:2009/kFprA1:2010
EN ISO 8835-3:2009/FprA1:2010 (E)
Foreword
This document (EN ISO 8835-3:2009/FprA1:2010) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215 “Respiratory
and anaesthetic equipment” the secretariat of which is held by BSI.
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 EU Directive(s).
Endorsement notice
The text of ISO 8835-3:2007/FDAM 1:2010 has been approved by CEN as a EN ISO 8835-
3:2009/FprA1:2010 without any modification.

3

---------------------- Page: 5 ----------------------

SIST EN ISO 8835-3:2009/kFprA1:2010

---------------------- Page: 6 ----------------------

SIST EN ISO 8835-3:2009/kFprA1:2010
FINAL ISO
AMENDMENT
DRAFT 8835-3:2007
FDAM 1

ISO/TC 121/SC 1
Inhalational anaesthesia systems —
Secretariat: ANSI
Part 3:
Voting begins on:
2
...

SLOVENSKI STANDARD
SIST EN ISO 8835-3:2009/A1:2011
01-januar-2011
Inhalacijski anestezijski sistemi - 3. del: Sistemi za prenos in sprejem sistemov za
odstranjevanje anestezijskih plinov (ISO 8835-3:2007/AMD 1:2010)
Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active
anaesthetic gas scavenging systems (ISO 8835-3:2007/AMD 1:2010)
Systeme für die Inhalationsanästhesie - Teil 3: Weiterleitungs- und Aufnahmesysteme
von aktiven Anästhesiegas-Fortleitungssystemen (ISO 8835-3:2007/AMD 1:2010)
Systèmes d'anesthésie par inhalation - Partie 3: Systèmes de transfert et de réception
des systèmes d'évacuation des gaz d'anesthésie (ISO 8835-3:2007/AMD 1:2010)
Ta slovenski standard je istoveten z: EN ISO 8835-3:2009/A1:2010
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 8835-3:2009/A1:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 8835-3:2009/A1:2011

---------------------- Page: 2 ----------------------

SIST EN ISO 8835-3:2009/A1:2011


EUROPEAN STANDARD
EN ISO 8835-3:2009/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2010
ICS 11.040.10
English Version
Inhalational anaesthesia systems - Part 3: Transfer and
receiving systems of active anaesthetic gas scavenging systems
(ISO 8835-3:2007/AMD 1:2010)
Systèmes d'anesthésie par inhalation - Partie 3: Systèmes Systeme für die Inhalationsanästhesie - Teil 3:
de transfert et de réception des systèmes d'évacuation des Weiterleitungs- und Aufnahmesysteme von aktiven
gaz d'anesthésie (ISO 8835-3:2007/AMD 1:2010) Anästhesiegas-Fortleitungssystemen (ISO 8835-
3:2007/AMD 1:2010)
This amendment A1 modifies the European Standard EN ISO 8835-3:2009; it was approved by CEN on 14 October 2010.

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. Up-to-date lists and bibliographical references concerning such
national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This amendment exists 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8835-3:2009/A1:2010: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 8835-3:2009/A1:2011
EN ISO 8835-3:2009/A1:2010 (E)
Contents Page
Foreword .3
Annex ZA .4

2

---------------------- Page: 4 ----------------------

SIST EN ISO 8835-3:2009/A1:2011
EN ISO 8835-3:2009/A1:2010 (E)
Foreword
This document (EN ISO 8835-3:2009/A1:2010) has been prepared by Technical Committee ISO/TC 121
“Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) in
collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat
of which is held by BSI.
This Amendment to the European Standard EN ISO 8835:2009 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by April 2011, and
conflicting national standards shall be withdrawn at the latest by April 2011.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
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 EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integra
...