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CEN

EN ISO 7396-1:2007/A3:2013

(Amendment)

Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum - Amendment 3: Terminology relating to alarm systems (ISO 7396-1:2007/Amd 3:2013)

Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum - Amendment 3: Terminology relating to alarm systems (ISO 7396-1:2007/Amd 3:2013)

2012-08-07 EMA: Draft for // vote received in ISO/CS (see notification of 2012-08-07 in dataservice).
DOW = DAV + 36 months
2011-07-07 GVN: Draft for // enquiry received in ISO/CS  (see notification of 2011-07-06 in dataservice)

Rohrleitungssysteme für medizinische Gase - Teil 1: Rohrleitungssysteme für medizinische Druckgase und Vakuum - Änderung 3: Terminologie für Alarmsysteme (ISO 7396-1:2007/Amd 3:2013)

Systèmes de distribution de gaz médicaux - Partie 1: Systèmes de distribution de gaz médicaux comprimés et de vide - Amendement 3: Terminologie relative aux systèmes d'alarme (ISO 7396-1:2007/Amd 3:2013)

Sistemi napeljav za medicinske pline - 1. del: Napeljave za stisnjene medicinske pline in podtlak - Terminologija v zvezi z alarmnimi sistemi - Dopolnilo A3 (ISO 7396-1:2007/Amd 3:2013)

Ta del ISO 7396 določa zahteve za načrt, namestitev, delovanje, dokumentacijo, preskušanje in usposobitev za zagon sistemov napeljav za stisnjene medicinske pline, pline za pogon kirurškega orodja in vakuum v zdravstvenih ustanovah, ki iz sistema napeljave zagotavljajo neprekinjeno oskrbo s pravim plinom in dovajanje vakuuma. Vključuje zahteve za sisteme oskrbe, cevovodne distribucijske sisteme, nadzorne sisteme, sisteme za spremljanje in alarm ter neizmenljivost med sestavnimi deli različnih plinskih sistemov. Ta del ISO 7396 velja za: a) sisteme napeljav za naslednje medicinske pline: - kisik; - dušikov oksid; - medicinski zrak; - ogljikov dioksid; - mešanice kisika/dušikovega oksida (glej Opombo 1); b) sisteme napeljav za naslednje pline: - s kisikom obogateni zrak; - zrak za pogon kirurškega orodja; - dušik za pogon kirurškega orodja; c) sisteme napeljav za vakuum. Ta del ISO 7396 velja tudi za: - podaljške obstoječih distribucijskih cevovodnih sistemov; - spremembe obstoječih distribucijskih cevovodnih sistemov; - spremembe ali zamenjavo sistemov oskrbe ali virov oskrbe.

General Information

Status
Withdrawn
Publication Date
05-Mar-2013
Withdrawal Date
15-Mar-2016
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
Completion Date
16-Mar-2016
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 7396-1:2007/A3:2013 - Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum - Terminology relating to alarm systems (ISO 7396-1:2007/Amd 3:2013)

Relations

Replaced By
EN ISO 7396-1:2016 - Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
Effective Date
23-Mar-2016
Amends
EN ISO 7396-1:2007 - Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)
Effective Date
08-Jun-2022

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Standards Content (Sample)


SLOVENSKI STANDARD
SIST EN ISO 7396-1:2007/oprA3:2011
01-december-2011
Sistemi napeljav za medicinske pline - 1. del: Napeljave za stisnjene medicinske
pline in podtlak - Dopolnilo A3 (ISO 7396-1:2007/DAM 3:2011)
Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases
and vacuum - Amendment 3 (ISO 7396-1:2007/DAM 3:2011)
Rohrleitungssysteme für medizinische Gase - Teil 1: Rohrleitungssysteme für
medizinische Druckgase und Vakuum (ISO 7396-1:2007/DAM 3:2011)
Systèmes de distribution de gaz médicaux - Partie 1: Systèmes de distribution de gaz
médicaux comprimés et de vide - Amendement 3: Terminologie relative aux systèmes
d'alarme (ISO 7396-1:2007/DAM 3:2011)
Ta slovenski standard je istoveten z: EN ISO 7396-1:2007/prA3
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 7396-1:2007/oprA3:2011 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST EN ISO 7396-1:2007/oprA3:2011

SIST EN ISO 7396-1:2007/oprA3:2011

EUROPEAN STANDARD
DRAFT
EN ISO 7396-1:2007
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA3
October 2011
ICS 11.040.10
English Version
Medical gas pipeline systems - Part 1: Pipeline systems for
compressed medical gases and vacuum - Amendment 3 (ISO
7396-1:2007/DAM 3:2011)
Systèmes de distribution de gaz médicaux - Partie 1: Rohrleitungssysteme für medizinische Gase - Teil 1:
Systèmes de distribution de gaz médicaux comprimés et
Rohrleitungssysteme für medizinische Druckgase und
de vide - Amendement 3: Terminologie relative aux Vakuum (ISO 7396-1:2007/DAM 3:2011)
systèmes d'alarme (ISO 7396-1:2007/DAM 3:2011)
This draft amendment is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee CEN/TC 215.

This draft amendment A3, if approved, will modify the European Standard EN ISO 7396-1:2007. 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, 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.

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
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7396-1:2007/prA3:2011: E
worldwide for CEN national Members.

SIST EN ISO 7396-1:2007/oprA3:2011
EN ISO 7396-1:2007/prA3:2011 (E)
Contents Page
Foreword .3

SIST EN ISO 7396-1:2007/oprA3:2011
EN ISO 7396-1:2007/prA3:2011 (E)
Foreword
This document (EN ISO 7396-1:2007/prA3:2011) 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 DIN.
This document is currently submitted to the parallel Enquiry.
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 7396-1:2007/DAM 3:2011 has been approved by CEN as a EN ISO 7396-1:2007/prA3:2011
without any modification.
SIST EN ISO 7396-1:2007/oprA3:2011

SIST EN ISO 7396-1:2007/oprA3:2011

DRAFT AMENDMENT ISO 7396-1:2007/DAM 3
ISO/TC 121/SC 6 Secretariat: ANSI
Voting begins on Voting terminates on

2011-10-06 2012-03-06
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION    МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ    ORGANISATION INTERNATIONALE DE NORMALISATION

Medical gas pipeline systems —
Part 1:
Pipeline systems for compressed medical gases and vacuum
AMENDMENT 3: Alarm system terminology
Systèmes de distribution de gaz médicaux —
Partie 1: Systèmes de distribution de gaz médicaux comprimés et de vide
AMENDEMENT 3: Terminologie relative aux systèmes d'alarme
ICS 11.040.10
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.

To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution,
...


SLOVENSKI STANDARD
01-junij-2013
Sistemi napeljav za medicinske pline - 1. del: Napeljave za stisnjene medicinske
pline in podtlak - Terminologija v zvezi z alarmnimi sistemi - Dopolnilo A3 (ISO
7396-1:2007/Amd 3:2013)
Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases
and vacuum - Terminology relating to alarm systems (ISO 7396-1:2007/Amd 3:2013)
Rohrleitungssysteme für medizinische Gase - Teil 1: Rohrleitungssysteme für
medizinische Druckgase und Vakuum (ISO 7396-1:2007/Amd 3:2013)
Systèmes de distribution de gaz médicaux - Partie 1: Systèmes de distribution de gaz
médicaux comprimés et de vide - Terminologie relative aux systèmes d'alarme (ISO
7396-1:2007/Amd 3:2013)
Ta slovenski standard je istoveten z: EN ISO 7396-1:2007/A3:2013
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 7396-1:2007/A3
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2013
ICS 11.040.10
English Version
Medical gas pipeline systems - Part 1: Pipeline systems for
compressed medical gases and vacuum - Terminology relating
to alarm systems (ISO 7396-1:2007/Amd 3:2013)
Systèmes de distribution de gaz médicaux - Partie 1: Rohrleitungssysteme für medizinische Gase - Teil 1:
Systèmes de distribution de gaz médicaux comprimés et Rohrleitungssysteme für medizinische Druckgase und
de vide - Terminologie relative aux systèmes d'alarme (ISO Vakuum (ISO 7396-1:2007/Amd 3:2013)
7396-1:2007/Amd 3:2013)
This amendment A3 modifies the European Standard EN ISO 7396-1:2007; it was approved by CEN on 9 February 2013.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 7396-1:2007/A3:2013: E
worldwide for CEN national Members.

Contents Page
Foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC . 4

Foreword
This document (EN ISO 7396-1:2007/A3:2013) 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 Amendment to the European Standard EN ISO 7396:2007 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by September 2013, and
conflicting national standards shall be withdrawn at the latest by March 2016.
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 integral part of this document.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: 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, Slovakia, Slovenia, Spain, Sweden, Switzerlan
...

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If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 4       Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2.
NOTE 5       See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. 
This document does not specify the requirements for:
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—    ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;
—    ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84;
—    ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72;
—    ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601‑2‑80;
—    sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;
—    high-frequency jet ventilators (HFJVs), which are given in ISO 80601‑2‑87;
—    high-frequency oscillatory ventilators (HFOVs);
—    respiratory high flow equipment, which are given in

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CEN
EN ISO 80601-2-80:2024(Main)
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2024)
SIST EN ISO 80601-2-80:2024

NOTE 1       There is guidance or rationale for this subclause contained in Clause AA.2.
This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.302, for ventilatory insufficiency, as defined in 201.3.302, hereafter also referred to as ME equipment, in combination with its accessories:
—    intended for use in the home healthcare environment;
NOTE 2     In the home healthcare environment, the supply mains driving the ventilatory support equipment is often not reliable.
NOTE 3     Such ventilatory support equipment can also be used in professional health care facilities.
—    intended for use by a lay operator;
—    intended for use with patients who have ventilatory insufficiency or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation;
—    intended for transit-operable use; and
—    not intended for patients who are dependent on artificial ventilation for their immediate life support.
EXAMPLE 1        Patients with moderate to severe chronic obstructive pulmonary disease (COPD), moderate amyotrophic lateral sclerosis (ALS), severe bronchopulmonary dysplasia or muscular dystrophy.
Ventilatory support equipment is not considered to use a physiologic closed-loop control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system of ventilatory support equipment for ventilatory insufficiency, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory insufficiency.
EXAMPLE 2        Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system.
If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 4       Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2.
NOTE 5       See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. 
This document does not specify the requirements for:
—    ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12;
—    ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;
—    ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84;
—    ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72;
—    ventilatory support equipment or accessories intended for ventilatory impairment, which are given in ISO 80601‑2‑79;
—    sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;
—    high-frequency jet ventilato

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EN ISO 5362:2024(Main)
Anaesthetic and respiratory equipment - Anaesthetic reservoir bags (ISO 5362:2024)
SIST EN ISO 5362:2024

This document specifies requirements for anaesthetic reservoir bags for use with anaesthetic and ventilator breathing systems. It includes requirements for the design of the neck, size designation and elasticity.
This document is not applicable to special-purpose bags, for example bellows, self-inflating bags and bags for use with anaesthetic gas scavenging systems.
The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190). All the common requirements that appear in the general standard for airway devices have been removed from this document.

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EN ISO 16571:2024(Main)
Systems for evacuation of plume generated by medical devices (ISO 16571:2024)
SIST EN ISO 16571:2024

This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.
 This document applies to all types of plume evacuation systems (PESs), including
a)       portable;
b)       mobile;
c)        stationary, including dedicated central pipelines;
d)       PESs integrated into other equipment;
e)       PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic)
This document applies to all healthcare facilities where PESs are used, including, but not limited to
a)       surgical facilities;
b)       medical offices;
c)        cosmetic treatment facilities;
d)       medical teaching facilities;
e)       dental clinics;
f)         veterinary facilities.
This document provides guidance on the following aspects of PESs:
a)       importance;
b)       purchasing;
c)        design;
d)       manufacture;
e)       documentation;
f)         function;
g)       performance;
h)       installation;
i)         commissioning;
j)         testing;
k)       training;
l)         use;
m)     risk assessment;
n)       servicing;
o)       maintenance.
This document does not apply to the following:
a)       anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;
b)       medical vacuum systems which are covered in ISO 7396-1;
c)        heating, ventilation, and air-conditioning (HVAC) systems;
d)       aspects of laser safety other than airborne contamination; and
e)       aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.

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EN ISO 15002:2024(Main)
Flow control devices for connection to a medical gas supply system (ISO 15002:2023)
SIST EN ISO 15002:2024

This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to:
a)    a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;
b)    the pressure outlet of a regulator conforming with ISO 10524-1:2018; or
c)    to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets).
This document applies to the following types of flow control devices (FCDs):
a)    flowmeters;
b)    flowgauge FCDs; and
c)    fixed orifice FCDs.
NOTE       Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1.
This document applies to flow control devices for the following gases:
—    oxygen;
—    oxygen 93 %;
—    nitrous oxide;
—    medical air;
—    carbon dioxide;
—    oxygen/nitrous oxide mixture 50/50 (% volume fraction);
—    oxygen-enriched air;
—    helium;
—    xenon; and
—    specified mixtures of the gases listed above.
NOTE Flow control devices can be available for other gases.
This document does not apply to flow control devices that are:
a)    for use with gases for driving surgical tools;
b)    an integral part of a regulator (see ISO 10524-1:2018); or
c)           an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).

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EN ISO 80601-2-55:2018/A1:2023(Amendment)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/Amd 1:2023)
SIST EN ISO 80601-2-55:2018/A1:2024
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