SIST EN ISO/IEC 80079-34:2020
(Main)Explosive atmospheres - Part 34: Application of quality systems for equipment manufacture (ISO/IEC 80079-34:2018)
Explosive atmospheres - Part 34: Application of quality systems for equipment manufacture (ISO/IEC 80079-34:2018)
This part of ISO/IEC 80079 specifies particular requirements and information for establishing and maintaining a quality system to manufacture Ex equipment productsincluding protective systems in accordance with the Ex certificate. While it does not preclude the use of other quality systems that are compatible with the objectives of ISO 9001:2008 2015 and which provide equivalent results, the minimum requirements shall be in accordance with this standard.
Explosionsgefährdete Bereiche - Teil 34: Anwendung von Qualitätsmanagementsystemen für die Herstellung von Ex-Produkten (ISO/IEC 80079-34:2018)
Dieses Dokument legt besondere Anforderungen an und Angaben für die Verwirklichung und Aufrechterhaltung von Qualitätsmanagementsystemen zur Herstellung von Ex Produkten in Übereinstimmung mit dem Zertifikat fest. Obwohl die Anwendung von anderen Qualitätsmanagementsystemen, die mit den Zielsetzungen der ISO 9001:2015 übereinstimmen und zu gleichwertigen Ergebnissen führen, nicht ausgeschlossen wird, werden die Mindestanforderungen in diesem Dokument angegeben.
Atmosphères explosives - Partie 34: Application des systèmes de qualité pour la fabrication d'équipements (ISO/IEC 80079-34:2018)
ISO/IEC 80079-34:2018 spécifie des exigences particulières et des informations destinées à établir et à maintenir un système de management de la qualité afin de fabriquer des produits Ex, conformément aux certificats existants. Même sil n'est pas incompatible avec l'utilisation d'autres systèmes de management de la qualité conciliables avec les objectifs de l'ISO 9001:2015 et donnant des résultats équivalents, le présent document indique les exigences minimales.
Cette deuxième édition annule et remplace la première édition, parue en 2011. Cette édition constitue une révision technique complète.
Il convient de considérer que les modifications importantes apportées à lédition précédente donnent lieu à une révision technique mineure. Toutefois, la numérotation des articles a été modifiée par rapport à lédition précédente afin dêtre conforme à lISO 9001:2015. Cest la raison pour laquelle, lhabituel « Tableau des modifications majeures » nest pas inclus.
Cette publication est publiée en tant que norme à double logo. Il convient dutiliser la présente norme conjointement avec l'ISO 9001:2015.
Eksplozivne atmosfere - 34. del: Uporaba sistemov kakovosti za izdelavo opreme (ISO/IEC 80079-34:2018)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO/IEC 80079-34:2020
01-junij-2020
Nadomešča:
SIST EN ISO/IEC 80079-34:2011
Eksplozivne atmosfere - 34. del: Uporaba sistemov kakovosti za izdelavo opreme
(ISO/IEC 80079-34:2018)
Explosive atmospheres - Part 34: Application of quality systems for equipment
manufacture (ISO/IEC 80079-34:2018)
Explosionsgefährdete Bereiche - Teil 34: Anwendung von
Qualitätsmanagementsystemen für die Herstellung von Ex-Produkten (ISO/IEC 80079-
34:2018)
Atmosphères explosives - Partie 34: Application des systèmes de qualité pour la
fabrication d'équipements (ISO/IEC 80079-34:2018)
Ta slovenski standard je istoveten z: EN ISO/IEC 80079-34:2020
ICS:
03.120.99 Drugi standardi v zvezi s Other standards related to
kakovostjo quality
13.230 Varstvo pred eksplozijo Explosion protection
SIST EN ISO/IEC 80079-34:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO/IEC 80079-34:2020
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SIST EN ISO/IEC 80079-34:2020
EN ISO/IEC 80079-34
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2020
EUROPÄISCHE NORM
ICS 29.260.20 Supersedes EN ISO/IEC 80079-34:2011
English Version
Explosive atmospheres - Part 34: Application of quality
systems for ex product manufacture (ISO/IEC 80079-
34:2018)
Atmosphères explosives - Partie 34: Application de Explosionsgefährdete Bereiche - Teil 34: Anwendung
systèmes de management de la qualité pour la von Qualitätsmanagementsystemen für die Herstellung
fabrication des produits Ex (ISO/CEI 80079-34:2018) von Ex-Produkten (ISO/IEC 80079-34:2018)
This European Standard was approved by CEN on 29 December 2019.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a 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 European Standard 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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO/IEC 80079-34:2020 E
worldwide for CEN national Members.
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SIST EN ISO/IEC 80079-34:2020
EN ISO/IEC 80079-34:2020 (E)
Contents Page
European foreword . 4
Annex ZA (normative) Normative references to international publications and the
corresponding European publications . 5
Annex ZB (informative) Information relevant to equipment and protective systems
according to standards harmonized under Directive 2014/34/EU . 6
ZB.1 Introduction . 6
ZB.2 Non-electrical equipment (EN 13463-1) . 6
ZB.3 Protection by flow restricting enclosure "fr" (EN 13463-2) . 6
ZB.4 Protection by flameproof enclosure "d" (EN 13463-3) . 6
ZB.5 Protection by constructional safety "c" (EN 13463-5) . 6
ZB.6 Protection by control of ignition sources "b" (EN 13463-6) . 6
ZB.7 Protection by pressurised enclosures "p" (EN 13463-7) . 6
ZB.8 Protection by liquid immersion "k" (EN 13463-8) . 7
ZB.9 Fans (EN 14986) . 7
ZB.9.1 General . 7
ZB.9.2 Material . 7
ZB.9.3 Assembled equipment and protective systems . 7
ZB.9.4 Routine tests . 7
ZB.10 Petrol dispensers (EN 13617-1) . 8
ZB.10.1 General . 8
ZB.10.2 Electrical installation . 8
ZB.10.3 Information for safe operation . 8
ZB.10.4 Assembly groups . 8
ZB.10.5 Assembling . 8
ZB.10.6 Monitoring equipment . 9
ZB.10.7 Electrostatic discharge capacity . 9
ZB.10.8 Routine tests . 9
ZB.11 Electrostatic spraying equipment . 9
ZB.11.1 General . 9
ZB.11.2 Electrical assembly . 10
ZB.11.3 Mechanical assembly . 11
ZB.11.4 Tests . 11
ZB.12 Protective systems . 12
ZB.12.1 General . 12
2
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EN ISO/IEC 80079-34:2020 (E)
ZB.12.2 Explosion resistant equipment (EN 14460) . 12
ZB.12.3 Explosion venting devices (EN 14797) . 12
ZB.12.4 Explosion isolation systems (EN 15089) . 13
ZB.12.5 Flameless explosion venting devices (EN 16009) . 14
ZB.12.6 Explosion diverters (EN 16020) . 14
ZB.12.7 Explosion isolation flap valves (EN 16447) . 15
Annex ZC (informative) Significant changes between these European Annexes and the
European Annexes of EN ISO/IEC 80079-34:2011 . 16
Annex ZD (informative) Relationship between this European Standard and the essential
requirements of 2014/34/EU [2014 OJ L96] aimed to be covered . 18
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SIST EN ISO/IEC 80079-34:2020
EN ISO/IEC 80079-34:2020 (E)
European foreword
The text of ISO/IEC 80079-34:2018 has been prepared by Technical Committee ISO/TMB "Technical
Management Board - groups” of the International Organization for Standardization (ISO) and has been
taken over as EN ISO/IEC 80079-34:2020 by Technical Committee CEN/TC 305 “Potentially explosive
atmospheres - Explosion prevention and protection” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by September 2020, and conflicting national standards
shall be withdrawn at the latest by March 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO/IEC 80079-34:2011.
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).
For relationship with EU Directives, see informative Annex ZA, ZB, ZC and ZD, which are 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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO/IEC 80079-34:2018 has been approved by CEN as EN ISO/IEC 80079-34:2020 without
any modification.
4
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EN ISO/IEC 80079-34:2020 (E)
Annex ZA
(normative)
Normative references to international publications and the corresponding
European publications
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
NOTE Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
Publication Year Title EN/HD Year
IEC 60050-426 — International Electrotechnical Vocabulary — — —
Part 426: Equipment for explosive
atmospheres
IEC 60079-0 — Explosive atmospheres — Part 0: EN IEC 60079-0 2018
Equipment — General requirements
ISO 9000 2015 Quality management systems — EN ISO 9000 2015
Fundamentals and vocabulary
5
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EN ISO/IEC 80079-34:2020 (E)
Annex ZB
(informative)
Information relevant to equipment and protective systems according to
standards harmonized under Directive 2014/34/EU
ZB.1 Introduction
The requirements laid down in the Directive and the standards harmonized under the Directive are the
basis for the quality assurance of the production process and the assessment of the quality system as
well. The quality system must ensure that the products resulting from the regular production process
comply with the types tested in the EU-type examination and with the applicable requirements of the
Directive.
This annex draws attention to a number of standards harmonized under the Directive which can be
used to gain detailed information on specific requirements. These references might be useful for
manufacturers to check whether the safety-relevant aspects are considered in the quality system and
covered by adequate procedures (see 8). They can also be used for internal or external quality audits
(see 9.1 and 9.2).
In quality system assessments according to Annexes IV and VII of Directive 2014/34/EU performed by
a Notified Body the auditing team must have knowledge with regard to the product specific
requirements according to the Directive.
NOTE The following examples do not cover all protection concepts and product specific requirements but
give some advice and will be supplemented to in the next edition.
ZB.2 Non-electrical equipment (EN 13463-1)
Safety aspects are covered by clause A.14 for non-electrical equipment (EN ISO 80079-36).
ZB.3 Protection by flow restricting enclosure "fr" (EN 13463-2)
Safety aspects are covered by the general clause for non-electrical equipment (EN ISO 80079-36).
ZB.4 Protection by flameproof enclosure "d" (EN 13463-3)
The same safety aspects as for electrical equipment apply (see A.3; for aspects of dust ignition
protection, see also A.10).
ZB.5 Protection by constructional safety "c" (EN 13463-5)
Safety aspects are covered by clause A.15 for non-electrical equipment (EN ISO 80079-37).
ZB.6 Protection by control of ignition sources "b" (EN 13463-6)
Safety aspects are covered by clause A.16 for non-electrical equipment (EN ISO 80079-37).
ZB.7 Protection by pressurised enclosures "p" (EN 13463-7)
The same safety aspects as for electrical equipment apply (A.6), according to A.14.1.
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ZB.8 Protection by liquid immersion "k" (EN 13463-8)
Safety aspects are covered by clause A.17 for non-electrical equipment (EN ISO 80079-37).
ZB.9 Fans (EN 14986)
ZB.9.1 General
The following safety aspects as specified in the technical file should be realised by systematic
production techniques and/or verifications and tests on the basis of written procedures.
ZB.9.2 Material
Selection of specified materials; material name complies with the requirement;
material properties (composition with regard to corrosion, thermal conduction and mechanical
sparks, mass fraction of aluminium, titanium, magnesium, zirconium, flammability);
cracks, inclusions, blow holes and porosity (either by a visual test or another suitable test method
depending on exposure);
heat treatment (e.g. hardening, tempering);
dimensional accuracy including all parts without machining.
ZB.9.3 Assembled equipment and protective systems
Adaption of suitable electrical equipment (explosion group, temperature class, equipment
category);
adaption of specified protective systems for fans of category 1G.
ZB.9.4 Routine tests
Sealing systems (fit, lubrication, initial tension, primary pressure);
dynamic vibrations (e.g. critical rotation speed, bearing at standstill or at transport);
functional test of the complete assembly (distance between rotor/stator modules, clamping,
clearance, free room of motion);
excess rotation speed;
thickness of linings;
impeller-shaft attachment (avoidance of drift, joint is secured against loosening);
mounting of autonomous protective systems, if applicable;
functional test of the temperature monitoring devices in the flame arresters, if applicable;
pressure test for fans of category 1G, if applicable.
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EN ISO/IEC 80079-34:2020 (E)
ZB.10 Petrol dispensers (EN 13617-1)
ZB.10.1 General
The following safety aspects as specified in the technical file should be realised by systematic
production techniques and/or verifications and tests on the basis of written procedures.
ZB.10.2 Electrical installation
Type of cable;
installation of cable;
correct wiring;
connection technique;
torque of screwed connections (traceability).
ZB.10.3 Information for safe operation
Availability of operating instructions;
marking on the type label (technical data, type of protection, etc.);
passing on of warning notes;
maintenance instructions.
ZB.10.4 Assembly groups
Drives or electrical equipment;
subassemblies (gears, couplings, belts);
components;
safety-relevant verifications for the interconnection of apparatus, subassemblies and components;
protective systems within the gas recirculation system.
ZB.10.5 Assembling
Correct components and parts;
minimum distances of moving parts (rotor/stator);
measures performed for equipotential bonding (to ground, between subassemblies);
protective covers.
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SIST EN ISO/IEC 80079-34:2020
EN ISO/IEC 80079-34:2020 (E)
ZB.10.6 Monitoring equipment
Installation of sensors and actuators (fail safe characteristics, separate power supply);
installation of sensors (position, correct interfacing, prevention of lag elements);
tests during maintenance (according to operating instructions);
functional tests and precision control;
insulation of cables.
For additional information, see also ZB.6.
ZB.10.7 Electrostatic discharge capacity
Materials (electrostatic discharge capacity resp. surface resistance of non-metallic parts, belts,
tubes, etc.);
limitation of the surface area for the corresponding explosion group;
thickness of the material for the corresponding explosion group.
ZB.10.8 Routine tests
Pressure test;
deactivation/activation of the controlling system before release;
insulation resistance;
functional test.
ZB.11 Electrostatic spraying equipment
ZB.11.1 General
The following safety aspects as specified in the technical file should be realised by systematic
production techniques and/or verifications and tests on the basis of written procedures.
Electrostatic spraying equipment according to the following harmonized standards:
EN 50050-1,
EN 50050-2,
EN 50050-3,
EN 50176,
EN 50177,
EN 50223.
NOTE This section ZB.11 may also be used for electrostatic spraying equipment in accordance with EN 50059
and EN 50348 harmonized under directive 2006/42/EC.
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EN ISO/IEC 80079-34:2020 (E)
ZB.11.2 Electrical assembly
The characteristics of the following parts including control devices and accessories should be tested
with respect to the application in electrostatic spraying equipment; this means normally that the
marking on the component parts or the packaging is verified where appropriate statistical methods
may be applied as necessary:
selection of the high voltage transformer (type, manufacturer, insulation, voltage);
equipotential bonding and grounding system for the spraying equipment and control device;
number of stages of the cascade and turn ratio of the high-voltage transformer and the capacity of
the cascade;
assembling, type and value of each current limiting resistor, diode, Zener diode, capacitor or any
other safety-relevant component (e.g. hardware-watch-dog);
manual or automatic assembly of printed circuit boards;
fixing and soldering of transformer, diodes, capacitors of the cascades;
date of expiry and storage of adhesives and casting compounds;
mixing procedures (e.g. pressure, temperature, time characteristics);
surface treatment (degreasing or equivalent measures are usually required immediately before the
potting process to ensure proper adhesion);
processing, e.g. filling instructions, void-free potting, temperature conditions;
curing process including: curing time, all relevant environmental factors, provisions made to ensure
that the curing process will proceed (e.g. mains power failure detection);
selection and installation of the display;
selection and installation of power supply and line filter of the control device;
selection of cable (high voltage, low voltage);
length, type and electric strength of the cable including grounding and screening if applicable;
connection techniques and fixing method of cables between controlling device and spraying
equipment.
NOTE 1 For printed circuit boards, the manufacturer should provide a list of safety-relevant electronic
components (e.g. resistors, Zener diodes) used. 100 % of the listed components should be tested. This can be done
by visual test or for SMD-components by assuring correct charging of the component insertion automat and by
visual test of correct positioning or by automated test equipment (ATE) provided that each individual safety-
relevant electronic component is considered and that a visual inspection is performed to check the type code and
direction of components.
NOTE 2 If the SMD-insertion automat selects the correct component carrier on the basis of a value
measurement of the component, this measuring function should be calibrated.
10
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SIST EN ISO/IEC 80079-34:2020
EN ISO/IEC 80079-34:2020 (E)
ZB.11.3 Mechanical assembly
Materials of spraying equipment and control devices should be inspected for stability, cracks,
inclusions, bubbling and porosity;
dimensional accuracy, evenness, surface roughness, fitting accuracy, depth of bushings, flanges and
threads of the nozzles of spraying equipment and accessories (extensions, angles, etc.);
dimensional accuracy and position accuracy of the electrode(s) with respect to the nozzle;
uniformity of joints;
gaps and dimensions between the bell and the stator;
balancing of rotating parts;
mounting of spraying equipment and control unit;
torque of the screwed connections if safety relevant;
IP protection (see ZB.2.6 for details);
continuous weld seams;
mounting of annular and flat gaskets;
continuity of moulded tongues and grooves;
application of adhesives.
ZB.11.4 Tests
I and I of the spraying equipment with and without associated accessories;
max short-circuit
U of the spraying equipment with and without associated accessories;
max
open-circuit monitoring between spraying equipment and control device, if applicable;
response of the safety facilities in case of simulated malfunction, if applicable.
Where spraying equipment and associated accessories are intended to be combined user-defined,
criteria of acceptance for the tests should consider the worst case.
11
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SIST EN ISO/IEC 80079-34:2020
EN ISO/IEC 80079-34:2020 (E)
ZB.12 Protective systems
ZB.12.1 General
The following safety aspects as specified in the technical file should be realised by systematic
production techniques and/or verifications and tests on the basis of written procedures:
the properties of dissipative plastics are proven by the manufacturer by dint of a material
certificate and examined at least through routine tests (e.g. in accordance with HD 429, neglecting
the climate);
layer thicknesses of non-conductive coatings are examined by routine tests at a sufficient amount of
adequate measuring points;
packing boxes without a temperature control are tightened with a predefined torque;
every examination is documented.
NOTE Routine tests can be a requirement in certificates or be required by the auditing notified body.
ZB.12.2 Explosion resistant equipment (EN 14460)
The following safety aspects as specified in the technical file should be realised by systematic
production techniques and/or verifications and tests on the basis of written procedures:
pressure shock resistant devices are manufactured according to EN 13445-4, if designed according
to EN 13445-3;
pressure test for each cast part is carried out;
pressure test is carried out according to EN 14460:2018, Table 1, lasting at least 3 min (routine
test); if this is impossible due to technical or safety-relevant reasons, there must be material;
certificates according to EN 10204, or non-destructive tests of the weld seams (at least supersonic)
as well as a dimensions comparison must be carried through;
weld seams are tested considering the weld seam factor;
material certificates according to EN 13445-2 are available for the pressure-loaded main parts;
correct marking and warning labels (e.g. maximum operational pressure, maximum operational
temperature, if necessary);
correct assembling.
For further aspects regarding pressure resistance, see A.3 of this standard.
ZB.12.3 Explosion venting devices (EN 14797)
The following safety aspects as specified in the technical file should be realised by systematic
production techniques and/or verifications and tests on the basis of written procedures:
the static activation overpressure (see EN 14491);
leak test, if applicable;
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SIST EN ISO/IEC 80079-34:2020
EN ISO/IEC 80079-34:2020 (E)
material certificates for the explosion venting devices (e.g. for the plates processed, rubber clamp
profiles);
stability tests are required for explosion venting valves as well as for the baskets for flameless
devices;
dimensional accuracy (e.g. gaps, predetermined breaking points of the bursting discs, wall
thicknesses of the processed plates;
gaskets;
mass of the insulation, if applicable;
heating installations on the moveable elements, if applicable;
weld seams are tested considering the weld seam factor;
correct marking and warning labels (e.g. maximum operational pressure, maximum operational
temperature, if necessary);
correct assembling;
number of tests according Table 2 (EN 14797) for non-reusable venting devices.
ZB.12.4 Explosion isolation systems (EN 15089)
The following safety aspects as specified in the technical file should be realised by systematic
production techniques and/or verifications and tests on the basis of written procedures:
closing time of the system (sum of the activation time of sensor, activation time of isolation device
and closing time of the isolation device) are tested in routine tests (see EN 15089);
operating values of all sensors (e.g. pressure, temperature, light);
correct implementation of required safety functions (e.g. control and indicating equipment
settings);
dimensional accuracy, particularly of the sealing elements;
dimensions of enclosure, rotors, blades, discs and gaskets;
gaps between rotors and enclosures of rotary valves;
mechanical integrity for the maximum explosion overpressure according to the intended use;
closing force of passive explosion protection valves;
installations in the interior necessary for safe operation (e.g. rotors of rotary valves, blades, discs,
sleeves);
proof of material (e.g. type of steel, suppressant);
welding procedure, if applicable;
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SIST EN ISO/IEC 80079-34:2020
EN ISO/IEC 80079-34:2020 (E)
correct marking and warning labels (e.g. maximum operational pressure, maximum operational
temperature, if necessary);
correct assembling;
maintenance when the wear limit is reached (in case of rotary valves);
use of the correct extinguishing powder and filling quantity (in case of extinguishing barriers);
information on maintenance.
ZB.12.5 Flameless explosion venting devices (EN 16009)
A flameless venting device is a combination of a venting device with flame extinguishing elements.
The following safety aspects as specified in the technical file should be realized by systematic
production techniques and/or verifications and tests on the basis of written procedures:
all aspects of ZB.12.3 "Explosion venting devices" (EN 14797);
material certificates of the flame extinguishing elements;
dimensional accuracy of the flame extinguishing elements (e.g. gaps, layer thickness);
gaskets;
pressure resistance of the mechanical mounting / casing of the flame extinguishing elements;
correct assembling;
information on maintenance;
correct marking and warning labels (e.g. maximum operational pressure, maximum operational
temperature, if necessary).
ZB.12.6 Explosion diverters (EN 16020)
An explosion diverter is a mech
...
SLOVENSKI STANDARD
oSIST prEN ISO/IEC 80079-34:2017
01-september-2017
Potencialno eksplozivne atmosfere - 34. del: Uporaba sistemov kakovosti za
izdelavo opreme (ISO/IEC/DIS 80079-34:2017)
Explosive atmospheres - Part 34: Application of quality systems for equipment
manufacture (ISO/IEC/DIS 80079-34:2017)
Explosionsgefährdete Bereiche - Teil 34: Anwendung von
Qualitätsmanagementsystemen für die Herstellung von Ex-Produkten (ISO/IEC/DIS
80079-34:2017)
Atmosphères explosives - Partie 34: Application des systèmes de qualité pour la
fabrication d'équipements (ISO/IEC/DIS 80079-34:2017)
Ta slovenski standard je istoveten z: prEN ISO/IEC 80079-34
ICS:
03.120.99 Drugi standardi v zvezi s Other standards related to
kakovostjo quality
13.230 Varstvo pred eksplozijo Explosion protection
oSIST prEN ISO/IEC 80079-34:2017 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO/IEC 80079-34:2017
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oSIST prEN ISO/IEC 80079-34:2017
DRAFT INTERNATIONAL STANDARD
ISO/IEC DIS 80079-34
ISO/TMBG Secretariat: ISO
Voting begins on: Voting terminates on:
2017-06-15 2017-09-07
Explosive atmospheres —
Part 34:
Application of quality systems for ex product manufacture
Atmosphères explosives —
Partie 34: Application des systèmes de qualité pour la fabrication d’équipements
ICS: 29.260.20
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/IEC DIS 80079-34:2017(E)
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oSIST prEN ISO/IEC 80079-34:2017
ISO/IEC DIS 80079-34:2017(E)
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ii © ISO/IEC 2017 – All rights reserved
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oSIST prEN ISO/IEC 80079-34:2017
ISO/IEC DIS 80079-34:2017(E)
ISO/IEC CDV 80079-34/Ed2 IEC:2017 – 2 – 31M/119/CDV
1 CONTENTS
2 FOREWORD . 6
3 INTRODUCTION . 8
4 1 Scope . 9
5 2 Normative references . 9
6 3 Terms and definitions . 9
7 4 Context of the organization . 11
8 4.1 Understanding the organization and its context . 11
9 4.2 Understanding the needs and expectations of interested parties . 11
10 4.3 Determining the scope of the quality management system . 11
11 4.4 Quality management system and its processes . 12
12 5 Leadership . 12
13 5.1 Leadership and commitment . 12
14 5.1.1 General . 12
15 5.1.2 Customer focus . 13
16 5.2 Policy . 13
17 5.2.1 Establishing the quality policy . 13
18 5.2.2 Communicating the quality policy . 13
19 5.3 Organizational roles, responsibilities and authorities . 13
20 6 Planning . 14
21 6.1 Actions to address risks and opportunities . 14
22 6.2 Quality objectives and planning to achieve them . 15
23 6.3 Planning of changes . 15
24 7 Support . 16
25 7.1 Resources . 16
26 7.1.1 General . 16
27 7.1.2 People . 16
28 7.1.3 Infrastructure . 17
29 7.1.4 Environment for the operation of processes . 17
30 7.1.5 Monitoring and measuring resources . 17
31 7.1.6 Organizational knowledge . 19
32 7.2 Competence . 19
33 7.3 Awareness . 19
34 7.4 Communication . 20
35 7.5 Documented information . 20
36 7.5.1 General . 20
37 7.5.2 Creating and updating . 20
38 7.5.3 Control of documented Information . 21
39 8 Operation . 22
40 8.1 Operational planning and control . 22
41 8.2 Requirements for products and services . 23
42 8.2.1 Customer communication . 23
43 8.2.2 Determining the requirements for products and services . 23
44 8.2.3 Review of the requirements for products and services . 23
45 8.2.4 Changes to requirements for products and services . 24
46 8.3 Design and development of products and services . 24
47 8.3.1 General . 24
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ISO/IEC DIS 80079-34:2017(E)
ISO/IEC CDV 80079-34/Ed2 IEC:2017 – 3 – 31M/119/CDV
48 8.3.2 Design and development planning . 24
49 8.3.3 Design and development Inputs . 24
50 8.3.4 Design and development controls . 25
51 8.3.5 Design and development outputs . 25
52 8.3.6 Design and development changes . 25
53 8.4 Control of externally provided processes, products and services . 26
54 8.4.1 General . 26
55 8.4.2 Type and extent of control . 27
56 8.4.3 Information for external providers . 29
57 8.5 Production and service provision . 29
58 8.5.1 Control of production and service provision . 29
59 8.5.2 Identification and traceability . 30
60 8.5.3 Property belonging to customers or external providers . 30
61 8.5.4 Preservation . 30
62 8.5.5 Post-delivery activities . 31
63 8.5.6 Control of changes . 31
64 8.6 Release of products and services . 31
65 8.7 Control of nonconforming outputs . 31
66 9 Performance evaluation . 32
67 9.1 Monitoring, measurement, analysis and evaluation . 32
68 9.1.1 General . 32
69 9.1.2 Customer satisfaction . 33
70 9.1.3 Analysis and evaluation . 33
71 9.2 Internal audit . 33
72 9.3 Management review . 34
73 9.3.1 General . 34
74 9.3.2 Management review inputs . 34
75 9.3.3 Management review outputs . 35
76 10 Improvement . 35
77 10.1 General . 35
78 10.2 Nonconformity and corrective action . 35
79 10.3 Continual improvement . 36
80 Annex A (informative) Information relevant to particular types of protection and
81 specific Ex Products . 37
82 A.1 Introduction . 37
83 A.2 General . 37
84 A.3 Ex “d” - flameproof enclosures . 37
85 A.3.1 Verification . 37
86 A.3.2 Castings . 37
87 A.3.3 Machining . 38
88 A.3.4 Cemented joints and potted assemblies . 38
89 A.3.5 Routine pressure testing . 38
90 A.3.6 Flanged joints . 39
91 A.3.7 Elements, with non-measurable paths, of breathing and
92 draining devices . 39
93 A.4 Ex “i” – intrinsic safety . 39
94 A.4.1 Components for intrinsically safe products . 39
95 A.4.2 Printed circuit boards (PCB) . 40
96 A.4.3 Sub-assemblies and assemblies . 40
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ISO/IEC DIS 80079-34:2017(E)
ISO/IEC CDV 80079-34/Ed2 IEC:2017 – 4 – 31M/119/CDV
97 A.4.4 Tests . 41
98 A.4.5 Intrinsically safe circuits and assemblies housed in Ex “d”, Ex
99 “p” or Ex “q” enclosures . 41
100 A.5 Ex “e” – Increased safety, including Ex “nA” – Non-sparking . 41
101 A.5.1 Ingress protection (IP) . 41
102 A.5.2 Internal wiring and contact integrity . 41
103 A.5.3 Rotating machines . 41
104 A.5.4 Windings . 42
105 A.5.5 Terminal boxes . 42
106 A.5.6 Cable glands, terminals and other accessories . 42
107 A.5.7 Routine verifications and tests . 42
108 A.6 Ex “p” – Pressurized equipment . 42
109 A.6.1 Ingress protection (IP) . 42
110 A.6.2 Components and manufacturing process . 42
111 A.6.3 Components, constructional characteristics . 42
112 A.6.4 Routine verifications and tests . 43
113 A.7 Ex “m” – Encapsulation . 43
114 A.7.1 Production documentation . 43
115 A.7.2 Routine verifications and tests . 43
116 A.8 Ex “o” – Liquid immersion . 43
117 A.9 Ex “q” – Powder filling . 43
118 A.9.1 Material control . 43
119 A.9.2 Filling . 43
120 A.9.3 Ingress protection (IP) . 43
121 A.9.4 Routine verifications and tests . 44
122 A.10 Ex “nC” – Sealed devices . 44
123 A.11 Ex “nR” – Restricted Breathing . 44
124 A.11.1 No operationally generated sparks . 44
125 A.11.2 Cable glands . 44
126 A.11.3 Plunger actuators, shafts and axles . 44
127 A.11.4 Test equipment . 45
128 A.11.5 Routine tests . 45
129 A.12 Ex “t” – dust ignition protection by enclosure . 45
130 A.12.1 Casting . 45
131 A.12.2 Enclosure parts . 45
132 A.12.3 Gaskets . 45
133 A.12.4 Protection devices . 45
134 A.12.5 Cemented and cast enclosure parts . 45
135 A.12.6 Ingress protection (IP) . 45
136 A.12.7 Examinations . 46
137 A.13 Ex “op” - Optical radiation . 46
138 A.14 Gas detectors . 46
139 A.15 Ex “h” – Non-electrical Equipment (ISO 80079-36) . 46
140 A.15.1 General . 46
141 A.15.2 Non-metallic parts . 46
142 A.15.3 Casing and external parts . 47
143 A.15.4 Earthing and equipotential bonding of conductive parts . 47
144 A.15.5 Light transmitting parts . 47
145 A.15.6 Ingress protection (IP) . 47
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ISO/IEC DIS 80079-34:2017(E)
ISO/IEC CDV 80079-34/Ed2 IEC:2017 – 5 – 31M/119/CDV
146 A.16 Non Electrical Equipment protected by constructional safety “c”
147 (ISO 80079-37) . 47
148 A.16.1 General . 47
149 A.16.2 Metal-based material . 47
150 A.16.3 Machining . 48
151 A.16.4 Cemented joints and potted assemblies . 48
152 A.16.5 Assembling . 48
153 A.16.6 Routine tests . 48
154 A.16.7 Power transmission systems . 48
155 A.17 Non-electrical equipment protected by control of ignition sources “b”
156 (ISO 80079-37) . 49
157 A.17.1 General . 49
158 A.17.2 Ignition protection system . 49
159 A.17.3 Installation . 49
160 A.17.4 Tests . 49
161 A.18 Non-electrical equipment protected by liquid immersion “k” (ISO 80079-
162 37) . 49
163 A.18.1 General . 49
164 A.18.2 Protective liquid . 49
165 A.18.3 Casing . 50
166 A.18.4 Measuring or indicating devices . 50
167 A.19 Flame arresters . 50
168 Annex B (informative) Verification criteria for elements with non-measurable paths
169 used as an integral part of a type of protection . 51
170 B.1 Introduction . 51
171 B.2 Verification guidance . 51
172 B.3 Tests . 51
173 B.4 Test examples . 51
174 B.4.1 Example 1 (pore size) . 52
175 B.4.2 Example 2 (density) . 52
176 B.5 Purchase information . 52
177 B.6 Pre-tested components . 52
178 B.7 Measurement and monitoring . 53
179 Annex C (informative) External Provider's Declaration of Conformity . 54
180 C.1 External Provider's Declaration of Conformity . 54
181 C.2 Additional Supporting information . 54
182 C.3 Responsibility of the Organization . 55
183 Annex D (informative) Example of an External Provider's Declaration of Conformity . 56
184 Annex E (informative) ISO/IEC 80079-34:2011 to ISO/IEC 80079-34 Ed.2 Correlation
185 Matrix . 57
186 Bibliography . 60
187
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oSIST prEN ISO/IEC 80079-34:2017
ISO/IEC DIS 80079-34:2017(E)
ISO/IEC CDV 80079-34/Ed2 IEC:2017 – 6 – 31M/119/CDV
188 INTERNATIONAL ELECTROTECHNICAL COMMISSION
189 __________
190
191 EXPLOSIVE ATMOSPHERES –
192
193 Part 34: Application of quality management systems
194 for Ex product manufacture
195
196 FOREWORD
197 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
198 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
199 international co-operation on all questions concerning standardization in the electrical and electronic fields. To
200 this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
201 Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
202 Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
203 in the subject dealt with may participate in this preparatory work. International, governmental and non-
204 governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
205 with the International Organization for Standardization (ISO) in accordance with conditions determined by
206 agreement between the two organizations.
207 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
208 consensus of opinion on the relevant subjects since each technical committee has representation from all
209 interested IEC National Committees.
210 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
211 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
212 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
213 misinterpretation by any end user.
214 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
215 transparently to the maximum extent possible in their national and regional publications. Any divergence
216 between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
217 the latter.
218 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
219 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
220 services carried out by independent certification bodies.
221 6) All users should ensure that they have the latest edition of this publication.
222 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
223 members of its technical committees and IEC National Committees for any personal injury, property damage or
224 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
225 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
226 Publications.
227 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
228 indispensable for the correct application of this publication.
229 9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
230 patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
231 International Standard ISO/IEC 80079-34 has been prepared by ISO/IEC subcommittee 31M:
232 Non-electrical equipment and protective systems for explosive atmospheres.
233 This second edition cancels and replaces the first edition, published in 2011, and constitutes
234 a full technical revision.
235 This publication is published as a double logo standard.
236 This standard should be read in conjunction with ISO 9001:2015.
237
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oSIST prEN ISO/IEC 80079-34:2017
ISO/IEC DIS 80079-34:2017(E)
ISO/IEC CDV 80079-34/Ed2 IEC:2017 – 7 – 31M/119/CDV
238 This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
239 A list of all parts of the IEC 60079 series, under the general title Explosive atmospheres, can
240 be found on the IEC website.
241 The committee has decided that the contents of this publication will remain unchanged until
242 2021 as indicated on the IEC web site under "http://webstore.iec.ch" in the data related to the
243 specific publication. At this date, the publication will be
244 • reconfirmed,
245 • withdrawn,
246 • replaced by a revised edition, or
247 • amended.
248
249
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oSIST prEN ISO/IEC 80079-34:2017
ISO/IEC DIS 80079-34:2017(E)
ISO/IEC CDV 80079-34/Ed2 IEC:2017 – 8 – 31M/119/CDV
250 INTRODUCTION
251 This document specifies requirements for a quality management system that can be used by
252 an organization for the manufacture of Ex products and for the provision of Ex services.
253 It can also be used by third parties including certification bodies, to assess the organization’s
254 ability to meet conformity assessments system requirements and/or regulatory requirements.
255 The application of this standard is intended to cover both electrical and non-electrical
256 equipment, protective sy
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