EN ISO 15001:2004

SLOVENSKI STANDARD
01-november-2004
Anestezijska in respiratorna oprema – Združljivost s kisikom (ISO 15001:2003)
Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2003)
Anästhesie- und Beatmungsgeräte - Verträglichkeit mit Sauerstoff (ISO 15001:2003)
Matériel d'anesthésie et respiratoire - Compatibilité avec l'oxygene (ISO 15001:2003)
Ta slovenski standard je istoveten z: EN ISO 15001:2004
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 15001
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2004
ICS 11.040.10
English version
Anaesthetic and respiratory equipment - Compatibility with
oxygen (ISO 15001:2003)
Matériel d'anesthésie et respiratoire - Compatibilité avec Anästhesie- und Beatmungsgeräte - Verträglichkeit mit
l'oxygène (ISO 15001:2003) Sauerstoff (ISO 15001:2003-
This European Standard was approved by CEN on 23 April 2004.
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 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 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, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15001:2004 E
worldwide for CEN national Members.

Contents Page
FOREWORD. 3
ANNEX ZA (NORMATIVE) NORMATIVE REFERENCES TO INTERNATIONAL PUBLICATIONS WITH
THEIR RELEVANT EUROPEAN PUBLICATIONS .4
ANNEX ZB (INFORMATIVE) CLAUSES OF THIS EUROPEAN STANDARD ADDRESSING ESSENTIAL
REQUIREMENTS OR OTHER PROVISIONS OF EU DIRECTIVES. 5
Foreword
The text of ISO 15001:2003 has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
secretariat of which is held by BSI.
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 November 2004, and conflicting national standards shall be withdrawn
at the latest by November 2004.
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 Directive(s), see informative Annex ZB, which is an integral part of this document.
Details of corresponding International and European standards are given in Annex ZA, which is normative.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland
and United Kingdom.
Endorsement notice
The text of ISO 15001:2003 has been approved by CEN as EN ISO 15001:2004 without any modifications.
Annex ZA
(normative)
Normative references to international publications with their relevant
European publications
This European Standard incorporates by dated or undated reference, provisions from other publications. These
normative references are cited at the appropriate places in the text and the publications are listed hereafter. For
dated references, subsequent amendments to or revisions of any of these publications apply to this European
Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the
publication referred to applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated by (mod.),
the relevant EN/HD applies.
Publication Year Title EN Year
ISO 14971 2000 Medical devices - Application of risk EN ISO 14971 2000
management to medical devices
Annex ZB
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42 EEC.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the normative
clauses of this standard given in Table ZB.1 confers, within the limits of the scope of this standard, a
presumption of conformity with the corresponding Essential Requirements of that Directive and associated
EFTA regulations.
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
TABLE ZB.1 - Correspondence between this European Standard and EU Directives
Clause/subclause of this Corresponding Essential Comments
European Standard Requirement of Directive
93/42/EEC
All 7.2, 7.3, 9.2, 9.3, 12.7.4 This standard specifies minimum
requirements for the oxygen
compatibility of materials,
components and devices that
can come into contect with
oxygen in normal or single fault
condition.
INTERNATIONAL ISO
STANDARD 15001
First edition
2003-05-15
Anaesthetic and respiratory equipment —
Compatibility with oxygen
Matériel d'anesthésie et respiratoire — Compatibilité avec l'oxygène

Reference number
ISO 15001:2003(E)
©
ISO 2003
ISO 15001:2003(E)
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ii © ISO 2003 — All rights reserved

ISO 15001:2003(E)
Contents Page
Foreword. iv
Introduction . v
1 R Scope. 1
2 Normative references . 1
3 Terms and definitions. 1
4 Cleanliness . 2
5 R Resistance to ignition . 3
6 Risk analysis . 3
Annex A (informative) Examples of cleaning procedures. 4
Annex B (informative) Typical methods for validation of cleaning procedures . 11
Annex C (informative) Design considerations. 14
Annex D (informative) Selection of materials . 19
Annex E (informative) Recommended method for combustion and quantitative analysis of
combustion products of non-metallic materials. 31
Annex F (informative) Rationale. 36
Bibliography . 37

ISO 15001:2003(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 15001 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 6, Medical gas systems.
iv © ISO 2003 — All rights reserved

ISO 15001:2003(E)
Introduction
Oxygen, pure or mixed with other medical gases, is widely used in medical applications. Because patients and
clinical personnel are often in close proximity to devices used with oxygen, the risk of serious injury is high if a
fire occurs in an oxygen-enriched atmosphere. A common cause of fire is the heat produced by adiabatic
compression, and the presence of hydrocarbon and particulate contaminants facilitates ignition. Some
combustion products, especially of some non-metals (e.g. plastics, elastomers and lubricants) are toxic and
thus patients remote from that equipment who are receiving oxygen from a medical gas pipeline system might
be injured when a problem occurs.
Other equipment which is in close proximity to the equipment using oxygen, or that utilizes oxygen as its
source of power can be damaged or fail to function properly if there is a problem with the oxygen equipment.
Reduction or avoidance of these risks depends on the choice of appropriate materials and cleaning
procedures and correct design and construction of equipment so that it is compatible with oxygen under the
conditions of use.
This document establishes recommended minimum criteria for the safe use of oxygen and the design of
systems for use in oxygen and oxygen-enriched atmospheres.
Annex F contains rationale statements for some of the requirements of this International Standard. It is
included to provide additional insight into the reasoning that led to the requirements and recommendations
that have been incorporated into this International Standard. The clauses and subclauses marked with R after
their number have corresponding rationale contained in Annex F. It is considered that knowledge of the
reasons for the requirements will not only facilitate the proper application of this International Standard, but will
expedite any subsequent revisions.
It is expected that particular device standards will make reference to this horizontal International Standard but
may, if appropriate, strengthen these minimum requirements.
Particular device standards may specify that some requirements of this International Standard may apply for
medical gases other than oxygen.

INTERNATIONAL STANDARD ISO 15001:2003(E)

Anaesthetic and respiratory equipment — Compatibility with
oxygen
1 R Scope
This International Standard specifies minimum requirements for the oxygen compatibility of materials,
components and devices for anaesthetic and respiratory applications which can come in contact with oxygen
in normal condition or in single fault condition at gas pressures greater than 50 kPa.
This International Standard is applicable to anaesthetic and respiratory equipment which are within the scope
of ISO/TC 121, e.g. medical gas pipeline systems, pressure regulators, terminal units, medical supply units,
flexible connections, flow-metering devices, anaesthetic workstations and lung ventilators.
Aspects of compatibility that are addressed by this International Standard include cleanliness, resistance to
ignition and the toxicity of products of combustion and/or decomposition.
2 Normative references
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.
ISO 14971:2000, Medical devices — Application of risk management to medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
adiabatic compression
compression process that occurs without transfer of heat into or out of a system
3.2
auto-ignition temperature
temperature at which a material will spontaneously ignite under specified conditions
3.3
lethal concentration
LC
concentration of a gas (or a gas mixture) in air administered by a single exposure during a short period of time
(24 h or less) to a group of young adult albino rats (males and females) which leads to the death of half of the
animals in at least 14 days
[ISO 10298:1995]
ISO 15001:2003(E)
3.4
oxygen index
minimum concentration of oxygen by percentage volume in a mixture of oxygen and nitrogen introduced at
(23 ± 2) °C that will just support combustion of a material under specified test conditions
[ISO 4589-2:1996]
3.5
qualified technical person
person who by virtue of education, training or experience knows how to apply physical and chemical principles
involved in the reactions between oxygen and other materials
3.6
single fault condition
condition in which a single means for protection against a safety hazard in equipment is defective or a single
external abnormal condition is present
3.7
threshold limit value
TLV
concentration in air to which nearly all workers may be exposed during an 8 h working day and a 40 h working
week without adverse effect
3.8
oxygen-enriched mixture
mixture that contains more than 25 % volume fraction of oxygen or whose partial pressure exceeds 275 kPa
NOTE The partial pressure value of 275 kPa is based on a maximum ambient pressure of 1 100 hPa.
4 Cleanliness
4.1 R Unless specified otherwise in particular device standards, surfaces of components that come in
contact with oxygen during normal operation or single fault condition shall:
a) R for applications in the pressure range of 50 kPa to 3 000 kPa, not have a level of hydrocarbon
contamination greater than 550 mg/m ;
The manufacturer should ensure that the level of particle contamination is suitable for the intended
application(s).
b) R for applications at pressure greater than 3 000 kPa:
 not have a level of hydrocarbon contamination greater than 220 mg/m , and
 not have particles of size greater than 50 µm.
These requirements shall be met either by an appropriate method of manufacture or by use of an appropriate
cleaning procedure. Compliance shall be checked either by verification of the cleanliness of the components
or by validation of the cleaning procedure or the manufacturing process.
NOTE 1 Annex A gives examples of cleaning procedures and Annex B gives examples of methods for validation of
cleaning procedures.
2 2
NOTE 2 The values of 550 mg/m and 220 mg/m for hydrocarbon contamination are taken from ASTM G 93 – 96 and
the value of 3 000 kPa is taken from EIGA IGC 33/97/E.
4.2 Means shall be provided to identify components and devices which have been cleaned for oxygen
service in accordance with this International Standard.
2 © ISO 2003 — All rights reserved

ISO 15001:2003(E)
4.3 Means (e.g. packaging and information supplied by the manufacturer) shall be provided to maintain the
cleanliness of components and devices which have been cleaned for oxygen service in accordance with this
International Standard.
5 R Resistance to ignition
Devices designed for pressures greater than 3 000 kPa shall not ignite when submitted to a pneumatic impact
test according to procedures described in the relevant product standards at a test pressure of 1,2 times the
maximum rated pressure.
If lubricants are used, the lubricated device shall be tested.
NOTE Examples of ignition test methods are given in ISO 10524, ISO 10297 and ISO 7291.
6 Risk analysis
6.1 The manufacturer of medical devices shall carry out a risk analysis in accordance with ISO 14971.
Attention is drawn to cleaning procedures (see Annex A), design considerations (see Annex C) and selection
of materials (see Annex D).
6.2 The specific hazards of toxic products of combustion or decomposition from non-metallic materials
(including lubricants, if used) and potential contaminants shall be addressed. Some potential products of
combustion and/or decomposition for some commonly available non-metallic materials are listed in Table D.7.
NOTE Typical “oxygen-compatible” lubricants can generate toxic products on combustion or decomposition.
Annex E gives details of suitable test and quantitative analysis methods for the products of combustion of non-
metallic materials. Data from such tests shall be considered in any risk evaluation.

ISO 15001:2003(E)
Annex A
(informative)
Examples of cleaning procedures
A.1 General
A.1.1 General guidelines
A cleaning programme that results in an increase in the degree of cleanliness of the component after each
cleaning operation should be selected. It then becomes a matter of processing the component through a
series of cleaning methods, or several cycles within a single cleaning method, or both, in order to achieve the
desired final degree of cleanliness.
It may be possible to obtain the desired degree of cleanliness in a single operation, but many cleaning
methods must progress in several stages, such as initial cleaning, intermediate cleaning and final cleaning. It
is essential that each stage be isolated from previous stages by appropriate rinsing, drying and purging
operations.
Of particular importance is the removal of lint, dust and organic matter such as oil and grease. These
contaminants are relatively easily ignited in oxygen and oxygen-enriched atmospheres.
It is essential that cleaning, washing and draining methods ensure that dead-end passages and possible traps
are adequately cleaned.
A.1.2 Initial cleaning
Initial cleaning should be used to remove gross contaminants such as excessive oxide or scale buildup, large
quantities of oil, grease and inorganic particulate matter.
Initial cleaning reduces the quantity of contaminants, thereby increasing the useful life and effectiveness of the
cleaning solutions used in subsequent cleaning operations.
A.1.3 Intermediate cleaning
Intermediate cleaning generally consists of subjecting the part to caustic or acid-cleaning solutions to remove
solvent residues and residual contaminants. The cleaning environment and handling procedures used for
intermediate cleaning operations are more critical than those used for initial cleaning. It is essential that the
cleaning environment and solutions be appropriately controlled in order to maximize solution efficiency and to
minimize the introduction of contaminants that might compromise subsequent cleaning operations.
A.1.4 Final cleaning
A.1.4.1 When components are required to meet very high degrees of cleanliness, they should be
subjected to a final cleaning. Final cleaning is generally performed using chemical cleaning methods. At this
stage, protection from recontamination by the cleaning solutions or the environment becomes critical and may
require strict controls, such as those found in classified clean rooms.
A.1.4.2 The final cleaning stage involves drying and purging operations followed by sealing to protect
against recontamination and packaging to prevent damage during storage and transportation.
4 © ISO 2003 — All rights reserved

ISO 15001:2003(E)
A.2 Selection of cleaning methods
In order to decide on the most practicable methods of cleaning, the following factors should be considered:
a) the type (e.g. organic, inorganic) and form (e.g. particulate, film, fluid) of contaminants;
b) the configuration of the component;
c) the base material or coating of the part to be cleaned;
d) initial condition of the part to be cleaned;
e) the required final cleanliness of the part;
f) environmental impact and lawful disposal of hazardous waste products generated by the cleaning
method;
g) effects of the selected cleaning methods on the mechanical, chemical and thermal properties of the part
to be cleaned.
A.3 Cleaning methods
A.3.1 General
It is essential that the cleaning method ensure that all surfaces of the component are cleaned. The methods
described are applicable to most metallic materials. However, special precautions may be necessary for non-
metallic components.
A.3.2 Categories
Cleaning methods can be categorized as mechanical, chemical or both. Some cleaning operations are
enhanced by combining mechanical and chemical methods, such as mechanical agitation of a chemical
solution.
Some mechanical cleaning methods such as abrasive blasting, tumbling, grinding and wire brushing on
finished machine components can damage surfaces, remove protective coatings and work-harden metals. It is
essential that sensitive surfaces of the component be protected before such methods are used on that
component.
Chemical cleaning methods can cause damage. Corrosion, embrittlement or other surface modifications can
occur. Crevice corrosion can occur, particularly in brazed or welded assemblies. Solvent cleaning solutions
are often damaging to non-metals. The supplier of the non-metals should be consulted or samples tested to
ensure that the solvent will not cause damage. It is essential that, if acidic or caustic chemical cleaners are
used, the chemical residue on the components be neutralized and/or removed immediately after cleaning.
A.3.3 Mechanical cleaning
A.3.3.1 General
Mechanical cleaning methods use mechanically generated forces to remove contaminants from the
components. Examples of mechanical cleaning methods are rinsing, abrasive blasting, tumbling and blowing.
Details of these and other methods are discussed in A.3.3.2 to A.3.3.8.
ISO 15001:2003(E)
A.3.3.2 Abrasive blast cleaning
A.3.3.2.1 Abrasive blast cleaning entails the forceful impingement of abrasive particles against the surfaces
to be cleaned to remove scale, rust, paint and other foreign matter. The abrasive particles are entrained in a
gas or liquid stream. A variety of systems can be used to propel the abrasive, e.g. airless abrasive blast
blades or vane-type wheels, pressure blast nozzles and suction (induction) blast nozzles. Propellant gases
should be oil-free.
A.3.3.2.2 Typical abrasive particle materials include metallic grit and shot, natural sands, manufactured
oxide grit, carbide grit, walnut shells and glass beads. The specific abrasive particle material used should be
suitable for performing the intended cleaning without depositing contaminants that cannot be removed by
additional operations, such as high velocity blowing, vacuuming and purging.
A.3.3.2.3 Care needs to be taken to minimize the removal of material from the component parent metal.
This cleaning method might not be suitable for components or systems with critical surface finishes or
dimensional tolerances.
A.3.3.3 Wire brush or grinding cleaning
A.3.3.3.1 Wire brushing or grinding methods generally use a power-driven wire brush, a non-metallic fibre-
filled brush or an abrasive wheel. These are used to remove scale, weld slag, rust, oxide films and other
surface contaminants. Wire brushes can be used dry or wet. The wet condition results when brushes are used
in conjunction with caustic cleaning solutions or cold water rinses.
A.3.3.3.2 These mechanical methods can imbed brush or grinding material particles in the surface being
cleaned. The selection of cleaning brushes depends upon the component or system parent material. Non-
metallic brushes are suitable for most materials to be cleaned. Carbon steel brushes should not be used on
aluminium, copper or stainless steel alloys. Any wire brushes previously used on carbon steel components
should not be used subsequently on aluminium or stainless steel. Wire brushing and grinding can affect
dimensions, tolerances and surface finishes.
A.3.3.4 Tumbling
This method involves rolling or agitation of parts within a rotating barrel or vibratory tub. An abrasive or
cleaning solution is added to the container. The container action (rotation or vibration) imparts relative motion
between the components to be cleaned and the abrasive medium or cleaning solution. This method can be
performed with dry or wet abrasives. The component size may vary from a large casting to a delicate
instrument component, but mixing different components in one container should be avoided. Damage can
occur from one component impacting on another. Tumbling can be used for descaling, deburring, burnishing
and general washing. Some factors to be considered in barrel cleaning are the component size and shape,
type of abrasive, abrasive size, load size, barrel rotational speed and ease of component/abrasive separation.
A.3.3.5 Swab, spray and dip cleaning
These are three methods of applying cleaning solutions to the component surfaces. Each method has its
particular advantages. Swabbing is generally used only to clean small selected areas. Spraying and dipping
are used for overall cleaning. These methods are generally employed with caustic, acid or solvent cleaning
methods that are discussed in A.3.4.5, A.3.4.6 and A.3.4.8.
A.3.3.6 Vacuuming and blowing
These methods remove the contaminant using currents of clean, dry, oil-free air or nitrogen. These methods
can be used to remove loose dirt, slag, scale and various particles, but they are not suitable for the removal of
surface oxides, greases and oils.
6 © ISO 2003 — All rights reserved

ISO 15001:2003(E)
A.3.3.7 Pig cleaning
Long continuous pipelines can be cleaned in situ using pigs. A pig is a piston-like cylinder with peripheral
seals that can be pushed through a pipeline using compressed gas, typically nitrogen. The pig can be
equipped with scrapers and wire brushes. Pairs of pigs can carry slugs of liquid cleaning agents between
them. Hence, a train of pigs can transport isolated slugs of liquids through a pipeline to produce various levels
of cleanliness and rinsing. The mechanical and chemical suitability of the solvents, scrapers and wire brushes
should be ensured.
A.3.3.8 Ultrasonic cleaning
Ultrasonic energy can be used in conjunction with a variety of chemical cleaning agents to produce intimate
contact between the components and the cleaning agent. The ultrasonic agitation aids the removal of lightly
adhering or embedded particles from solid surfaces. It is generally employed in solvent cleaning of small
components, precious metals and components requiring a very high degree of cleanliness.
A.3.4 Chemical cleaning
A.3.4.1 General
The methods described in A.3.4.2 to A.3.4.9 are based on achieving an interaction between the cleaning
solution and the surface of the component to produce the removal of the contaminant by subsequent
mechanical methods. The interaction can involve surface activation, contaminant breakdown, oxide
conversion and hydrophobic or hydrophilic transformations.
A.3.4.2 Hot water cleaning
Hot water cleaning is used to remove gross organic and particulate contamination from components by the
use of low to moderate heat, detergent and some mechanical agitation. Equipment used during hot water
cleaning consists of a spray system or a cleaning vat with or without suitable agitation of the solution. Hot
water cleaning with detergent can be used where steam is not necessary to free and fluidize contaminants.
Consideration should be given to the size, shape and the number of components to assure adequate contact
between surfaces of the components and the solution. The solution temperature should be that recommended
by the manufacturer of the detergent. Water-soluble contaminants are removed by prompt flushing with
sufficient quantities of clean water before the cleaning agents have had time to precipitate. The components
are then dried by blowing with dry, oil-free air or nitrogen, which can be heated to shorten the drying time.
A.3.4.3 Detergent cleaning
This method relates to the cleaning of vessels, piping system, or components either externally or internally.
Detergents are supplied in powder, crystal or concentrated liquid form. They are prepared for use by mixing
with water to form aqueous solutions. Prepared solutions can be used in static tanks or vessels for the
immersion of components, or the solution can be re-circulated by pump or jetted onto or through the
component. Some types of detergent are toxic and/or corrosive. Properties of detergent materials should be
checked with their manufacturer or supplier.
A.3.4.4 Steam cleaning
Steam cleaning is used to remove contaminants, especially organic and particulate, from components by the
use of pressure, heat and sometimes detergents. Some organic contaminants are removed by decreasing
their viscosity or thinning them with steam heat. A detergent that disperses and emulsifies the organic
contaminants, allowing the rinsing off of the contaminants by the condensed steam, can be added. The
system should provide control over the flows of the steam, water and detergent to maximize the efficiency of
the detergent's chemical action, the heating effect of the steam and the scrubbing action of the steam jet.
ISO 15001:2003(E)
A.3.4.5 Caustic cleaning
A.3.4.5.1 Caustic cleaning uses solutions of high alkalinity for the removal of organic contaminants, such as
hydrocarbons, oils, greases and waxes. There are many effective cleaning products available for caustic
cleaning. The water used for rinsing should be free from substances or impurities that may cause reactions
with the caustic cleaner. It is recommended that distilled water be used to minimize problems. The cleaning
solution can be applied by spraying, immersing, or swabbing. Usually caustic cleaning solutions are applied at
temperatures up to 80 °C. It is important that the cleaning solution reach all areas of the components to be
cleaned. The cleaning solution can be reused until it becomes ineffective, as determined by pH measurement
or contaminant concentration analysis. Experience will establish a contaminant level of the cleaning solution
above which a surface cannot be acceptably cleaned.
A.3.4.5.2 It is essential that the cleaning solution be thoroughly rinsed from the component to prevent the
cleaning solution and contaminants from re-depositing on the surface. The surface should not be allowed to
dry between the cleaning phase and the rinsing phase. Frequently, some form of water rinsing helps to
remove the cleaning solution and aids the drying process. A method of determining when the rinsing is
complete is to monitor the used rinse water until a pH of ± 0,2 of that of the starting pH is achieved. Drying, if
required, can be accomplished with heated or unheated dry, oil-free air or nitrogen.
A.3.4.6 Acid cleaning
A.3.4.6.1 Acid cleaning is a process in which a solution of a mineral acid, organic acid or acid salt (often in
combination with a wetting agent and detergent) is used to remove oxides, oils and other contaminants from
components with or without the application of heat. It is essential that acid cleaning be carefully controlled to
avoid damage to the surface of components, such as undesired etching or pickling. The type of cleaning agent
selected will depend in most cases on the material or component to be cleaned. A general guide to the use of
acid cleaning is given in A.3.4.6.2 to A.3.4.6.5.
A.3.4.6.2 Phosphoric acid cleaning agents can be used for most metals. These agents will remove oxides,
rust, soils and fluxes.
A.3.4.6.3 Hydrochloric acid cleaning agents are recommended for carbon and low alloy steels only. These
agents will remove rust, scale and oxide coatings and will strip chromium, zinc and cadmium platings. Certain
acidic solutions, including hydrochloric or nitric acids, should contain an inhibitor to prevent harmful attacks on
base metals. Hydrochloric acid should not be used on stainless steel because it may cause stress corrosion or
stress-corrosion cracking.
A.3.4.6.4 Chromic acid and nitric acid cleaning compounds are recommended for aluminium, copper and
their alloys. These compounds are not true cleaning agents, but are used for deoxidizing, brightening, and for
removing the black residue that forms during cleaning with a caustic solution. Some compounds are available
as liquids and others as powders. They are mixed in concentrations of 5 % to 50 % volume fraction in water,
depending on the cleaning agent and the amount of oxide or scale to be removed.
A.3.4.6.5 A storage or immersion tank, recirculation pump, associated piping and valves compatible with
the cleaning solution are required. Common techniques for acid cleaning are immersion, swabbing and
spraying. Acid cleaning compounds should not be used unless their application and performance are known
or are discussed with the cleaning compound manufacturer. The manufacturer's recommendations regarding
concentration and temperature should be followed. After acid cleaning, it is essential that the surfaces be
thoroughly rinsed with water to remove all traces of the acid and thoroughly dried after the final rinse. To
minimize staining, surfaces should not be permitted to dry between successive steps of the acid cleaning and
rinsing procedure.
A neutralizing treatment may be necessary under some conditions. It is essential that neutralization be
followed by repeated water rinsing to remove all traces of the neutralizing agent. If drying is required, it can be
completed with heated or unheated dry, oil-free air or nitrogen.
8 © ISO 2003 — All rights reserved

ISO 15001:2003(E)
A.3.4.7 Emulsion cleaning
Emulsion cleaning is a process for removing contamination from the surface of components by using organic
solvents dispersed in an aqueous medium by an emulsifying agent. Emulsion cleaners are composed of
petroleum-derived solvents and surfactants. The cleaning action of emulsion cleaners combines the
advantages of both the aqueous and organic phases. A variety of emulsion cleaners is available. Some
emulsion cleaners tend to separate into individual solutions if left standing for extended periods of time so it
may be necessary to agitate the cleaner periodically. Emulsion cleaners are normally applied to components
by methods such as immersion, spraying or swabbing. It is essential that emulsion cleaners be removed by
rinsing and subsequent cleaning operations.
A.3.4.8 Solvent cleaning
A.3.4.8.1 Solvent cleaning or degreasing is considered to be the principal procedure for the removal of
soluble organic contaminants from components to be used in oxygen service and is suitable for use with most
metals.
However, many of the solvents that have been used for this method of cleaning are now banned under the
“Montreal Protocol”. Alternative cleaning methods that use acceptable solvents should be identified and put
into practice as soon as possible.
Solvent cleaning is limited by the ability of the solvent to reach and dissolve any contaminants present. Before
starting a solvent cleaning procedure, a portion of fresh clean solvent should be set aside to be used as a
reference. At intervals throughout the procedure aliquots of used solvent can be compared with the reference
to determine the level of contamination and the effectiveness of the cleaning. Clean glass bottles should be
used to store the reference and used solvents. Methods for determining the concentration of hydrocarbon
contaminants are discussed in Annex B.
A.3.4.8.2 After the completion of any method of solvent cleaning, it is essential that all gross residual
cleaning fluid be drained from the component to prevent drying in pools. The component should then be
purged and dried with warm, dry, oil-free air or nitrogen. Small components can be air-dried if appropriate.
A.3.4.8.3 Solvent cleaning can be performed using methods such as swabbing and spraying. Cleaning can
also be effected by immersing the component in a tank of solvent and applying a means of agitation.
Disassembled components can be cleaned by this method. The process may be improved by the use of
ultrasonic cleaning techniques. Cleaning by forced circulation of the solvent through the component can also
be carried out. Cleaning by circulation should be continued, using clean solvent, until the used solvent
emerges from the component as clean as the reference sample.
A.3.4.8.4 Solvents frequently require inhibitor(s) to control corrosive reactions. The addition of inhibitor(s)
may require monitoring to ensure continued effectiveness of the inhibitor. This method is often applied to
assemblies that cannot be disassembled, to large components and to prefabricated circuits, pipe works, etc.
A.3.4.9 Vapour degreasing
Vapour degreasing is the removal of soluble organic materials and subsequent washing action of the surfaces
of components by the continuous condensation of solvent vapour on the cold component. Vapour degreasing
equipment consists essentially of a vaporizer for generating clean vapour from a contaminated solvent and a
container for holding the components in the vapour. Refrigerant grade solvents should not be used because
they have been known to contain oils. Some of these solvents are flammable in air under certain conditions
and have various degrees of toxicity; therefore caution should be exercised in their use. It is essential that the
temperature of the component be below the boiling point of the solvent, so that the solvent vapours will
condense and wash down by gravity over the surfaces of the component. The component should be
positioned and connected so that the condensate will drain freely from the ports. Continuous circulation of the
condensate and its transport back into the vaporizer will carry the dissolved contaminants into the vaporizer
where they will remain. No further cleaning will occur after the temperature of the component reaches the
temperature of the vapour.
ISO 15001:2003(E)
A.3.4.10 Purging
A.3.4.10.1 It is very important to purge the component to ensure that all residues from the previous cleaning
operation(s) are removed before subsequent cleaning operations or final packaging is performed. This can be
achieved by rinsing, drying and blowing. Rinsing is dependent upon the cleaning solutions used, but in most
cases filtered water can be used. Drying can be achieved by the application of heat to the component using
ovens or infrared lights, or by blowing with clean, oil-free, dry air. Under no circumstances should compressed
air for pneumatic tools be used for drying, since it can contain traces of oil or other contaminants. Removal of
solvents at elevated temperatures requires additional attention, because the solvents are more likely to attack
the component surfaces or to decompose
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