Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2003)

This European Standard specifies minimum requirements for the oxygen compatibility of materials which can come in contact with oxygen at pressures greater than 50 kPa in medical devices. Aspects of compatibility that are addressed include: cleanliness, resistance to ignition and the toxicity of products of combustion and/or decomposition. NOTE: It is expected that particular device standards will make reference to this horizontal standard but may, if appropriate, strengthen these minimum requirements.

Anästhesie- und Beatmungsgeräte - Verträglichkeit mit Sauerstoff (ISO 15001:2003)

Diese Internationale Norm legt Mindestanforderungen an die Sauerstoffverträglichkeit von Werkstoffen, Bauteilen und Geräten für Anwendungen bei der Anästhesie und Beatmung fest, die im Normalzustand oder beim Ersten Fehler mit Sauerstoff bei Drücken über 50 kPa in Berührung kommen können.
Diese Internationale Norm gilt für Anästhesie- und Beatmungsgeräte, die innerhalb des Aufgabenbereichs des ISO/TC 121 liegen, z. B. Rohrleitungssysteme für medizinische Gase, Druckregler, Entnahmestellen, medizinische Versorgungseinheiten, flexible Verbindungsstücke, Durchflussmessgeräte, Anästhesie-Arbeitsplätze und Lungenbeatmungsgeräte.
Zu den in dieser Internationalen Norm behandelten Gesichtspunkten der Sauerstoffverträglichkeit gehören die Sauberkeit, die Widerstandsfähigkeit gegen Zündung und die Toxizität von Verbrennungs- und/oder Zerfallsprodukten.

Matériel d'anesthésie et respiratoire - Compatibilité avec l'oxygène (ISO 15001:2003)

Anestezijska in respiratorna oprema – Združljivost s kisikom (ISO 15001:2003)

General Information

Status
Withdrawn
Publication Date
25-May-2004
Withdrawal Date
31-May-2010
Current Stage
9960 - Withdrawal effective - Withdrawal
Due Date
01-Jun-2010
Completion Date
01-Jun-2010

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SLOVENSKI STANDARD
SIST EN ISO 15001:2004
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
SIST EN ISO 15001:2004 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15001:2004
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SIST EN ISO 15001:2004
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.
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SIST EN ISO 15001:2004
EN ISO 15001:2004 (E)
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

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SIST EN ISO 15001:2004
EN ISO 15001:2004 (E)
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

EN ISO 15001:2004 by Technical Committee CEN/TC 215 "Respiratory and anaesthetic equipment", the

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.

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SIST EN ISO 15001:2004
EN ISO 15001:2004 (E)
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
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SIST EN ISO 15001:2004
EN ISO 15001:2004 (E)
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.
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SIST EN ISO 15001:2004
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SIST EN ISO 15001:2004
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
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SIST EN ISO 15001:2004
ISO 15001:2003(E)
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© ISO 2003

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ii © ISO 2003 — All rights reserved
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SIST EN ISO 15001:2004
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 2003 — All rights reserved iii
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SIST EN ISO 15001:2004
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
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SIST EN ISO 15001:2004
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.
© ISO 2003 — All rights reserved v
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SIST EN ISO 15001:2004
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SIST EN ISO 15001:2004
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

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 2003 — All rights reserved 1
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SIST EN ISO 15001:2004
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
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SIST EN ISO 15001:2004
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 2003 — All rights reserved 3
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SIST EN ISO 15001:2004
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
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SIST EN ISO 15001:2004
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 2003 — All rights reserved 5
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SIST EN ISO 15001:2004
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 compon
...

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