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Tiêu đề Medical Gas Pipeline Systems é Part 1: Terminal Units For Compressed Medical Gases And Vacuum
Trường học British Standards Institution
Chuyên ngành Medical Gas Pipeline Systems
Thể loại British Standard
Năm xuất bản 1998
Thành phố London
Định dạng
Số trang 18
Dung lượng 186,16 KB

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The European Standard EN 737-1:1998 has the status of a

British Standard

ICS 11.040.10; 23.040.60

NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW

Medical gas pipeline

systems Ð

Part 1: Terminal units for compressed

medical gases and vacuum

Trang 2

This British Standard, having

been prepared under the

direction of the Health and

Environment Sector Board, was

published under the authority of

the Standards Board and comes

into effect on 15 June 1998

Amendments issued since publication

This British Standard is the English language version of EN 737-1:1998 and covers terminal units for compressed medical gases and vacuum Together with

BS EN 739:1998, which covers hose assemblies and non-interchangeable screw-threaded (NIST) connectors, it partially supersedes BS 5682:1984 (as amended by AMD 5419:1987) which covered hose assemblies, terminal units and their connectors The remainder of the content of BS 5682:1984, i.e ªquick connectº probes, is the subject of EN 737-6, currently in preparation

When published, EN 737-6 is expected to have a lengthy transitional period, the date

of withdrawal of conflicting national standards (DOW) being set several years in the future BS 5682:1984 will be withdrawn on 13 June 1998 and replaced by a new edition (BS 5682:1998) which will retain only the requirements for quick connect probes given in the amended 1984 edition This new edition is expected to co-exist with the forthcoming BS EN 737-6 until the expiry of the DOW of EN 737-6, at which time BS 5682:1998 will be withdrawn

The UK participation in its preparation was entrusted to Technical Committee CH/44, Anaesthetic machines, breathing attachments, medical gas pipeline systems and hose assemblies, to Subcommittee CH/44/2, Medical gas supply systems, which has the responsibility to:

Ð aid enquirers to understand the text;

Ð present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed;

Ð monitor related international and European developments and promulgate them in the UK

A list of organizations represented on this committee can be obtained on request to its secretary

Cross-references

The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled ªInternational Standards Correspondence Indexº, or by using the ªFindº facility of the BSI Standards Electronic Catalogue

A British Standard does not purport to include all the necessary provisions of a contract Users of British Standards are responsible for their correct application

Compliance with a British Standard does not of itself confer immunity from legal obligations.

Summary of pages

This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 15 and a back cover

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European Committee for Standardization Comite EuropeÂen de Normalisation EuropaÈisches Komitee fuÈr Normung

Central Secretariat: rue de Stassart 36, B-1050 Brussels

1998 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members

Ref No EN 737-1:1998 E

ICS 11.040.10; 23.040.60; 23.060.01

Descriptors: Gas distribution, medical gases, compressed gas, junctions, definitions, design, equipment specifications, mechanical

properties, tests, marking, colour codes, packing

English version Medical gas pipeline systems Ð Part 1: Terminal units for compressed medical gases and vacuum

SysteÁmes de distribution de gaz meÂdicaux Ð

Partie 1: Prises murales pour gaz meÂdicaux

comprimeÂs et pour le vide (aspiration)

Rohrleitungssysteme fuÈr medizinische Gase Ð Teil 1: Entnahmestellen fuÈr medizinische Druckgase und Vakum

This European Standard was approved by CEN on 5 July 1997

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 Central Secretariat 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 Central Secretariat has the

same status as the official versions

CEN members are the national standards bodies of Austria, Belgium, Czech

Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,

Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and

United Kingdom

Trang 4

This European Standard has been prepared 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 July 1998, and

conflicting national standards shall be withdrawn at

the latest by July 1998

This European Standard 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 special national conditions and transition periods

for clause 7.2.1, see annex C.

EN 737 consists of the following parts under the

general title Medical gas pipeline systems:

Part 1: Terminal units for compressed medical gases

and vacuum;

Part 2: Anaesthetic gas scavenging disposal systems;

Part 3: Pipelines for compressed medical gases and

vacuum;

Part 4: Terminal units for anaesthetic gas scavenging

systems;

Part 5: Oxygen concentrators;

Part 6: Dimensions of probes for terminal units for

compressed medical gases and vacuum.

Dimensions of probes are specified in prEN 737-6,

which has a Date of Withdrawal (DoW) of

(DOP + 15 years)

Until this time, products complying with national

standards may continue to be used for the

maintenance and repair of probes

Annex C forms a normative part of this part of this

European Standard Annexes A and B are informative

For relationship with EU Directive(s), see informative

annex ZA, which is an integral part of this standard

According to the CEN/CENELEC Internal Regulations,

the national standards organizations of the following

countries are bound to implement this European

Standard: Austria, Belgium, Czech Republic, Denmark,

Finland, France, Germany, Greece, Iceland, Ireland,

Italy, Luxembourg, Netherlands, Norway, Portugal,

Spain, Sweden, Switzerland and the United Kingdom

Contents

Page

8 Information to be supplied by the

Annex C (normative) Special national conditions 13 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other

Trang 5

Terminal units are the points on a medical gas pipeline

system where the operator makes connections and

disconnections for the supply of specified medical

gases to anaesthetic machines, lung ventilators or other

items of medical equipment, and where a wrong

connection may create a hazard to the life of a patient

It is important that terminal units and their

components are designed, manufactured, installed and

maintained in such a way as to meet the basic

requirements specified in this part of this European

Standard This part of this European Standard pays

particular attention to:

Ð suitability of materials;

Ð gas-specificity;

Ð cleanliness;

Ð testing;

Ð identification;

Ð information supplied

In any health care facility, it is strongly recommended

that terminal units of only one type (i.e with the same

set of dimensions for probe and socket) are used for

any particular gas During hospital renovation it may

be desirable to upgrade existing medical gas

installations rather than renew them completely

It is recognized that with modified terminal units it

may not be possible to achieve the flow and pressure

drop requirements of this part of this European

Standard, due to limitations imposed by the pipeline

system itself or by those components of the original

terminal units that remain in the pipeline system

This part of this European Standard specifies the

provision of information for the installation and testing

of terminal units Testing after installation is critical to

patient safety and it is essential that terminal units are

not used until full testing in accordance with

prEN 737-3 has been completed

Rationales for some of the requirements of this part of

this European Standard are given in annex B These

requirements are indicated by the letter ªRº after the

clause number

1 Scope

1.1 This part of this European Standard specifies

requirements for terminal units intended for use in

medical gas pipeline systems specified in

prEN 737-3 for use with the following medical gases:

Ð oxygen;

Ð nitrous oxide;

Ð air for breathing;

Ð carbon dioxide;

Ð oxygen/nitrous oxide mixture [50 %/50 % (V/V)];

Ð air for driving surgical tools;

Ð nitrogen for driving surgical tools;

Ð vacuum

It is intended especially to ensure the gas-specific assembly of terminal units and to prevent their interchange between different gases

1.2 This part of this European Standard also specifies

requirements for:

Ð terminal units for the supply and disposal of air for driving surgical tools;

Ð probes intended to be connected to the gas-specific connection point which is part of a terminal unit;

1.3 This part of this European Standard does not

specify:

Ð the dimensions of probes and of the gas-specific connection points of the terminal unit

(see prEN 737-6);

Ð the dimensions of NIST connectors (see EN 739);

Ð requirements for terminal units for anaesthetic gas scavenging systems (see EN 737-4)

2 Normative references

This part of 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

prEN 737-3, Medical gas pipeline systems Ð

Part 3: Pipelines for compressed medical gases and vacuum Ð Basic requirements.

EN 739, Low-pressure hose assemblies for use with

medical gases.

prEN 1441, Medical devices Ð Risk analysis.

ISO 32, Gas cylinders for medical use Ð Marking for

identification of content.

ISO 554, Standard atmospheres for conditioning

and/or testing Ð Specifications.

3 Definitions

For the purposes of this part of this European Standard, the following definitions apply

3.1 gas-specific

having characteristics which prevent interchangeability and thereby allow assignment to one gas or vacuum service only

3.2 gas-specific connection point

that part of the socket which is the receptor for a gas-specific probe

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gas-specific connector

NIST (non-interchangeable screw-threaded) connector

(see EN 739) or a probe (see prEN 737-6)

3.4

low-pressure hose assembly

assembly which consists of a flexible hose with

permanently-attached gas-specific inlet and outlet

connectors which is designed to conduct a medical gas

at pressures between 300 kPa and 1 400 kPa and for use

with a vacuum service at pressures above 10 kPa

absolute (see EN 739)

3.5

medical gas

any gas or mixture of gases intended to be

administered to patients for therapeutic, diagnostic or

prophylactic purposes or for surgical tool application

3.6

medical gas pipeline system

central supply system with control equipment, a

pipeline distribution system and terminal units at the

points where medical gases or vacuum are required

3.7

medical gas supply system

either:

a) a medical gas pipeline system; or

b) any other installation having no permanent

pipeline system but employing a medical gas supply

source complete with pressure regulators

3.8

NIST connectors; non-interchangeable

screw-threaded connectors

range of male and female components intended to

maintain gas-specificity by the allocation of a set of

different diameters and a left or right hand screw

thread to the mating components for each particular

gas

3.9

nominal distribution pressure

pressure which the pipeline distribution system is

intended to deliver at the terminal units

3.10

probe

non-interchangeable male component designed for

acceptance by and retention in the socket

3.11 quick connector

pair of non-threaded gas-specific components which can be easily and rapidly joined together by a single action of one or both hands without the use of tools

3.12 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

3.13 socket

that part of a terminal unit which is either integral or attached to the base block by a gas-specific interface and which contains the gas-specific connection point

3.14 terminal unit

outlet assembly (inlet for vacuum) in a medical gas supply system at which the operator makes connections and disconnections

3.15 terminal unit base block

that part of a terminal unit which is attached to the pipeline distribution system

3.16 terminal unit check valve

valve which remains closed until opened by insertion

of an appropriate probe and which then permits flow

in either direction

3.17 terminal unit for supply and disposal of air for driving tools

combination of an outlet assembly (for the supply) and

an inlet assembly (for disposal) which are connected

to a supply system and to a disposal system respectively and at which the operator makes connections and disconnections by means of a combined probe

3.18 terminal unit maintenance valve

valve which permits maintenance of the terminal unit without shutting down the pipeline system to other terminal units

4 Terminology

A diagram of a typical terminal unit with examples of terminology is given in Figure 1

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5 General requirements

5.1 Safety

Terminal units shall, when transported, stored,

installed, operated in normal use and maintained

according to the instructions of the manufacturer,

cause no safety hazard which could be foreseen using

risk analysis procedures in accordance with

prEN 1441 and which is connected with their intended

application, in normal condition and in single fault

condition

5.2 R Alternative construction

Terminal units and components or parts thereof, using

materials or having forms of construction different

from those detailed in clause 5 of this part of this

standard shall be accepted if it can be demonstrated

that an equivalent degree of safety is obtained

Such evidence shall be provided by the manufacturer

See annex C for special national conditions and

transition periods

5.3 Materials

5.3.1 The materials in contact with the gas shall be

compatible with oxygen, the other medical gases and

their mixtures in the temperature range specified

in 5.3.2.

NOTE 1 Corrosion resistance includes resistance against

moisture and surrounding materials.

NOTE 2 Compatibility with oxygen involves both combustibility

and ease of ignition Materials which burn in air will burn violently

in pure oxygen Many materials which do not burn in air will do

so in pure oxygen, particularly under pressure Similarly, materials

which can be ignited in air require lower ignition energies for

ignition in oxygen Many such materials may be ignited by

adiabatic compression produced when oxygen at high pressure is

rapidly introduced into a system initially at low pressure.

NOTE 3 A standard, Compatibility of medical equipment with

oxygen, is in preparation by ISO/TC 121/SC6.

5.3.2 The materials shall permit the terminal units and

their components to meet the requirements of 5.4 in

the temperature range of 220 ÊC to +60 ÊC

5.3.3 Terminal units shall be capable, while packed

for transport and storage, of being exposed to

environmental conditions as stated by the

manufacturer

5.3.4 R Evidence of conformity with the requirements

of 5.3.1, 5.3.2 and 5.3.3 shall be provided by the

manufacturer

5.4 Design requirements

5.4.1 Medical gas supply pressure

5.4.1.1 R Terminal units for oxygen, nitrous oxide, air

for breathing, carbon dioxide and oxygen/nitrous oxide

mixture 50 %/50 % (V/V) shall operate and meet the

requirements of this part of this European Standard for

a medical gas supply having a pressure range

from 320 kPa to 600 kPa

5.4.1.2 R Terminal units for oxygen, nitrous oxide, air

for breathing, carbon dioxide and oxygen/nitrous oxide

mixture 50 %/50 % (V/V) shall not create a hazard to the

patient or operator at an inlet pressure of 1 000 kPa Evidence shall be provided by the manufacturer

5.4.1.3 R Terminal units for oxygen, nitrous oxide, air

for breathing, carbon dioxide and oxygen/nitrous oxide

mixture 50 %/50 % (V/V) shall meet the requirements

of 5.4.1.1 following exposure to an inlet pressure

of 1 000 kPa for 10 min

5.4.1.4 R Terminal units for air for driving surgical

tools and nitrogen for driving surgical tools shall operate and meet the requirements of this part of this European Standard for a medical gas supply having a pressure range from 640 kPa to 1 200 kPa

5.4.1.5 R Terminal units for air for driving surgical

tools and nitrogen for driving surgical tools shall not create a hazard to the patient or operator at an inlet pressure of 2 000 kPa

Evidence shall be provided by the manufacturer

5.4.1.6 R Terminal units for air for driving surgical

tools and nitrogen for driving surgical tools shall meet

the requirements of 5.4.1.4 following exposure to an

inlet pressure of 2 000 kPa for 10 min

5.4.1.7 R Terminal units for vacuum shall operate and

meet the requirements of this part of this European Standard for a vacuum supply having a minimum absolute pressure of 10 kPa

5.4.2 Terminal units for different pressures

Terminal units for the same gas at different nominal operating pressures shall have gas-specific connection points for each pressure (e.g the supply of air for driving surgical tools and air for breathing)

5.4.3 Incomplete assembly

If any gas-specific component is removed from the terminal unit, either the terminal unit shall be rendered inoperable or the gas-specificity of the terminal unit shall be maintained

If the terminal unit can be dismantled, the components shall not be capable of being reassembled in such a way that the fully-assembled terminal unit is no longer gas-specific

5.4.4 Gas-specific connection point

Each terminal unit shall include a gas-specific connection point which shall accept the appropriate gas-specific probe only This connection point shall be included in a socket

5.4.5 Terminal unit check valve

Each terminal unit shall include a check valve which shall open the gas supply when the probe is connected and which shall shut off automatically when the probe

is disconnected The check valve shall be a separate component or assembly from the maintenance valve

specified in 5.4.6.

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Table 1 Ð Requirements for flow and pressure drop across terminal units with probe inserted

Terminal unit nominal

distribution pressure

(see prEN 737-3)

across a terminal unit

5.4.6 Terminal unit maintenance valve

Except for vacuum services, each terminal unit shall

be equipped with a maintenance valve, which can be

manual or automatic The maintenance valve shall be a

separate component or assembly from the check valve

specified in 5.4.5.

5.4.7 Connection of terminal units to the pipeline

NOTE See also 8.2.

5.4.7.1 The base block of a terminal unit shall be

designed and manufactured for either permanent or

gas-specific connection to a pipeline

5.4.7.2 Except for connection to a disposal system,

connection to a pipeline distribution system shall be by

brazing, welding or by means of a NIST body and shall

comply with prEN 737-3

5.4.7.3 Connection to a low-pressure flexible

connecting assembly shall be either by direct ferruling

or by means of a NIST body and shall comply

with EN 739

5.4.8 Socket

The arrangement for attaching a socket to its base

block for a particular service shall be of a design

which prevents interchangeability with the base block

of any other service

5.4.9 Testing

Compliance with clauses 5.4.2 to 5.4.8 shall be tested

by visual inspection

5.4.10 Endurance (connection/release)

5.4.10.1 Socket

The socket shall meet the requirements given

in 5.4.11, 5.4.12, 5.4.13, 5.4.14, 5.4.15, 5.4.16

and 5.4.17 after testing in accordance with

clause 6.2.1.

5.4.10.2 Probe

The probe shall meet the requirements given

in 5.4.11, 5.4.12, 5.4.13, 5.4.14, 5.4.15, 5.4.16

and 5.4.17 after testing in accordance with 6.2.2.

5.4.11 R Pressure drop

The pressure drop across the terminal unit and its probe shall not exceed the values given in Table 1 For terminal units for supply and disposal of air for driving surgical tools, the pressure drop across the outlet assembly shall not exceed the value given in Table 1; the pressure drop across the inlet assembly shall not exceed 25 kPa with a back pressure not exceeding 15 kPa

The test for pressure drop is given in 6.3.

5.4.12 Connection force and torque

The force and the torque required to insert the probe into the terminal unit shall be:

a) an axial force not exceeding 100 N and/or b) a torque not exceeding 1 N´m

The test for connection force and torque is given

in 6.4.

5.4.13 Disconnection force and torque

The force and the torque required to release the locking mechanism shall be:

a) a push or pull of not more than 110 N and not less than 20 N and/or

b) a torque of not more than 1 N´m and not less than 0,1 N´m

When all locking provisions have been released, according to the manufacturer's instructions, disconnection of the probe from the terminal unit shall require a force of not more than 100 N

The test for disconnection force and torque is given

in 6.5.

NOTE Danger to personnel can occur as a result of the rapid expulsion of probes from terminal units The design should prevent this from occurring.

5.4.14 Mechanical strength

The terminal unit shall withstand the application of a steady axial tensile force of not less than 500 N

The test for mechanical strength is given in 6.6.

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5.4.15 Leakage

The leakage from a terminal unit with and without the

probe inserted shall not exceed 0,296 ml/min

(0,03 kPa l/min) The test for leakage is given in 6.7.1

and 6.7.2.

The leakage from a terminal unit with the probe

inserted and with side force applied shall not

exceed 0,296 ml/min (0,03 kPa l/min)

The test for leakage with side force applied is given

in 6.7.3.

5.4.16 Gas-specificity

The terminal unit shall only accept the probe for the

medical gas for which it is intended

The test for gas specificity is given in 6.8.

5.4.17 Effective connection of probes

A tactile or audible indication of locking shall be

perceived on retention of the gas-specific probe

The test for effective connection of probes is given

in 6.9.

5.5 Constructional requirements

5.5.1 R Cleaning

The components of terminal units for all services shall

be supplied clean and free from oil, grease and

particulate matter

Evidence shall be provided by the manufacturer

NOTE 1 Any method of cleaning and degreasing can be used

which effectively removes all surface dirt and hydrocarbons, and

which leaves no residue itself Chemical cleaning methods will

normally require a subsequent washing and drying process to

remove residues.

NOTE 2 Examples of cleaning procedures will be described in a

standard, Compatibility of medical equipment with oxygen,

which is in preparation by ISO/TC 121/SC6.

5.5.2 R Lubricants

If lubricants are used, they shall be compatible with

oxygen, the other medical gases and their mixtures in

the temperature range specified in 5.3.2.

Evidence shall be provided by the manufacturer

6 Test methods

6.1 General

6.1.1 Ambient conditions

Except if otherwise stated, carry out tests at

(23±2) ÊC

6.1.2 Test gas

Carry out tests in accordance with ISO 554 with clean,

oil-free dry air or nitrogen

In all cases, carry out tests with dry gas with a

maximum moisture content of 50 ppm (parts per

million = 1026) corresponding to a dew point

of 248 ÊC at atmospheric pressure

6.1.3 Reference conditions

Correct flows to 23 ÊC and 101,3 kPa

6.2 Test method for endurance

6.2.1 Socket

Fix the terminal unit to a horizontal or vertical surface,

as appropriate, using the procedure recommended by the manufacturer

Apply a test pressure at the inlet to the base block of the terminal unit Use a test pressure of 1 200 kPa for terminal units for air for driving surgical tools and for nitrogen for driving surgical tools, or a test pressure

of 600 kPa for all other terminal units Using a test probe made of corrosion-resistant steel of minimum chromium content 17 % and a surface Brinell hardness

of 210 HB 1/30, connect and release the probe 10 000 times, at a frequency of not more than

10 operations per minute, changing the seals every

1 000 operations or according to the manufacturer's instructions, whichever is the greater interval

Test the socket for compliance with 5.4.11, 5.4.12,

5.4.13, 5.4.14, 5.4.15, 5.4.16 and 5.4.17.

6.2.2 Probe

Fix a terminal unit complying with this part of this European Standard to a horizontal or vertical surface,

as appropriate, using the procedure recommended by the manufacturer

Apply a test pressure at the inlet to the base block of the terminal unit Use a test pressure of 1 200 kPa for terminal units for air for driving surgical tools and for nitrogen for driving surgical tools, or a test pressure

of 600 kPa for all other terminal units Connect and release the probe 10 000 times, at a frequency of not more than 10 operations per minute, changing the seals every 1 000 operations or according to the

manufacturer's instructions, whichever is the greater interval

Test the probe for compliance with 5.4.11, 5.4.12,

5.4.13, 5.4.14, 5.4.15, 5.4.16 and 5.4.17.

6.3 Test method for pressure drop

Using an apparatus of typical configuration shown in Figure 2 for terminal units for compressed medical gases, Figure 3 for terminal units for vacuum or Figure 4 for terminal units for supply and disposal of air for driving surgical tools, set the test pressure and flow at the inlet of the terminal unit to the appropriate

values given in Table 1 and in 5.4.11.

Measure the pressure drop across the terminal unit with the probe inserted

For terminal units for the supply and disposal of air for driving surgical tools, measure the pressure drops across the outlet and inlet assemblies simultaneously

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6.4 Test method for connection force and torque

Adapt a probe to accommodate a suitable measuring

device

Fix the terminal unit to a horizontal or vertical surface,

as appropriate, using the procedure recommended by

the manufacturer

Apply a test pressure at the inlet to the base block of

the terminal unit Use a test pressure of 1 200 kPa for

terminal units for air for driving surgical tools and for

nitrogen for driving surgical tools, or a test pressure

of 600 kPa for all other terminal units

In accordance with the manufacturer's instructions,

insert the adapted probe into the terminal unit and

record the force and/or torque required to insert and

engage the probe fully

6.5 Test method for disconnection force and

torque

Adapt a probe to accommodate a suitable measuring

device

Fix the terminal unit to a horizontal or vertical surface,

as appropriate, using the procedure recommended by

the manufacturer

Apply a test pressure at the inlet to the base block of

the terminal unit Use a test pressure of 640 kPa for

terminal units for driving surgical tools and for

nitrogen for driving surgical tools, or a test pressure of

320 kPa for all other terminal units

Insert the adapted probe into the terminal unit in

accordance with the manufacturer's instructions and

ensure that it is fully engaged

Disconnect the probe in accordance with the

manufacturer's instructions and record the force and/or

torque required to release the locking mechanism

If the recommended disconnection method involves

applying, for example, compressive force to the probe

to reduce the effort required to disengage the locking

mechanism, measure each separate force/torque

involved

6.6 Test method for mechanical strength

Adapt a blanked probe in order to apply tensile force

Fix the terminal unit to a suitable surface using the

procedure recommended by the manufacturer

Apply a test pressure at the inlet to the base block of

the terminal unit Use a test pressure of 1 200 kPa for

terminal units for air for driving surgical tools and for

nitrogen for driving surgical tools, or a test pressure

of 600 kPa for all other terminal units

Insert the adapted probe

Apply a tensile force of 500 N and hold it for 1 min

Remove the tensile force, check that the terminal unit

is completely functional and the leakage is according

to 5.4.15.

Dismantle the terminal unit and check that no damage

6.7 Test methods for leakage 6.7.1 Fix the terminal unit to a horizontal or vertical

surface, as appropriate, using the procedure recommended by the manufacturer

Apply a test pressure at the inlet of the base block of the terminal unit Use the following test pressures a) 320 kPa and 600 kPa for terminal units for compressed medical gases;

b) 640 kPa and 1 200 kPa for terminal units for air for driving surgical tools and nitrogen for driving surgical tools;

c) 40 kPa absolute pressure for terminal units for vacuum

Measure the leakage under the conditions of maximum and minimum test pressure

6.7.2 Keep the terminal unit pressurized as described

in 6.7.1 and insert a gas-specific blanked probe.

Measure the leakage under the conditions of maximum and minimum test pressure

6.7.3 Apply a force of 20 N perpendicular to the long

axis of the probe, 50 mm from the outermost surface of the terminal unit Measure the leakage whilst the force

is applied to the probe under the conditions of maximum and minimum test pressure

6.8 Test method for gas-specificity

Carry out the test by attempting to connect all gas-specific test probes in turn to the gas-specific connection point of each socket

6.9 Test method for effective connection of probes

Carry out the test by inserting the gas-specific probe and checking that a tactile or audible indication of locking is given

6.10 Test method for durability of markings and colour coding

Rub markings and colour coding by hand, without undue pressure, first for 15 s with a cloth rag soaked with distilled water, then for 15 s with a cloth rag soaked with methylated spirit and then for 15 s with a cloth rag soaked with isopropyl alcohol Carry out this test at ambient temperature

7 Marking, colour coding and packaging

7.1 Marking 7.1.1 Terminal units, probes and their gas-specific

components shall be durably and legibly marked with the symbol of the relevant gas in accordance

with Table 2

NOTE In addition to the symbol, the name of the gas can be used.

The test for the durability of markings is given in 6.10.

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