Designation: F 960 86 (Reapproved 2000)

An American National Standard

Standard Specification for

Medical and Surgical Suction and Drainage Systems1

This standard is issued under the fixed designation F 960; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
This standard has been approved for use by agencies of the Department of Defense.

2.1.1 aspirationthe withdrawal, by means of suction, of

fluids or friable tissue.
2.1.2 collection vessel assemblya container whose primary function is to collect liquids.
2.1.3 disclosureinformation on performance and test
methods to be made available by manufacturers.
2.1.4 drainagethe removal of fluids from a body cavity or
wound by a process utilizing gravity; drainage may be assisted
by the application of vacuum.
2.1.5 filtera device for reducing airborne particulate matter.
2.1.6 flow-direction sensitivityperformance is dependent
on the direction of fluid flow.
2.1.7 free air flowthe flow of air into a vacuum source
when its inlet is open to atmosphere.
2.1.8 gastrointestinal drainagethe removal of gastrointestinal contents, consisting of fluids and solid particles, by means
of an indwelling tube which may be supplemented by gravity
syphon or by vacuum.
2.1.9 graduation indicatorsvisible means of displaying
measurement increments.
2.1.10 inletthe port of a component into which fluid
enters under use conditions.
2.1.11 mediastinal drainagethe removal of fluids from
the mediastinum which may be supplemented by vacuum.
2.1.12 outletthe port of a component from which fluid
exits in normal use.
2.1.13 patient connectionthe point at which the suction
catheter, curette, or drainage tube inserted into the patient is
attached to the suction system.
2.1.14 pleural drainagethe removal of fluids from the
pleural space, maintaining a relatively constant partial vacuum
within that space.
2.1.15 regulatora device, which may be adjustable, that
limits vacuum to a predetermined level.
2.1.16 reprocessingpreparation for reuse.
2.1.17 shutoff mechanisma device designed to avoid overflow of suctioned material.
2.1.18 stand-alone componenta device which is not an
integral part of any other component of the suction system.
2.1.19 static vacuumthe vacuum level without fluid
movement.

1. Scope
1.1 This specification describes minimum safety and performance requirements for medical and surgical suction and
drainage apparatus.
1.2 This specification covers apparatus to be used for:
1.2.1 Oral, nasal, tracheal (ONT) suction,
1.2.2 Gastrointestinal drainage,
1.2.3 Pleural space and mediastinal drainage,
1.2.4 Closed wound drainage, and
1.2.5 Surgical suction (including uterine aspiration).
1.2.6 This specification also covers devices powered by
centrally piped vacuum systems, compressed gases, electricity,
and manual operation.
1.3 This specification does not cover the following:
1.3.1 Central vacuum pumps and piping systems of vehicles
and buildings,
1.3.2 Catheters, tubes, drains, curettes, and suction tips
inserted into the patient,
1.3.3 Syringes,
1.3.4 Breast pumps,
1.3.5 General dentistry suction equipment,
1.3.6 Waste gas scavenging systems,
1.3.7 Laboratory suction,
1.3.8 Fetal vacuum extractor or vacuum forceps with selfcontained suction,
1.3.9 Autotransfusion,
1.3.10 Cardiopulmonary bypass pumps, and
1.3.11 Urinary drainage.
1.4 The following precautionary caveat pertains only to the
test method portion, Section 5, of this specification: This
standard does not purport to address all of the safety problems,
if any, associated with its use. It is the responsibility of the user
of this standard to consult and establish appropriate safety and
health practices and determine the applicability of regulatory
limitations prior to use. See 5.3.3.
2. Terminology
2.1 Definitions of Terms Specific to This Standard:
1
This specification is under the jurisdiction of ASTM Committee F29 on
Anesthetic and Respiratory Equipmentand is the direct responsibility of Subcommittee F29.17 on Medical Surgical Suction and Drainage.
Current edition approved Jan. 8, 1986. Published March 1986.

Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.

F 960
able leakage rates. Pumps and regulators are excluded (see 4.4
and 4.6.1.2).
4.3.3 Resistance to ImplosionIf the collection vessel assembly will not resist loss of integrity and implosion at an
applied vacuum of 690 mm Hg (27 in. Hg) for suction vessels,
and at 200 cm H2O (147 mm Hg) applied vacuum for pleural
and mediastinal drainage vessels, labeling shall state the
maximum vacuum the collection vessel assembly will withstand. This requirement does not apply to wound drainage.
4.4 Vessel Air Leak Capacity:
4.4.1 Suction Collection VesselsThe maximum leak rate
of suction collection vessels shall be less than 10 bubbles in 10
s (approximately 13 mL/min) when exposed to a vacuum level
of 300 mm Hg.
4.4.2 Closed-Wound Drainage VesselsClosed-wound
drainage vessels shall not lose more than 20 % of their
maximum capacity after 2 h.
4.4.3 Pleural Drainage Collection VesselsPleural drainage collection vessels should not leak between the patient and
the underwater seal (or one-way valve, if used).
4.5 Indicator Performance:
4.5.1 Accuracy of IndicatorsIndicators shall be accurate
to within 610 % of full-scale calibration. The graduation
increments of the indicator should not be less than the accuracy
of the indicating device.
4.5.2 StabilityThe regulator reading shall return to its
original setting within 610 % of full scale when the flow is
cycled off and on.
4.6 Tubing Performance:
4.6.1 If Connectors are Permanently Attached to Suction,
Pleural, and Mediastinal Drainage Tubing:
4.6.1.1 Inside Diameter (ID)The smallest inside diameter
of the connector shall not be less than 80 % of the nominal ID
of the tubing, or 5 mm, whichever is greater.
4.6.1.2 Integrity of Connector AttachmentFor connectors
which are formed (molded) separately and subsequently attached to the tube, the bond shall be sufficiently strong to
withstand a pull of 24.5 N (5.5 lbf) for 10 min and not exceed
the leakage requirement of less than 10 bubbles in 10 s
(approximately 13 mL/min) when exposed to a vacuum of 300
mm Hg. Tubing intended for use with drainage systems should
not leak.
4.6.1.3 Resistance to CollapseTubing shall retain at least
50 % of its outside diameter throughout its length for at least 5
min when subjected to the disclosed vacuum (6.6.2).
4.6.1.4 Connector StrengthConnectors should resist collapse under normal use conditions.
4.6.2 Flexibility Tubing should be flexible to permit
bending and positioning and to reduce strain on connections.
4.6.3 Translucency Tubing should be sufficiently translucent to permit observation of the contents.
4.7 Filtering Device Performance (If used in a suction
system):
4.7.1 Filtering Device IntegrityThe filtering device shall
maintain integrity of housing, if present, and filter medium
when subjected to the flow and vacuum tests in 5.7.1.

2.1.20 suctionthe removal of fluids or solids by the

application of vacuum.
2.1.21 suction systema series of components, devices, or
assemblies which may include tubing, connectors, filters,
collection vessels, shutoff mechanisms, regulators, portable
pumps, safety overflow traps, and gages, beginning at the point
of connection with the patient.
2.1.22 vacuuma pressure less than atmospheric pressure.
2.1.23 wound drainagethe removal of fluids from a
wound; removal may be supplemented by vacuum.
3. General Requirements
3.1 Shutoff MechanismsA suction or vacuum-assisted
drainage system shall incorporate a shutoff mechanism which
may stand alone or may be an integral part of a component of
the system, unless the system is intended to continue operating
after invasion or overflow of aspirated liquids and solids.
3.2 Tubing ConsiderationsTubing used in suction and
drainage systems should be kept as short as practical and
should be arranged to minimize loops and drapes which can
accumulate liquid and increase the potential for occlusion from
pinching and kinks. Tubing diameter influences the total
system resistance (see Appendix X1).
3.3 Liquid ConnectionsThe connections which conduct
liquids should be designed to minimize occlusion.
3.4 Stand Alone Suction Tubing Connectors:
3.4.1 Lumen Size and CharacteristicsThe size of stand
alone suction tubing connector lumen chosen should not be less
than 80 % of the nominal inside diameter of the suction tubing
or 5 mm, whichever is greater. Internal passageways should be
smooth. This requirement does not apply to wound and
gastrointestinal drainage systems.
4. Performance Requirements
4.1 Shutoff Mechanism PerformanceThe shutoff mechanism shall not pass more than 5 mL of water distal to the
shutoff mechanism. If the shutoff mechanism is integral to a
collection vessel, it shall not activate before 90 % of the stated
useable collection capacity of the system is reached.
4.2 Electric ConductivityAll components labeled conductive shall have a resistance not greater than 1 MV.
4.3 System PerformanceWhen assembling the components of a suction or drainage system, the user should consider
the flow resistance characteristics of the components in series
and ensure that the system has the necessary performance
characteristics for the suction procedure (see Appendix X2).
The user should consider whether the system performance will
be compromised by the use of a Y-piece or other multiport
connector.
4.3.1 Maximum Pleural Drainage System Pressure
Pleural drainage systems shall not develop a pressure in excess
of +10 cm H2O at the patient inlet, at a flow of 10 L/min. If the
pleural drainage system requires periodic adjustment to prevent
intrapleural pressures above 10 cm H2O, this shall be stated in
the labeling.
4.3.2 LeakageThe leakage of a suction or drainage system is affected by the leaks of its components. Therefore,
individual components shall not exceed their respective allow-

5. Test Methods
5.1 Shutoff MechanismConnect the shutoff mechanism in
2

F 960
the system in accordance with the manufacturers instructions.
Suction (draw) room temperature water into the system until
the shutoff mechanism is activated. Measure the volume of
water which passed the shutoff. Measure the volume collected
in the vessel if the shut-off mechanism is an integral part of a
vessel.
5.2 Electric ConductivityMeasure the electrical resistance
of the component between inlet and outlet with an ohm meter.
Resistance shall not be greater than 1 MV.
5.3 System Performance:
5.3.1 Maximum Pleural Drainage System PressureAttach
the patient end of the pleural drainage system set up for normal
operation in accordance with manufacturers recommendations, to a pressure source adjusted to produce a flow of 10
L/min and measure the pressure at that point (Fig. 1).
5.3.1.1 Reprocessing of Reuseable Components
Reprocess the component as recommended and assure that the
manufacturers stated performance is not impaired. Check the
labeling for conformance.
5.3.2 LeakageThe leakage of the system is affected by the
leaks of its components. See 5.4 and 5.6.1.2.
5.3.3 Resistance to ImplosionPlace the collection vessel
in a protective enclosure, that is, a box, bag, etc. Attach a
vacuum source to the collection vessel outlet and occlude all
other collection vessel openings. Evacuate suction collection
vessels to not less than 690 mm Hg (27 in. Hg) vacuum; pleural
or mediastinal drainage collection vessels to 200 cm H2O (147
mm Hg), or to the manufacturers labeled maximum vacuum.
Hold vacuum for 5 min. Release vacuum. Repeat cycle once
(see Fig. 2). WarningThis test can be hazardous and proper
care should be taken to protect personnel from possible flying
debris.
5.3.3.1 Graduation Indicator AccuracyThe accuracy of
the collection vessel graduation indicators shall be tested by
filling the vessel with a premeasured amount of liquid and
checking the volume indication to be within the disclosed
accuracy.
5.4 Vessel Air Leak Capacity Tests:
5.4.1 Suction Collection VesselsSet the regulator to 300
mm Hg. Open the valve and allow test component to reach the
set vacuum. Close valve. Observe water bottle for bubbles. The
test is passed if no more than 9 bubbles are observed in 10 s.
5.4.2 Closed-Wound Drainage Vessels:
5.4.2.1 Activate the vacuum in accordance with manufacturers instructions.
5.4.2.2 Cap or plug all ports tightly.
5.4.2.3 Allow 2 h to elapse. Avoid excessive temperature
fluctuations.
5.4.2.4 Place the unit in a water bath so that the patient port

FIG. 2 Suction and Drainage Collection Vessel Assembly

is immersed approximately 2 cm deep.

5.4.2.5 Open the cap of the patient port and allow water to
enter the vessel until the vacuum is spent.
5.4.2.6 Remove from bath and expel all the aspirated water
into a graduated cylinder to measure the residual capacity.
5.4.2.7 Reactivate the vessel and seal all ports.
5.4.2.8 Repeat the residual capacity determination of the
vessel immediately after activation. This is the maximum
capacity.
5.4.2.9 The capacity remaining after 2 h (5.4.2.6) shall be at
least 80 % of the maximum capacity (5.4.2.8).
5.5 Indicators and Suction Regulators:
5.5.1 Accuracy of IndicatorsCheck accuracy of the indicator against a mercury or water column as appropriate for the
device.
5.5.2 StabilitySet regulator at 50 % of the maximum
setting at any vacuum level with the inlet occluded. Open and
close the inlet several times and observe that the vacuum
indicator returns to the set value with 610 % of full-scale
calibration.
5.5.3 Vacuum Indicator (gage)Check the markings for
conformance.
5.5.4 Vacuum Control MechanismAttach the vacuum
source, occlude inlet, and observe that adjusting the vacuum
control mechanism in the indicated direction will change the
level of vacuum in that direction.
5.5.5 Operation and Repair Manual for RegulatorsCheck
the manual for conformance.
5.6 Tubing:
5.6.1 Connectors Permanently Attached to Suction, Pleural,
and Mediastinal Drainage Tubing:
5.6.1.1 Inside Diameter Direct measurement.
5.6.1.2 Integrity of Connector AttachmentSecurely plug
one end of the tube and attach the other connector to the set up
of Fig. 3. Apply a 2.5-kg weight to the vertically suspended
tube. After 10 min, with the weight attached, test for air leaks
in accordance with the test in 5.4.
5.6.1.3 Resistance to Collapse Under VacuumAt 20 to
25C, uncoil the test specimen to its full length and plug one
end to prevent any air flow through the tube. Attach a vacuum
source to the other end of the tube and adjust the level of
vacuum to the disclosed maximum (see Fig. 4). The specimen
passes the test if the tube retains at least 50 % of the nominal
diameter throughout its length for at least 5 min. The calculation of the degree of collapse may be determined by measurements performed on the outside diameter, as illustrated in Fig.
5.
5.7 Filtering Devices (If used in a suction system):
5.7.1 Filtering Device IntegrityAttach by tubing, the
filtering device to a regulated vacuum source and occlude the
inlet of the filtering device. Apply 300 mm Hg vacuum for 15

FIG. 1 Typical Test Setup for Evaluating Pleural Drainage System

Performance

F 960

FIG. 3 Typical Test Setup for Evaluating Leakage

read the meter. Check the manual for conformance.

6. Labeling and Operating Manual Requirements
6.1 General Requirements:
6.1.1 LegibilityAll markings pertaining to the operation
of the device (for example, controls, gages, graduation indicators) must be legible to a person with 20/20 vision (corrected)
at a distance of 1 m at a light level of 215 lux.
6.1.2 Connection LabelingMeans, preferably marking,
shall be provided to identify correct connections when misconnection is possible.
6.1.3 Single UseComponents that are not intended for
reuse shall be marked, in substance, for single use.
6.2 Electric ConductivityAll components labeled conductive shall have a resistance not greater than 1 MV.
6.3 System Performance:
6.3.1 Reprocessing If the component is intended for
reuse, recommended methods for reprocessing shall be stated
in the labeling. The component shall withstand the methods of
reprocessing stated in the labeling.
6.4 Suction and Drainage Collection Vessels:
6.4.1 CapacityProduct labeling shall indicate the useable
capacity, in millilitres, of the collection vessel.
6.4.2 Positioning Labeling shall include instructions for
positioning of the collection vessel assembly for proper function.
6.5 Indicators:
6.5.1 Graduation Indicator AccuracyGraduation indicator accuracy shall be stated in the labeling or identified as being
for approximation only.
6.5.2 Vacuum Indicator (gage)The indicator shall be
marked, in substance, vacuum to indicate the gas service and
shall be appropriately graduated in any of the following units:
kilopascals, mm Hg, cm H2O, or in. Hg.
6.5.3 Vacuum Control MechanismIf a vacuum level control mechanism is present, it shall show clearly the direction for
increase or decrease in vacuum level.
6.5.4 Operation and Repair Manual for RegulatorsA
manual containing warnings and limitations, reprocessing instructions, performance specifications, operating and maintenance instructions, and a list of operator replaceable parts shall
be included.
6.6 Tubing:
6.6.1 Inside Diameter and LengthUnit package labeling
shall state the nominal inside diameter, in millimetres, and the

FIG. 4 Vacuum Assembly

FIG. 5 Measurements for Calculation of Degree of Collapse

s. Release the vacuum. Visually inspect housing for damage

and then subject the test component to a leak test (5.4, Fig. 3).
5.7.2 Suggested Method for Exposing the Filtering Device
to Electrocautery SmokeConnect the vacuum port of the
filtering device to the vacuum source with a 6-ft length of
tubing. Connect the outlet of the filtering device to a regulated
vacuum source with a 6-ft length of tubing. Establish a flow
rate of 20 L/min. Place the suction tip 4 in. above a 112-lb flank
steak. Make a cut in the steak 2 cm deep and 5 cm long in 5 s,
using the active electrode of an electrosurgical unit (Bovie
setting at 60, Cut 2 mode). Perform this for 5 s each minute
for 10 min. Measure the filtering devices performance.
5.8 Portable and Mobile Suction Pumps:
5.8.1 Available Static VacuumWith the suction equipment
in its operating mode, connect a vacuum measuring indicator to
the suction inlet. Observe the indicated static vacuum. Check
the manual for conformance.
5.8.2 Available Free AirflowWith the suction equipment
in its operating mode, connect a flow meter indicator to the
suction inlet. Check the manual for conformance.
5.8.3 Equipment Noise LevelWith the suction equipment
operating under conditions disclosed, and a sound level meter
(dampened mode) positioned at one meter from the equipment,
4

F 960
operational power requirements for the device, except
operator-powered vacuum sources.
6.8.3 Operating Environment InformationEnvironmental
limitations shall be marked on the suction source.
6.8.3.1 If the source is electrically powered and is not an
explosion-proof design, it shall be marked, in substance, that
the device is NOT FOR USE IN THE PRESENCE OF
FLAMMABLE GASES.
6.8.3.2 If the source is gas powered and oxygen may be
used, it shall be marked, USE NO OIL.
6.8.4 Source Connection MarkingWhere misconnection
is possible, the suction inlet port shall be clearly marked, in
substance, SUCTION.
6.8.5 Available Static VacuumThe manufacturer shall disclose in the manual the maximum static vacuum capability of
the source and the time required to achieve maximum static
vacuum. This does not apply to drainage systems.
6.8.6 Available Free Air FlowThe manufacturer shall
disclose in the manual the free air flow capability of the source.
This requirement does not apply to closed wound, mediastinal,
and gastrointestinal drainage systems.
6.8.7 Equipment Noise LevelThe manufacturer shall disclose in the manual the maximum sound pressure level (dBA)
at a distance of 1 m, during normal operation. This does not
apply to operator-powered vacuum sources.

nominal length, in metres or fractions thereof. In addition,

other units of measure may be shown.
6.6.2 Resistance to Collapse Under VacuumUnit labeling
shall include a statement of the maximum vacuum for which
the tubing is intended to be used.
6.6.3 SterilityThe labeling shall state whether the tubing
is sterile.
6.7 Filtering Devices (If used in a suction system):
6.7.1 Flow Resistance The manufacturer shall disclose
the filter flow resistance under dry, wet, and electrocautery
smoke conditions.
6.7.2 Flow Direction If the filtering device is standalone and flow-direction sensitive, the flow direction shall be
marked on the device.
6.7.3 Accompanying InformationInstructions for use shall
accompany the filtering device.
6.7.4 Reduction of Airborne Particulate MatterThe
manufacturer shall disclose the test method and filtration
efficiency in reduction of airborne particulate matter.
6.8 Portable and Mobile Suction Sources:
6.8.1 Operating Manual The manual shall contain appropriate operating environment warnings and limitations, specifications, operating and maintenance instructions, warranty
statement, list of user replaceable parts, and, where intended to
be user repairable, detailed repair instructions. For non-user
repairable items, information on how to obtain service shall be
provided where applicable.
6.8.2 Power Requirement LabelLabeling shall include

7. Keywords
7.1 drainage; suction

APPENDIXES
(Nonmandatory Information)
X1. LUMEN (PASSAGEWAY) SIZE AND ITS EFFECTS ON FLOW

X1.3 Table X1.1 shows the relative flow rates of various

sizes of straight tubing under similar conditions. The flow
through a 6.35-mm (14-in.) ID tube is designated as 100 %.

X1.1 The laminar flow of fluid (gas or liquid) is approximately proportional to the fourth power of the inside diameter
(ID) of the lumen, and inversely proportional to the length.
X1.2 For each system setup it is suggested that the largest
diameter and shortest tube practical should be used.

F 960
TABLE X1.1 Relative Flow Rates of Straight Tubing
Diameter,
in. (mm)
316 (4.76)
(5)
732 (5.56)
(6)
14C (6.35)
(7)
932 (7.14)
516 (7.14)
(8)

Flow, %

Estimated Pressure
Drop for 2-m (6-ft)
Length, mm HgA

Approximate Water
Flow (mL/min)
through 2-m
(6-ft) LengthB

30
40
60
80
100
150
160
240
250

47
39
25
19
15
10
8
5
4.8

2.7
3.2
4.0
4.7
5.5
6.2
6.5
7.7
7.8

A
Estimated vacuum loss per 2-m (6-ft) length of straight tubing flowing 20 L/min
air at a source vacuum of 300 mm Hg. Specific brands of tubing may give slightly
different results depending on smoothness of lumen and properties of material.
B
These flow rates are for horizontally positioned tubing at ambient temperature
and an applied vacuum of 300 mm Hg.
C
Suggested minimum diameter.

X2. MINIMUM AND MAXIMUM FREE AIR FLOW RATES AND VACUUM LEVELS FOR SUCTION AND DRAINAGE

X2.1 The committee felt the flow rates and vacuum levels
for the types of procedures given in Table X2.1 may be
experienced in clinical practice. Systems and their components

should be selected to provide appropriate performance capability. Performance disclosure should help in making this
selection.

TABLE X2.1 Air Flow Rates and Vacuum LevelsA

Type of Procedure
Infant Oral-Nasal Tracheal Suction
Adult Oral-Nasal Tracheal Suction
Surgical Suction
Gastrointestinal Abdominal Drainage
Wangensteen Drainage
Wound Drainage
Pleural or Mediastinal Drainage
Pleural or Mediastinal Drainage (Pediatric)
Nasal-Gastric Drainage
Sump Drainage

Static Vacuum
Level

Flow Rate,
L/min

0100 mm Hg
0160 mm Hg
0500 mm Hg
0120 mm Hg
060 mm Hg
095 mm Hg
050 cm H2O
010 cm H2O
0120 mm Hg
050 mm Hg

040
040
040
08
03
02
010
08
03
03

A
This table should not be used as a specification for equipment performance,
nor is it a recommendation to users in selecting airflow rates and vacuum levels;
airflow rates and vacuum levels should be based on clinical considerations.

X3. RATIONALE

during suctioning procedures as the user is unable to continuously monitor the liquid flow.

X3.1 The rationales for the requirements of this standard

are set forth in this Appendix X3. The following is a sequence
of annotations to specific sections of this standard:

NOTE X3.1The committee realizes that variables of turbulence, foam,

and special hookup are encountered in clinical practice and recognizes that
users may choose to devise alternate tests to evaluate products best suited
to their needs.

X3.1.1 Shutoff Mechanism:

Section 3.1A shutoff mechanism is necessary to prevent
aspirated liquids and solids from adversely affecting the
internal components of the suction system. The committee
realizes that this requirement addresses the entire system rather
than individual components, and that a user may choose a
suction system consisting of components from several different
manufacturers. It is the committees intent to convey the
importance of using a shutoff mechanism and encourage the
user to ensure that one is incorporated into each system.
Section 4.1The function of the shutoff mechanism is to
interrupt suction flow when a collection vessel is full. This
feature needs to be self-actuating to protect suction systems

X3.1.2 Electric Conductivity:

Section 4.2Users need assurance that components labeled
conductive will dissipate static charges.
X3.1.3 System Performance:
Section 3.2Occlusion of passageways result in reduction
of flow and inadequate suction.
Section 4.3.1If a patient has air in the pleural space and
coughs there may be relatively high flows from the patient
through the drainage system. It is important to keep the
positive pressure below 10 cm H2O since intrapleural pressure
levels above this may cause an acute physiological disturbance.
6

F 960
excessive suction can result. Repeatability ensures a return to a
previously set vacuum level.
Section 6.5.1Monitoring of the aspirated liquid volume
may be necessary.
Section 6.5.2The user needs to be able to readily determine that the gas service being supplied is vacuum.
Section 6.5.3Adjusting the regulator the wrong way could
cause excessive or insufficient suction.
Section 6.5.4This information is for users to select,
operate, and when indicated, to maintain the regulator.
X3.1.6 Tubing:
Section 3.2This is for educational purposes. The committee felt this an important point to convey and recognizes that
current hospital practice may include the use of loops and
drapes which may give rise to changes in diameter and kinking
and adversely affect flow. See Appendix X1 for the effects of
tubing diameter on flow.
Section 3.4.1Connectors chosen with less than 7-mm ID
(minimum 14-in. ID) tubing create further significant reduction
in flow. Smooth passageways reduce turbulence and the
collection of particulate matter, which can cause a reduction in
flow.
Section 4.6.1.1To ensure proper fit with connectors and
minimize restrictions, consideration was given to establishing a
single requirement that the smallest ID of the connector shall
not be less than the ID of the tubing. However, it was
concluded that this could impose problems because of the
variety of connectors presently used by hospitals.
Section 4.6.1.2This requirement is intended to safeguard
the integrity of the connector and tube. In some situations, a
leak might be mistaken for a slow flow. Accordingly, a
requirement was adopted to aid in assuring that any slow flow
observed would not actually be a leak.
Section 4.6.1.3See 6.6.2.
Section 4.6.1.4Weak connectors compromise system function.
Section 4.6.2Flexibility is desirable for ease of handling
and use.
Section 4.6.3Translucency may be necessary to identify
the location of obstructions.
Section 6.6.1Inside diameter is the commonly accepted
identifier for tubing size. Metric measurements are used for
standardization.
Section 6.6.2Depending on the application, medical tubing may be subjected to a vacuum level that might cause the
tube to collapse and thus limits its ability to transmit fluids. A
statement in the labeling, disclosing the level of vacuum for
which the product is suitable, will aid users in selecting
appropriate units. In order for such selections to be valid,
however, a standard test method is necessary (see 4.6.1.3).
Section 6.6.3The user needs to know this information for
proper selection.
X3.1.7 Filtering Devices:
Section 4.7.1Filtering devices may be used in surgical
suction systems. There are two major areas of concern that
have been voiced with respect to contaminants generated in
surgical suction:
(1) Airborne particulates reaching the regulator or pump, or

In single bottle drainage systems, adjustment of the underwater

seal or emptying of the drainage bottle may be required to
reduce the positive pressure during exhalation.
Section 4.3.2When developing this standard, the committee was unaware of any suction system that would be compromised by small leaks. This requirement recognizes that multiple components are used in a system, and if each leaked at a
rate of 10 bubbles in 10 s (approximately 13 mL/min) the total
leak of the system would not compromise its function.
Section 4.3.3Safety to personnel from implosion of the
suction collection vessel, as well as the integrity of the
collection vessel, are deemed necessary. This requirement does
recognize the use of collection vessels with a vacuum of less
than 690 mm Hg (27 in. Hg). Collection vessels used in pleural
and mediastinal drainage are typically exposed to vacuum
levels up to 20 cm H2O, but may occasionally be used at up
to 60 cm H2O. Nasogastric and gastrointestinal drainage
typically utilizes vacuum levels up to 120 mm Hg. If continuity of operation is important to patient safety, it is important
that there be no loss of integrity of the system when subjected
to these vacuum levels. The use of 200 cm H2O adds a factor
of safety for testing pleural and mediastinal drainage collection
vessels.
Section 6.3.1The proper method of reprocessing the device is necessary to ensure that the performance is not
compromised. Products sold with the intent of reuse need to be
able to withstand the suggested reprocessing.
X3.1.4 Vessel Air Leak Capacity:
Section 4.4Excessive air leakage can impair the proper
function of a suction collection vessel to the point where
adequate suction is no longer available; this could pose a
hazard to the patient.
Section 4.4.2Closed-wound drainage systems must provide continuous drainage for proper function; therefore, leaks
should be minimal.
Section 4.4.3In the event of a leak in that portion of the
system defined by the underwater seal (or one-way valve, if
employed) at one end and the patient at the opposite end, fluids
drained from the pleural cavity may be returned.
Section 6.4Required capacity and translucency of suction
collection vessels have not been addressed in this standard
because these may vary according to the needs and preferences
of the user.
Section 6.4.1The capacity is important for user selection
and proper use of the collection vessel.
Section 6.4.2The collection vessel may be sensitive to
positioning and may fail to function correctly if not positioned
correctly. Accuracy of the graduation markings may be adversely affected if the collection vessel is tilted from upright.
Additionally, the shutoff mechanism may activate prematurely
if the vessel is tilted. The user needs to be provided this
information for proper function.
X3.1.5 Indicators:
Section 4.5.1The user relies on the indicating device to
determine the level of vacuum applied. Inaccuracy of the
indicating device can result in inadequate or excessive suction,
which can be hazardous to the patient.
Section 4.5.2If the vacuum level varies, inadequate or
7

F 960
Section 6.7.2The user may need an indication of how to
attach a filter to the suction circuit for proper performance.
Section 6.7.3The user may need to have instructions for
proper use of the filtering device readily available.
Section 6.7.4The user needs assurance of the ability of the
filtering device to reduce airborne particulates.
X3.1.8 Portable and Mobile Suction Sources:
Section 6.8.1This information is necessary for users to
select, operate, and, when indicated, maintain the suction
source.
Section 6.8.4Labeling is necessary to assure correct connection.
Sections 6.8.5, 6.8.6, and 6.8.7This information is necessary for users to determine which equipment is appropriate for
the intended purpose and if it is functioning properly.
X3.1.9 General Marking Requirements:
Section 6.1.1Without clearly legible instructions, the user
may not be sufficiently familiar with the control movements or
procedures to make necessary manipulations.
Section 6.1.2If the component is flow direction sensitive,
the function of the system will be jeopardized if the correct
connections are not used.
Section 6.1.3It is important for the user to know when a
vessel should not be reused; reuse of a vessel intended for
single use may compromise the vessels integrity.

both, causing increased maintenance and its associated costs.

(2) Microbial contaminants from the patients suctionate
reaching the environment as airborne particulate, or through
touch contamination.
The majority of the subcommittee thought that item ( 1) was
a nearly universal concern, but that the clinical consequences
of item (2) had not been sufficiently documented so as to merit
inclusion in the standard. Therefore, the standard for filtering
devices addresses only the function of reducing airborne
contaminants to protect the regulator or pump, or both.
Concerning test procedures for performance, the subcommittee decided that disclosure was the best method of meeting
this requirement because there exists in the filtration industry a
wide variety of techniques and conditions for evaluating filter
performance.
An imploded filtering device may produce increased flow
resistance. A leak in the filtering device housing will reduce air
flow rate at the catheter tip. A damaged filtering device may
produce a reduction in efficiency and may compromise the
filtering characteristics of the device.
Section 6.7.1The user should know the resistance of a
suction filter to ensure that the minimum suction required is
available. The user needs to know the flow resistance of a
filtering device under wet conditions, since the flow may be
reduced. Electrocautery smoke may obstruct certain filtering
devices and impede system performance.

ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentioned
in this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the risk
of infringement of such rights, are entirely their own responsibility.
This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years and
if not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standards
and should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of the
responsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you should
make your views known to the ASTM Committee on Standards, at the address shown below.
This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,
United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the above
address or at 610-832-9585 (phone), 610-832-9555 (fax), or service@astm.org (e-mail); or through the ASTM website
(www.astm.org).