ISO 4074:2002
Warning: Withdrawn Standard. This document has been withdrawn without replacement. You may wish to search for a more up to date equivalent.
Natural latex rubber condoms — Requirements and test methods
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TitlePage - Natural latex rubber condoms— Requirements and test methods
TableofContent - Contents Page
Foreword - Foreword
Introduction - Introduction
Scope - 1 Scope
NormativeReference - 2 Normative references
Clause1 - 4 Quality verification
Clause1 - 5 Design
Subclause2 - 5.1 Integral bead
Subclause2 - 5.2 Lubrication
Subclause2 - 5.3 Dimensions
Subclause3 - 5.3.1 Length
Subclause3 - 5.3.2 Width
Subclause3 - 5.3.3 Thickness
Clause1 - 6 Burst volume and pressure
Subclause2 - 6.1 Untreated condoms
Subclause2 - 6.2 Lot testing for oven-treated condoms
Subclause2 - 6.3 Extra strength
Subclause3 - 6.3.1 General
Subclause3 - 6.3.2 Requirements for mechanical properties
Subclause3 - 6.3.3 Requirements for clinical data
Clause1 - 7 Tests for stability and shelf life
Subclause2 - 7.1 General
Subclause2 - 7.2 Minimum stability requirements
Subclause2 - 7.3 Procedure for determining shelf life by real-time stability studies
Subclause2 - 7.4 Estimating shelf life based upon accelerated stability studies
Clause1 - 8 Freedom from holes
Clause1 - 9 Visible defects
Clause1 - 10 Package integrity
Clause1 - 11 Packaging and labelling
Subclause2 - 11.1 Packaging
Subclause2 - 11.2 Labelling
Subclause3 - 11.2.1 Symbols
Subclause3 - 11.2.2 Individual container
Subclause3 - 11.2.3 Consumer package
Subclause4 - 11.2.3.1 General
Subclause4 - 11.2.3.2 Labelling of extra-strong condoms
Subclause3 - 11.2.4 Additional information on the consumer package
Subclause2 - 11.3 Inspection
Clause1 - 12 Test report
AnnexNormative - Sampling plans intended for assessing compliance of a continuing series of lots ...
Clause1 - A.1 Quality verification
Clause1 - A.2 Sampling plans and compliance levels
AnnexInformative - Sampling plans intended for assessing compliance of isolated lots
AnnexNormative - Determination of total lubricant for condoms in individual containers
Clause1 - C.1 Principle
Clause1 - C.2 Apparatus
UntitledSubclause2 - C.2.1 Ultrasonic cleaning bath(s)
UntitledSubclause2 - C.2.2 Balance
UntitledSubclause2 - C.2.3 Propan-2-ol
Clause1 - C.3 Procedure
UntitledSubclause2 - C.3.1 Weigh each individual container to the nearest
UntitledSubclause2 - C.3.2 Slit the individual container carefully around three edges and remo...
UntitledSubclause2 - C.3.3 Before unrolling the condom cut up one side using scissors, then un...
UntitledSubclause2 - C.3.4 When using the ultrasonic bath, immerse the condom and individual c...
UntitledSubclause2 - C.3.5 When washing the condoms manually: immerse the condom and individua...
UntitledSubclause2 - C.3.6 Remove the condom and individual container from the propan-2-ol and...
UntitledSubclause2 - C.3.7 Dry the condom and individual container to constant mass (within
UntitledSubclause2 - C.3.8 Weigh each dry condom and individual container to the nearest
Clause1 - C.4 Accuracy of lubricant recovery
Clause1 - C.5 Expression of results
AnnexNormative - Determination of length
Clause1 - D.1 Principle
Clause1 - D.2 Apparatus
UntitledSubclause2 - D.2.1 Mandrel
Clause1 - D.3 Procedure
UntitledSubclause2 - D.3.1 Move the condom inside the package such that it is away from the ar...
UntitledSubclause2 - D.3.2 Unroll the condom, stretch it slightly twice but by no more than
UntitledSubclause2 - D.3.3 Put the condom over the mandrel (
UntitledSubclause2 - D.3.4 Note, to the nearest millimetre, the smallest value of the length o...
UntitledSubclause2 - D.3.5 Condoms subjected to this test may also be used for determination o...
Clause1 - D.4 Expression of results
AnnexNormative - Determination of width
Clause1 - E.1 Principle
Clause1 - E.2 Apparatus
UntitledSubclause2 - E.2.1 Ruler
Clause1 - E.3 Procedure
UntitledSubclause2 - E.3.1 Move the condom inside the package such that it is away from the ar...
UntitledSubclause2 - E.3.2 Unroll the condom and lay it flat over the edge of the ruler (
UntitledSubclause2 - E.3.3 Measure, to the nearest
UntitledSubclause2 - E.3.4 Condoms subjected to this test may also be used for determination o...
Clause1 - E.4 Expression of results
AnnexNormative - Determination of thickness
Clause1 - F.1 Principle
Clause1 - F.2 Apparatus
UntitledSubclause2 - F.2.1 Laboratory scale
UntitledSubclause2 - F.2.2 Cutting die
UntitledSubclause2 - F.2.3 Hydraulic
UntitledSubclause2 - F.2.4 Ruler
Clause1 - F.3 Procedure
UntitledSubclause2 - F.3.1 Move the condom inside the package such that it is away from the ar...
UntitledSubclause2 - F.3.2 Unroll the condom ensuring that it is not excessively stretched in ...
UntitledSubclause2 - F.3.3 Lay the condom flat with its length at right angles to the cutting ...
UntitledSubclause2 - F.3.4 Cut the ring open and measure the length, to the nearest
UntitledSubclause2 - F.3.5 Repeat
UntitledSubclause2 - F.3.6 Wash the specimens in propan-2-ol and dry to constant mass,
UntitledSubclause2 - F.3.7 Weigh the three test specimens separately to the nearest
UntitledSubclause2 - F.3.8 Calculate the thickness of each specimen as follows:
Clause1 - F.4 Expression of results
AnnexNormative - Determination of bursting volume and pressure
Clause1 - G.1 Principle
Clause1 - G.2 Apparatus
UntitledSubclause2 - G.2.1 Inflation apparatus
UntitledSubclause2 - G.2.2 Clamping device
UntitledSubclause2 - G.2.3 Inflation cabinet
Clause1 - G.3 Procedure
UntitledSubclause2 - G.3.1 Carry out the test under controlled temperature of
UntitledSubclause2 - G.3.2 Move the condom inside the package such that it is away from the ar...
UntitledSubclause2 - G.3.3 It is recommended that suitable gloves or finger cots be worn while...
UntitledSubclause2 - G.3.4 Unroll the condom ensuring that it is not excessively stretched in ...
UntitledSubclause2 - G.3.5 Hang the condom on the rod [
UntitledSubclause2 - G.3.6 If the condom does not leak, measure and record the bursting volume...
Clause1 - G.4 Expression of results
AnnexNormative - Oven treatment for condoms
Clause1 - H.1 Principle
Clause1 - H.2 Apparatus
UntitledSubclause2 - H.2.1 Oven
Clause1 - H.3 Preparation of condoms for test
Clause1 - H.4 Procedure
UntitledSubclause2 - H.4.1 Condition the condoms in an oven at the temperature stipulated in t...
UntitledSubclause2 - H.4.2 Remove the condoms from the oven after the time stipulated in the r...
UntitledSubclause2 - H.4.3 Within
AnnexNormative - Determination of force and elongation at break of test pieces of condoms
Clause1 - I.1 Principle
Clause1 - I.2 Apparatus
UntitledSubclause2 - I.2.1 Cutting die
UntitledSubclause2 - I.2.2 Tensile testing machine
Clause1 - I.3 Preparation of test specimen
UntitledSubclause2 - I.3.1 Move the condom inside the package such that it is away from the ar...
UntitledSubclause2 - I.3.2 Unroll the condom ensuring that it is not excessively stretched in ...
UntitledSubclause2 - I.3.3 Lay the condom flat with its length at right angles to the cutting ...
UntitledSubclause2 - I.3.4 Lay the test piece flat and put the ruler on top and measure, to th...
Clause1 - I.4 Procedure
UntitledSubclause2 - I.4.1 Carry out the test under controlled conditions of
UntitledSubclause2 - I.4.2 Place the test piece over the rollers of the tensile testing machine (
UntitledSubclause2 - I.4.3 At break, record the load, to the nearest
Clause1 - I.5 Calculation of results
UntitledSubclause2 - I.5.1 Record the force at break (
UntitledSubclause2 - I.5.2 When requested, calculate elongation at break (
AnnexNormative - Determination of shelf life by real-time stability studies
Clause1 - J.1 Principle
Clause1 - J.2 Procedure
Subclause2 - J.2.1 General
Subclause2 - J.2.2 Testing
Clause1 - J.3 Confirmation of shelf-life claim
Clause1 - J.4 Test report
AnnexInformative - Guidance on conducting and analysing accelerated ageing studies
Clause1 - K.1 Principle
Clause1 - K.2 Procedure for conducting accelerated ageing studies
Clause1 - K.3 Analysis of accelerated ageing data to estimate provisional shelf-life
Clause1 - K.4 Test of shelf-life estimates
Clause1 - K.5 Guidance on analysing accelerated ageing studies using the Arrhenius equation
Subclause2 - K.5.1 Background to applying the time-temperature superposition method
Subclause2 - K.5.2 Procedure for constructing time-temperature superposition plots
Subclause2 - K.5.3 Test of shelf-life estimates based upon Arrhenius shift factors
AnnexNormative - Testing for holes
Clause1 - L.1 General
Clause1 - L.2 Water leak test
Subclause2 - L.2.1 Principle
Subclause2 - L.2.2 Apparatus
UntitledSubclause3 - L.2.2.1 Mounting equipment
UntitledSubclause3 - L.2.2.2 Coloured absorbent paper
UntitledSubclause3 - L.2.2.3 Rolling device
UntitledSubclause3 - L.2.2.4 Clamping device
Subclause2 - L.2.3 Procedure
UntitledSubclause3 - L.2.3.1 Move the condom inside the package such that it is away from the ...
UntitledSubclause3 - L.2.3.2 Unroll the condom ensuring that it is not excessively stretched i...
UntitledSubclause3 - L.2.3.3 Record condoms with other visible defects, namely: Broken, missin...
UntitledSubclause3 - L.2.3.4 Fit the open end of the condom onto the mount so that the condom ...
UntitledSubclause3 - L.2.3.5 Add
UntitledSubclause3 - L.2.3.6 If there is no visible leakage through the condom after suspensio...
UntitledSubclause3 - L.2.3.7 Transfer the condom onto a dry sheet of absorbent paper, and roll...
UntitledSubclause3 - L.2.3.8 Roll the condom back and forth at least once for a distance at le...
UntitledSubclause3 - L.2.3.9 Inspect the paper for any sign of leakage of water from the condo...
Clause1 - L.3 Electrical test
Subclause2 - L.3.1 Principle
Subclause2 - L.3.2 Apparatus
UntitledSubclause3 - L.3.2.1 Electrical testing equipment
UntitledSubclause3 - L.3.2.2 Electrolyte solution
Subclause2 - L.3.3 Procedure
UntitledSubclause3 - L.3.3.1 Move the condom inside the package such that it is away from the ...
UntitledSubclause3 - L.3.3.2 Unroll the condom ensuring that it is not excessively stretched i...
UntitledSubclause3 - L.3.3.3 Examine the condom visually under normal or corrected vision. Dee...
UntitledSubclause3 - L.3.3.4 Record condoms with other visible defects, namely a broken, missi...
UntitledSubclause3 - L.3.3.5 Fit the open end of the condom onto the mount (
UntitledSubclause3 - L.3.3.6 Add
UntitledSubclause3 - L.3.3.7 Add sufficient electrolyte/water to make the volume within the co...
Clause1 - L.4 Expression of results
AnnexNormative - Tests for package integrity
Clause1 - M.1 General
Clause1 - M.2 Test method
Subclause2 - M.2.1 Apparatus
UntitledSubclause3 - M.2.1.1 Vacuum chamber
Subclause2 - M.2.2 Reagent
UntitledSubclause3 - M.2.2.1 Immersion fluid
Subclause2 - M.2.3 Sampling
Subclause2 - M.2.4 Test specimen
Subclause2 - M.2.5 Conditioning
Subclause2 - M.2.6 Procedure
Subclause2 - M.2.7 Interpretation of results
Subclause2 - M.2.8 Test report
AnnexNormative - Test report
AnnexInformative - Calibration of air inflation equipment for determination of burst volume and p...
Clause1 - O.1 System check algorithm
Clause1 - O.2 Clamp slip force check
Clause1 - O.3 Inflation length check
Clause1 - O.4 Cuff leak check
Clause1 - O.5 Air supply leak check
Clause1 - O.6 Pressure gauge calibration
Clause1 - O.7 Air flowrate adjustment and calibration
Clause1 - O.8 In-line volume or flowrate meter calibration
Clause1 - O.9 Timer check
Clause1 - O.10 Verification of automatic recording
Clause1 - O.11 Important equations
AnnexInformative - Rationale
Clause1 - P.1 General
Clause1 - P.2 5.3.2
Clause1 - P.3 6.3
Clause1 - P.4 Clause7
Clause1 - P.5 Clause11
Clause1 - P.6 C.4
Clause1 - P.7 D.3.2
Clause1 - P.8 E.3.2
Clause1 - P.9 AnnexI
Clause1 - P.10 AnnexL
Bibliography - Bibliography
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TitlePage - Natural latex rubber condoms— Requirements and test methods
TableofContent - Contents Page
Foreword - Foreword
Introduction - Introduction
Scope - 1 Scope
NormativeReference - 2 Normative references
Clause1 - 4 Quality verification
Clause1 - 5 Design
Subclause2 - 5.1 Integral bead
Subclause2 - 5.2 Lubrication
Subclause2 - 5.3 Dimensions
Subclause3 - 5.3.1 Length
Subclause3 - 5.3.2 Width
Subclause3 - 5.3.3 Thickness
Clause1 - 6 Burst volume and pressure
Subclause2 - 6.1 Untreated condoms
Subclause2 - 6.2 Lot testing for oven-treated condoms
Subclause2 - 6.3 Extra strength
Subclause3 - 6.3.1 General
Subclause3 - 6.3.2 Requirements for mechanical properties
Subclause3 - 6.3.3 Requirements for clinical data
Clause1 - 7 Tests for stability and shelf life
Subclause2 - 7.1 General
Subclause2 - 7.2 Minimum stability requirements
Subclause2 - 7.3 Procedure for determining shelf life by real-time stability studies
Subclause2 - 7.4 Estimating shelf life based upon accelerated stability studies
Clause1 - 8 Freedom from holes
Clause1 - 9 Visible defects
Clause1 - 10 Package integrity
Clause1 - 11 Packaging and labelling
Subclause2 - 11.1 Packaging
Subclause2 - 11.2 Labelling
Subclause3 - 11.2.1 Symbols
Subclause3 - 11.2.2 Individual container
Subclause3 - 11.2.3 Consumer package
Subclause4 - 11.2.3.1 General
Subclause4 - 11.2.3.2 Labelling of extra-strong condoms
Subclause3 - 11.2.4 Additional information on the consumer package
Subclause2 - 11.3 Inspection
Clause1 - 12 Test report
AnnexNormative - Sampling plans intended for assessing compliance of a continuing series of lots ...
Clause1 - A.1 Quality verification
Clause1 - A.2 Sampling plans and compliance levels
AnnexInformative - Sampling plans intended for assessing compliance of isolated lots
AnnexNormative - Determination of total lubricant for condoms in individual containers
Clause1 - C.1 Principle
Clause1 - C.2 Apparatus
UntitledSubclause2 - C.2.1 Ultrasonic cleaning bath(s)
UntitledSubclause2 - C.2.2 Balance
UntitledSubclause2 - C.2.3 Propan-2-ol
Clause1 - C.3 Procedure
UntitledSubclause2 - C.3.1 Weigh each individual container to the nearest
UntitledSubclause2 - C.3.2 Slit the individual container carefully around three edges and remo...
UntitledSubclause2 - C.3.3 Before unrolling the condom cut up one side using scissors, then un...
UntitledSubclause2 - C.3.4 When using the ultrasonic bath, immerse the condom and individual c...
UntitledSubclause2 - C.3.5 When washing the condoms manually: immerse the condom and individua...
UntitledSubclause2 - C.3.6 Remove the condom and individual container from the propan-2-ol and...
UntitledSubclause2 - C.3.7 Dry the condom and individual container to constant mass (within
UntitledSubclause2 - C.3.8 Weigh each dry condom and individual container to the nearest
Clause1 - C.4 Accuracy of lubricant recovery
Clause1 - C.5 Expression of results
AnnexNormative - Determination of length
Clause1 - D.1 Principle
Clause1 - D.2 Apparatus
UntitledSubclause2 - D.2.1 Mandrel
Clause1 - D.3 Procedure
UntitledSubclause2 - D.3.1 Move the condom inside the package such that it is away from the ar...
UntitledSubclause2 - D.3.2 Unroll the condom, stretch it slightly twice but by no more than
UntitledSubclause2 - D.3.3 Put the condom over the mandrel (
UntitledSubclause2 - D.3.4 Note, to the nearest millimetre, the smallest value of the length o...
UntitledSubclause2 - D.3.5 Condoms subjected to this test may also be used for determination o...
Clause1 - D.4 Expression of results
AnnexNormative - Determination of width
Clause1 - E.1 Principle
Clause1 - E.2 Apparatus
UntitledSubclause2 - E.2.1 Ruler
Clause1 - E.3 Procedure
UntitledSubclause2 - E.3.1 Move the condom inside the package such that it is away from the ar...
UntitledSubclause2 - E.3.2 Unroll the condom and lay it flat over the edge of the ruler (
UntitledSubclause2 - E.3.3 Measure, to the nearest
UntitledSubclause2 - E.3.4 Condoms subjected to this test may also be used for determination o...
Clause1 - E.4 Expression of results
AnnexNormative - Determination of thickness
Clause1 - F.1 Principle
Clause1 - F.2 Apparatus
UntitledSubclause2 - F.2.1 Laboratory scale
UntitledSubclause2 - F.2.2 Cutting die
UntitledSubclause2 - F.2.3 Hydraulic
UntitledSubclause2 - F.2.4 Ruler
Clause1 - F.3 Procedure
UntitledSubclause2 - F.3.1 Move the condom inside the package such that it is away from the ar...
UntitledSubclause2 - F.3.2 Unroll the condom ensuring that it is not excessively stretched in ...
UntitledSubclause2 - F.3.3 Lay the condom flat with its length at right angles to the cutting ...
UntitledSubclause2 - F.3.4 Cut the ring open and measure the length, to the nearest
UntitledSubclause2 - F.3.5 Repeat
UntitledSubclause2 - F.3.6 Wash the specimens in propan-2-ol and dry to constant mass,
UntitledSubclause2 - F.3.7 Weigh the three test specimens separately to the nearest
UntitledSubclause2 - F.3.8 Calculate the thickness of each specimen as follows:
Clause1 - F.4 Expression of results
AnnexNormative - Determination of bursting volume and pressure
Clause1 - G.1 Principle
Clause1 - G.2 Apparatus
UntitledSubclause2 - G.2.1 Inflation apparatus
UntitledSubclause2 - G.2.2 Clamping device
UntitledSubclause2 - G.2.3 Inflation cabinet
Clause1 - G.3 Procedure
UntitledSubclause2 - G.3.1 Carry out the test under controlled temperature of
UntitledSubclause2 - G.3.2 Move the condom inside the package such that it is away from the ar...
UntitledSubclause2 - G.3.3 It is recommended that suitable gloves or finger cots be worn while...
UntitledSubclause2 - G.3.4 Unroll the condom ensuring that it is not excessively stretched in ...
UntitledSubclause2 - G.3.5 Hang the condom on the rod [
UntitledSubclause2 - G.3.6 If the condom does not leak, measure and record the bursting volume...
Clause1 - G.4 Expression of results
AnnexNormative - Oven treatment for condoms
Clause1 - H.1 Principle
Clause1 - H.2 Apparatus
UntitledSubclause2 - H.2.1 Oven
Clause1 - H.3 Preparation of condoms for test
Clause1 - H.4 Procedure
UntitledSubclause2 - H.4.1 Condition the condoms in an oven at the temperature stipulated in t...
UntitledSubclause2 - H.4.2 Remove the condoms from the oven after the time stipulated in the r...
UntitledSubclause2 - H.4.3 Within
AnnexNormative - Determination of force and elongation at break of test pieces of condoms
Clause1 - I.1 Principle
Clause1 - I.2 Apparatus
UntitledSubclause2 - I.2.1 Cutting die
UntitledSubclause2 - I.2.2 Tensile testing machine
Clause1 - I.3 Preparation of test specimen
UntitledSubclause2 - I.3.1 Move the condom inside the package such that it is away from the ar...
UntitledSubclause2 - I.3.2 Unroll the condom ensuring that it is not excessively stretched in ...
UntitledSubclause2 - I.3.3 Lay the condom flat with its length at right angles to the cutting ...
UntitledSubclause2 - I.3.4 Lay the test piece flat and put the ruler on top and measure, to th...
Clause1 - I.4 Procedure
UntitledSubclause2 - I.4.1 Carry out the test under controlled conditions of
UntitledSubclause2 - I.4.2 Place the test piece over the rollers of the tensile testing machine (
UntitledSubclause2 - I.4.3 At break, record the load, to the nearest
Clause1 - I.5 Calculation of results
UntitledSubclause2 - I.5.1 Record the force at break (
UntitledSubclause2 - I.5.2 When requested, calculate elongation at break (
AnnexNormative - Determination of shelf life by real-time stability studies
Clause1 - J.1 Principle
Clause1 - J.2 Procedure
Subclause2 - J.2.1 General
Subclause2 - J.2.2 Testing
Clause1 - J.3 Confirmation of shelf-life claim
Clause1 - J.4 Test report
AnnexInformative - Guidance on conducting and analysing accelerated ageing studies
Clause1 - K.1 Principle
Clause1 - K.2 Procedure for conducting accelerated ageing studies
Clause1 - K.3 Analysis of accelerated ageing data to estimate provisional shelf-life
Clause1 - K.4 Test of shelf-life estimates
Clause1 - K.5 Guidance on analysing accelerated ageing studies using the Arrhenius equation
Subclause2 - K.5.1 Background to applying the time-temperature superposition method
Subclause2 - K.5.2 Procedure for constructing time-temperature superposition plots
Subclause2 - K.5.3 Test of shelf-life estimates based upon Arrhenius shift factors
AnnexNormative - Testing for holes
Clause1 - L.1 General
Clause1 - L.2 Water leak test
Subclause2 - L.2.1 Principle
Subclause2 - L.2.2 Apparatus
UntitledSubclause3 - L.2.2.1 Mounting equipment
UntitledSubclause3 - L.2.2.2 Coloured absorbent paper
UntitledSubclause3 - L.2.2.3 Rolling device
UntitledSubclause3 - L.2.2.4 Clamping device
Subclause2 - L.2.3 Procedure
UntitledSubclause3 - L.2.3.1 Move the condom inside the package such that it is away from the ...
UntitledSubclause3 - L.2.3.2 Unroll the condom ensuring that it is not excessively stretched i...
UntitledSubclause3 - L.2.3.3 Record condoms with other visible defects, namely: Broken, missin...
UntitledSubclause3 - L.2.3.4 Fit the open end of the condom onto the mount so that the condom ...
UntitledSubclause3 - L.2.3.5 Add
UntitledSubclause3 - L.2.3.6 If there is no visible leakage through the condom after suspensio...
UntitledSubclause3 - L.2.3.7 Transfer the condom onto a dry sheet of absorbent paper, and roll...
UntitledSubclause3 - L.2.3.8 Roll the condom back and forth at least once for a distance at le...
UntitledSubclause3 - L.2.3.9 Inspect the paper for any sign of leakage of water from the condo...
Clause1 - L.3 Electrical test
Subclause2 - L.3.1 Principle
Subclause2 - L.3.2 Apparatus
UntitledSubclause3 - L.3.2.1 Electrical testing equipment
UntitledSubclause3 - L.3.2.2 Electrolyte solution
Subclause2 - L.3.3 Procedure
UntitledSubclause3 - L.3.3.1 Move the condom inside the package such that it is away from the ...
UntitledSubclause3 - L.3.3.2 Unroll the condom ensuring that it is not excessively stretched i...
UntitledSubclause3 - L.3.3.3 Examine the condom visually under normal or corrected vision. Dee...
UntitledSubclause3 - L.3.3.4 Record condoms with other visible defects, namely a broken, missi...
UntitledSubclause3 - L.3.3.5 Fit the open end of the condom onto the mount (
UntitledSubclause3 - L.3.3.6 Add
UntitledSubclause3 - L.3.3.7 Add sufficient electrolyte/water to make the volume within the co...
Clause1 - L.4 Expression of results
AnnexNormative - Tests for package integrity
Clause1 - M.1 General
Clause1 - M.2 Test method
Subclause2 - M.2.1 Apparatus
UntitledSubclause3 - M.2.1.1 Vacuum chamber
Subclause2 - M.2.2 Reagent
UntitledSubclause3 - M.2.2.1 Immersion fluid
Subclause2 - M.2.3 Sampling
Subclause2 - M.2.4 Test specimen
Subclause2 - M.2.5 Conditioning
Subclause2 - M.2.6 Procedure
Subclause2 - M.2.7 Interpretation of results
Subclause2 - M.2.8 Test report
AnnexNormative - Test report
AnnexInformative - Calibration of air inflation equipment for determination of burst volume and p...
Clause1 - O.1 System check algorithm
Clause1 - O.2 Clamp slip force check
Clause1 - O.3 Inflation length check
Clause1 - O.4 Cuff leak check
Clause1 - O.5 Air supply leak check
Clause1 - O.6 Pressure gauge calibration
Clause1 - O.7 Air flowrate adjustment and calibration
Clause1 - O.8 In-line volume or flowrate meter calibration
Clause1 - O.9 Timer check
Clause1 - O.10 Verification of automatic recording
Clause1 - O.11 Important equations
AnnexInformative - Rationale
Clause1 - P.1 General
Clause1 - P.2 5.3.2
Clause1 - P.3 6.3
Clause1 - P.4 Clause7
Clause1 - P.5 Clause11
Clause1 - P.6 C.4
Clause1 - P.7 D.3.2
Clause1 - P.8 E.3.2
Clause1 - P.9 AnnexI
Clause1 - P.10 AnnexL
Bibliography - Bibliography