ISO 11140-4:2001
Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators for steam penetration test packs
| Get this standard | Prices exclude GST | |
|---|---|---|
| PDF ( Single user document) |
$118.26 NZD
|
|
| HardCopy |
$152.17 NZD
|
|
| Networkable PDF |
Price varies
|
Sterilization of health care products— Chemical indicators—
Contents Page
Foreword
Introduction
Sterilization of health care products— Chemical indicators—
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 The requirements of
4.2 Test samples shall be conditioned in accordance with
4.3 Compliance with the requirements of
4.4 The indicator shall have sufficient strength to withstand steam sterilization and subseque...
4.5 Test cycles for demonstrating compliance with the requirements of
4.6 A thermometric recording instrument(s) shall be used in conjunction with temperature senso...
5 Indicator system format
5.1 When the indicator system is one in which the indicator reagent is distributed on a substr...
5.2 When the indicator system depends on migration of the indicator reagent to demonstrate cha...
5.3 When the indicator system is intended for use with a user-assembled pack, the indicator sy...
5.4 When the indicator system is provided by the manufacturer already incorporated into the te...
6 Performance requirements
6.1 The indicator, when tested in combination with the test load specified by the manufacturer...
6.2 The indicator shall show no colour change, an incomplete, or an uneven colour change when ...
6.3 The indicator system shall show no discernible colour change after exposure to dry heat at
6.4 Indicators intended for use only with a sterilization temperature
6.5 Indicator systems intended for use with re-usable user-assembled packs shall not visibly t...
6.6 The indicator shall comply with the requirements of
7 Packaging and labelling
7.1 Each indicator, or indicator system, shall be marked with
7.2 When the indicator is supplied assembled, i.e. with the indicator system within the test l...
7.3 The transport package shall be such that the product can be removed easily. The package sh...
7.4 The outside of each package shall be marked with the sterilization temperature(s) at which...
7.5 The information supplied by the manufacturer (see5.6 of
7.6 When requested by the purchaser, the manufacturer shall supply a certificate of conformity...
8 Quality assurance
8.1 The manufacturer's quality system shall ensure that an acceptable quality level (AQL) of 1...
8.2 Suitable records shall be maintained to ensure that, if necessary, faulty batches can be r...
8.3 The manufacturing and distribution records shall be retained for a period of five years, o...
Determination of indicator strength during and after steam sterilization
A.1 Apparatus
A.1.1 Steam exposure apparatus
A.2 Procedure
A.2.1 Expose the indicator to three successive test cycles at the stated sterilization tempera...
A.2.2 Remove the pre-assembled or user-assembled indicator from the exposure apparatus and exa...
A.2.3 If the indicator has remained intact, perform a drop test in accordance with
A.2.4 Carry out this test with three samples for each of three separate production batches.
A.2.5 Damage occurring during the drop test which can be demonstrated as not impairing the int...
Standard test cycles
B.1 General
B.2 Cycle1: Air removal by sub-atmospheric pulsing
B.3 Cycle2: Air removal by trans-atmospheric pulsing
B.4 Cycle3: Air removal by super-atmospheric pulsing
B.5 Acceptance limits during steam admission
B.5.1 The rate of pressure rise during steam admission to set operating pressure over the range
B.5.2 Select the operating temperature of the exposure time such that it corresponds to the te...
B.5.3 The integral [Integrated Come-up Exposure (ICE)] between the chamber reference temperatu...
Estimation of visual difference between colours of the substrate and of the changed or unchanged ...
C.1 Principle
C.2 Apparatus
C.2.1 Steam exposure apparatus
C.2.2 Illuminant
C.2.3 Photoelectric reflectance photometer
C.3 Sample conditioning
C.4 Test procedure
C.5 Test report
Demonstration of uniform colour change on exposure to saturated steam
D.1 Apparatus
D.1.1 Steam exposure apparatus
D.1.2 Standard test pack
D.1.3 Temperature sensors and thermometric recording instruments
D.2 Test procedure
D.2.1 Expose the indicator (or the indicator system combined with its test load for user-assem...
D.2.2 At the end of the operating cycle, remove the indicator from the steam exposure apparatu...
D.2.3 Carry out the test on three samples for each of three production batches using operating...
D.2.4 Before and after each series of three tests, run an operating cycle containing a standar...
D.2.5 Run the tests required on any one production batch on separate operating cycles.
Determination of equivalence of the alternative indicator to the Bowie and Dick test
E.1 Principle
E.2 Apparatus
E.2.1 Steam exposure apparatus
E.2.2 Standard test pack
E.2.3 Thermometric recording instrument
E.3 Test procedure
E.3.1 Perform the tests on the standard test loads at the operating temperature(s) of the indi...
E.3.2 Remove the wrapping from the standard test pack and place not less than five, and not mo...
E.3.3 Provided at least two of the sensors in the standard test pack show a temperature depres...
E.3.4 Use the following conditions to produce a reference fault condition and when testing the...
E.3.5 During the tests, vary the orientation of the product between replicate tests (within an...
E.3.6 Carry out the test three times for each of three production batches, using operating cyc...
E.3.7 Before and after each series of three tests, run an operating cycle containing a standar...
E.3.8 Run the three tests required on any one production batch on separate operating cycles to...
E.3.9 After each test, inspect the indicator system visually for compliance with
E.3.10 The position of all temperature sensors in the test pack (see
Determination of reproducibility of fail conditions created in a standard test pack by air inject...
F.1 General
F.2 Criteria for acceptability of test cycles
F.2.1 General
F.2.2 Reference fault condition
F.2.3 No Fault condition
F.3 Statistical evaluation of reproducibility
F.3.1 Run 10 consecutive cycles on each of twodays.
F.3.2 From the cycle records confirm that each cycle meets the acceptance criteria and determi...
F.3.3 Calculate the mean and estimate of variance for the two sets of runs.
F.3.4 Carry out the
F.3.5 Compare the calculated value of
Evaluation of indicator colour change on exposure to dry heat
G.1 Apparatus
G.1.1 Dry heat oven
G.2 Procedure
G.2.1 General
G.2.2 Test 1
G.2.2.1 Pre-heat the oven to the operating temperature.
G.2.2.2 Place the indicator systems in the oven and subject them to dry heat as required in
G.2.3 Test 2
G.2.3.1 Fit the indicator system in combination with its specified test load (the indicator) w...
G.2.3.2 Dry new samples of the indicator system in combination with its specified test load (t...
G.2.3.3 Transfer the dried indicators to the oven without undue delay and in a manner which wi...
Demonstration of shelf life of product
Accelerated ageing of test samples
Steam exposure apparatus and steam for test purposes
J.1 General
J.1.1 The steam exposure apparatus shall consist of a steam sterilizer for wrapped goods and p...
J.1.2 The control system shall permit the operation of the steam exposure apparatus with the s...
J.2 Instrumentation
J.2.1 General
J.2.2 Indicator, controller and recorder sensors
J.2.3 Calibration
J.3 Cycle control
J.3.1 Steam control
J.3.2 Air detector
J.3.3 Signals
J.4 Operating cycle stages and control limits required
J.4.1 Cycle stages
J.4.2 Control limits
J.4.2.1 Pressure-attained control points shall be capable of being attained reproducibly to wi...
J.4.2.2 Elapsed-time control points shall be capable of being attained reproducibly to an accu...
J.4.2.3 Temperature-attained control points shall be capable of being attained reproducibly to...
J.4.2.4 The rate of pressure change during steam admission shall be within
J.4.2.5 The rate of pressure change during evacuation shall be adjustable up to at least
J.5 Steam supply
J.5.1 Particular attention shall be paid to the levels of non-condensable gases in the steam s...
J.5.2 The condensate obtained from steam supplied to the chamber of the steam exposure apparat...
Standard test pack
Air injection system
Bibliography
Keep me up-to-date
Register to receive notifications when updates are made to this standard.
Related Information
Similar Standards
-
AS/NZS ISO 11137.1:2006
Sterilization of health care products - Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices
-
AS/NZS ISO 11137.3:2006
Sterilization of health care products - Radiation - Guidance on dosimetric aspects
-
BS EN 556-1:2001
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE", Requirements for terminally sterilized medical devices
-
BS EN 556-2:2015
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE", Requirements for aseptically processed medical devices
Sterilization of health care products— Chemical indicators—
Contents Page
Foreword
Introduction
Sterilization of health care products— Chemical indicators—
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 The requirements of
4.2 Test samples shall be conditioned in accordance with
4.3 Compliance with the requirements of
4.4 The indicator shall have sufficient strength to withstand steam sterilization and subseque...
4.5 Test cycles for demonstrating compliance with the requirements of
4.6 A thermometric recording instrument(s) shall be used in conjunction with temperature senso...
5 Indicator system format
5.1 When the indicator system is one in which the indicator reagent is distributed on a substr...
5.2 When the indicator system depends on migration of the indicator reagent to demonstrate cha...
5.3 When the indicator system is intended for use with a user-assembled pack, the indicator sy...
5.4 When the indicator system is provided by the manufacturer already incorporated into the te...
6 Performance requirements
6.1 The indicator, when tested in combination with the test load specified by the manufacturer...
6.2 The indicator shall show no colour change, an incomplete, or an uneven colour change when ...
6.3 The indicator system shall show no discernible colour change after exposure to dry heat at
6.4 Indicators intended for use only with a sterilization temperature
6.5 Indicator systems intended for use with re-usable user-assembled packs shall not visibly t...
6.6 The indicator shall comply with the requirements of
7 Packaging and labelling
7.1 Each indicator, or indicator system, shall be marked with
7.2 When the indicator is supplied assembled, i.e. with the indicator system within the test l...
7.3 The transport package shall be such that the product can be removed easily. The package sh...
7.4 The outside of each package shall be marked with the sterilization temperature(s) at which...
7.5 The information supplied by the manufacturer (see5.6 of
7.6 When requested by the purchaser, the manufacturer shall supply a certificate of conformity...
8 Quality assurance
8.1 The manufacturer's quality system shall ensure that an acceptable quality level (AQL) of 1...
8.2 Suitable records shall be maintained to ensure that, if necessary, faulty batches can be r...
8.3 The manufacturing and distribution records shall be retained for a period of five years, o...
Determination of indicator strength during and after steam sterilization
A.1 Apparatus
A.1.1 Steam exposure apparatus
A.2 Procedure
A.2.1 Expose the indicator to three successive test cycles at the stated sterilization tempera...
A.2.2 Remove the pre-assembled or user-assembled indicator from the exposure apparatus and exa...
A.2.3 If the indicator has remained intact, perform a drop test in accordance with
A.2.4 Carry out this test with three samples for each of three separate production batches.
A.2.5 Damage occurring during the drop test which can be demonstrated as not impairing the int...
Standard test cycles
B.1 General
B.2 Cycle1: Air removal by sub-atmospheric pulsing
B.3 Cycle2: Air removal by trans-atmospheric pulsing
B.4 Cycle3: Air removal by super-atmospheric pulsing
B.5 Acceptance limits during steam admission
B.5.1 The rate of pressure rise during steam admission to set operating pressure over the range
B.5.2 Select the operating temperature of the exposure time such that it corresponds to the te...
B.5.3 The integral [Integrated Come-up Exposure (ICE)] between the chamber reference temperatu...
Estimation of visual difference between colours of the substrate and of the changed or unchanged ...
C.1 Principle
C.2 Apparatus
C.2.1 Steam exposure apparatus
C.2.2 Illuminant
C.2.3 Photoelectric reflectance photometer
C.3 Sample conditioning
C.4 Test procedure
C.5 Test report
Demonstration of uniform colour change on exposure to saturated steam
D.1 Apparatus
D.1.1 Steam exposure apparatus
D.1.2 Standard test pack
D.1.3 Temperature sensors and thermometric recording instruments
D.2 Test procedure
D.2.1 Expose the indicator (or the indicator system combined with its test load for user-assem...
D.2.2 At the end of the operating cycle, remove the indicator from the steam exposure apparatu...
D.2.3 Carry out the test on three samples for each of three production batches using operating...
D.2.4 Before and after each series of three tests, run an operating cycle containing a standar...
D.2.5 Run the tests required on any one production batch on separate operating cycles.
Determination of equivalence of the alternative indicator to the Bowie and Dick test
E.1 Principle
E.2 Apparatus
E.2.1 Steam exposure apparatus
E.2.2 Standard test pack
E.2.3 Thermometric recording instrument
E.3 Test procedure
E.3.1 Perform the tests on the standard test loads at the operating temperature(s) of the indi...
E.3.2 Remove the wrapping from the standard test pack and place not less than five, and not mo...
E.3.3 Provided at least two of the sensors in the standard test pack show a temperature depres...
E.3.4 Use the following conditions to produce a reference fault condition and when testing the...
E.3.5 During the tests, vary the orientation of the product between replicate tests (within an...
E.3.6 Carry out the test three times for each of three production batches, using operating cyc...
E.3.7 Before and after each series of three tests, run an operating cycle containing a standar...
E.3.8 Run the three tests required on any one production batch on separate operating cycles to...
E.3.9 After each test, inspect the indicator system visually for compliance with
E.3.10 The position of all temperature sensors in the test pack (see
Determination of reproducibility of fail conditions created in a standard test pack by air inject...
F.1 General
F.2 Criteria for acceptability of test cycles
F.2.1 General
F.2.2 Reference fault condition
F.2.3 No Fault condition
F.3 Statistical evaluation of reproducibility
F.3.1 Run 10 consecutive cycles on each of twodays.
F.3.2 From the cycle records confirm that each cycle meets the acceptance criteria and determi...
F.3.3 Calculate the mean and estimate of variance for the two sets of runs.
F.3.4 Carry out the
F.3.5 Compare the calculated value of
Evaluation of indicator colour change on exposure to dry heat
G.1 Apparatus
G.1.1 Dry heat oven
G.2 Procedure
G.2.1 General
G.2.2 Test 1
G.2.2.1 Pre-heat the oven to the operating temperature.
G.2.2.2 Place the indicator systems in the oven and subject them to dry heat as required in
G.2.3 Test 2
G.2.3.1 Fit the indicator system in combination with its specified test load (the indicator) w...
G.2.3.2 Dry new samples of the indicator system in combination with its specified test load (t...
G.2.3.3 Transfer the dried indicators to the oven without undue delay and in a manner which wi...
Demonstration of shelf life of product
Accelerated ageing of test samples
Steam exposure apparatus and steam for test purposes
J.1 General
J.1.1 The steam exposure apparatus shall consist of a steam sterilizer for wrapped goods and p...
J.1.2 The control system shall permit the operation of the steam exposure apparatus with the s...
J.2 Instrumentation
J.2.1 General
J.2.2 Indicator, controller and recorder sensors
J.2.3 Calibration
J.3 Cycle control
J.3.1 Steam control
J.3.2 Air detector
J.3.3 Signals
J.4 Operating cycle stages and control limits required
J.4.1 Cycle stages
J.4.2 Control limits
J.4.2.1 Pressure-attained control points shall be capable of being attained reproducibly to wi...
J.4.2.2 Elapsed-time control points shall be capable of being attained reproducibly to an accu...
J.4.2.3 Temperature-attained control points shall be capable of being attained reproducibly to...
J.4.2.4 The rate of pressure change during steam admission shall be within
J.4.2.5 The rate of pressure change during evacuation shall be adjustable up to at least
J.5 Steam supply
J.5.1 Particular attention shall be paid to the levels of non-condensable gases in the steam s...
J.5.2 The condensate obtained from steam supplied to the chamber of the steam exposure apparat...
Standard test pack
Air injection system
Bibliography