GB 18282.3-2009 English PDF (GB18282.3-2009)

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GB 18282.3-2009: Sterilization of health care products -- Chemical indicators -- Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
GB 18282.3-2009
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.01
C 47
GB 18282.3-2009 / ISO 11140-3:2007
Sterilization of Health Care Products – Chemical Indicators
– Part 3: Class 2 Indicator Systems for Use in the Bowie and
Dick-Type Steam Penetration Test
(ISO 11140-3:2007, IDT)
ISSUED ON: NOVEMBER 15, 2009
IMPLEMENTED ON: DECEMBER 01, 2010
Issued by: General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative References ... 5
3 Terms and Definitions ... 6
4 General Requirements ... 6
5 Indicator System Format ... 6
6 Performance Requirements ... 7
7 Packaging and Labelling ... 8
8 Quality Assurance ... 9
Annex A (Normative) Determination of Strength after Steam Sterilization ... 10
Annex B (Normative) Estimation of Visual Difference between Color of the Substrate
and the Changed (or Unchanged) Indicator System by Determination of Relative
Reflectance Density ... 11
Annex C (Normative) Determination of Indicator Color Change on Exposure to Dry
Saturated Steam ... 15
Annex D (Normative) Determination of Indicator Color Change on Exposure to Dry
Heat ... 16
Annex E (Normative) Accelerated Ageing of Test Samples ... 17
Annex F (Normative) Determination of Transfer of Indicator to Standard Test Pack on
Processing ... 18
Annex G (Normative) Determination of Shelf Life of the Product ... 19
Annex H (Normative) Steam Exposure Apparatus ... 20
Annex I (Normative) Determination of Sensitivity of the Indicator to the Presence of
Air ... 22
Annex J (Normative) Air Injection System ... 24
Annex K (Normative) Standard Test Pack ... 26
Bibliography ... 27
Foreword
All the technical contents in this Part are mandatory.
GB 18282 Sterilization of Health Care Products – Chemical Indicators consists of the following
parts:
--- Part 1: General;
--- Part 3: Class 2 Indicator Systems for Use in the Bowie and Dick-Type Steam Penetration
Test;
--- Part 4: Class 2 Indicators as an Alternative to the Bowie and Dick-Type Test for Detection
of Steam Penetration;
--- Part 5: Class 2 Indicators for Bowie and Dick-Type Air Removal Tests.
This Part is Part 3 of GB 18282.
This Part equivalently adopts ISO 11140-3:2007 Sterilization of Health Care Products –
Chemical Indicators – Part 3: Class 2 Indicator Systems for Use in the Bowie and Dick-Type
Steam Penetration Test.
Compared with ISO 11140-3:2007, the major differences with this Part are as follows:
--- Make the editorial modifications as per the requirements in GB/T 1.1;
--- Delete the Foreword of the international standard;
--- For other international standards cited in this Part, if they have been converted into
Chinese standards, this Part will replace the referenced international standard number
with the corresponding national standard number, and indicate the adoption relationship.
The Annexes A ~ K of this Part are normative.
This Part was proposed by State Food and Drug Administration.
This Part shall be under the jurisdiction of National Technical Committee on Disinfection
Technology and Equipment of Standardization Administration of China (SAC/TC 200).
Drafting organizations of this Part: Guangzhou Medical Device Quality Supervision and
Inspection Center of State Food and Drug Administration; Beijing Medicare Jincheng Medical
Devices Co., Ltd.; and Shinva Medical Instrument Co., Ltd.
Chief drafters of this Part: Lu Wenjuan, Lu Zhong, Yuan Qin, Hu Xianghua, Lv Liansheng, and
Wan Jiuru.
Sterilization of Health Care Products – Chemical Indicators
– Part 3: Class 2 Indicator Systems for Use in the Bowie and
Dick-Type Steam Penetration Test
1 Scope
This Part of GB 18282 specifies the requirements for chemical indicators to be used in the
steam penetration test for steam sterilizers for wrapped goods, e.g., instruments and porous
materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1.
Indicators complying with this Part of GB 18282 are intended for use in combination with the
standard test pack as described in EN 285. This Part of GB 18282 does not consider the
performance of the standard test pack, but does specify the performance of the indicator systems.
2 Normative References
The provisions in following documents become the provisions of this Part through reference in
this Part of GB 18282. For dated references, the subsequent amendments (excluding
corrigendum) or revisions do not apply to this Standard, however, parties who reach an
agreement based on this Standard are encouraged to study if the latest versions of these
documents are applicable. For undated references, the latest edition of the referenced document
applies.
GB/T 11501 Photography - Density Measurement - Part 3: Spectral Conditions (GB/T
11501-2008, ISO 5-3:1995, IDT)
GB/T 12823.1 Photography - Density Measurement - Part 1: Terms, Symbols and
Notations (GB/T 12823.1-2008, ISO 5-1:1984, IDT)
GB/T 12823.4-2008 Photography – Density Measurement - Part 4: Geometric Conditions
for Reflection Density (ISO 5-4:1995, IDT)
ISO 187:1990 Paper, Board and Pulps -- Standard Atmosphere for Conditioning and
Testing and Procedure for Monitoring the Atmosphere and Conditioning of Samples
ISO 2248 Packaging - Complete, Filled Transport Packages - Vertical Impact Test by
Dropping
manufacturer.
Compliance shall be tested in accordance with Annex B.
f) It shall permit writing in permanent ink to be made legibly on both processed and
unprocessed materials. Markings made before processing shall be legible after
processing.
g) It shall be of size A4 in accordance with ISO 5457.
6 Performance Requirements
6.1 The indicator shall meet the following requirements.
a) It shall show a uniform color change complying with 5 e) after exposure to dry saturated
steam at 134 (+1.5 0 )°C for 3.5 min ± 5 s or after exposure to dry saturated steam at 121
(+1.5 0 )°C for 15 min ± 5 s or both.
Compliance shall be tested in accordance with Annex C.
b) When placed in the center of a standard test pack, it shall show a non-uniform color
change when the temperature at the center of the standard test pack is 2°C lower than the
temperature of the chamber drain of the steam exposure apparatus (see Annex H).
Compliance shall be tested in accordance with Annex I.
c) It shall show no discernible color change after exposure to dry heat at (140 ± 2)°C for not
less than 30 min.
Compliance shall be demonstrated in accordance with Annex D.
With some indicators a slight color change can occur. This shall be acceptable if the
change that occurs is markedly different from that brought about by exposure to steam
in accordance with 6.1 a) and within the limits specified by the manufacturer.
d) It shall not visibly transfer indicator reagent to the material of the test load in intimate
contact with the indicator during processing.
Compliance shall be demonstrated in accordance with Annex F.
6.2 The indicator shall comply with the requirements of this part of GB 18282 for the duration
of the shelf life specified by the manufacturer.
If any change in the indicator occurs during ageing, it shall be different to the change on
exposure to dry saturated steam [as described in 6.1 a)], and shall have either inactivated the
indicator so that no further change can take p...