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GB 8599-2023: Technical requirements for large steam sterilizers
Status: Valid GB 8599: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB 8599-2023 | English | 729 |
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Technical requirements for large steam sterilizers
| Valid |
GB 8599-2023
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| GB 8599-2008 | English | 839 |
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Technical requirements for large steam sterilizers -- Automatic type
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GB 8599-2008
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| GB 8599-1988 | English | 279 |
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Specifications for automated autoclave sterilizer
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GB 8599-1988
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PDF similar to GB 8599-2023
Basic data | Standard ID | GB 8599-2023 (GB8599-2023) | | Description (Translated English) | Technical requirements for large steam sterilizers | | Sector / Industry | National Standard | | Classification of Chinese Standard | C47 | | Classification of International Standard | 11.080.10 | | Word Count Estimation | 38,340 | | Date of Issue | 2023-09-08 | | Date of Implementation | 2026-10-01 | | Older Standard (superseded by this standard) | GB 8599-2008 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB 8599-2023: Technical requirements for large steam sterilizers---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.080.10
CCSC47
National Standards of People's Republic of China
Replace GB 8599-2008
Technical requirements for large pressure steam sterilizers
Published on 2023-09-08
Implemented on 2026-10-01
State Administration for Market Regulation
Released by the National Standardization Administration Committee
Table of contents
Preface III
1 Scope 1
2 Normative reference documents 1
3 Terms and Definitions 1
4 Category 3
5 Requirements 3
6 Test methods 10
Appendix A (Informative) Environmental Impact 19
Appendix B (informative) Qualification standards for sterilizers of the same series20
Appendix C (informative) Allowable range of temperature and time during small load temperature test 21
Appendix D (Normative) Test instruments, equipment and materials 22
Appendix E (informative) Information and documents provided by the manufacturer28
Appendix F (informative) Normal working conditions 30
Reference 33
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents"
Drafting.
This document replaces GB 8599-2008 "Technical Requirements for Large Steam Sterilizers Automatic Control Type". Compared with GB 8599-2008, except
In addition to structural adjustments and editorial changes, the main technical changes are as follows.
a) Changed the scope of the standard (see Chapter 1, Chapter 1 of the.2008 edition);
b) Changes in terms and definitions (see Chapter 3, Chapter 3 of the.2008 edition);
c) Basic parameters are deleted (see 4.2 of the.2008 version);
d) Changed the requirements for double-door sterilizers (see 5.1.1.2, 5.4.2 of the.2008 edition);
e) Changed the requirements for testing connectors (see 5.1.1.3, 5.4.3 of the.2008 version);
f) Normal working conditions are deleted (see 5.1 of the.2008 version);
g) Changed the requirements for structure and sterilization chamber size (see 5.2.1.1, 5.2.3 of the.2008 edition);
h) The requirements for appearance are deleted (see 5.2.1 and 5.2.2 of the.2008 version);
i) Removed material requirements (see 5.3 of the.2008 version);
j) The requirement for interlocking devices is deleted (see 5.4.1.2 of the.2008 edition);
k) The requirements for thermal insulation materials are deleted (see 5.4.4 of the.2008 edition);
l) Changed the requirements for pipelines (see 5.2.2.1, 5.5.1 of the.2008 version);
m) Changed the requirements for steam generating devices (see 5.2.2.2, 5.5.2 of the.2008 edition);
n) Changed the requirements for air filters (see 5.2.2.3, 5.5.3 of the.2008 edition);
o) Changes to the content of measuring systems, display and recording devices (see 5.2.3, 5.6 of the.2008 version);
p) Changed the requirements for control systems (see 5.2.4, 5.7 of the.2008 edition);
q) Changed the criteria for BD test (see 5.3.1.1, 5.8.1.1 of the.2008 version);
r) The relevant requirements, test methods and appendices for the killing of biological indicators have been changed (see 5.3.2, 6.4.2, D.3,.2008 edition
5.8.2, 6.8.2, F.8);
s) Added the calculation method of the theoretical temperature of saturated steam [see 5.3.3.1c)];
t) Changed the requirements for small load temperature [see 5.3.3.1d),.2008 version of 5.8.3.2d)];
u) Changed the requirements for full load temperature [see 5.3.3.2d),.2008 version of 5.8.3.3d)];
v) Delete the relevant requirements for marking (see 5.12 of the.2008 version);
w) Changed the requirements for cavity load test (see 6.4.1.2, 6.8.1.2 of the.2008 edition);
x) Added relevant requirements for wireless temperature sensors in temperature performance testing (see 6.4.3, 6.8.3 of the.2008 version);
y) Changed the test requirements for noise test (see 6.4.6, 6.9 of the.2008 edition);
z) Change the normative appendix "Temperature and time allowable range during small load temperature test" to an informative appendix (see Appendix C,
Appendix E of the.2008 edition);
aa) The requirements of the normative appendix "Testing instruments, equipment and materials" have been changed (see Appendix D, Appendix F of the.2008 version).
Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents.
This document is proposed and managed by the National Medical Products Administration.
The previous versions of this document and the documents it replaces are as follows.
---First published in 1988 as GB 8599-1988 "Technical Conditions for Automatic Control of Pressure Steam Sterilizers";
---In the first revision in.2008, the contents of GB 8600-1988 "Sterilization Effect Test Method of Pressure Steam Sterilizer" were integrated.
content, the name was changed to "Technical Requirements for Large Steam Sterilizer Automatic Control Type";
---This is the second revision.
Technical requirements for large pressure steam sterilizers
1 Scope
This document defines the terms and definitions of large pressure steam sterilizers (hereinafter referred to as "sterilizers"), stipulates classifications, requirements, and describes
experiment method.
This document is applicable to sterilization chambers with side openings that can load at least one sterilization unit or a volume of not less than 60L and a vacuum function.
Bacteria. This sterilizer is mainly used for sterilizing medical and health care products and their accessories (excluding liquid items, flammable and explosive items, biological waste, human
sterilization of body tissue).
Note. Sterilizers designed and produced according to this document also need to consider the impact of environmental factors in the product life cycle. See Appendix A for environmental impact factors.
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to
this document.
GB/T 3768 Acoustic sound pressure method determines the sound power level and sound energy level of noise sources using a simplified method of enveloping the measuring surface above the reflecting surface.
Yifa
GB/T 3785 (all parts) Electroacoustic sound level meter
GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use Part 1.General requirements
GB 4793.4 Safety requirements for electrical equipment for measurement, control and laboratory use Part 4.Sterilizers for processing medical materials
and special requirements for washer-disinfectors
GB/T 16839.1 Thermocouples Part 1.Electromotive force specifications and tolerances
GB/T 18268.1 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use Part 1.General requirements
GB 18278.1-2015 Moist heat sterilization of health care products Part 1.Development, validation and routine of sterilization process of medical devices
Control requirements
GB 18281.3 Biological indicators for sterilization of medical and health care products Part 3.Biological indicators for moist heat sterilization
GB 18282.1 Chemical indicators for sterilization of health care products Part 1.General principles
GB 18282.3 Chemical Indicators for Sterilization of Healthcare Products Part 3.Class II Indicators for BD Class Vapor Penetration Testing
physical system
GB/T 19633 (all parts) Packaging of terminally sterilized medical devices
GB/T 19971-2015 Terminology for sterilization of medical and healthcare products
GB/T 30121 Industrial platinum thermal resistor and platinum temperature sensing element
3 Terms and definitions
The following terms and definitions as defined in GB 18278.1-2015 and GB/T 19971-2015 apply to this document.
3.1
Absolute pressureabsolutepressure
The pressure with absolute vacuum as the zero reference.
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