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YY/T 0646-2022: Small steam sterilizers
Status: Valid YY/T 0646: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0646-2022 | English | 879 |
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Small steam sterilizers
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YY/T 0646-2022
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| YY/T 0646-2015 | English | RFQ |
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Small steam sterilizers - Automatic type
| Obsolete |
YY/T 0646-2015
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| YY 0646-2008 | English | RFQ |
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Small steam sterilizers. automatic type
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YY 0646-2008
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PDF similar to YY/T 0646-2022
Standard similar to YY/T 0646-2022 YY/T 0802.1 YY 0451 YY/T 1268 YY/T 0802.2 Basic data | Standard ID | YY/T 0646-2022 (YY/T0646-2022) | | Description (Translated English) | Small steam sterilizers | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C47 | | Word Count Estimation | 43,441 | | Issuing agency(ies) | State Drug Administration | YY/T 0646-2022: Small 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.
Small steam sterilizers
ICS 11.080.10
CCSC47
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0646-2015
Small pressure steam sterilizer
2023-06-01 Implementation
Released by the State Drug Administration
directory
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Sterilization cycle type 3
5 Requirements 3
6 Test methods 12
7 Inspection rules 22
Appendix A (Informative) Class A Cavity Loads and Class B Cavity Loads 25
Appendix B (Informative) Instructions for Sterilizer Water 27
Appendix C (Informative) Process Evaluation System 28
Appendix D (normative) Inspection and Test Equipment 29
Appendix E (normative) Sterilization load 31
Appendix F (Informative) Loading Device 35
Appendix G (Informative) Information for Users 36
Appendix H (Informative) Test Rationale 38
Reference 40
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"
drafted.
This document replaces YY/T 0646-2015 "Small pressure steam sterilizer automatic control type", compared with YY/T 0646-2015,
In addition to structural adjustments and editorial changes, the main technical changes are as follows.
--- Changed the standard scope (see Chapter 1, Chapter 1 of the.2015 edition);
--- Changed normative references (see Chapter 2, Chapter 2 of the.2015 edition);
--- Changed terms and definitions (see Chapter 3, Chapter 3 of the.2015 edition);
--- Changed the type of sterilization cycle (see Chapter 4, Chapter 4 of the.2015 edition);
--- Deleted normal working conditions (see 5.1.1 of the.2015 edition);
--- Changed the requirements for the appearance, structure and size of the sterilization chamber (see 5.2, 5.2 of the.2015 edition);
--- Changed the requirements for pressure vessels (see 5.3.1, 5.3.1 of the.2015 edition);
--- Changed the requirements for doors and interlocking devices (see 5.3.3, 5.3.3 of the.2015 edition);
--- Changed the requirements for air filters (see 5.3.5, 5.3.5 of the.2015 edition);
--- Delete the requirements for safety valves, steam traps and pressure reducing valves (see 5.3.6, 5.3.7, 5.3.8 of the.2015 edition);
--- Changed the requirements for the instrument (see 5.4.2, 5.4.2 of the.2015 edition);
--- Changed the requirements for acoustic signals (see 5.4.3.3, 5.4.3.3 of the.2015 edition);
--- Changed the requirements for recording devices and records (see 5.4.4, 5.4.4 of the.2015 edition);
--- Change the requirements for saturated steam temperature and time (see 5.11, 5.11 of the.2015 edition);
--- Increased test water condition requirements (see 6.1.1);
--- Deleted the test method for the factory inspection or installation inspection process (see 6.11.4.2.2, 6.11.5.3, 6.11.6.3 of the.2015 edition);
--- Deleted the test method for factory inspection (see 7.3 of the.2015 edition);
--- Deleted the test method for installation inspection (see 7.4 of the.2015 edition);
--- Changed the inspection items (see 7.3, see 7.5 of the.2015 edition);
--- Deleted the requirements for signs and instructions for use (see Chapter 8 of the.2015 edition);
--- Delete the requirements for packaging, transportation and storage (see Chapter 9 of the.2015 edition);
--- Deleted the relevant specification of the simplified test package (see E.1.2.2 of the.2015 edition).
Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed and managed by the National Standardization Technical Committee of Disinfection Technology and Equipment (SAC/TC200).
This document is drafted by. Guangdong Medical Device Quality Supervision and Inspection Institute, Shandong Broke Disinfection Equipment Co., Ltd., Jiangyin Binjiang Medical Equipment Co., Ltd.
Equipment Co., Ltd., Ningbo Yongan Medical Equipment Manufacturing Co., Ltd.
The main drafters of this document. Zhou Yuxin, Hu Changming, Yuan Wenhu, Cha Shihong, Zhang Mingzhao, Huang Hongxin.
The previous versions of this document and its superseded documents are as follows.
---First published in.2008 as YY 0646-2008;
---The first revision in.2015 was YY/T 0646-2015;
---This is the second revision.
Small pressure steam sterilizer
1 Scope
This document specifies the sterilization cycle types, requirements, test methods and inspection rules for small pressure steam sterilizers (hereinafter referred to as sterilizers).
This document applies to steam generated by electric heating or external steam, the side opening of the sterilization chamber, the volume is less than 60L, and a sterilizer cannot be loaded.
The bacteria unit (300mm×300mm×600mm), the rated working pressure is not more than 0.25MPa and the preset sterilization temperature is 115℃~
Automatically controlled small pressure steam sterilizer in the range of 138°C.
Note. The pressure mentioned in this document refers to gauge pressure unless indicated as absolute pressure.
This document does not apply to vertical pressure steam sterilizers, portable pressure steam sterilizers, cassette steam sterilizers and liquid sterilization.
This document does not specify safety requirements involving the scope of use risk, nor does it specify requirements for validation and routine control of moist heat sterilization.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document.
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 Handling Medical Materials
and special requirements for washer-disinfectors
GB/T 14710 Environmental Requirements and Test Methods for Medical Electrical Appliances
GB/T 18268.1 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1.General Requirements
GB 18281.1 Biological Indicators for Sterilization of Healthcare Products Part 1.General
GB 18281.3 Biological Indicators for Sterilization of Healthcare Products Part 3.Biological Indicators for Moist Heat Sterilization
GB 18282.1 Sterilization Chemical Indicators for Healthcare Products Part 1.General
GB/T.19971 Terms for Sterilization of Healthcare Products
GB/T.19974 Characterization of Sterilization Factors for Sterilization of Healthcare Products and Development, Validation and Routine Control of Sterilization Processes for Medical Devices
general requirements
YY/T 0698 (all parts) Packaging materials for terminally sterilized medical devices
3 Terms and Definitions
GB/T.19971 and the following terms and definitions apply to this document.
3.1
remove air airremoval
Remove as much air as possible from the sterilization chamber and sterilization bag to aid the penetration of steam.
3.2
Automatic controller automaticcontroler
A device that controls the sterilizer to run automatically in sequence according to preset parameters.
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