YY 0504-2016_English: PDF (YY0504-2016)
Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
YY 0504-2016 | English | 239 |
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Portable mode steam sterilizers
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YY 0504-2016
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YY 0504-2005 | English | 359 |
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Portable mode steam sterilizers
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YY 0504-2005
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Standard ID | YY 0504-2016 (YY0504-2016) | Description (Translated English) | Portable mode steam sterilizers | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | Classification of Chinese Standard | C47 | Classification of International Standard | 11.080.10 | Word Count Estimation | 12,175 | Date of Issue | 2016-03-23 | Date of Implementation | 2018-01-01 | Older Standard (superseded by this standard) | YY 0504-2005 | Quoted Standard | GB 150.1; GB 150.2; GB 150.3; GB 150.4; GB/T 191; GB/T 1226; GB 4793.1; GB/T 9969; GB/T 14710; GB 18281.3; GB/T 19971; YY 0154; YY/T 0157; IEC 61010-2-040-2005 | Drafting Organization | Lianyungang 1000 Sakura Medical Equipment Co., Ltd | Administrative Organization | National Disinfection Technology and Equipment Standardization Technical Committee | Regulation (derived from) | Notice of the General Administration of Food and Drug Administration (No. 74 of 2016) | Proposing organization | State Food and Drug Administration | Issuing agency(ies) | State Food and Drug Administration | Summary | This standard specifies the terms and definitions, classification, structure and basic parameters, requirements, test methods, inspection rules, marking and operating instructions, and packaging, transport and storage of portable steam sterilizers. This standard applies to the sterilization temperature is not greater than 132 �� portable steam sterilizer (hereinafter referred to as sterilizer). | Standard ID | YY 0504-2005 (YY0504-2005) | Description (Translated English) | Portable mode steam sterilizers | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | Classification of Chinese Standard | C47 | Classification of International Standard | 11.080.10 | Word Count Estimation | 9,923 | Date of Issue | 2005-04-05 | Date of Implementation | 2006-04-01 | Older Standard (superseded by this standard) | YY 91006-1999; YY 91124-1999 | Quoted Standard | GB/T 191; GB 1226; GB/T 2829-2002; GB 4793.4-2001; GB 9969.1; GB/T 14710-1993; GB 18281.3-2000; YY 0154; YY/T 0157; YY/T 0158; special equipment monitor the safety regulations; ISO 11139-2003 | Drafting Organization | State Drug Administration of Guangzhou Medical Device Quality Supervision and Inspection Center | Administrative Organization | National Standardization Technical Committee of disinfection technology and equipment | Regulation (derived from) | Industry standard filing Notice 2005 No. 5 (No. 65 overall) | Proposing organization | State Food and Drug Administration | Issuing agency(ies) | State Food and Drug Administration | Summary | This standard specifies the portable pressure steam sterilizer terms and definitions, classification, requirements, test methods and inspection rules, marking, labeling, packaging, transportation and storage. This standard applies to Portable Pressure Steam Sterilizer (hereinafter referred to as sterilization). |
YY 0504-2016
Portable mode steam sterilizers
ICS 11.080.10
C47
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0504-2005
Portable steam sterilizer
2016-03-23 release
2018-01-01 implementation
State Food and Drug Administration issued
Preface
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0504-2005 "Portable Steam Sterilizer". This standard compared with YY 0504-2005, the main technical changes
as follows.
--- Increased supply of sterilizer supply (see 5.1.2);
- the technical requirements for the addition of the seal of the sterilization chamber cap (see 5.2.3);
- to increase and modify the specific requirements for the sterilization of the sterilizer (see 5.3,.2005 edition 5.12);
--- Increased requirements for sterilizer materials (see 5.4);
- Increased technical requirements for sterile loading attachments (see 5.10);
- The sterilization temperature is specified as specified by the manufacturer, the lower limit is the sterilization temperature, and the upper limit is the sterilization temperature 3 ° C (see 5.12,.2005
Version 5.8);
--- Increased sterilizer alarm indication (see 5.14);
- modified environmental testing requirements (see 5.19,.2005, 5.14);
- Modification of the sterilization test method (see 6.16, Appendix B,.2005 Edition 6.13);
- the inspection classification was deleted (2005 version 7.1);
--- Increased supply of water quality indicators (see Appendix A).
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Disinfection Technology and Equipment Standardization Technical Committee (SAC/TC200) centralized.
The drafting of this standard unit. Lianyungang 1000 Sakura Medical Equipment Co., Ltd., the State Food and Drug Administration Guangzhou Medical Device Quality Supervision
Inspection Center, Ningbo Yongan Medical Equipment Manufacturing Co., Ltd.
The main drafters of this standard. Huang Xiulian, Liu Zhenjian, Zhang Mingzhao.
This standard replaced the previous version of the standard release.
YY 91006-1999, YY 91124-1999;
YY 0504-2005.
Portable steam sterilizer
1 Scope
This standard specifies the terminology and definition, classification, structure and basic parameters of the portable steam sterilizer, requirements, test methods, inspection rules,
Logo and instructions and packaging, transportation and storage.
This standard applies to the sterilization temperature of not more than 132 ℃ portable steam sterilizer (hereinafter referred to as sterilizer).
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB 150 (all parts) pressure vessel
GB/T 191 packaging and storage icon
GB/T 1226 general pressure gauge
GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements
General rules for the use of industrial products GB/T 9969
Environmental requirements and test methods for medical appliances GB/T
GB 18281.3 Sterilization products for health care products - Part 3. Biological indicators for damp heat sterilization
GB/T.19971 Sterilization terminology for health care products
YY 0154 Springs for steam sterilization equipment
Standard type spring valves for pressure steam sterilization equipment YY/T 0157
IEC 61010-2-040..2005 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-040. Procedures for the treatment of medical equipment
With the special requirements of sterilizers and cleaning sterilizers (Safetyrequirementsforelectricalequipmentformeasure-
ment, controlandlaboratoryuse-Part 2-040. Particularrequirementsforsterilizersandwasher-disin-
fectorsusedtotreatmedicalmaterials
3 terms and definitions
The terms and definitions defined in GB/T.19971 apply to this document.
4 Classification, structure and basic parameters
4.1 Classification
The heating method of the sterilizer is divided into electric type and other heating type.
4.2 Structural form
The structure of the sterilizer is portable.
4.3 basic parameters
4.3.1 The maximum working pressure is less than 0.22MPa.
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