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YY 0504-2016 English PDF

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YY 0504-2016: Portable mode steam sterilizers
Status: Valid

YY 0504: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY 0504-2016English239 Add to Cart 3 days [Need to translate] Portable mode steam sterilizers Valid YY 0504-2016
YY 0504-2005English359 Add to Cart 3 days [Need to translate] Portable mode steam sterilizers Obsolete YY 0504-2005

PDF similar to YY 0504-2016


Standard similar to YY 0504-2016

YY/T 0802.1   YY/T 1268   YY 0451   YY 0503   YY 0503   

Basic data

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 12,112
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Older Standard (superseded by this standard) YY 0504-2005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
Regulation (derived from) Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
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).

YY 0504-2016: Portable mode 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.
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

Foreword

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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