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YY 0731-2009 English PDF

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YY 0731-2009: Large steam sterilizers. Manual control type
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YY 0731-2009English439 Add to Cart 4 days [Need to translate] Large steam sterilizers. Manual control type Valid YY 0731-2009

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Standard similar to YY 0731-2009

YY/T 0802.1   YY 0451   YY/T 1268   YY/T 0734.5   YY/T 0734.2   YY/T 0734.1   

Basic data

Standard ID YY 0731-2009 (YY0731-2009)
Description (Translated English) Large steam sterilizers. Manual control type
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C47
Classification of International Standard 11.080.10
Word Count Estimation 19,130
Date of Issue 2009-06-16
Date of Implementation 2010-12-01
Older Standard (superseded by this standard) YY 91008-1999; YY 91009-1999
Quoted Standard GB 150; GB/T 191; GB/T 1226; GB 4793.1; GB 4793.3; GB/T 7397; GB 9969.1; GB/T 12244; GB/T 14710; GB/T 16839.2-1997; GB 18281.3; GB/T 19971; JB/T 8622-1997; YY 0154; YY/T 0158; YY/T 0159; special Equipment Safety Supervision Regulations of the PRC State Council Order (No. 373); pressure vessel safety technology to monitor the process of the State Quality and Technical Supervision (1999)
Regulation (derived from) Industry standard filing Notice 2009 No. 9
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the type of manual control large steam sterilizers terms and definitions, types and basic parameters, requirements, test methods, inspection rules, marking and instruction manual and packaging, transportation and storage. This standard applies to the rated working pressure of 0. 25 MPa or less, the lower volume greater than 60 L exhaust, manual control type steam sterilizer (hereinafter referred to as sterilization). This standard does not apply to automatic control type large steam sterilizers, does not apply to vacuum sterilizer.

YY 0731-2009: Large steam sterilizers. Manual control type

---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.
Large steam sterilizers.Manual control type ICS 11.080.10 C47 People's Republic of China pharmaceutical industry standards Replacing YY 91008-1999, YY 91009-1999 Large steam sterilizers manual control type Posted 2009-06-16 2010-12-01 implementation State Food and Drug Administration issued

Table of Contents

Preface Ⅰ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 Types and basic parameters 2 5 Requirement 2 6 Test methods 6 7 Inspection rules 8 8 Marking and Instructions 9 9 packaging, transportation and storage 9 Quality Indicators Appendix A (informative) feed water and steam condensate 11 Appendix B (normative) test instruments, equipment and materials 12 References 15

Foreword

5.1.2 This standard is recommended, the rest are mandatory. This standard also replace the YY 91008-1999 "pressure steam sterilizer horizontal circular --- technical conditions", YY 91009-1999 "pressure Power steam sterilizer technical conditions --- horizontal rectangle "and other two pharmaceutical industry standards. Since the implementation of this standard, the above two criteria Abolished. Appendix B of this standard is a normative appendix, Appendix A is an information appendix. This standard was proposed by the State Food and Drug Administration. This standard by the National Standardization Technical Committee disinfection technology and equipment (SAC/TC200) centralized. This standard was drafted. State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Lianyungang SENOH medical equipment Ltd., Shanghai Medical Nuclear Instrument Co., Ltd. China line. The main drafters of this standard. Li Jing, Huang Xiulian, Hu Changming, Liuzhen Jian, Zheng Hongqin. This standard by the National Standardization Technical Committee disinfection technology and equipment responsible for the interpretation. This standard replaces the standards previously issued as follows. --- YY 91008-1999, YY 91009-1999. --- GB 4027.3-1983, GB 4027.4-1983. Large steam sterilizers manual control type

1 Scope

This standard specifies the terms and definitions manually controlled large steam sterilizer, type and basic parameters, requirements, test methods, inspection regulations Then, marking and instruction manual and packaging, transportation and storage. This standard applies to the rated working pressure of 0.25MPa or less, under the exhaust volume greater than 60L, manual control type steam off Bacteria filter (hereinafter referred to as sterilization). This standard does not apply to automatic control type large steam sterilizers, does not apply to vacuum type sterilizer.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard. GB 150 steel pressure vessels GB/T 191 Packaging - Pictorial signs (GB/T 191-2008, ISO 780.1997, MOD) GB/T 1226 General Pressure Gauge GB 4793.1 measurement, control and laboratory safety requirements for electrical equipment Part 1. General requirements (GB 4793.1- 2007, IEC 61010-1.2001, IDT) GB 4793.4 measurement, control and laboratory use electrical safety laboratory equipment used in the treatment of medical materials to be autoclaved Particular Seek (GB 4793.4-2001, idt IEC 61010-2-041.1995) GB/T 7307 55 ° non-sealing pipe thread (GB/T 7307-2001, eqv ISO 228-1.1994) GB 9969.1 Instructions General Industrial Products GB/T 12244 valve general requirements GB/T 14710 Medical electrical equipment environmental requirements and test methods GB/T 16839.2-1997 thermocouple Part 2. Tolerances (idt IEC 60584-2. 1982) GB 18281.3 Sterilization of health care products - Biological indicators - Part 3. Biological indicators for moist heat sterilization (GB 18281.3- 2000, idt ISO 11138-3.1995) GB/T 19971 Sterilization of health care products Terminology (GB/T 19971-2005, ISO /T S11139.2001, IDT) JB/T 8622-1997 industrial platinum RTD Technical conditions and indexing table (neqIEC 751. 1983) YY 0154 pressure steam sterilization equipment with a spring-loaded safety valve YY/T 0158 Pressure Steam Sterilization Equipment Gasket YY/T 0159 Pressure Steam sterilization equipment with trap Regulations on Safety Supervision of Special Equipment People's Republic of China State Council Decree (No. 373) Pressure Vessel Safety Technology Supervision Quality and Technical Supervision (1999)

3 Terms and Definitions

GB/T 19971 and identified the following terms and definitions apply to this standard. 3.1 Reaches sterilization temperature measurement from the reference point, to all parts of the load has reached the sterilizing temperature desired time.

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