YY 1275-2016 English PDF

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YY 1275-2016: Dry heat (heated air) sterilizers
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 1275-2016	339	Add to Cart	4 days	Dry heat (heated air) sterilizers	Valid

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Basic data

Standard ID: YY 1275-2016 (YY1275-2016)
Description (Translated English): Dry heat (heated air) sterilizers
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C47
Classification of International Standard: 11.080.10
Word Count Estimation: 17,175
Date of Issue: 2016-03-23
Date of Implementation: 2018-01-01
Quoted Standard: GB/T 191; GB 4793.1; GB/T 4982; GB/T 14710-2009; GB/T 18268; YY/T 0466.1-2016; IEC 61010-2-040-2005
Adopted Standard: ANSI/AAMI ST50-2004, NEQ
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, requirements, test methods, inspection rules and signs, packaging, instructions, transport and storage of hot air dry heat sterilizers. This standard applies to convection hot air as a sterilization medium for dry heat sterilizer (hereinafter referred to as sterilizer). The sterilizer is mainly used for sterilization of medical devices and their accessories in laboratories, nursing clinics, hospitals and other health care establishments. This standard does not apply to conductive or radiant dry heat sterilizers, does not specify safety requirements related to the use of the risk range, does not require dry heat (hot air) sterilization confirmation and routine control and dry heat pyrogen removal requirements.

YY 1275-2016: Dry heat (heated air) 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.
Dry heat (heated air) sterilizers ICS 11.080.10 C47 People's Republic of China Pharmaceutical Industry Standard Hot air type dry heat sterilizer 2016-03-23 release 2018-01-01 implementation State Food and Drug Administration issued Directory Preface I 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 4 classification and basic parameters 2 5 request 2 6 Test Method 7 7 Inspection rules 10 8 mark, instruction manual, packing, transportation, storage 10 Appendix A (normative) Temperature sensor arrangement 12 Appendix B (informative) Requirements for sterilizers for sterilizers 14

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. The technical content of this standard refers to ANSI/AAMIST50..2004 "dry heat (hot air) sterilizer" (English version), and ANSI / AAMIST50..2004 Consistency is non-equivalent. 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. Appendix A of this standard is a normative appendix, Appendix B is an informative appendix. 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. Shandong Xinhua Medical Devices Co., Ltd., the State Food and Drug Administration Guangzhou medical equipment quality Supervision and inspection center, Lianyungang thousands of cherry Medical Equipment Co., Ltd. The main drafters of this standard. Wang Jianxin, Wang Hongmin, Hu Changming, Huang Xiulian, Zou Hongwu, Liu Zhenjian. Hot air type dry heat sterilizer

1 Scope

This standard specifies the terms and definitions of hot air dry heat sterilizers, requirements, test methods, inspection rules and signs, packaging, use Brochures, transportation and storage. This standard applies to convective hot air as a sterilization medium for dry heat sterilizer (hereinafter referred to as sterilizer). The sterilizer is mainly used for experiments Indoor, nursing clinics, hospitals and other medical establishments and their accessories. This standard does not apply to conductive or radiant dry heat sterilizers, does not specify the safety requirements related to the use of the risk range, does not require dry heat (Hot air) sterilization confirmation and routine control and dry heat pyrogen removal requirements.

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/T 191 Packaging and Storage Icons (GB/T 191-2008, ISO 780..1997, MOD) GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements (GB 4793.1-2007, IEC 61010-1..2001, IDT) GB/T 4982 Vacuum technology - Quick release connector dimensions - Part 1. Clamping type [GB/T 4982-2003, ISO 2861-1. 1974 (E), IDT] Environmental requirements and test methods for medical appliances GB/T 14710-2009 GB/T 18268 Electromagnetic compatibility requirements for electrical equipment for measurement, control and laboratory use (GB/T 18268-2000, IEC 61326- 1-1997, IDT) YY/T 0466.1-2016 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General purpose (ISO 15223-1..2007, IDT) 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 Disinfection technical specifications of the People's Republic of China Ministry of Health (2002 edition)

3 terms and definitions

The following terms and definitions apply to this document. 3.1 Hot air heat dry sterilization dryHeat (heatedair) sterilize Use convective hot air as a sterilization medium for sterilization. 3.2 Hold time holdingtime Sterilization chamber reference measurement point and the temperature of each part are kept in the sterilization temperature range. ......

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