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YY 1493-2016 English PDF

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YY 1493-2016: Gravity control peritoneal dialysis equipment
Status: Obsolete

YY 1493: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY 1493-2016English399 Add to Cart 3 days [Need to translate] Gravity control peritoneal dialysis equipment Obsolete YY 1493-2016
YY/T 1493-2016English219 Add to Cart 3 days [Need to translate] Gravity control peritoneal dialysis equipment Valid YY/T 1493-2016

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Basic data

Standard ID YY 1493-2016 (YY1493-2016)
Description (Translated English) Gravity control peritoneal dialysis equipment
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C45
Classification of International Standard 11.040.30
Word Count Estimation 10,199
Date of Issue 2016-07-29
Date of Implementation 2018-06-01
Quoted Standard GB/T 191; GB 9706.1; GB 9706.39; GB/T 9969; GB/T 13074; GB/T 14710-2009; YY/T 0466.1; YY 0709
Regulation (derived from) State Food and Drug Administration Announcement No. 2016 (No. 129)
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the terms and definitions, requirements, test methods, marks, instructions for use, and packaging, transport and storage of gravity controlled peritoneal dialysis equipment. This standard applies to gravity-controlled peritoneal dialysis equipment (hereinafter referred to as equipment). This standard does not apply to: one-time consumption of materials in the process of peritoneal dialysis (such as dialysis fluid, dialysis fluid pipeline); pressure control peritoneal dialysis equipment.

YY 1493-2016: Gravity control peritoneal dialysis equipment

---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.
Gravity control peritoneal dialysis equipment ICS 11.040.30 C45 People's Republic of China Pharmaceutical Industry Standard Gravity controlled peritoneal dialysis equipment 2016-07-29 released 2018-06-01 implementation State Food and Drug Administration issued Directory Preface I 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 4 requirements 2 5 Test methods 3 6 mark, instruction manual, packing, transportation, storage 5

Foreword

The technical content of this standard is mandatory. This standard is drafted in accordance with the rules given in GB/T 1.1-2009. 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 Medical Extracorporeal Circulation Equipment Standardization Technical Committee (SAC/TC158) centralized. The drafting of this standard. the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Fuzhou Dongze medical equipment Limited company. The main drafters of this standard. Li Shi, He Min, Wang Ping, Zhou Shaowen. Gravity controlled peritoneal dialysis equipment

1 Scope

This standard specifies the terminology and definitions, requirements, test methods, logos, instructions and packaging for gravity-controlled peritoneal dialysis equipment, Transport, storage. This standard applies to gravity-controlled peritoneal dialysis equipment (hereinafter referred to as equipment). This standard does not apply to. Peritoneal dialysis in the process of disposable materials (such as dialysis solution, dialysis fluid line); --- Pressure-controlled peritoneal dialysis equipment.

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 9706.1 Medical electrical equipment - Part 1. General requirements for safety (GB 9706.1-2007, IEC 60601-1. 1988, IDT) GB 9706.39 Medical electrical equipment - Part 2-39. Particular requirements for the safety of peritoneal dialysis equipment (GB 9706.39-2008, IEC 60601-2-29..2003, IDT) General rules for the use of industrial products GB/T 9969 Glacier for blood purification GB/T 13074 Environmental requirements and test methods for medical appliances GB/T 14710-2009 YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements (YY/T 0466.1-2009, ISO 15223-1..2007, IDT) YY 0709 Medical electrical equipment - Part 1-8. Safety requirements for general requirements. General requirements, medical electrical equipment and medical use Test and guidance for alarm systems in electrical systems (YY 0709-2009, IEC 60601-1-8..2003, IDT)

3 terms and definitions

GB 9706.39 and GB/T 13074 and the following terms and definitions apply to this document. 3.1 Gravity control type gravitycontroltype Use gravity to achieve irrigation and drainage. 3.2 Pressure control type pressurecontroltype The use of pressure changes to achieve irrigation and drainage. 3.3 Stay belly dwel Dialysis fluid remains in the abdominal cavity stage.

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