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YY/T 1493-2016 English PDF

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YY/T 1493-2016: Gravity control peritoneal dialysis equipment
Status: Valid

YY/T 1493: Evolution and historical versions

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

PDF similar to YY/T 1493-2016


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Basic data

Standard ID YY/T 1493-2016 (YY/T1493-2016)
Description (Translated English) Gravity control peritoneal dialysis equipment
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C45
Classification of International Standard 11.040.30
Word Count Estimation 10,192
Date of Issue 2016-07-29
Date of Implementation 2018-06-01
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the terms, definitions, classifications, requirements, test methods, signs, instructions for use, packaging, transportation and storage requirements of gravity-controlled peritoneal dialysis equipment. This standard applies to gravity-controlled peritoneal dialysis equipment. This standard does not apply to disposable consumable materials (such as dialysate, dialysate tubing) and pressure-controlled peritoneal dialysis equipment during peritoneal dialysis. This standard does not apply to: disposable consumable materials (such as dialysate, dialysate tubing) during peritoneal dialysis; pressure-controlled peritoneal dialysis equipment.

YY/T 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.
ICS 11:040:30 C45 Pharmaceutical Industry Standard of the People's Republic of China YY 1493-2016 Gravity-controlled peritoneal dialysis equipment According to the State Drug Administration medical device industry Standard Announcement (No: 76 of 2022), this standard is from From September 7, 2022, it will be converted into a recommended standard, no Enforce it again: Released on:2016-07-29 2018-06-01 Implementation Issued by China Food and Drug Administration

table of contents

Preface I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Requirements 2 5 Test method 3 6 Signs, instructions for use, packaging, transportation, storage 5 YY 1493-2016

foreword

All technical contents of this standard are mandatory: This standard is drafted in accordance with the rules given in GB/T 1:1-2009: Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying these patents: This standard was proposed by China Food and Drug Administration: This standard is under the jurisdiction of the National Standardization Technical Committee of Medical Extracorporeal Circulation Equipment (SAC/TC158): This standard was drafted by: State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Fuzhou Dongze Medical Device Co:, Ltd: Ltd: The main drafters of this standard: Li Shi, He Min, Wang Ping, Zhou Shaowen: YY 1493-2016 Gravity-controlled peritoneal dialysis equipment

1 Scope

This standard specifies the terms and definitions, requirements, test methods, signs, instructions for use and packaging of gravity-controlled peritoneal dialysis equipment, Transportation, storage: This standard applies to gravity-controlled peritoneal dialysis equipment (hereinafter referred to as equipment): This standard does not apply to: --- Disposable consumable materials during peritoneal dialysis (such as dialysate, dialysate tubing); ---Pressure-controlled peritoneal dialysis equipment:

2 Normative references

The following documents are indispensable for the application of this document: For dated references, only the dated version applies to this document pieces: For undated references, the latest version (including all amendments) applies to this document: GB/T 191 Packaging, storage and transportation icons (GB/T 191-2008, ISO 780:1997, MOD) GB 9706:1 Medical Electrical Equipment Part 1: General Safety Requirements (GB 9706:1-2007, IEC 60601-1:1988, IDT) GB 9706:39 Medical electrical equipment Part 2-39: Special requirements for the safety of peritoneal dialysis equipment (GB 9706:39-2008, IEC 60601-2-29:2003, IDT) GB/T 9969 General Rules for Instructions for Use of Industrial Products GB/T 13074 Terminology for blood purification GB/T 14710-2009 Environmental requirements and test methods for medical electrical appliances YY/T 0466:1 Symbols for Medical Device Labeling, Marking and Information Provision for Medical Devices Part 1: General Requirements (YY/T 0466:1-2009, ISO 15223-1:2007, IDT) YY 0709 Medical Electrical Equipment Part 1-8: General Safety Requirements Collateral Standard: General Requirements, Medical Electrical Equipment and Medical Tests and guidelines for alarm systems in electrical systems (YY 0709-2009, IEC 60601-1-8:2003, IDT)

3 Terms and Definitions

The terms and definitions defined in 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 infusion and drainage: 3:2 pressure control type pressurecontroltype Use pressure changes to achieve infusion and drainage: 3:3 stay belly dwell The period in which the dialysate remains in the peritoneal cavity: YY 1493-2016

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