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Position: Chinese Standard in English/YY 0778-2010
YY 0778-2010   Radio frequency ablation catheter (English Version)
Standard No.: YY 0778-2010 Status:superseded remind me the status change

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Language:English File Format:PDF
Word Count: 7000 words Price(USD):170.0 remind me the price change

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Implemented on:2012-6-1 Delivery: via email in 1 business day
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Standard No.: YY 0778-2010
English Name: Radio frequency ablation catheter
Chinese Name: 射频消融导管
Chinese Classification: C42    Physiotherapy and TCM instrument and equipment
Professional Classification: YY    Professional Standard - Pharmaceutics
ICS Classification: 11.040.60 11.040.60    Therapy equipment 11.040.60
Issued by: SDA
Issued on: 2010-12-27
Implemented on: 2012-6-1
Status: superseded
Superseded by:YY 0778-2018 Radio frequency ablation catheter
Superseded on:2020-6-1
Language: English
File Format: PDF
Word Count: 7000 words
Price(USD): 170.0
Delivery: via email in 1 business day
1 Scope This standard specifies the terms and definitions, requirements, test methods, inspection rules, marking, packaging, transportation and storage of radio frequency ablation catheters. This standard is applicable to radio frequency ablation catheter defined in 3.1 (hereinafter referred to as catheter). 2 Normative References The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 191-2008 Packaging — Pictorial Markings for Handling of Goods GB/T 2828.1-2003 Sampling Procedures for Inspection by Attributes — Part 1: Sampling Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-Lot Inspection GB/T 2829-2002 Sampling Procedures and Tables for Periodic Inspection by Attributes (Apply to Inspection of Process Stability) GB/T 4122.1-2008 Packaging Terms — Part 1: Basic GB 9706.1-2007 Medical Electrical Equipment — Part 1: General Requirements for Safety GB 9706.4-2009 Medical Electrical Equipment — Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment GB 9706.19-2000 Medical Electrical Equipment — Part 2: Particular Requirements for the Safety of Endoscopic Equipment GB/T 14233.1-2008 Test Methods for Infusion, Transfusion, Injection Equipments for Medical Use — Part 1: Chemical Analysis Methods
Foreword I 1 Scope 2 Normative References 3 Terms and Definitions 4 Requirements 5 Test Methods 6 Inspection Rules 7 Marking, Labeling and Operating Instructions 8 Packaging, Transportation and Storage Annex A (Normative) Test Method of Bending Fatigue
Referred in YY 0778-2010:
*GB/T 191-2008 Packaging - Pictorial Marking for Handling of Goods
*GB/T 2828.1-2003 Sampling procedures for inspection by attributea-Part1:Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection
*GB/T 2829-2002 Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of process stability)
*GB/T 4122.1-2008 Packaging terms - Part 1:Basic
*GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety
*GB 9706.4-2009 bMedical electrical equipment - Part 2-2: Particular requirements for the safety 0f high frequency surgical equipment
*GB 9706.19-2000 Medical electrical equipment-Part 2:Particular requirements for the safety of endoscopic equipment
*GB/T 14233.1-2008 Test methods for infusion transfusion injection equipments for medical use - Part 1: Chemical analysis methods
*GB/T 14233.2-2005 Test methods for infusion, transfusion, injection equipment for medical use-Part 2: Biological test methods
*GB/T 16886.4-2003 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
*GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity
*GB/T 16886.10-2005 Biological evaluation of medical devices-Part 10:Tests for irritation and delayed-type hypersensitivity
*GB/T 16886.11-1997 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity
*YY 0285.1-2004 Sterile, single-use intravascular catheters - Part 1: General requirements
*YY 0033-2000 Good manufacture practice for sterile medical devices
Code of China
Standard
YY 0778-2010  Radio frequency ablation catheter (English Version)
Standard No.YY 0778-2010
Statussuperseded
LanguageEnglish
File FormatPDF
Word Count7000 words
Price(USD)170.0
Implemented on2012-6-1
Deliveryvia email in 1 business day
Detail of YY 0778-2010
Standard No.
YY 0778-2010
English Name
Radio frequency ablation catheter
Chinese Name
射频消融导管
Chinese Classification
C42
Professional Classification
YY
ICS Classification
Issued by
SDA
Issued on
2010-12-27
Implemented on
2012-6-1
Status
superseded
Superseded by
YY 0778-2018 Radio frequency ablation catheter
Superseded on
2020-6-1
Abolished on
Superseding
Language
English
File Format
PDF
Word Count
7000 words
Price(USD)
170.0
Keywords
YY 0778-2010, YY/T 0778-2010, YYT 0778-2010, YY0778-2010, YY 0778, YY0778, YY/T0778-2010, YY/T 0778, YY/T0778, YYT0778-2010, YYT 0778, YYT0778
Introduction of YY 0778-2010
1 Scope This standard specifies the terms and definitions, requirements, test methods, inspection rules, marking, packaging, transportation and storage of radio frequency ablation catheters. This standard is applicable to radio frequency ablation catheter defined in 3.1 (hereinafter referred to as catheter). 2 Normative References The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 191-2008 Packaging — Pictorial Markings for Handling of Goods GB/T 2828.1-2003 Sampling Procedures for Inspection by Attributes — Part 1: Sampling Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-Lot Inspection GB/T 2829-2002 Sampling Procedures and Tables for Periodic Inspection by Attributes (Apply to Inspection of Process Stability) GB/T 4122.1-2008 Packaging Terms — Part 1: Basic GB 9706.1-2007 Medical Electrical Equipment — Part 1: General Requirements for Safety GB 9706.4-2009 Medical Electrical Equipment — Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment GB 9706.19-2000 Medical Electrical Equipment — Part 2: Particular Requirements for the Safety of Endoscopic Equipment GB/T 14233.1-2008 Test Methods for Infusion, Transfusion, Injection Equipments for Medical Use — Part 1: Chemical Analysis Methods
Contents of YY 0778-2010
Foreword I 1 Scope 2 Normative References 3 Terms and Definitions 4 Requirements 5 Test Methods 6 Inspection Rules 7 Marking, Labeling and Operating Instructions 8 Packaging, Transportation and Storage Annex A (Normative) Test Method of Bending Fatigue
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