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
