1 Scope
This part of YY/T 1287 specifies the requirements of intracranial external drainage catheter (hereinafter referred to as "drainage catheter") expected to be used for craniocerebral puncture and lumbar puncture in the intracranial external drainage system, so as to ensure its safe and effective use in the intracranial external drainage system.
Introducers and puncture instruments in intracranial external drainage system are not included in the scope of this part.
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 1962 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment
GB/T 14233.2 Test methods for infusion, transfusion, injection equipment for medical use — Part 2: Biological test methods
GB/T 15812.1-2005 Catheters other than intravascular catheters — Part 1: Test methods for common properties
GB/T 16886.1 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
YY 0334 General specification for surgical implants made of silicone elastomer
YY/T 0466.1 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
YY/T 0586 Medical polymer products — Test methods of radiopacity
YY/T 0615.1 Requirements for medical devices to be designated STERILE — Part 1: Requirements for terminally sterilized medical devices
YY/T 1287.1 Intracranial external drainage system — Part 1: Collecting sets for external drainage by intracranial puncture
YY/T 1287.2 Intracranial external drainage system — Part 2: Collecting sets for external drainage by lumbar puncture
ISO 11607-1:2006 Packaging for terminally sterilized medical devices — Part 1: Requirements1) for materials, sterile barrier systems and packaging systems
3 Terms and definitions
For the purpose of this document, the terms and definitions given in YY/T 1287.1, YY/T 1287.2 and the following apply.
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Physical requirements
6 Biological requirements
7 Type inspection
8 Marking
9 Packaging
Annex A (Normative) Bending resistance test
Bibliography
