Metal double-wing vagina dilator
1 Scope
This standard specifies the structural type, requirements, test methods, inspection rules, marking, packaging, transportation and storage of metal double-wing vagina dilators.
This standard is applicable to metal double-wing vagina dilators (hereinafter referred to as dilators). This type of products is used for vaginal dilation, cervical examination, vaginal flushing and general operation in department of obstetrics and gynecology. This standard is not applicable to disposable vaginal dilators.
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 2040 Copper and copper alloy sheet
GB/T 2828.1 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
GB/T 2829 Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of stability for productive process)
GB/T 3280 Cold rolled stainless steel plate, sheet and strip
GB/T 6463 Metallic and other inorganic coatings - Review of methods of measurement of thickness
GB/T 10610 Geometrical product specifications (GPS) - Surface texture: Profile method - Rules and procedures for the assessment of surface texture
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
GB/T 16886.10 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
YY 0076 Coating classifications for metal product - Technical conditions
YY/T 0149-2006 Medical instruments of stainless steel - Test methods of corrosion resistance
YY/T 0171 Surgical instruments - Packaging, marking and instructions
YY/T 1052 Marking requirements for surgical instruments
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3 Structural type
3.1 The two wings of a dilator shall be made of copper plate as specified in GB/T 2040 or stainless steel plate as specified in GB/T 3280.
3.2 The types of dilators shall be as specified in Table 1 and Figures 1, 2 and 3.
Foreword I
1 Scope
2 Normative references
3 Structural type
4 Requirements
5 Test methods
6 Inspection rules
7 Marking
8 Packaging, transportation and storage
