Standard No.:	YY 0006-2013
English Name:	Metal double-wing vagina dilator
Chinese Name:	金属双翼阴道扩张器
Chinese Classification:	C36    Other special devices
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.30 11.040.30    Surgical instruments and materials 11.040.30
Source Content Issued by:	China Food and Drug Administration
Issued on:	2013-10-21
Implemented on:	2014-10-1
Status:	valid
Superseding:	YY 0006-1990 Double-Wing vagina dilator
Target Language:	English
File Format:	PDF
Word Count:	8000 words
Translation Price(USD):	220.0
Delivery:	via email in 1 business day

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   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