Standard No.:	YY 0091-2013
English Name:	Cervix dilator
Chinese Name:	子宫颈扩张器
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
Issued by:	China Food and Drug Administration
Issued on:	2013-10-21
Implemented on:	2014-10-1
Status:	valid
Superseding:	YY 0091-1992 Cervical dilator
Language:	English
File Format:	PDF
Word Count:	6000 words
Price(USD):	180.0
Delivery:	via email in 1 business day

YY 0091-2013 Cervix dilator 1 Scope This standard specifies the structural types and materials, technical requirements, test methods, inspection rules, marking and packaging, and transportation and storage of cervix dilators. This standard is applicable to cervix dilators (hereinafter referred to as dilators), which are used for dilating the cervix in obstetrics and gynecology. This standard is not applicable to disposable cervix 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 1220 Stainless steel bars GB/T 1527 Drawn tube of copper and copper alloys 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 process stability) 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 YY 0076-1992 Coating classifications for metal product - Technical conditions YY/T 0149-2006 Medical instruments of stainless steel - Test methods of corrosion resistance YY/T 0171-2008 Surgical instruments - Packaging, marking and instructions YY/T 1052 Marking requirements for surgical instruments 3 Structural types and materials 3.1 The types, basic dimensions, and limit deviations of dilators shall meet the requirements of Figure 1 and Tables 1 and 2. 3.2 The dilators shall be made of copper materials as specified in GB/T 1527 or stainless steel materials as specified in GB/T 1220. Note: The handle may also have no holes. Figure 1 Cervix dilator   Table 1 Basic dimensions of cervix dilators (round head) In: mm

Foreword I 1 Scope 2 Normative references 3 Structural types and materials 4 Technical requirements 5 Test methods 6 Inspection rules 7 Marking and packaging 8 Transportation and storage