YY 0091-2013Cervix dilator (English PDF)
子宫颈扩张器
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
October 21, 2013
Implementation date
October 1, 2014
Scope
YY 0091-2013 is the English-translated version of 子宫颈扩张器.
YY 0091-2013 is the Chinese pharmaceutical industry standard for the cervix dilator, the graduated sound with which the cervical canal is opened.
It specifies the structural type and the material, the technical requirements, the test methods, the inspection rules, the marking and the rules for packaging, transport and storage, covering the dimensions of each size and their tolerances, the form of the tip, the surface finish, the hardness and the strength of the instrument, its corrosion resistance and its ability to be cleaned and sterilized. Issued on 21 October 2013, it has applied since 1 October 2014.
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Document preview — YY 0091-2013
National Standard of the People's Republic of China
- Replacing
- YY 0091-1992
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative references4
- 3 Structural type and material5
- 4 Technical requirements7
- 5 Test methods8
- 6 Inspection rules9
- 7 Marking and packaging10
- 8 Transportation and storage11
1 Scope
This Standard specifies the structural type and material, technical requirements, test methods, inspection rules, marking, packaging, transportation, and storage of cervix dilator.
This Standard applies to cervix dilator (hereinafter referred to as dilator). This product is used in obstetrics and gynecology to dilate the cervix. This Standard does not apply to disposable cervix dilator.
2 Normative references
The following documents are indispensable for the application of this document. For the dated references, only the editions with the dates indicated are applicable to this document. For the undated references, the latest edition (including all the amendments) are applicable to this document.
GB/T 1220 Stainless steel rod
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 as cracks, sharp edges, burrs, and dents.
4 Technical requirements
4.1.2 The markings on the dilator shall be clear and obvious.
4.1.3 The head of the dilator shall be round and smooth. After using absorbent cotton to wipe it, no fibers shall be pulled out.
4.2 Dimensions
The diameter dimension D of dilator rod AND the overall length dimension L shall comply with the provisions of Table 1 and Table 2.
4.3 Surface roughness
The surface roughness Ra of the dilator shall not be greater than 0.4 µm.
4.4 Coating
The coating of copper dilator shall not be lower than the D · L3Ni7/Cr0.3 requirements specified in YY 0076-1992.
4.5 Corrosion resistance
4.5.1 The copper dilator shall not be damaged after a saturated steam test at 134 °C~138 °C for 20 min. After wiping, there shall be no irremovable traces of corrosion.
4.5.2 If the dilator is made of stainless steel, its corrosion resistance shall not be lower than the requirements of level 5.4 b in YY/T 0149-2006.
5 Test methods
5.1 Appearance
Use absorbent cotton to wipe the head of the dilator. Observe the other parts visually and use hands to touch them. It shall comply with the provisions of 4.1.1, 4.1.2, and 4.1.3.
5.2 Dimensions
Use special and general measuring tools to measure. It shall comply with the provisions of 4.2.
5.3 Surface roughness
Use the sample comparison method OR the profile method specified in GB/T 10610 to conduct the test. The profile method shall be used for arbitration. It shall comply with the provisions of 4.3.
5.4 Coating
Determine according to the method specified in GB/T 6463. It shall comply with the provisions of 4.4.
5.5 Corrosion resistance
5.5.1 Use saturated steam at a temperature of 134 °C~138 °C to carry out the test for 20 min; repeat the test 20 times (The interval is based on the specimen cooling to room temperature). It shall comply with the provisions of 4.5.1.
5.5.2 It shall be carried out according to the boiling water test method specified in YY/T 0149-2006. It shall comply with the provisions of 4.5.2.
6 Inspection rules
6.1 Acceptance
The dilator shall be inspected by the quality inspection department of the manufacturer.
Only after passing the inspection, can it be submitted to the buyer for acceptance.
6.2 Inspection method
Dilators shall be submitted for inspection in lots. The inspection is divided into lot-by-lot inspection (exit-factory inspection) and periodic inspection (type inspection).
6.3 Lot-by-lot inspection
6.3.1 Lot-by-lot inspection shall be in accordance with the provisions of GB/T 2828.1.
6.3.2 Lot-by-lot inspection shall adopt the single sampling plan for normal inspection.
Its nonconformity classification, inspection group, inspection items, inspection level, and acceptance quality limit (AQL) shall be in accordance with Table 3 (calculated based on the number of nonconformity products per 100 units of product). […]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 1220Stainless steel bars
- GB/T 1527Drawn tube of copper and copper alloys
- GB/T 2828.1Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
- GB/T 2829Sampling procedures and tables for periodic inspection by attributes
- GB/T 6463Metallic and other inorganic coatings -- Review of methods of measurement of thickness
- GB/T 10610Geometrical product specifications (GPS) -- Surface texture: Profile method -- Rules and procedures for the assessment of surface texture
Editions of YY 0091
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY 0091-2013 | Cervix dilator | current edition | Current |
| YY 0091-1992 | Cervix dilator | previous edition | Superseded |
This page sells the current edition, YY 0091-2013. Earlier editions are listed for reference only.
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Related Standards
GB/T 10610-2009 — Geometrical product specifications (GPS) -- Surface texture: Profile method -- Rules and procedures for the assessment of surface texture
GB/T 1220-2007 — Stainless steel bars
GB/T 1527-2017 — Drawn tube of copper and copper alloys
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YY 0091-2013
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