YY 0091-2013 English PDF (YY0091-2013)

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YY 0091-2013: Cervix dilator
YY 0091-2013
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.30
C 36
Replacing YY 0091-1992
Cervix dilator
子宫颈扩张器
ISSUED ON: OCTOBER 21, 2013
IMPLEMENTED ON: OCTOBER 1, 2014
Issued by: China Food and Drug Administration
According to the medical device industry standard announcement of National
Medical Products Administration (No. 76 of 2022), starting from September 7,
2022, this Standard becomes a recommended standard and will no longer be
mandatory.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Structural type and material ... 5
4 Technical requirements ... 7
5 Test methods ... 8
6 Inspection rules ... 9
7 Marking and packaging ... 10
8 Transportation and storage ... 11
Cervix dilator
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.
4.1.2 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).