YY/T 0090-2014_English: PDF (YY/T0090-2014)
Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
YY/T 0090-2014 | English | 209 |
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3 days [Need to translate]
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Uterine curette
| Valid |
YY/T 0090-2014
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YY 0090-1992 | English | 199 |
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3 days [Need to translate]
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Uterine cruet
| Obsolete |
YY 0090-1992
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Standard ID | YY/T 0090-2014 (YY/T0090-2014) | Description (Translated English) | Uterine curette | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of Chinese Standard | C36 | Classification of International Standard | 11.040.30 | Word Count Estimation | 9,994 | Date of Issue | 2014/6/17 | Date of Implementation | 2015/7/1 | Older Standard (superseded by this standard) | YY 0090-1992 | Quoted Standard | GB/T 1220; GB/T 1804; GB/T 2828.1; GB/T 2829; GB/T 4340.1; GB/T 4423; GB/T 6463; GB/T 10610; YY 0076-1992; YY/T 0149-2006; YY/T 1052 | Drafting Organization | Shanghai Medical Devices (Group) Co., Ltd. Surgical Instruments Factory | Administrative Organization | National family planning devices Standardization Technical Committee | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | Proposing organization | National Standardization Technical Committee for Family Planning (SAC/TC 169) | Issuing agency(ies) | State Food and Drug Administration | Summary | This Standard applies to scrape the uterine lining of the uterus with a curette. This Standard specifies the type of construction and materials uterine curette, requirements, test methods, inspection rules, marking, packaging, transportation, storage and | Standard ID | YY 0090-1992 (YY0090-1992) | Description (Translated English) | Uterine cruet | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | Classification of Chinese Standard | C36 | Word Count Estimation | 4,483 | Date of Issue | 1992/6/8 | Date of Implementation | 1992/10/1 | Older Standard (superseded by this standard) | WS 2-95-1974 | Quoted Standard | GB 191; GB 230; GB 1220; GB 2828; GB 4423; GB 6463; ZB C30001; ZB C30022; YY 0076 | Drafting Organization | Shanghai surgical instruments Liu Chang | Administrative Organization | Planned Parenthood National Standardization Technical Committee | Proposing organization | National Standardization Technical Committee for Family Planning | Issuing agency(ies) | State Administration of Medicine | Summary | This standard specifies the product classification, technical requirements, test methods, inspection rules uterine curette, logos, packaging, transportation, storage and other requirements. This standard applies to the uterine curette, when the product for gynecologic surgery, using scraping the uterine lining. |
YY/T 0090-2014
Uterine curette
ICS 11.040.30
C36
People's Republic of China pharmaceutical industry standards
Replacing YY 0090-1992
Uterine curette
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard replaces YY 0090-1992 "uterine curette."
The main technical differences between this standard and YY 0090-1992 follows.
--- Modify the reference standards and standard reference year (see Chapter 2);
--- Increased uterine curette structural type, the original standard product named ring, while increasing the spoon-shaped (see 3.1);
--- Increased 12Cr18Ni9 material (see 3.2).
--- Remove the main part of the Central African icon size requirements and inspection requirements (see 3.1 and Chapter 6).
--- Modify the surface roughness requirements (see 4.5).
Please note that some of the content of this standard may involve patents. The standard release mechanism does not assume the responsibility to identify these patents.
This standard by the national family planning equipment Standardization Technical Committee (SAC/TC169) and focal points.
This standard was drafted. Shanghai Medical Devices (Group) Co., surgical instruments factory, China Food and Drug Administration Shanghai Medical
Device Quality Supervision and Inspection Center, Zhejiang Medical Devices Co. down.
The main drafters of this standard. Fangxue Jing, Yao Tianping Cai Zhong, Wengbing Hao, Xia Jiming.
The standard standard replaces the previous editions.
--- WS2-95-1974;
--- YY 0090-1992.
Uterine curette
1 Scope
This standard specifies the structure type and material of the uterus curette, requirements, test methods, inspection rules, marking, packaging, transportation and storage.
This standard applies to scrape the uterine lining of the uterus with a curette (hereinafter referred to as a curette).
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 1220 stainless steel rods
GB/T 1804 General tolerances Tolerances for linear and angular dimensions without individual tolerance
GB/T 2828.1 Sampling procedures for inspection - Part 1. by acceptance quality limit (AQL) retrieval batch inspection sampling plan
GB/T 2829 periodic inspection Sampling procedures and tables (suitable for process stability test)
GB/T 4340.1 metallic materials - Vickers hardness test - Part 1. Test methods
GB/T 4423 copper and copper alloy rod drawing
Reviews on the cover layer thickness measurement GB/T 6463 Metallic and other inorganic
GB/T 10610 Geometrical product specifications (GPS) Surface texture Profile method - Rules and procedures for evaluation of the surface structure
YY 0076-1992 plating metal parts classification and technical conditions
YY/T 0149-2006 stainless steel medical equipment corrosion test methods
YY/T 1052 surgical instruments logo
3 structure type and material
3.1 curette may be made of a flexible and non-flexible. Structure type curette and basic dimensions should be in accordance with Table 1 and Figure 1.
Table 1 basic dimensions in millimeters
Structure type specification
length
width
thickness
Annulus
Spatulate
Blunt
Rui mouth
4 ~ 30 140 ~ 30 2504 ~
2 to 3.5
4 to 25
NOTE. Product specifications and shank form self-imposed by the manufacturer.
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