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YY/T 0090-2014 English PDF (YY 0090-1992)

YY/T 0090-2014_English: PDF (YY/T0090-2014)
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0090-2014English209 Add to Cart 3 days [Need to translate] Uterine curette Valid YY/T 0090-2014
YY 0090-1992English199 Add to Cart 3 days [Need to translate] Uterine cruet Obsolete YY 0090-1992


BASIC DATA
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Older Standard (superseded by this standard) YY 0090-1992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

BASIC DATA
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Older Standard (superseded by this standard) WS 2-95-1974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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