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YY/T 0172-2014 English PDF

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YY/T 0172-2014: Uterine probe
Status: Valid

YY/T 0172: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0172-2014English209 Add to Cart 3 days [Need to translate] Uterine probe Valid YY/T 0172-2014
YY/T 0172-1994English239 Add to Cart 2 days [Need to translate] Explorer for womb Obsolete YY/T 0172-1994

PDF similar to YY/T 0172-2014


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Basic data

Standard ID YY/T 0172-2014 (YY/T0172-2014)
Description (Translated English) Uterine probe
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C36
Classification of International Standard 11.040.30
Word Count Estimation 9,972
Date of Issue 6/17/2014
Date of Implementation 7/1/2015
Older Standard (superseded by this standard) YY/T 0172-1994
Quoted Standard GB/T 1220; 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
Regulation (derived from) China Food and Drug Administration in 2014 Bulletin No. 30
Issuing agency(ies) State Food and Drug Administration
Summary This Standard applies to the uterus probes for the detection of cervical direction and depth of Obstetrics and Gynecology use. This Standard specifies the form of uterine probe structure, requirements, test methods, inspection rules, marking, packaging, t

YY/T 0172-2014: Uterine probe

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Uterine probe ICS 11.040.30 C36 People's Republic of China pharmaceutical industry standards Replacing YY/T 0172-1994 Uterine probes 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. Instead of the standard YY/T 0172-1994 "uterine probe." This standard YY/T 0172-1994 and the main technical differences are as follows. --- Added "This standard does not apply to disposable probe womb" (see Chapter 1); --- Increasing the "GB/T 1220 provisions stainless steel" (see 3.2); --- Modify the head end and an outer surface of the surface roughness Ra value by "0.2μm" changed to "0.4μm" (see 4.5) --- Increase the corrosion resistance of the product requirements (see 4.7); --- Test Method for increasing the shank and handle firmly connected degree (see 5.1.2); --- Increased corrosion resistance Test Method (see 5.7); --- Increased product cycle inspection requirements (see 6.4). 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. Drafting of this standard. Shanghai medical suture needle Co., Ltd., China Food and Drug Administration oversight Shanghai Medical Devices Inspection Center. The main drafters of this standard. Yuguo En, Jiangju Ling, Jin Yaoming, Wengbing Hao, Zhou Yaping. The standard standard replaces the previous editions. --- YY/T 0172-1994. Uterine probes

1 Scope

This standard specifies the formal structure of the uterus probe, requirements, test methods, inspection rules, marking, packaging, transportation and storage. This standard applies to the uterine probe, the product of obstetrics and gynecology for detecting cervical direction and depth with. This standard does not apply to disposable uterine probe.

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 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 Vickers hardness test - Part 1. Test methods GB/T 4423 copper and copper alloy rod drawing GB/T 6463 Metallic and other inorganic coating thickness - Measurement Methods GB/T 10610 Geometrical product specifications (GPS) Surface texture Profile method - Rules and procedures for evaluation of the surface structure YY 0076-1992 metal parts coating technology classification conditions YY/T 0149-2006 stainless steel medical equipment corrosion test methods YY/T 1052 surgical instruments logo

3 structure type

3.1 uterine probe may be made of a flexible and non-flexible, its schematic structure, basic dimensions and limit deviations should meet the requirements of Figure 1. 3.2 uterine probe should be used in 4423 as specified in GB/T of H62, H65, H68 or copper material selection GB/T 1220 provisions 12Cr18Ni9 stainless steel.

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