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US$279.00 · In stock Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY 0006-2013: Metal double-wing vagina dilator Status: Valid YY 0006: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0006-2013 | English | 279 |
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3 days [Need to translate]
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Metal double-wing vagina dilator
| Valid |
YY 0006-2013
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| YY 0006-1990 | English | 399 |
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3 days [Need to translate]
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Double-Wing Vagina Dilator
| Obsolete |
YY 0006-1990
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PDF similar to YY 0006-2013
Basic data | Standard ID | YY 0006-2013 (YY0006-2013) | | Description (Translated English) | Metal double-wing vagina dilator | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C36 | | Classification of International Standard | 11.040.30 | | Word Count Estimation | 12,127 | | Older Standard (superseded by this standard) | YY 0006-1990 | | Quoted Standard | GB/T 2040; GB/T 2828.1; GB/T 2829; GB/T 3280; GB/T 6463; GB/T 10610; GB/T 16886.1; GB/T 16886.5; GB/T 16886.10; YY 0076; YY/T 0149-2006; YY/T 0171; YY/T 1052 | | Regulation (derived from) | State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the metal wings vaginal dilator structure type, requirements, test methods, inspection rules, marking, packaging, transport and storage. This standard applies to metal wings vaginal dilator (hereinafter referred to as dilator), the |
YY 0006-2013: Metal double-wing vagina dilator---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.
Metal double-wing vagina dilator
ICS 11.040.30
C36
People's Republic of China pharmaceutical industry standards
Replacing YY 0006-1990
Metal wings vaginal dilator
Issued on. 2013-10-21
2014-10-01 implementation
China Food and Drug Administration released
Foreword
Drafted in accordance with the standard GB/T 1.1-2009 given rules.
This standard replaces YY 0006-1990 "wings vaginal dilator."
The main technical differences between this standard and YY 0006-1990 follows.
--- Modify the reference standards and reference standards year;
--- Canceled a standard icon to use parts of the Central African dimension;
--- Modify the "deflection" to "deformation";
--- Modify the surface roughness;
--- Increase the corrosion resistance of the product performance requirements and test methods;
--- Increased biological evaluation requirements and test methods for products.
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. Tait Zhejiang Medical Devices Co., Ltd., the State Food and Drug Administration of Quality Supervision, Inspection Shanghai Medical Devices
Inspection center, Shanghai 40 Link instrumentarija.
The main drafters of this standard. Zhu Jianjun, Yaotian Ping, music Weimin, Xia Jiming, Wengbing Hao, Sun Hongzhi.
The standard standard replaces the previous editions.
--- WS2-45-1974;
--- WS2-35-1974;
--- YY 0006-1990.
Metal wings vaginal dilator
1 Scope
This standard specifies the structure type metal wings vaginal dilator, requirements, test methods, inspection rules, marking, packaging, transport and
Storage.
This standard applies to the metal wings vaginal dilator (hereinafter referred to as dilator), expansion of the product for obstetrics and gynecology vagina, cervix examination,
Douching and general surgery. This standard does not apply to single-use vaginal dilators.
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 2040 copper and copper alloy sheet
GB/T 2828.1 Sampling procedures for inspection, Part 1. batch inspection sampling plan according to accepted quality limit (AQL) retrieval
GB/T 2829 periodic inspection Sampling procedures and sample forms (suitable for process stability test)
GB/T 3280 stainless steel cold-rolled steel sheet and strip
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
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and test
GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity tests
GB/T 16886.10 Biological evaluation of medical devices - Part 10. irritation and delayed-type hypersensitivity test
YY 0076 metal parts coating technology classification conditions
YY/T 0149-2006 stainless steel medical equipment corrosion test methods
YY/T 0171 surgical instruments, packaging and marking and instructions for use
YY/T 1052 surgical instruments logo
3 structure type
3.1 dilator wings should be copper or GB GB/T 2040 stipulated/T 3280 specified in stainless steel.
3.2 dilator type specified in Table 1 and Figures 1, 2 and 3.
Table 1 dilator types and specifications in millimeters
Type specifications
Check the type adjustable
118 × 37
100 × 30
90 × 22
Surgery type
Stationary
Adjustable
90 × 34
85 × 32
90 × 34
85 × 32
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