YY 0006-2013Metal double-wing vagina dilator (English PDF)
金属双翼阴道扩张器
This is a limited preview
Buy now to download the full PDF (22 pages)
Need quotation for your management?
Get a formal quotation for YY 0006-2013 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
October 21, 2013
Implementation date
October 1, 2014
Scope
YY 0006-2013 is the English-translated version of 金属双翼阴道扩张器.
YY 0006-2013 is the Chinese pharmaceutical industry standard for the metal double-wing vaginal dilator used in obstetric and gynaecological examination of the vagina and the cervix.
It specifies the structural types, the requirements, the test methods, the inspection rules, the marking and the rules for packaging, transport and storage, covering the material and its corrosion resistance, the dimensions of the blades and their tolerances, the smoothness of the surfaces and the absence of sharp edges, the opening mechanism and its holding, and the ability of the instrument to be cleaned and sterilized. Issued on 21 October 2013, it has applied since 1 October 2014.
Found what you need?
Document preview — YY 0006-2013
National Standard of the People's Republic of China
- ICS
- 11.040.30
- Classification
- C 36
- Replacing
- YY 0006-1990
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Structure type
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.
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.
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.
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 Material of the wings
Dilator wings should be copper or GB GB/T 2040 stipulated/T 3280 specified in stainless steel.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 22 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 2040Copper and copper alloy sheet
- GB/T 2828.1Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
- GB/T 2829Sampling procedures and tables for periodic inspection by attributes
- GB/T 3280Cold rolled stainless steel plate, sheet and strip
- GB/T 10610Geometrical product specifications (GPS) -- Surface texture: Profile method -- Rules and procedures for the assessment of surface texture
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Similar standards
Editions of YY 0006
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY 0006-2013 | Metal double-wing vagina dilator | current edition | Current |
| YY 0006-1990 | Metal double-wing vagina dilator | previous edition | Superseded |
This page sells the current edition, YY 0006-2013. Earlier editions are listed for reference only.
How to Download YY 0006-2013
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
GB/T 10610-2009 — Geometrical product specifications (GPS) -- Surface texture: Profile method -- Rules and procedures for the assessment of surface texture
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.10-2024 — Biological evaluation of medical devices - Part 10: Tests for skin sensitization
Secure payment via Stripe
Payments accepted
YY 0006-2013
$205.00