YY/T 0942-2014Ophthalmic optics—Injection system of intraocular lenses (English PDF)
眼科光学 人工晶状体植入系统
This is a limited preview
Buy now to download the full PDF (15 pages)
Need quotation for your management?
Get a formal quotation for YY/T 0942-2014 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 17, 2014
Implementation date
July 1, 2015
Scope
YY/T 0942-2014 is the English-translated version of 眼科光学 人工晶状体植入系统.
YY/T 0942-2014 is the Chinese pharmaceutical industry standard for the injection system of intraocular lenses, the cartridge and injector with which a folded lens is delivered into the eye.
It specifies its field of application, the requirements, the test methods, the marking, the instructions for use and the rules for packaging, transport and storage, covering the force needed to inject the lens, the integrity of the lens after injection, the dimensions of the cartridge tip and its compatibility with the incision, the materials and their biological evaluation and sterility. Issued on 17 June 2014, it has applied since 1 July 2015.
Found what you need?
Document preview — YY/T 0942-2014
National Standard of the People's Republic of China
- ICS
- 11.040.70
- Classification
- C 32
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
1 Scope
This standard specifies the scope of application of artificial lens implantation systems, requirements, test methods, marking and instructions for use, packaging, transport and Storage.
This standard applies to in-one (pre-installed) or separate IOL implantation system (hereinafter referred to as implant system. Contains bolus, a guide The top member). Implant system used after cataract or refractive surgery will be folded and foldable IOL implantation crystalline Body capsular bag or ciliary sulcus.
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 14233.1-2008 Infusion, transfusion, injection equipment - Part 1. Chemical analysis
GB/T 14233.2-2005 Infusion, transfusion, injection equipment test methods - Part 2. Biological test methods
GB/T 14486-2008 plastic molding dimensional tolerances
GB 15810-2001 disposable sterile syringes Biological evaluation of GB/T 16886 (all parts) Medical Devices
YY/T 0149 stainless steel medical equipment corrosion test methods
YY 0290.3-2008 IOL optics Part 3. Mechanical properties and test methods
YY/T 0313 Medical Polymer Co., packaging, labeling, transportation and storage Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 Import head cartridge
Having a mounting groove and folding IOL bolus passage of surgical instruments.
3.2 Bolus injector device
For pushing the folded intraocular lens into the eye of the surgical instrument may be reusable or disposable.
NOTE: Importing head and bolus can be integrated as a fixed structure, may also be a separate structure.
3.3 Bolus passage injectionchannel
IOL and move out of the pipe portion of the implant system port before under thrust.
3.4 Advance stroke injectioncourse
Putted from the state to the fully retracted position of the distance up.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 14233.1-2008Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods
- GB/T 14233.2-2005Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods
- GB/T 14486-2008Dimensional tolerances for moulded plastic parts
- GB 15810-2001Sterile syringes for single use
- YY/T 0149Medical instruments of stainless steel - Test methods of corrosion resistance
- YY 0290.3-2008Ophthalmic optics—Intraocular lenses - Part 3: Mechanical properties and test methods
Similar standards
How to Download YY/T 0942-2014
- 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 14233.1-2008 — Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use — Part 1: Chemical Analysis Methods
GB/T 14233.2-2005 — Test methods for infusion, transfusion, injection equipment for medical use-Part 2: Biological test methods
GB/T 14486-2008 — Dimensional tolerances for moulded plastic parts
Secure payment via Stripe
Payments accepted
YY/T 0942-2014
$115.00