YY/T 0955-2014Medical endoscopes—Endoscope surgical equipment—Shaver (English PDF)
医用内窥镜 内窥镜手术设备 刨削器
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 0955-2014 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
June 17, 2014
Implementation date
July 1, 2015
Scope
YY/T 0955-2014 is the English-translated version of 医用内窥镜 内窥镜手术设备 刨削器.
YY/T 0955-2014 is the Chinese pharmaceutical industry standard for the shaver used in endoscopic surgery, the instrument whose rotating inner blade cuts tissue drawn into the window of a fixed outer tube.
It specifies the requirements and the test methods, covering the dimensions and the window, the cutting performance and the speed, the suction through the instrument, the strength and the concentricity of the rotating parts, the corrosion resistance, the materials and their biological evaluation and the cleaning and sterilization. Issued on 17 June 2014, it has applied since 1 July 2015.
Found what you need?
Document preview — YY/T 0955-2014
National Standard of the People's Republic of China
- ICS
- 11.040.99
- Classification
- C 40
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Definitions
- 4 Requirements
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
1 Scope
This standard specifies the rotary planing medical endoscope with the requirements, test methods.
This standard applies to the use of minimally invasive endoscopic surgery, spin their heads shaved by the outer portion of the fixed portion of the rotating band formed within the window Rotary planing device. Other works of planing device may choose to use suitability.
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 9706.1 Medical Electrical Equipment Part 1. General requirements for safety
GB 9706.19 electrical equipment - Part 2. Safety of endoscopic equipment
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 14710 medical electrical environmental requirements and test methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test
YY/T 0149-2006 stainless steel medical equipment corrosion test methods
YY 91057 medical foot switch General technical conditions
3 Definitions
The following terms and definitions apply to this document.
3.1 Endoscopic surgical equipment
In the minimally invasive endoscopic diagnosis and/or treatment/surgery, direct mechanical contact with the tissue, or to transfer energy directly to the organization, or to Organization of surgical instruments delivering energy to provide energy to achieve tissue or foreign bodies minced, planing, cutting, coagulation and other effects of surgery equipment.
4 Requirements
4.1 No-load speed
4.1.1 Pre-load speed of the adjustment range
When planing the pre-load speed is adjustable, the manufacturer shall be given pre-load speed of the adjustment range, and should be planing the pre-load The actual speed of adjustment is consistent range.
4.1.2 Preset accuracy of load speed
When setting load speed >=1000r/min, load speed tolerances set for ± 10%; when the set load speed < 1000r/min
......
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 9706.1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB 9706.19Medical electrical equipment. Part 2: Particular requirements for the safety of endoscopic equipment
- 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 14710The environmental requirement and test methods for medical electrical equipment
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Similar standards
How to Download YY/T 0955-2014
- 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 9706.1-2020 — Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB 9706.19-2000 — Medical electrical equipment. Part 2: Particular requirements for the safety of endoscopic equipment
GB/T 14233.1-2008 — Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use — Part 1: Chemical Analysis Methods
Secure payment via Stripe
Payments accepted
YY/T 0955-2014
$145.00