YY/T 0283-2007 PDF English
US$160.00 · In stock · Download in 9 secondsYY/T 0283-2007: Large intestine fiber endoscope Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Obsolete YY/T 0283: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 0283-2007 | English | 160 |
Add to Cart
|
0-9 seconds. Auto-delivery
|
Large intestine fiber endoscope
| Obsolete |
| YY/T 0283-1995 | English | 439 |
Add to Cart
|
4 days
|
(Fiber colonoscopy)
| Obsolete |
Excerpted PDFs (Download full copy in 9 seconds upon purchase)PDF Preview: YY/T 0283-2007
YY/T 0283-2007: Large intestine fiber endoscope---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0283-2007
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.70
C 40
Replacing YY/T 0283-1995
Large intestine fiber endoscope
Issued by. China Food and Drug Administration
Issued on. JULY 02, 2007
Implemented on. MARCH 01, 2008
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative references... 4
3 Classification... 5
4 Requirements... 5
5 Test methods... 8
6 Inspection rules... 14
7 Marking and operation instructions... 15
8 Package, transportation and storage... 16
Annex A... 18
Annex B... 25
Annex C... 26
Foreword
This Standard is the revision of YY/T Q283-1995 “Large Intestine Fiber Endoscope”.
Compared with YY/T 0283-1995, main differences in this Standard are as follows.
— Specify the name of standard;
— Add the classification of waterproof ability of product;
— Increase the quantity index of broken-fiber number;
— Add the coincidence requirements between illumination source and observation
view-field;
— Modify the requirements on product marking;
— Add the requirements on waterproof product;
— Add the requirements on biocompatibility;
— Modify the test method of view-field angle;
— Delete the requirements on sealing property in previous standard;
— Add Annex A (Normative).
For electrical connection part, it shall comply with GB 9706.1-1995 “Medical Electrical
Equipment - Part 1.General Requirements for Safety”, GB 9706.4-1999 “Medical Electrical
Equipment - Part 2.Particular Requirements for the Safety of High Frequency Surgical
Equipment”, and GB 9706.19-2000 “Medical Electrical Equipment - Part 2.Particular
Requirements for the Safety of Endoscopic Equipment”. The details are given in Annex A
(Normative).
Annex A and B of this Standard are normative; Annex C is informative.
This Standard replaces YY/T 0283-1995, since the date of issuance.
This Standard was approved by State Food and Drug Administration.
This Standard shall be under jurisdiction of National Technical Committee on Medical
Optical Instruments of Standardization Administration of China.
Drafting organization of this Standard. Medical Optical Equipment Factory of Shanghai
Medical Instruments Co., Ltd.
Main drafters of this Standard. Li Yafen, Sun Qi, and Shen Tianming.
This Standard was first-time published in November 1995.
Large Intestine Fiber Endoscope
1 Scope
This Standard specifies the classification, marking, requirements, test methods, inspection
rules, identification, operation instructions, packaging, transportation, and storage of large
intestine fiber endoscope.
This Standard is applicable to large intestine fiber endoscope (hereinafter referred as fiber
endoscope). This product is used to the examination and diagnosis of large intestine cavity
and can also be used in the relevant surgical operation.
2 Normative references
The provisions in following documents become the provisions of this Standard through
reference in this Standard. For dated references, the subsequent amendments (excluding
corrections) or revisions do not apply to this Standard, however, parties who reach an
agreement based on this Standard are encouraged to study if the latest versions of these
documents are applicable. For undated references, the latest edition of the referenced
document applies.
GB/T 191-2008 Packaging - Pictorial marking for handling of goods
GB/T 2829-2002 Sampling procedures and tables for periodic inspection by attributes
(Apply to inspection of process stability)
GB 9706.1-1995 Medical electrical equipment - Part 1.General requirements for safety
GB 9706.4-1999 Medical electrical equipment - Part 2.Particular requirements for the
safety of high frequency surgical equipment
GB 9706.19-2000 Medical electrical equipment - Part 2.Particular requirements for the
safety of endoscopic equipment
GB 11244-2005 General requirements for the medical endoscope and endoscope
accessories
GB/T 14710-1993 The environmental requirements and test methods for medical
electrical equipment
GB/T 16886.1-2001 Biological evaluation of medical devices - Part 1.Evaluation and
testing
3 Classification
3.1 Fiber endoscope includes sigmoidoscope and colonoscope.
4 Requirements
4.1 Working conditions
The normal working conditions of fiber endoscope.
4.2 Surface requirements
4.2.1 The coherence of each connecting part shall be reliable and fixed. The welding part
shall be flat without fake welding, de-soldering or overlaying.
4.2.2 The external surface of head-end, bend part and inserted hose part shall be flat and
smooth, without obvious bulge, scratch or burr.
4.3 Performance of optical system
4.3.1 Illumination shall not be less than 8 000 lx, at working distance.
4.3.2 Resolution ratio shall not be lower than 3.51 lp/mm, at working distance.
4.3.3 The quantity of the broken-fiber of coherent fiber bundle must not be more than 5
pieces, within 50% of view-field scope. The total quantity must not be more than 10 pieces.
4.4 Water supply and suction system
4.4.1 Supplied water can wash the surface of lens. The flow of supplied water shall not be
lower than 45 mL/min.
4.5 Bend-angle operation system
4.5.1 Bend-angle locking structure shall be able to tightly lock the hand-wheel. The
bend-angle part shall be able to do bend action under locking state. After locking is
released, it shall not affect the operating function of bend-angle hand-wheel. There is no
too-tight, too loose or stuck-up phenomenon during operation.
4.6 Sealing
4.6.1 Fiber endoscope shall be soaked in water as a whole. Its internal cavity can withstand
pressure of 22 kPa for 3 min; without air leakage (applicable to waterproof type).
4.6.2 The head-end part shall be used within 20°C ~ 40°C. The surface of optical parts
shall not generate mist due to temperature variation that affect observation.
4.7 Marking
4.7.1 The inserted flexible tube shall be marked with length marking. The marked line and
words shall be legible.
4.9 Biocompatibility
Fiber endoscope is a medical device which contacts with mucous membrane for short-term
in accordance with GB 16886.1-2001.The surface of the part inserted into human body
shall be made of materials which are proved to conform to biocompatibility or pass the
following tests.
4.11 Requirements on ambient test
Conform to atmosphere environmental test group II, mechanical environmental test group
II and table 3 in GB/T 14710-1993.
4.12 Safety
Fiber endoscope shall conform to the relevant requirements in GB 9706.1-1995, GB
9706.4-1999 and GB 9706.19-2000.For details, refer to annex A (Normative).
5 Test methods
5.1 Surface requirements
Adopt visual inspection and hand-touch inspection to check the surface. It shall conform to
Article 4.2.
5.2 Performance of optical system
5.2.1 Illumination test
5.2.1.1 Under the voltage of 220V, insert the illumination tester specified in Annex B
(Normative) into the cold lighting surface (150W). Adjust the illumination value of cold light
source to above 70 000 lx.
5.2.3 Broken-fiber test
Place a white paper with two circles drawn on it on the working surface; light it uniformly;
observe from lens. The quantity of broken-fibers, within 50% of view-field and out of 50% of
view-field shall conform to Article 4.3.3.
5.2.4 View-field angle test
5.2.4.1 Measuring instruments
5.2.5 Coincidence of illumination source and observation view-field
Visual inspection shall be conducted under the maximum illumination of the provided lamp
in accordance with Article 4.3.5.
5.2.6 Clear observation range
Fix the endoscope; adjust the distance between objective lens and the observed object.
When it is at 5mm and 100mm positions, observe through the eyepiece of endoscope; it
shall be able to clearly see 1.0mm-wide strip; it shall conform to Article 4.3.6.
5.3 Water supply and suction performance test
5.6 Marking
Adopt visual inspection to check whether the operation conform to Article 4.7.
5.7 Dimensions
Measured by general measuring tools, it shall conform to Article 4.8.
5.8 Biocompatibility test
5.8.1 Cytotoxicity shall be tested in accordance with the method specified in Chapter 8 of
GB/T 16886.5-2003.Cytotoxicity shall conform to the requirements in Article 4.9.1.
5.10 Environmental test
Environmental test shall be conducted in accordance with the relevant requirements in
GB/T 14710-1993 and Article 4.11 of this Standard.
5.11 Safety test
Safety test shall be conducted in accordance with the methods specified in GB
9706.1-1995, GB 9706.4-1999, and GB 9706.19-2000.It shall conform to the requirements
in Article 4.12.
6 Inspection rules
6.1 Classification of inspection
The inspections of fiber endoscope are divided into exit-factory inspection and type
inspection.
6.2 Exit-factory inspection
6.2.1 Product can be delivered out of factory after being confirmed as qualified through
exit-factory inspection.
6.3 Type inspection
6.3.1 In case of the following circumstances, type inspection shall be conducted.
6.4 Biocompatibility evaluation
6.4.1 In case of the following circumstances, biocompatibility evaluation shall be
conducted.
6.4.2 When conducting biocompatibility evaluation, select the samples according to test
needs. All of samples shall pass inspection.
7 Marking and operation instructions
7.1 Marking
7.1.1 Fiber endoscope shall have the following marks.
7.1.2 Product qualification certificate shall have the following marks.
7.1.3 Outer package shall have the following marks.
7.2 Operation instruction
It shall conform to the requirements specified in No. 10 “Management Regulations on
Manual, Labelling, and Packaging Logo of Medical Instruments” issued by China Food and
Drug Administration, and the relevant requirements in GB 9706.1-1995 and GB
9706.19-2000.
8 Package, transportation and storage
8.1 Package
8.2 Transportation
It shall conform to the relevant requirements in order contract.
8.3 Storage
The packed fiber endoscope shall be stored in the well-ventilated indoor environment
where is free of corrosive gas, with the relative humidity not exceeding 80%.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
Tips & Frequently Asked QuestionsQuestion 1: How long will the true-PDF of English version of YY/T 0283-2007 be delivered?Answer: The full copy PDF of English version of YY/T 0283-2007 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice. Question 2: Can I share the purchased PDF of YY/T 0283-2007_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0283-2007_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. www.ChineseStandard.us -- YY/T 0283-2007 -- Click this link and select your country/currency to pay, the exact amount in your currency will be printed on the invoice. Full PDF will also be downloaded/emailed in 9 seconds. Question 5: Should I purchase the latest version YY/T 0283-2007?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0283-2007 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. How to buy and download a true PDF of English version of YY/T 0283-2007?A step-by-step guide to download PDF of YY/T 0283-2007_EnglishStep 1: Visit website https://www.ChineseStandard.net (Pay in USD), or https://www.ChineseStandard.us (Pay in any currencies such as Euro, KRW, JPY, AUD).
Step 2: Search keyword "YY/T 0283-2007".
Step 3: Click "Add to Cart". If multiple PDFs are required, repeat steps 2 and 3 to add up to 12 PDFs to cart.
Step 4: Select payment option (Via payment agents Stripe or PayPal).
Step 5: Customize Tax Invoice -- Fill up your email etc.
Step 6: Click "Checkout".
Step 7: Make payment by credit card, PayPal, Google Pay etc. After the payment is completed and in 9 seconds, you will receive 2 emails attached with the purchased PDFs and PDF-invoice, respectively.
Step 8: Optional -- Go to download PDF.
Step 9: Optional -- Click Open/Download PDF to download PDFs and invoice.
See screenshots for above steps: Steps 1~3 Steps 4~6 Step 7 Step 8 Step 9
|