YY/T 1797-2021 PDF English
US$320.00 · In stock · Download in 9 secondsYY/T 1797-2021: Endoscopic surgical instruments - Endoscopic cutter stapler and reload Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 1797-2021 | English | 320 |
Add to Cart
|
0-9 seconds. Auto-delivery
|
Endoscopic surgical instruments - Endoscopic cutter stapler and reload
| Valid |
Excerpted PDFs (Download full copy in 9 seconds upon purchase)PDF Preview: YY/T 1797-2021
YY/T 1797-2021: Endoscopic surgical instruments - Endoscopic cutter stapler and reload---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/YYT1797-2021
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.040.30
C 36
Endoscopic surgical instruments - Endoscopic cutter stapler
and reload
Issued on. SEPTEMBER 06, 2021
Implemented on. SEPTEMBER 01, 2022
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative references... 4
3 Structure and materials... 5
4 Requirements... 9
5 Test methods... 13
6 Type inspection... 17
7 Label, instruction manual... 17
8 Packaging... 19
Appendix A (Informative) Test materials for anastomosis and cutting performance.. 20
Appendix B (Normative) Staple line suture strength test... 21
Appendix C (Normative) Test method for cutting edge sharpness... 23
Appendix D (Normative) Pressure performance test... 26
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing
organization of this document is not responsible for identifying these patents.
This Standard was proposed by the National Medical Products Administration.
This Standard shall be under the jurisdiction of National Technical Committee 94 on
Chirurgicum Apparatus of Standardization Administration of China (SAC/TC 94).
Drafting organizations of this Standard. Shanghai Medical Device Testing Institute,
Victor Medical Instruments Co., Ltd., Shandong WeRay Surgical Medical Products Co.,
Ltd. and EziSurg Medical Co., Ltd.
Chief drafting staffs of this Standard. Huang Shuze, Jiang Shihua, Yao Daqiang, Liu
Qingfeng, Zou Fengping, Wang Wei, Zhang Qijin, Wang Lei, Yao Yao, Wang Hailong,
Chen Zhaowei, Bao Minghui.
Endoscopic surgical instruments - Endoscopic cutter stapler
and reload
1 Scope
This Standard specifies the structure and materials, requirements, test methods, type
inspection, labels, instruction manuals and packaging of endoscopic cutter stapler and
reload (hereinafter referred to as stapler) used in endoscopic surgery.
This Standard applies to disposable endoscopic cutter stapler and reload used in
endoscopic surgery.
Note. This stapler applies to anastomotic establishment and stump or incision closure
in digestive tract reconstruction and organ resection.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies to this document. For
undated references, the latest edition (including any amendment) applies to this
document.
GB/T 228.1, Metallic materials - Tensile testing - Part 1.Method of test at room
temperature
GB/T 1220, Stainless steel bars
GB/T 3280, Cold rolled stainless steel plate, sheet and strip
GB/T 4237, Hot rolled stainless steel plate, sheet and strip
GB/T 4340.1, Metallic materials - Vickers hardness test. Part 1.Test method
GB/T 6682-2008, Water for analytical laboratory use - Specification and test
methods
GB/T 10610, Geometrical product specifications (GPS) - Surface texture. Profile
method - Rules and procedures for the assessment of surface texture
GB/T 13810, Wrought titanium and titanium alloy for surgical implants
GB/T 14233.1-2008, Test methods for infusion, transfusion, injection equipment for
medical use - Part 1.Chemical analysis methods
GB/T 16886, Biological evaluation of medical devices
3 Structure and materials
3.1 The stapler consists of a stapler body and some assemblies. According to the design
of the cutter knife, the stapler can be divided into a type where the cutter knife is
assembled to the assembly and a type where the cutter knife is assembled to the stapler
body; according to the joint structure, it can be divided into the bending type and the
non-bending type.
4 Requirements
4.1 Staple materials
4.2 Appearance
4.2.1 The stapler shall be smooth in appearance, clear in outline, free from defects such
as burrs and scratches; the metal outer surface of the weld shall be free from defects
such as cracks, welding slags, and weld tumors.
Specifications of the staple line (nominal value)
Staple original height (nominal value)
4.2.2 The shape and structure of the stapler head end shall be blunt, without sharp edges
or corners.
4.2.3 The surface of the stapler (assemblies and stapler rod parts) shall be matt.
4.3 Corrosion resistance
The corrosion resistance of the metal parts on the outer surface of the stapler head end
shall not be lower than that specified in 5.4b) of YY/T 0149-2006.
4.4 Surface roughness
The roughness Ra of the metal outer surface of the stapler assemblies and the stapler
rod parts shall not be greater than 1.6 μm.
4.5 Dimensions
The basic dimensions of the stapler shall meet the requirements of Table 1.
4.6 Hardness
The hardness of the cutter knife shall not be less than 377HV0.2.
4.7 Assembly
4.8 Flexibility
4.8.1 The opening and closing of the stapler jaws shall be flexible, and there shall be
no blocking phenomenon.
4.8.2 The joint structure and rotational structure of the stapler shall be flexible and free
of obstacles.
4.9 Performance
4.9.1 The connection between the stapler body and the assemblies shall be firm and
reliable.
4.9.5 The stapler shall be available for one-hand operability.
4.9.6 The stapler shall be provided with good stapling and cutting performance. When
the assemblies are replaced, the cutting edge after each anastomosis shall be neat and
free of burrs, and the distal-end length of the staple line shall be at least 1.5 times longer
than the cutting line. The staples after each anastomosis shall be shaped like "B".
4.12 Protective device
4.12.1 The stapler shall have an empty staple cartridge protective device, so that it
cannot be fired when the empty staple cartridge is installed by mistake.
Note. Empty cartridge refers to fired assemblies.
4.13 Matching performance with trocar
The stapler shall be smoothly inserted into the matched trocar specified in the manual,
and pulled out smoothly.
4.14 Sterility
The stapler shall be sterilized by a validated sterilization process and the product shall
be sterile.
4.15 Bacterial endotoxin
The bacterial endotoxin content of the stapler used for blood vessels shall be less than
or equal to 20 EU/piece.
4.17.4 Reducing substances
The difference of the consumption of potassium permanganate solution [c(1/5KMnO4)
= 0.01 mol/L], compared with the same volume of blank control solution in the same
batch, shall be less than or equal to 2.0 mL.
4.17.5 Evaporation residue
The total dry residue of the dissolution solution shall be less than or equal to 2.0 mg.
4.18 Biological evaluation
The stapler shall be biologically evaluated according to the provisions of the GB/T
16886 series standards, and there shall be no biocompatibility hazards.
4.19 Instruction manual
5 Test methods
5.1 Staple materials
5.2 Appearance
Under the illumination of 300 lx ~ 750 lx, observe by normal or corrected visual acuity,
and rub with hands, which shall meet the requirements of 4.2.
5.3 Corrosion resistance
Carry out the test according to the boiling water test method in YY/T 0149-2006, which
shall meet the requirements of 4.3.
5.4 Surface roughness
The surface roughness shall be tested by the sample block comparison method or the
profile method specified in GB/T 10610, which shall meet the requirements of 4.4.
Use the profile method during arbitration.
5.7 Assembly
5.7.1 Imitate the use action to load and replace assemblies, which shall comply with the
provisions of 4.7.1.
5.8 Flexibility
After correctly loading the assemblies, imitate the use action to check the flexibility,
which shall meet the provisions of 4.8.
5.9 Performance
5.9.3 Use the instrument to clamp the EVA low-foamed plate sample whose total
thickness is 1/2 ~ 2/3 the original height of the staples; fix the stapler body on the fixture;
apply a push-pull device to clamp the EVA low-foamed plate sample; then, measure the
clamping force in axial direction, which shall comply with the provisions of 4.9.3.
5.9.6 Imitate the use action to match the EVA low-foamed plate sample whose total
thickness is 1/2 ~ 2/3 the original height of the staples, where the cutter knife is
assembled to the assembly,
5.9.7 Carry out the test according to the method specified in Appendix B, which shall
meet the requirements of 4.9.7.
5.9.8 Imitate the use action to fire the stapler, which shall comply with the provisions
of 4.9.8.
5.10 Cutter knife sharpness
Carry out the test according to the method specified in Appendix C, which shall comply
with the provisions of 4.10.
5.17 Chemical properties (polymer material of the part in contact with the patient)
5.17.1 Test liquid preparation
Take the sample; put it in a glass container according to the ratio of 0.2 g of sample to
1 mL of test water (grade-2 water in accordance with GB/T 6682-2008); leach at the
constant temperature of 37 ℃ ± 1 ℃ for 24 h; separate the sample from the liquid; cool
to room temperature; use it as a test solution.
Take the same volume of test water and place it in a glass container; prepare a blank
control solution in the same way.
5.17.2 Appearance
Take the test solution and observe the solution visually, which shall meet the
requirements of 4.17.1.
5.17.3 pH value
5.18 Biological evaluation
The stapler shall be biologically evaluated in accordance with the provisions of the
GB/T 16886 series standards, which shall comply with the provisions of 4.18.
5.19 Instruction manual
Observe visually, which shall meet the provisions of 4.19.
6 Type inspection
Type inspection items of the stapler are those specified in 4.1 ~ 4.17 and 4.19.
7 Label, instruction manual
7.1 Label
The label of the stapler shall have at least the following contents or symbols.
7.2 Instruction manual
The instruction manual for the stapler shall contain at least the following.
8 Packaging
8.1 The minimum sales package of the stapler shall be accompanied by an instruction
manual, a quality certification mark or a product certification.
8.2 The product shall be packaged in a suitable way for sterilization.
......
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 1797-2021 be delivered?Answer: The full copy PDF of English version of YY/T 1797-2021 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 1797-2021_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1797-2021_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 1797-2021 -- 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. How to buy and download a true PDF of English version of YY/T 1797-2021?A step-by-step guide to download PDF of YY/T 1797-2021_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 1797-2021".
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
|