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YY/T 0245-2008 English PDF (YYT0245-2008)

YY/T 0245-2008 English PDF (YYT0245-2008)

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YY/T 0245-2008: General specifications for stapler

This Standard specifies classification and type, requirements, test methods, inspection rules, marks, instruction manual, packaging, transport and storage for stapler. This Standard is applicable to reusable stapler and disposable stapler. This product is used for the stapler whose components are mounted on the stapler as round tubular incision as well as circular resection and anastomosis of the upper mucosa or stump incision closed suture.
YY/T 0245-2008
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.040.30
C 31
Replacing YY/T 0245.1-1997
General specifications for stapler
ISSUED ON: APRIL 25, 2008
IMPLEMENTED ON: JUNE 01, 2009
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Classification and type ... 5
4 Requirements ... 5
5 Test methods ... 7
6 Inspection rules ... 9
7 Marks, instruction manual ... 11
8 Packaging, transport, storage ... 14
Annex A (normative) Test method for suture pressure ... 16
Annex B (normative) Test method for peel strength ... 18
General specifications for stapler
1 Scope
This Standard specifies classification and type, requirements, test methods, inspection rules, marks, instruction manual, packaging, transport and storage for stapler.
This Standard is applicable to reusable stapler and disposable stapler. This product is used for the stapler whose components are mounted on the stapler as round tubular incision as well as circular resection and anastomosis of the upper mucosa or stump incision closed suture.
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 corrigendum) 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 230.1, Metallic materials - Rockwell hardness test - Part 1: Test method (GB/T 230.1-2004, ISO 6508-1:1999, MOD)
GB/T 1220, Stainless steel bars
GB/T 2828.1, Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection (GB/T 2828.1-2003, ISO 2859-1:1999, IDT)
GB/T 2829, Sampling procedures and tables for periodic inspection by
attributes (Apply to inspection of process stability)
GB/T 4340.1, Metallic materials - Vickers hardness test - Part 1: Test method (GB/T 4340.1-1999, eqv ISO 6507-1:1997)
GB 9969.1, General principles for preparation of instructions for use of industrial products
GB 12672, Acrylonitrile-butadiene-styrene (ABS) resin
GB/T 13810, Wrought titanium and titanium alloy for surgical implants (GB/T 4.7 Appearance
The shape of stapler shall be flat, smooth, without sharp edges, burrs and cracks. The scale value or mark on the stapler body shall be clear.
4.8 Size
The size of stapler shall comply with the provisions of product standard. The error between the scale value and the head end shall be no more than 0.2mm. 4.9 Sterilization
4.9.1 The disposable stapler that has been sterilized by the confirmed
sterilization process shall be sterile.
4.9.2 Use ethylene oxide sterilization. The ethylene oxide residue of its exit- factory product shall not exceed 10??g/g.
4.10 Biological evaluation
4.10.1 The cytotoxicity of the components and disposable body shall be no more than level 1.
4.10.2 The delayed hypersensitivity (sensitization) of components and
disposable body shall be no more than level 1.
4.10.3 The intradermal response score of the components and the disposable body shall be no more than 1.
5 Test methods
5.1 Material inspection
The chemical composition analysis of pure titanium material shall be performed according to the method specified in GB/T 13810. The chemical composition analysis of tantalum wire material shall be performed according to the method specified in GB/T 15076.1~15076.15, in accordance with the provisions of 4.1. 5.2 Use performance
5.2.1 Imitate the use action. Assemble and disassemble each part and
component. Swing the stapler. Visually inspect according to the provisions of 4.2.1.
5.2.2 Imitate the use action. Use the sample that is composed of two layers of blown paper sandwiched with a layer of sponge, that is 8mm~10mm thick for inspection. Visually inspect. The stapler nail after being stapled shall be neat, 7.2.2 On the small packaging of stapler, there shall be the following marks: a) manufacturer?€?s name, address and trademark;
b) product?€?s name, type, quantity, specification and product number;
c) sterilization lot number or date and expiration date;
d) reference to product standard;
e) product registration number;
f) sterilization method, eye-catching "sterile" and signs of prohibiting secondary use;
g) "If the package is damaged, it is forbidden to use" or the words that express the equivalent content.
7.2.3 On the stapler box, there shall be the following marks:
a) manufacturer?€?s name and trademark;
b) product?€?s name, type, quantity, specification;
c) sterilization method, sterilization batch number or date and expiration date. 7.2.4 On the inspection certificate, there shall be the following marks: a) manufacturer?€?s name;
b) inspector code;
c) date of inspection.
7.2.5 The packaging box shall be sealed with tag. On the sealing tag, there shall be the following marks:
a) sealing date;
b) packager code.
7.2.6 On the large packaging, there shall be the following marks:
a) manufacturer?€?s name, address and trademark;
b) product?€?s name, type, quantity, specification;
c) volume (length ?? width ?? height), weight (gross weight, net weight); d) "heat protection", "moisture prevention", "anti-hook" and other words or 8 Packaging, transport, storage
8.1 Packaging
8.1.1 Reusable stapler has two packaging patterns: the device is packaged with the components at the same time & the device and the components are
packaged separately. Load in a neutral plastic bag. There shall be inspection certificate in the bag. It must be sealed.
8.1.2 The sealed stapler or components shall be loaded in the packaging lox. There shall be sealed tag on the box.
8.2 Aseptic packaging
8.2.1 Disposal stapler has two packaging patterns: device (containing
components) separate packaging and component separate packaging. The
small packaging is the minimum packaging for one-time use. The packaging material is polyethylene terephthalate (PET). The packaging pattern is sealed packaging, which shall ensure product sterility until it is unsealed.
8.2.2 Load each piece of stapler into the small packaging then into the box. In the box, there shall be the instruction manual and the inspection certificate accompanied.
8.2.3 The large packaging of stapler shall be able to ensure it is not damaged under normal transportation and storage conditions. It shall ensure that the words or signs on the large packaging clear as time goes by.
8.3 Packaging of special requirements
The packaging of special requirements is in accordance with the provisions of the order contract.
8.4 Transport
The requirements for packing and transport are in accordance with the
provisions of the order contract.
8.5 Storage
8.5.1 The words and signs on the packaging box shall be still clear as time goes by.
8.5.2 The stapler after packaged shall be stored in a room with a relative humidity of no more than 80%, without corrosive gas and good ventilation. 8.5.3 The stapler after packaged shall, when it is subject to storage rules, Annex A
(normative)
Test method for suture pressure
A.1 Definition
A.1.1 Pressure-endurance of suture: the pressure that the suture can endure after the stapler is used to stitch the intestine.
A.1.2 Matching: two round tubular incisions are butt jointed and completely unobstructed.
A.1.3 Stitching: closure of the stump incision.
A.2 Instrument requirements
A.2.1 The instrument shall be manufactured in accordance with the drawings and documents approved by the prescribed procedures.
A.2.2 The power supply voltage required by the instrument: 220V??22V; power frequency: 50Hz??0.5Hz.
A.2.3 The unit of measurement of the instrument: "kPa".
A.2.4 The indication range of the instrument: 0~6kPa, indication error: ??0.12kPa.
A.2.5 The instrument has water inlet, water drainage and stop action.
A.2.6 Check the instrument's pressure gauge every other year.
A.2.7 The inlet and outlet pipes of the instrument shall be unobstructed. The control device shall be reliable.
A.3 Test material
A.3.1 The test material is fresh pig intestine (also known as intestinal lumen). A.3.2 Before the test, clean the intestinal lumen. Clear the excess fat tissue at the place to be stapled.
A.4 Test methods
A.4.1 Imitate the use action. Use stapler to staple the intestinal lumen.

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