YY 0876-2013_English: PDF (YY0876-2013)
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Linear cutter stapler and cartridge
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YY 0876-2013
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Standards related to: YY 0876-2013
| Standard ID | YY 0876-2013 (YY0876-2013) | | Description (Translated English) | Linear cutter stapler and cartridge | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.060.20 | | Word Count Estimation | 20,291 | | Quoted Standard | GB/T 228; GB/T 1220; GB/T 3280; GB/T 10610; GB/T 12672; GB/T 13810; GB/T 16886.1; GB/T 16886.5; GB/T 16886.7; GB/T 16886.10; GB/T 19633; YY 0167; YY/T 0171-2008; YY/T 0174; YY/T 0294.1; HG/T 2503; ISO 13782-1996 | | Drafting Organization | Changzhou Medical Stapler Co. Condit | | Administrative Organization | National Standardization Technical Committee Surgical Instruments | | Regulation (derived from) | State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall) | | Proposing organization | National Technical Committee on Surgical Instruments Standardization (SAC/TC 94) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the linear cutting stapler and components of structure type and material requirements, test methods, marking, manual and packaging, transport and storage. This standard applies to linear cutting stapler (hereinafter referred to as | YY 0876-2013
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.060.20
C 31
Linear cutter stapler and cartridge
ISSUED ON: OCTOBER 21, 2013
IMPLEMENTED ON: OCTOBER 01, 2014
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Structural types and materials ... 5
4 Requirements ... 8
5 Test methods ... 10
6 Marks, instructions for use ... 12
7 Packaging, transportation, storage ... 13
Annex A (normative) Cutting edge sharpness test ... 15
Annex B (informative) Test material for anastomosis performance ... 18
Annex C (normative) Pressure resistance performance test ... 19
Annex D (informative) Sealing performance test ... 21
Annex E (normative) Peel strength test ... 23
Annex F (informative) Type inspection ... 25
Bibliography ... 26
Linear cutter stapler and cartridge
1 Scope
This document specifies structural types and materials, requirements, test methods,
marks, instructions for use and packaging, transportation and storage for linear cutter
stapler and cartridge.
This Standard applies to linear cutter stapler and cartridge (hereinafter referred to as the
stapler). The stapler is suitable for gastrointestinal reconstruction, anastomosis,
amputation and resection of tissues and organs in organ resection.
This Standard does not apply to the stapler for endoscopic use.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
GB/T 228, Metallic materials - Tensile testing - Part 1: Method of test at room
temperature
GB/T 1220, Stainless steel rod
GB/T 3280, Cold rolled stainless steel plate, sheet and strip
GB/T 10610, Geometrical product specifications (GPS) - Surface texture: Profile
method - Rules and procedures for the assessment of surface texture
GB/T 12672, Acrylonitrile-butadiene-styrene (ABS) resin
GB/T 13810, Wrought titanium and titanium alloy for surgical implants
GB/T 16886.1, Biological evaluation of medical devices - Part 1: Evaluation and
testing within a risk management process
GB/T 16886.5, Biological evaluation of medical devices - Part 5: Tests for in vitro
cytotoxicity
GB/T 16886.7, Biological evaluation of medical devices - Part 7: Ethylene oxide
sterilization residuals
GB/T 16886.10, Biological evaluation of medical devices - Part 10: Tests for
irritation and skin sensitization
GB/T 19633, Packaging for terminally sterilized medical devices
YY 0167, Non-absorbable surgical suture
YY/T 0171-2008, Surgical instruments - Packaging, Marking and Instructions
YY/T 0174, Surgical blades
YY/T 0294.1, Surgical instruments - Metallic materials - Part 1: Stainless steel
HG/T 2503, Specification for polycarbonate resins by melt method
Pharmacopoeia of the People's Republic of China (2010 Edition) Part II
ISO 13782:1996, Implants for surgery - Metallic materials - Unalloyed tantalum for
surgical implant applications
3 Structural types and materials
3.1 According to the assembly position of the cutting knife, the stapler is divided into
two types: instrument with knife (type I) and cartridge with knife (type II).
3.2 The stapler consists of a body and cartridge:
a) Type I stapler body consists of anvil seat, locking rod, cutting assembly frame and
cutting knife. The cartridge is composed of staple cartridge, push piece and staple
and so on;
b) Type II stapler body consists of anvil seat, locking rod, cutting assembly frame.
The cartridge consists of a staple cartridge, a pusher, a cutting knife, and staples.
3.3 See Figure 1, Figure 2 and Table 1 for the structural types and basic dimensions of
the stapler and cartridge.
4.3 Assembly
4.3.1 The replacement of stapler components shall be convenient and reliable.
4.3.2 After the assembly is shaken, the staples shall not be exposed on the surface of
the staple cartridge.
4.4 Sharpness
The cutting edge shall be sharp. The cutting force shall not be greater than 0.80N.
4.5 Anastomotic and cutting performance
4.5.1 The stapler shall have good anastomotic and cutting performance, replaceable
components. Make no less than 5 cutting anastomosis. The staples after each
anastomosis shall be shaped like a "B".
4.5.2 At the same time, the cutting edge after each anastomosis shall be neat. There
shall be no burrs.
4.5.3 The length of each staple line is at least 1.5 times longer than the length of the
cutting line.
4.6 Pressure resistance
The anastomotic stoma after anastomosis shall be able to withstand a pressure of not
less than 3.6×103Pa. Leak no more than 10 drops within 15s.
4.7 Safety device
The stapler shall have an empty cartridge safety device. Maintain its reliability.
NOTE: Empty cartridges refer to fired components.
4.8 Surface roughness
The roughness Ra of the metal outer surface of the stapler shall not be greater than
0.8μm.
4.9 Package seal
4.9.1 The stapler and cartridge shall be packaged in good condition. The adhesive seal
area shall be free of channels or perforations.
4.9.2 The packaging and sealing peel strength of the stapler and cartridge shall not be
less than 0.10N/mm. After peeling off, the two contact surfaces shall be smooth and
continuous. There is no delamination or tearing.
4.10 Appearance
4.10.1 The stapler has a smooth shape, clear outline, no burrs, scratches and other
defects.
4.10.2 The handwriting and signs on the outer surface of the stapler shall be clear. There
shall be no defects such as dislocation and skew.
4.10.3 There shall be no burrs, dents and other defects on the surface of the staples.
4.11 Size
The size of the stapler and cartridge shall meet the requirements of Table 1.
4.12 Sterilization
4.12.1 The stapler and cartridge shall be sterilized by a validated sterilization process.
The product shall be sterile.
4.12.2 If ethylene oxide is used for sterilization, the residual amount of ethylene oxide
in the stapler and cartridge shall not exceed 10μg/g.
4.13 Biological evaluation
4.13.1 Staples, when they use pure titanium, titanium alloy materials and pure tantalum
materials whose surface is modified, or other materials not specified in Table 2, shall
be biologically evaluated according to the provisions of GB/T 16886.1. The evaluation
results shall be free of biocompatibility hazards.
4.13.2 The cytotoxicity score of the anti-staple seat and the staple cartridge shall not be
greater than 1.
4.13.3 The level of delayed type hypersensitivity reaction of the anti-staple seat and the
staple cartridge shall not be greater than 1.
4.13.4 The score of the intradermal reaction of the anti-staple seat and the staple
cartridge shall not be greater than 1.
5 Test methods
5.1 Material inspection
The chemical composition inspection of pure titanium and titanium alloy materials
made of staples is carried out according to the method specified in GB/T 13810.
The chemical composition test of the tantalum wire material made of staples is carried
out according to the method specified in ISO 13782.
The tensile strength of staple material is carried out according to the method specified
Carry out the test according to the method specified in Annex D, which shall meet the
requirements of 4.9.1.
5.9.2 Peel strength test
Carry out the test according to the method of Annex E, which shall meet the
requirements of 4.9.2.
5.10 Appearance inspection
Visually inspect and touch with hands, which shall meet the requirements of 4.10.
5.11 Size inspection
Measure with a general-purpose measuring tool or a special measuring tool, which shall
comply with the provisions of 4.11.
5.12 Sterility and ethylene oxide residue inspection
5.12.1 Carry out according to the method in Pharmacopoeia of the People's Republic
of China (2010 Edition) Part II, which shall comply with the provisions of 4.12.1.
5.12.2 The determination of the residual amount of ethylene oxide shall be carried out
according to the method specified in GB/T 16886.7, which shall meet the requirements
of 4.12.2.
5.13 Biological evaluation
5.13.1 Staples made of pure titanium, titanium alloy materials and pure tantalum
materials with modified surfaces or other materials not specified in Table 2 shall be
biologically evaluated according to the items specified in GB/T 16886.1. It shall comply
with the provisions of 4.13.1.
5.13.2 Carry out according to the method specified in 8.2 (extract test) of GB/T
16886.5-2003, which shall meet the requirements of 4.13.2.
5.13.3 Carry out according to the method specified in 7.4 (maximum dose test) in GB/T
16886.10-2005, which shall meet the requirements of 4.13.3.
5.13.4 Carry out according to the method specified in GB/T 16886.10-2005
(intradermal reaction test in Annex B.2), which shall meet the requirements of 4.13.4.
6 Marks, instructions for use
6.1 Marks, instructions for use
6.1.1 The body of each stapler shall have the manufacturer's code or trademark.
6.1.2 Packaging marks for the stapler and cartridge:
a) The single package mark shall comply with the provisions of 4.1.3 in YY/T 0171-
2008;
b) The outer packaging mark shall comply with the provisions of 4.2.3 in YY/T
0171-2008.
6.1.3 The mark on the certificate shall comply with the provisions of 4.3 in YY/T 0171-
2008.
6.2 Instructions for use
The preparation of the instructions for use shall comply with the provisions of Chapter
5 in YY/T 0171-2008.
7 Packaging, transportation, storage
7.1 Packaging
7.1.1 Stapler packaging
7.1.1.1 The stapler shall be packaged in a single unit. Sterility shall be maintained
during the storage period.
7.1.1.2 The single package shall leave traces of opening after opening.
7.1.1.3 Put the single package into the packaging box. The instructions for use and
certificate of conformity shall be attached.
7.1.2 Cartridge packaging
7.1.2.1 The cartridge shall be packaged in a single unit. Sterility shall be maintained
during the storage period.
7.1.2.2 The single package shall leave traces of opening after opening.
7.1.2.3 Put several single packages into the packaging box. The instructions for use and
certificate of conformity shall be attached.
7.2 Transportation and storage
7.2.1 The outer packaging of the stapler and cartridge shall ensure that they will not be
damaged under normal transportation and storage conditions.
7.2.2 The words or signs on the outer packaging shall be guaranteed not to be blurred
for a long time.
Annex C
(normative)
Pressure resistance performance test
C.1 Definition
C.1.1 Anastomosis (suture) pressure resistance: It refers to the pressure that the
anastomosis (suture) can withstand after the tissue or organ is anastomosed (sutured)
with a stapler.
C.1.2 Anastomosis: The incision of the tissue or organ is butted and completely
anastomosed and unobstructed.
C.1.3 Suture: Closure of the stump incision.
C.2 Instrument requirements
C.2.1 The instrument shall be manufactured according to the drawings and documents
approved by the prescribed procedures.
C.2.2 The power supply voltage required by the instrument: 220V+22V. The power
supply frequency: 50Hz±0.5Hz.
C.2.3 Measurement unit of the instrument: kPa (kilopa).
C.2.4 The instrument's indication range: 0~6kPa. Indication error: ±0.12kPa.
C.2.5 The instrument has water inlet, drain and stop actions.
C.2.6 The instrument's pressure gauge is checked every other year.
C.2.7 The water inlet and drainage pipes of the instrument shall be unobstructed. The
control device shall be reliable.
C.3 Test material
C.3.1 The test material is fresh pig intestines. In vitro time is less than 24h. Store in the
range of 5℃~15℃. No ice crystals are formed.
C.3.2 The intestinal cavity shall be cleaned before the test. Remove the intestinal fat
and mesentery at the commissure to be anastomosed (sutured).
C.4 Test methods
C.4.1 Choose two bowels for side-to-side anastomosis.
Annex D
(informative)
Sealing performance test
D.1 Overview
This appendix uses the dye penetration test method to test the sealing performance of
packaging seals.
D.2 Instrument and reagent preparation
D.2.1 1L beaker.
D.2.2 25mL graduated cylinder.
D.2.3 0.0005g balance.
D.2.4 Non-ionic surfactant TritonX-100.
D.2.5 Toluidine blue indicator dye.
D.3 Permeate formula
D.3.1 Add 5g of surfactant TritonX-100 to 100mL of grade three test water in
compliance with GB/T 6682. Stir well.
D.3.2 Add grade three test water to 1000mL in C.3.1. Stir well again.
D.3.3 Take 0.5g of toluidine blue and add it to C.3.2. Stir well.
D.4 Test steps
D.4.1 During the test, the test personnel shall check that the test environment
temperature is within the range of 23°C ± 2°C, and the relative humidity is within the
range of 50% ± 2%.
D.4.2 Aspirate enough permeate with a syringe. Inject it into the sterilized primary
package at the center of the package. Make the liquid cover the height of the sealing
edge to 5mm.
Attention: Avoid splashing liquids on the skin. If necessary, wash hands with soap
immediately to avoid damage to the skin.
D.4.3 The time for the permeation to cover the sealing edge shall be controlled within
the range of 5s~20s.
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