YY/T 0245-2008 PDF English
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| YY/T 0245-2008 | English | 120 |
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General specifications for stapler
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| YY/T 0245.1-1997 | English | 279 |
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Specifications for suture forceps
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YY/T 0245-2008: General specifications for stapler---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/YYT0245-2008
PHARMACEUTICAL INDUSTRY STANDARD
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
Foreword
This Standard replaces YY/T 0245.1-1997 “Specifications for suture forceps”.
The main differences between this Standard and YY/T 0245.1-1997 are as
follows.
- expanded product’s application scope in this Standard, that is, it is
applicable to reusable stapler and disposable stapler;
- rearranged the requirements in YY/T 0245.1-1997 according to the
characteristics, which makes the content more distinct in level;
- directly specified the requirements for hardness of main parts of stapler in
this Standard;
- directly listed the pressure-endurance indicators for stapler in this Standard,
which shall be assessed uniformly;
- added Annex B “Test method for peel strength”.
Annex A and Annex B of this Standard are normative.
This Standard was proposed by and shall be under the jurisdiction of National
Technical Committee on Surgical Instrument of Standardization Administration
of China.
Main drafting organizations of this Standard. Shanghai Medical Devices (Group)
Co., Ltd. Surgical Instrument Factory, Changzhou Kangdi Medical Stapler Co.,
Ltd.
Main drafters of this Standard. Liu Weiqun, Yu Guo’an.
The historical versions substituted by this Standard are.
- GB 8667-1988;
- YY/T 0245.1-1997.
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
3 Classification and type
3.1 Type and basic size of stapler shall comply with the provisions in
corresponding product standards.
4 Requirements
4.1 Material of stapler nail
Stapler nail may use TA1, TA2 materials specified in GB/T 13810 or Ta1
tantalum wire. The chemical composition of tantalum wire shall comply with the
provisions of Table 2.
4.2 Use performance
4.2.1 The components and the body frame of stapler shall be assembled and
disassembled smoothly. Each moving part shall be easy to push, without
jamming or looseness. The components shall be firm when they are loaded into
the body. Stapler nail shall not fall off.
4.3 Hardness
The parts made of 20Cr13 material must be heat-treated. Its hardness is
40HRC ~ 48HRC. The hardness of the cutting blade shall not be lower than
377HV0.2.
4.4 Surface roughness
The value of external surface roughness parameter Ra of reusable stapler shall
not exceed. 0.4µm for the one with brightness, 0.8µm for the one without
brightness.
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
4.10 Biological evaluation
4.10.1 The cytotoxicity of the components and disposable body shall be no
more than level 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
5.3 Hardness
Perform according to the method specified in GB/T 230.1 or GB/T 4340.1.
Measure three points at the heat-treating surface. Take the arithmetic mean of
each three points, in accordance with the provisions of 4.3.
5.4 Surface roughness
Use sample block comparison method or electrical measurement method. Use
electrical measurement method for arbitration, in accordance with the
provisions of 4.4.
5.5 Corrosion resistance performance
Perform according to the boiling water test method in YY/T 0149, in accordance
with the provisions of 4.5.
5.8 Size
Use general or particular measuring tool to measure, in accordance with the
provisions of 4.8.
5.9 Inspection of sterile and ethylene oxide residues
5.9.1 Randomly inspect 3 pieces from the same batch and perform according
to the method specified in the pharmacopoeia, in accordance with the
provisions of 4.9.1.
5.9.2 Perform the determination of ethylene oxide residue according to the
method specified in GB/T 16886.7, in accordance with the provisions of 4.9.2.
5.10 Biological evaluation
5.10.1 Perform according to the method of direct contact test in 8.3 of GB/T
16886.5-2003, in accordance with the provisions of 4.10.1.
6 Inspection rules
6.1 Acceptance
Staplers shall be inspected by manufacturer technical inspection department.
Only the qualified ones are submitted to purchaser for acceptance.
6.2 Inspection
Staplers must be submitted in batches for inspection. The inspection is divided
into batch inspection (exit-factory inspection) and period inspection (type
inspection).
6.3 Batch inspection
6.4.2 Inspection items and sampling method of periodic inspection are in
accordance with the provisions of Table 4.In any of the following cases, the
biological evaluation specified in 4.10 shall be added (exemption can be made
if it is not one of the following cases).
6.4.5 The qualified periodic inspection refers that periodic inspections of all test
groups within this period are qualified; otherwise the periodic inspection shall
be regarded as rejected.
7 Marks, instruction manual
7.1 Marks
7.1.1 Each piece of stapler or component, according to the provisions of YY/T
1052, shall have the following marks.
7.1.2 On the box, there shall be the following marks.
7.1.3 On the inspection certificate, there shall be the following marks.
7.1.4 On the seal, there shall be the following marks.
7.2 Aseptic packaging mark
7.4 Instruction manual
7.4.1 The instruction manual shall contain the following information.
7.4.2 Aseptic packaging instruction manual shall contain the following
information.
7.4.3 The preparation of instruction manual shall comply with the provisions of
GB 9969.1.
8 Packaging, transport, storage
8.1 Packaging
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.
8.3 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
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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