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YY 0341-2009 English PDF (YY0341-2009)

YY 0341-2009 English PDF (YY0341-2009)

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YY 0341-2009: General technological requirements for non-active metallic surgical implants for osteosynthesis

This Standard specifies the definitions, requirements, testing methods, inspection rules, usage instructions, marks, packaging, transportation, storage, usage requirements etc. of the non-active surgical implants for osteosynthesis. This Standard is applicable to non-active surgical implants for osteosynthesis which are made of metallic materials. This Standard is not applicable to implants for osteosynthesis which have coating on the surface.
YY 0341-2009
YY
ICS 11.040.40
C 35
Pharmaceutical Industry Standard
of the PEOPLE Republic of China
YY/T 0341-2009
Replacing 0341-2002
General technological requirements for
non-active metallic surgical implants for
osteosynthesis
ISSUED ON. DECEMBER 30, 2009
IMPLEMENTED ON. JUNE 1, 2011
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Terms and definitions ... 5
4 Requirements ... 6
5 Test methods ... 7
6 Inspection rules ... 8
7 Usage instructions ... 9
8 Marks of implants ... 9
9 Packaging and label ... 10
Annex A ... 12
Annex B ... 14
Annex C ... 16
Annex D ... 17
Foreword
Definitions in this Standard are quoted from YY/T 0340-2009 ?€?Surgical Implant ?€? Basic Principles?€? (ISO/TR 14283.2004, IDT), YY/T 0640-2008 ?€?Non-active Surgical Implant ?€? General Requirements?€? (ISO 14630.2005, IDT), and GB/T 12417.1-2008
?€?Non-active Surgical Implant ?€? Osteosynthesis and Joint Replacement Implant. Part 1. Special Requirements for Implants for Osteosynthesis?€? (ISO 14602.1998, IDT). This Standard replaces YY 0341-2002 ?€?General technological requirements for non-active metallic surgical implants for osteosynthesis?€?.
Main differences between this Standard and YY 0341-2002 are as follows. - REVISE chapter 3, 6, 7, 8, and 9, according to corresponding international standards; - ADD static and/or dynamic load evaluation tests according to GB/T 12417.1-2008; - ADD informative annex D; as a reference, introduce some American standards for testing and evaluation.
Annex A, Annex B, Annex C, and Annex D of this Standard are all informative. This Standard was proposed by State Food and Drug Administration.
This Standard shall be under the jurisdiction of national standardization technical committee of surgical implants and orthopedic devices (SAC/TC 110).
Drafting organization of this Standard. Tianjin Medical Device Quality Supervision and Inspection Center of State Food and Drug Administration.
Main drafters of this Standard. Fan Bo, Yang Jiangang, Song Duo, Qi Baofen, and Jiang Hua.
General technological requirements for non-active
metallic surgical implants for osteosynthesis
1 Scope
This Standard specifies the definitions, requirements, testing methods, inspection rules, usage instructions, marks, packaging, transportation, storage, usage requirements etc. of the non-active surgical implants for osteosynthesis. This Standard is applicable to non-active surgical implants for osteosynthesis (abbreviated as ?€?implants for osteosynthesis?€?) which are made of metallic materials. This Standard is not applicable to implants for osteosynthesis which have coating on the surface.
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 Packaging - Pictorial marking for handling of goods (GB/T 191-2008, ISO 780.1997, MOD)
GB/T 228 Metallic materials - Tensile testing at ambient temperature (GB/T 228-2002, eqv ISO 6892.1998)
GB/T 2829 Sampling procedures and tables for periodic inspection by attributes (Applicable 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/T 14233.2 Test methods for infusion, transfusion, injection equipment for medical use - Part 2. Biological test methods
GB/T 15239 Sampling procedures and tables for isolated lot inspection by attributes
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing (GB/T 16886.1-2001, IDT; ISO 10993-1. 1997, IDT)
YY/T 0343 Liquid penetrant inspection of metallic surgical implants (YY/T 0343-2002, ISO 9583.1993, NEQ)
YY/T 0640-2008 Non-active surgical implants - General requirements (ISO 14630. 2005, IDT)
YY/T 1074 Implants for surgery - Measuring method for pitting corrosion potential on stainless products
3 Terms and definitions
The following terms and definitions apply to this Standard.
3.1
Surgical implant
Device for the following purposes.
- Totally embedded into human body, or
- REPLACE the epithelial surface or ocular surface,
Device remains at the above operation positions through surgical invasion method. Note. Through surgically invasion methods, some medical devices which are embedded into human body and remained at the operation position for at least 30 days shall also be regarded as implants.
3.2
Non-active surgical implant
It refers to the surgical implant that operates without electric energy or other energy sources, except the energy directly generated by human body or gravity. 3.3
Non-active surgical implant for osteosynthesis
It refers to the non-active surgical implant providing support for bones, cartilages, tendons or ligament structures.
3.4
non-sterile status. Implants for osteosynthesis delivered in sterile status shall pass an effective and confirmed sterilization process to make the products to be in sterile status.
5 Test methods
5.1 Materials
5.1.1 Material samples for chemical component and microscopic structure testing shall be sampled from the final products of the implants for osteosynthesis; the testing shall be conducted according to the methods specified in corresponding product standards.
5.1.2 Biological property test shall be conducted according to the recommended methods in GB/T 16886.1, or comply with the provisions of other related standards. 5.2 Mechanical property
5.2.1 When evaluating the implant by static and/or dynamic load test, it can adopt the existing inspection standards or formulate the testing models according to the implant?€?s characteristics.
Note. As there are many kinds of implants and large characteristic differences, the inspection standard may not yet exist or may need to be revised.
5.2.2 Hardness. Test shall be conducted according to the methods specified in GB/T 4340.1.
5.2.3 Tensile strength. Test shall be conducted according to the methods specified in GB/T 228.
5.3 Electrochemical corrosion test
Pitting potential. Test shall be conducted according to the methods specified in YY/T 1074.
5.4 Surface quality
5.4.1 Surface flaw. CONDUCT according to the methods specified in YY/T 0343. 5.4.2 Surface roughness. USE sample piece comparison method or electrometric method.
5.4.3 Appearance. OBSERVE by eyesight.
5.5 Dimension of important parts
10.2 Transportation signs shall comply with the specifications of GB/T 191. 10.3 After packaging, the implant products shall be stored indoor with relative humidity not more than 80%, without corrosive gas, and with good ventilation.
11 Usage requirements
11.1 Implant products that have been used can?€?t be used again.
11.2 Implant usage shall be under strict conditions and meet clinical usage requirements. The patient?€?s own conditions may affect the implant?€?s properties. 11.3 If the implant is planned to be used with other implants or devices, the whole combination (including connection system) shall be safe and not impair the implants?€? specified properties. Any usage limitations shall be indicated in the label or in the usage instructions.
mechanical requirements
ISO 5838-2 Implants for surgery - Skeletal pins and wires - Part 2. Steinmann pins; dimensions
ISO 5838-3 Implants for surgery - Skeletal pins and wires - Part 3. kirschner skeletal wires
YY 0345 Implants for osteosynthesis - Metal bone pins
A.1.6 Staples
ISO 8827 Implants for surgery - Staples with parallel legs for orthopaedic use - General requirements
A.1.7 Cerclage and other malleable metal wires for fixation
ISO 10334 Implants for surgery - Malleable wires for use as sutures and other surgical applications.
A.1.8 Implant for bone external fixation1
A.1.9 Implant for spinal fixation2
YY0119 Implants for osteosynthesis - Metal correctional nail
YY0120 Implants for osteosynethesis - Metal correctional stick
A.2 Device standards
A.2.1 Twisted connecting devices
ISO 8319-1 Orthopaedic instruments - Drive connections - Part 1. Keys for use with screws with hexagon socket heads
ISO 8319-2 Ortho...

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