YY Translated English of Chinese Standard: YY

Transcription

1 Translated English of Chinese Standard: YY YY ICS C 35 Pharmaceutical Industry Standard of the People s Republic of China YY/T Replacing General technological requirements for non-active metallic surgical implants for osteosynthesis 骨接合用无源外壳金属植入物通用技术条件 Issued on: December 30, 2009 Implemented on: June 1, 2011 Issued by: China Food and Drug Administration Page 1 of 17

2 Table of Contents Foreword Scope Normative references Terms and definitions Requirements Test methods Inspection rules Usage instructions Marks of implants Packaging and label Annex A Annex B Annex C Annex D Page 2 of 17

3 Foreword Definitions in this Standard are quoted from YY/T Surgical Implant Basic Principles (ISO/TR 14283:2004, IDT), YY/T Non-active Surgical Implant General Requirements (ISO 14630:2005, IDT), and GB/T 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 General technological requirements for non-active metallic surgical implants for osteosynthesis. Main differences between this Standard and YY 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 ; - 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. Page 3 of 17

4 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 , ISO 780:1997, MOD) GB/T 228 Metallic materials - Tensile testing at ambient temperature (GB/T , eqv ISO 6892:1998) GB/T 2829 Sampling procedures and tables for periodic inspection by attributes (Applicable to inspection of process stability) GB/T Metallic materials - Vickers hardness test - Part 1: Test method (GB/T , eqv ISO :1997) GB/T Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods GB/T attributes Sampling procedures and tables for isolated lot inspection by Page 4 of 17

5 GB/T Biological evaluation of medical devices - Part 1: Evaluation and testing (GB/T , IDT; ISO : 1997, IDT) YY/T 0343 Liquid penetrant inspection of metallic surgical implants (YY/T , ISO 9583:1993, NEQ) YY/T : 2005, IDT) Non-active surgical implants - General requirements (ISO 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 Page 5 of 17

6 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 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 Biological property test shall be conducted according to the recommended methods in GB/T , or comply with the provisions of other related standards. 5.2 Mechanical property 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 Hardness: Test shall be conducted according to the methods specified in GB/T Tensile strength: Test shall be conducted according to the methods specified in GB/T Electrochemical corrosion test Pitting potential: Test shall be conducted according to the methods specified in YY/T Surface quality Surface flaw: CONDUCT according to the methods specified in YY/T Surface roughness: USE sample piece comparison method or electrometric method Appearance: OBSERVE by eyesight. 5.5 Dimension of important parts Page 7 of 17

7 10.2 Transportation signs shall comply with the specifications of GB/T 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 Implant usage shall be under strict conditions and meet clinical usage requirements. The patient s own conditions may affect the implant s properties 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. Page 11 of 17

8 mechanical requirements ISO Implants for surgery - Skeletal pins and wires - Part 2: Steinmann pins; dimensions ISO 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 Implants for surgery - Malleable wires for use as sutures and other surgical applications. A.1.8 Implant for bone external fixation 1 A.1.9 Implant for spinal fixation 2 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 Orthopaedic instruments - Drive connections - Part 1: Keys for use with screws with hexagon socket heads ISO Orthopaedic instruments-- Drive connections - Part 2: Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws A.2.2 Drill and taps ISO Orthopaedic drilling instruments - Part 1: Drill bits, taps and countersink cutters 1 There has been no international standard at present, but it has been proposed. 2 International standard is being drafted, but it is only in the working draft stage. This standard consists of several standards. Page 13 of 17

9 Annex B (Informative) ISO standards for acceptable materials proved by clinical usage ISO Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (GB , ISO ,1997, MOD) ISO Implants for surgery - Metallic materials - Part 2: Unalloyed titanium (GB/T , eqv ISO :1993) ISO Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy ISO Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy (GB , eqv ISO :1996) ISO Implants for surgery - Metallic materials - Part 5: Wrought cobalt-chromium-tungsten-nickel alloy (YY/T , ISO , 2005, IDT) ISO Implants for surgery - Metallic materials - Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy (YY/T , ISO : 1997,IDT) ISO Implants for surgery - Metallic materials - Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy (YY/T , ISO , 1994, IDT) ISO Implants for surgery - Metallic materials - Part 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy (YY/T , ISO :1997, IDT) ISO Implants for surgery - Metallic materials - Part 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy (YY , ISO , 1992, IDT) ISO Implants for surgery - Metallic materials - Part 11: Wrought titanium-6-aluminium 7-niobium alloy (GB , ISO :1994, IDT) ISO Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy (YY , ISO :1996, IDT) ISO 5833 Implants for surgery; acrylic resin cements (YY , ISO 5833:2002, IDT) Page 14 of 17

10 Annex C (Informative) ISO standards and industrial standards related to design evaluation and test ISO 6475 Implants for surgery; metal bone screws with asymmetrical thread and spherical under-surface; mechanical requirements and test methods (YY/ T , ISO 6475, 1989, IDT) ISO 9583 Implants for surgery; non-destructive testing; liquid penetrant inspection of metallic surgical implants (YY/T , ISO 9583:1993, NEQ) ISO 9584 Implants for surgery; non-destructive testing; radiographic examination of cast metallic surgical implants ISO 9585 Implants for surgery; determination of bending strength and stiffness of bone plates (YY/T , ISO 9585:1990, IDT) YY/T 1074 Implants for surgery - Measuring method for pitting corrosion potential on stainless products Page 16 of 17

11 Annex D (Informative) ASTM standards related to design evaluation and test ASTM F 366 Standard Specification for Fixation Pins and Wires ASTM F 382 Standard Specification and Test Method for Metallic Bone Plates ASTM F 384 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture ASTM F 452 Standard Specification for Preformed Cranioplasty Plates ASTM F 543 Standard Specification and Test Methods for Metallic Medical Bone Screws ASTM F 564 Standard Specification and Test Methods for Metallic Bone Staples ASTM F 622 Standard Specification for Preformed Cranioplasty Plates That Can Be Altered ASTM F 1264 Standard Specification and Test Methods for Intramedullary Fixation Devices ASTM F 1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model ASTM F 1798 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants ASTM F 2077 Test Methods For Intervertebral Body Fusion Devices ASTM F 2180 Standard Specification for Metallic Implantable Strands and Cables ASTM F 2193 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System ASTM F 2267 Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression END Page 17 of 17