아크릴릭 레진계 골시멘트의 기준규격 개발연구 (Development of Standards for Acrylic Resin Cements)

서지정보

· 발행기관 : 한국생체재료학회
· 수록지 정보 : 생체재료학회지 / 13권 / 4호 / 159 ~ 173페이지
· 저자명 : 양원선, 조은정, 신채민, 오현주, 노혜원, 백성인, 김민아, 정정자, 유규하, 오현진, 조양하

초록

Acrylic resin bone cement is designed to fix artificial joints and implants onto bones. As such, bone cement functions
to fill spaces between an implant and a bone, evenly disperse the pressure on the implant across the bone, and deliver
antibiotics. This study surveyed the use status and development trends of acrylic resin bone cement and researched
into various standards and literature in an effort to induce standard criteria for acrylic resin bone cement. Bone cement
consists of powder and liquid; powder contains PMMA, polymerization initiators, and radiopaquer materials, and the
liquid consist mainly of MMA monomers. Bone cement polymerization constitutes exothermic reaction, and the physical
and mechanical properties of bone cement change according to polymerization conditions. Bone cement aims to
couple implants with bones, but in the case of acrylic resin bone cement, tissue necrosis problems are being raised
in association with not only such osteoconduction but also exothermic reaction; thus various research institutes are
recently striving to develop diverse bioactive materials-based products in a bid to maintain the strength of bone cement
and boost the adhesion of cement and bone. These products are producing good results with animal experiments, but,
compared with existing PMMA products, they offer inconsistent manipulation and physical properties, and other problems
such as unconfirmed internal side effects. A survey of bone cement standards in various nations indicated that
there are such standards as ISO, ASTM, FDA Guidance and KS; ISO, ASTM, and KS offer similar test methods and
test standards, while the FDA Guidance offers various methods designed to analyze physical, chemical and mechanical
properties of bone cement. With an analysis of these standards, this study tested bone cement's compressive strength,
bending strength, bending modulus, maximum temperature, and setting time by conducting physical and mechanical
tests of bone cement. An extractable test was also conducted through chemical tests. In addition, for the verification
of biological safety, pyrogen test, intracutaneous test, and acute toxicity test were conducted. Various test methods
specified in each standard thus were verified, and finally the bone cement standards were determined. The suggested
standards for bone cement offer results of the test of acrylic resin bone cement's physiochemical and mechanical properties,
and biological safety, and the research findings are intended to lend themselves to the public notification of
medical device standards in an effort to be used in reviewing technical files.

영어초록

Acrylic resin bone cement is designed to fix artificial joints and implants onto bones. As such, bone cement functions
to fill spaces between an implant and a bone, evenly disperse the pressure on the implant across the bone, and deliver
antibiotics. This study surveyed the use status and development trends of acrylic resin bone cement and researched
into various standards and literature in an effort to induce standard criteria for acrylic resin bone cement. Bone cement
consists of powder and liquid; powder contains PMMA, polymerization initiators, and radiopaquer materials, and the
liquid consist mainly of MMA monomers. Bone cement polymerization constitutes exothermic reaction, and the physical
and mechanical properties of bone cement change according to polymerization conditions. Bone cement aims to
couple implants with bones, but in the case of acrylic resin bone cement, tissue necrosis problems are being raised
in association with not only such osteoconduction but also exothermic reaction; thus various research institutes are
recently striving to develop diverse bioactive materials-based products in a bid to maintain the strength of bone cement
and boost the adhesion of cement and bone. These products are producing good results with animal experiments, but,
compared with existing PMMA products, they offer inconsistent manipulation and physical properties, and other problems
such as unconfirmed internal side effects. A survey of bone cement standards in various nations indicated that
there are such standards as ISO, ASTM, FDA Guidance and KS; ISO, ASTM, and KS offer similar test methods and
test standards, while the FDA Guidance offers various methods designed to analyze physical, chemical and mechanical
properties of bone cement. With an analysis of these standards, this study tested bone cement's compressive strength,
bending strength, bending modulus, maximum temperature, and setting time by conducting physical and mechanical
tests of bone cement. An extractable test was also conducted through chemical tests. In addition, for the verification
of biological safety, pyrogen test, intracutaneous test, and acute toxicity test were conducted. Various test methods
specified in each standard thus were verified, and finally the bone cement standards were determined. The suggested
standards for bone cement offer results of the test of acrylic resin bone cement's physiochemical and mechanical properties,
and biological safety, and the research findings are intended to lend themselves to the public notification of
medical device standards in an effort to be used in reviewing technical files.

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