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[CE 씤利] 쓽猷뚭린湲 CE씤利/MDD씤利-씤利앹젅李-씤利앸퉬슜-EU吏移-93/42/EEC-2007/47/EC
ADMIN  2011-05-23 15:57:50, 議고쉶 : 783, 異붿쿇 : 96

[CE 씤利] 쓽猷뚭린湲 CE씤利/MDD씤利-씤利앹젅李-씤利앸퉬슜-EU吏移-93/42/EEC-2007/42/EC-移쇰━뀒뒪듃씤利앹썝(www.kalitest.co.kr)



A. Medical Device Derectives 93/42/EEC(1993뀈뿉 怨듯몴맂 넻빀쑀읇쓽 蹂댁궗遺怨좎떆)-2007/42/EC(媛쒖젙)

B. 쓽猷뚭린湲곗쓽 젙쓽 諛 踰붿쐞 (Definitions & Scop of Medical Devices )

C. 遺꾨쪟 (Classification)

D. 젅李 (Procedures )

E. 벑濡 (Registrantion)

F. 쓽猷뚯궗怨좎뿉 븳 넻蹂댁젅李 (Vigilance System)

G. 湲곗닠臾몄꽌 (Technical Documentations)



A.  Medical Device Derectives 93/42/ECC (1993뀈뿉 怨듯몴맂 넻빀쑀읇 쓽 蹂댁궗遺 怨좎떆)

- 1993뀈 6썡 14씪 쑀읇怨듬룞泥 쐞썝쉶(The Council of the European Communities)뿉꽌 쑀읇뿭궡 援誘쇰뱾쓽 嫄닿컯怨 븞쟾쓣 蹂댁옣븯湲 쐞븯뿬 쓽猷뚭린湲곗쓽 젣議, 쑀넻뿉 븳 洹쒖젙쓣 怨듯몴븯뿬 1998뀈 6썡 14씪 遺濡 媛뺤젣洹쒖젙쑝濡 쟻슜룄濡 踰뺤젣솕븳 吏移.

- MDD뒗 珥 23媛쒖쓽 議(Article) 12媛쒖쓽 遺냽꽌(Annex)濡 援ъ꽦릺뼱 엳쑝硫, 쓽猷뚭린湲곗뿉 븳 젙쓽, 遺꾨쪟, 씤利앹젅李, 쓽猷뚭린湲곌 媛뽰떠빞 븷 븘닔슂援ъ궗빆, 떆옣뿉 異쒗븯븷 寃쎌슦쓽 洹쒖젙궗빆, 쑀읇떦援뿉 蹂닿퀬빐빞 븷 궗빆 벑쓽 궡슜씠 怨좎떆릺뼱 엳떎.

- 뵲씪꽌, 쓽猷뚭린湲곕 쑀읇뿭궡뿉꽌 쑀넻떆궎젮硫 CE 留덊궧 븘닔쟻씠硫, 쓽猷뚭린湲곗쓽 쐞뿕 꽦뿉 뵲씪 Class1쓽 寃쎌슦뿉뒗 理쒖냼븳 湲곗닠臾몄꽌(TCF : Technical Construction File)瑜 媛뽰텛怨 쑀읇援媛쓽 蹂댁궗遺뿉 떊怨좊 븘빐빞 븯硫, Class 2 3쓽 寃쎌슦뿉뒗 쑀읇蹂댁궗遺뿉꽌 吏젙븳 怨듭씤湲곌(Notified Body)[移쇰━뀒뒪듃씤利앹썝(www.kalitest.co.kr)]뿉 떖궗瑜 諛쏆븘빞 CE瑜 遺李 븷 닔 엳떎.-移쇰━뀒뒪듃씤利앹썝(CE2179)

- MDD뒗 쓽猷뚭린湲 젣議곗뾽泥대굹 쑀넻뾽옄媛 뵲씪빞 븷 洹쒖젙궗빆 쇅뿉룄 쑀읇쓽 愿怨꾧린愿 (Competent Authority)씠굹 怨듭씤湲곌(Notified Body)[移쇰━뀒뒪듃씤利앹썝(www.kalitest.co.kr)]뿉 젣異, 떊怨, 벑濡 븯嫄곕굹 떖궗 諛쏆븘빞 븷 꽌瑜, 蹂닿퀬꽌, 떆뒪뀥 벑쓣 洹쒖젙븯怨 엳떎. 留뚯씪 쑀읇뿭궡뿉 젣뭹쓣 異쒗븯븯뿬 쓽猷뚯궗怨좉 諛쒖깮븯쓣 寃쎌슦뿉뒗 珥덇린蹂닿퀬瑜 鍮꾨’븯뿬 醫낅즺蹂닿퀬뿉 씠瑜닿린源뚯 뾼寃⑺븳 궗썑愿由ъ떆뒪뀥(Vigilance system)쓣 슂援ы븯怨 엳떎.



B. 쓽猷뚭린湲곗쓽 젙쓽 諛 踰붿쐞 (Definitions & Scop of Medical Devices )  

- 쟻슜踰붿쐞
쓽猷뚭린湲곗 洹 遺냽뭹뿉 쟻슜

- 젙쓽
"쓽猷뚭린湲곕" 湲곌린, 湲곌뎄, 옱猷, 臾쇱쭏 삉뒗 湲고 뭹紐⑹쑝濡쒖꽌 떒룆궗슜씠굹 議고빀궗슜쑝濡, 삉
쟻슜쓣 쐞빐 븘슂븳 냼봽듃썾뼱瑜 룷븿빐, 젣議곗옄媛 씤泥댁뿉쓽 궗슜쓣 쓽룄븯怨, 궗슜紐⑹쟻씠
쨌 吏덈퀝쓽 吏꾨떒, 삁諛, 議곗젙, 移섎즺, 寃쎄컧
쨌 遺긽씠굹 옣븷쓽 吏꾨떒, 삁諛, 議곗젙, 移섎즺, 寃쎄컧, 蹂댁“
쨌 빐遺븰 삉뒗 깮由ы븰쟻 쁽긽쓽 議곗궗, 泥, 議곗젙
쨌 엫떊議곗젅濡 洹 二쇰ぉ쟻쓣 떖꽦븯湲 쐞빐 빟븰, 硫댁뿭븰 삉뒗 湲댁쭊궗쓽 닔떒쓣 泥대궡 삉뒗
泥댄몴뿉꽌꽌 궗슜븯吏 븡吏留, 湲곕뒫쓣 蹂댁“븯湲 쐞빐 씠윭븳 닔떒쓣 궗슜븯뒗 寃껋씠 엳쓣
닔 엳쓬쓣 쓽誘명븳떎.

- 遺냽뭹(Accessory)
洹 옄泥대뒗 쓽猷뚭린湲곌 븘땲吏留, 젣議곗옄媛 쓽猷뚭린湲곗 븿猿 궗슜븯룄濡 듅蹂꾪엳 쓽룄븳
寃껋쑝濡쒖꽌, 젣議곗옄媛 쓽룄븯뒗 쓽猷뚭린湲 궗슜諛⑸쾿뿉 뵲씪 궗슜븷 닔 엳뒗 寃껋쓣 쓽誘명븳떎.

- 二쇰Ц삎 쓽猷뚭린湲(Custom-made Device)
쟻젙븳 옄寃⑹쓣 媛吏 쓽猷뚯쥌궗옄쓽 吏떆꽌뿉 뵲씪, 듅蹂꾪엳 젣議곕맂 쓽猷뚭린湲곕줈꽌, 洹 吏떆꽌
뿉뒗 媛숈 궗엺쓽 梨낆엫뿉 엳뼱 듅젙 꽕怨꾪듅꽦씠 湲곗닠릺怨, 듅젙솚옄 1씤뿉 빐꽌留 궗슜
븯뒗 쓽猷뚭린湲.

- 蹂 吏移⑥뿉 쟻슜릺吏 븡뒗 궗빆
泥댁쇅吏꾨떒슜 湲곌린, 옉룞 엫뵆듃, 빟뭹, 솕옣뭹, 媛쒖씤슜 蹂댄샇옣援, 궗엺쓽 삁븸, 삁옣, 꽭룷,
泥대궡 異붿텧臾, 룞臾쇱쓽 議곗쭅.



C. 遺꾨쪟 ( Classification)

- MDD Article 9쓽 (1)뿉 뵲씪 뀪, 뀫a, 뀫b, 뀬쓽 꽕媛吏 벑湲됱쑝濡 遺꾨쪟븯硫, 젣議곗옄媛 遺꾨쪟
洹쒖튃(Annex 9)뿉 뵲씪 옄쑉쟻쑝濡 遺꾨쪟. 留뚯빟, 遺꾨쪟뿉 븳 臾몄젣濡 遺꾩웳씠 깮湲 寃쎌슦
Article 9(2)뿉 뵲씪 理쒖쥌뙋떒 씤利앷린愿씠 냽븳 援媛쓽 踰뺤썝뿉꽌쓽 뙋寃곗뿉 쓽븯뒗 寃껋쑝濡
洹쒖젙릺뼱 엳떎.

- 媛숈 뭹紐⑹씠씪룄 궗슜紐⑹쟻怨 슚뒫, 궗슜릺뒗 떆媛 洹몃━怨 援ъ“굹 썝옄옱뿉 뵲씪 벑湲됱
떖씪吏 닔 엳떎.

- 遺꾨쪟湲곗(Classification criteria)
쨌 湲곌컙(Duration) : 엫떆-60遺 씠궡, 떒湲-30씪 씠븯, 옣湲-30씪 씠긽
쨌 궫엯 쓽猷뚭린湲(Invasive device) : 泥닿컯 삉뒗 뵾遺瑜 넻븯뿬 씤泥대궡뿉 쟾泥 삉뒗 遺遺꾩쟻쑝濡 궫엯 릺뒗 湲곌린
쨌 옉룞 쓽猷뚭린湲(Active device): 쟾湲곗쟻씤 뿉꼫吏굹 룞젰뿉 쓽빐 궗슜릺뒗 湲곌린

- 遺꾨쪟(Classification)
쨌 鍮꾩궫엯湲곌린(Non-invasive devices) : Rule 1댘4
쨌 궫엯湲곌린(Invasive devices) : Rule 5댘8
쨌 옉룞湲곌린(Active device) : Rule 9댘12
쨌 듅蹂꾧퇋移(Special rules) : Rule 13댘18



D. 젅李 (Procedures )

- 1벑湲됱쓽 씤利앹젅李

1. 젣뭹쓽 빐떦 EN, ISO, IEC 洹쒓꺽 솗씤
2. 洹쒓꺽쓣 꽕怨꾩뿉 諛섏쁺
3. 젣뭹쓽 쐞뿕꽦 遺꾩꽍(EN 1441)
4. 뀒뒪듃 諛 寃利
5. 湲곗닠臾몄꽌(TCF) 옉꽦
6. 쟻빀꽦꽑뼵(DOC)
7. 궗썑愿由 諛 蹂닿퀬떆뒪뀥(Vigilance system 샊 Medical device reporting) 援ъ텞
8. 쑀읇由ъ씤 꽑젙
9. 쑀읇뿉 떊怨
10. 벑濡앸쾲샇 遺뿬

- DOC (Declaration of conformity)

1벑湲됱 옄泥댁씤利앹젅李⑥뿉 뵲瑜대룄濡 Article 11(5), Annex 뀰뿉 洹쒖젙릺뼱 엳쑝硫, 뵲씪꽌 湲곗닠臾몄꽌 옉꽦 셿猷 썑 긽샇紐, 二쇱냼, 쟻슜맂 遺꾨쪟洹쒖튃, 젣뭹紐, 빐떦씤利앷린愿, 궇옄, 궗옣떂쓽 꽌紐낅벑씠 湲곗닠맂 옄泥 臾몄꽌瑜 옉꽦븯뿬 CE留덊겕瑜 遺李⑺븷 닔 엳떎. 씠븣 二쇱쓽빐빞 븷 궗빆 쑀읇뿭궡뿉 二쇱냼瑜 몦 쑀읇由ъ씤쓣 吏젙븯怨, 쑀읇쓽 떇빟泥뿉 떊怨좏븯뿬빞 븳떎.

- 2벑湲 씠긽쓽 씤利앹젅李
뀫벑湲 씠긽쓽 쓽猷뚭린湲곕뒗 1벑湲됱뿉 빐떦릺뒗 젅李⑥뿉 뭹吏덉떆뒪뀥 씤利앹젅李④ 異붽맂떎.
뭹吏덈낫利앹떆뒪뀥 洹쒓꺽씤 ISO 9001뿉 뜑븯뿬 쓽猷뚭린湲 젣議곗뾽옄쓽 듅蹂꾩슂援ъ궗빆씤 ISO 13485쓽 援ъ텞씠 븘슂븯떎. MDD뿉꽌뒗 씠 洹쒓꺽뱾뿉 븳 洹쒖젙 뾾쑝굹 遺遺꾩쓽 씤利앷린愿[移쇰━뀒뒪듃씤利앹썝(www.kalitest.co.kr)]뿉꽌 씠 洹쒓꺽쓽 씤利앹쓣 슂援ы븯怨 엳쑝誘濡 씠뿉 븳 以鍮꾨 媛뽰텛怨 떖궗瑜 떊泥븯뿬빞 븳떎. 뀫b벑湲 씠긽쓽 寃쎌슦뿉뒗 뭹吏덉떆뒪뀥 떖궗뿉 꽕怨꾨 룷븿븯뒗 寃껋씠 湲곌컙怨 鍮꾩슜硫댁뿉꽌 쑀由ы븯떎. 떖궗뒗 뭹吏덉떆뒪뀥 援ъ텞 썑 臾몄꽌떖궗, 쁽옣떖궗 닚쑝濡 吏꾪뻾맂떎.-移쇰━뀒뒪듃씤利앹썝(CE2179)

뭹吏덉떆뒪뀥쓣 援ъ텞븷 떆뿉 臾댁뾿蹂대떎 쑀쓽빐빞 븷 젏 젣議곕Ъ諛곗긽梨낆엫踰(PL)뿉 鍮꾪븯뿬 寃궗湲곕줉쓣 泥좎븯寃 궓湲곌퀬 濡쒗듃뿉 븳 異붿쟻씠 援щℓ뿉꽌 뙋留ㅺ퉴吏 씠猷⑥뼱吏寃 븯뒗 옉뾽씠떎. 삉븳, 듅蹂꾧났젙 怨듭젙뿉 븳 쑀슚꽦솗씤(Process Validation)쓣 떆뻾븯뿬빞 븯硫, 媛옣 寃됱쑝濡 뱶윭궇 닔 엳뒗 씪踰⑤쭅怨 궗슜옄꽕紐낆꽌쓣 援ъ꽦븷 븣룄 빐떦 洹쒖젙怨 洹쒓꺽뿉 쟻빀븯룄濡 꽭떖븳 二쇱쓽瑜 湲곗슱뿬빞 븳떎.

- COC(Certificate of conformity)
2벑湲 씠긽씤 寃쎌슦 씤利앷린愿 떖궗 썑 빐떦씤利앷린愿뿉꽌 떆뒪뀥 씤利앹꽌 諛 CE留덊겕 씤利앹꽌瑜 諛쒗뻾븳떎.

- 援궡뿉 엳뒗 CE 怨듭씤湲곌: 移쇰━뀒뒪듃씤利앹썝(www.kalitest.co.kr)-CE2179



E. 벑濡( Registrantion)

- 쑀읇由ъ씤(Authorized Reprezentative)
Article 14뿉 뵲씪 쑀읇뿭궡뿉 援ъ냼瑜 몦 由ъ씤 吏젙븯뿬 愿怨꾨떦援(Competent Authority)뿉 벑濡앺븯뿬빞 븯硫, 떎닔援뿉 떎닔쓽 由ъ씤 벑濡앸룄 媛뒫븯떎. 삉븳 1媛쒓뎅 벑濡앹쑝濡 쑀읇뿭궡 援媛뿉 젣뭹 뙋留ㅻ룄 媛뒫븯떎.

- 愿怨꾨떦援(Competent Authority)
쑀읇援媛쓽 떇빟泥 삉뒗 蹂댁궗遺뿉 빐떦릺硫, 吏젙맂 뼇떇쓣 궗슜븯뿬 떊怨좏븳떎.



F. 쓽猷뚯궗怨좎뿉 븳 넻蹂댁젅李( Vigilance System)

Article 10 뿉 뵲씪 쑀읇뿭궡 삉뒗 洹 쇅 吏뿭뿉꽌 諛쒖깮븳 쓽猷뚭린湲 궗怨좎뿉 븯뿬 MEDDEV 2뿉 뵲瑜 궗썑愿由ъ떆뒪뀥쓣 援ъ텞븯뿬빞 븳떎. 씠븣뿉뒗 Incident report form뿉 쓽븯뿬 愿怨꾨떦援뿉 珥덇린蹂닿퀬瑜 븯뿬빞 븯硫, 씠뿉뵲씪 愿怨꾨떦援뿉꽌 議곗궗瑜 떎떆븳떎.

젣議곗뾽泥대뒗 異붽 궗썑愿由щ굹 궗슜以묒씤 젣뭹뿉 븳 궗썑寃넗 삉뒗 떆젙議곗튂, 沅뚭퀬 넻吏臾(advisory notice)諛쒗뻾, 由ъ퐳(諛섏넚, 議곗젙/닔由, 援먰솚, 룓湲)벑쓽 議곗튂瑜 痍⑦븯怨 Final report form뿉 뵲씪 理쒖쥌蹂닿퀬瑜 떎떆븯뿬빞 븳떎.



G. 湲곗닠臾몄꽌 (Technical Documentations)

援궡뿉꽌 쓽猷뚭린湲 젣議곗뾽쓣 븯湲 쐞빐꽌뒗 빟궗踰뺤뿉 뵲씪 "湲곗 諛 떆뿕諛⑸쾿"쓣 옉꽦빐빞븯벏씠 쓽猷뚭린湲곗뿉 CE留덊겕瑜 遺李⑺븯湲 쐞빐꽌뒗 "湲곗닠臾몄꽌"瑜 옉꽦븯뿬빞 븳떎. 뵲씪꽌 젣議곗옄뒗 Annex뀰뿉 뵲씪 湲곗닠臾몄꽌(Technical documentation)瑜 옉꽦븯뿬빞 븳떎. 삉븳 젣議곗옄 쑀읇 由ъ씤 湲곗닠臾몄꽌瑜 理쒖쥌젣뭹쓣 젣議고븳 썑 쟻뼱룄 5뀈 씠긽 蹂댁쑀븯뿬빞 븯硫, 쑀읇쓽 愿怨꾨떦援뿉 젣異쒗븷 닔 엳뼱빞 븳떎.

湲곗닠臾몄꽌뿉 룷븿릺뼱빞 븷 궡슜 洹쒖젙릺뼱 엳吏 븡쑝굹 씪諛섏쟻쑝濡 떎쓬怨 媛숈씠 援ъ꽦맂떎.
- 씪諛섏궗빆 : 빐떦 궡슜씠 쉶궗쓽 湲곗닠쟻 湲곕궗빆엫쓣 紐낆떆, 臾몄꽌愿由ъ긽깭, 옉꽦/듅씤 諛 씪옄,
媛쒖젙궗빆, 紐⑹감, 쉶궗뿉 븳 냼媛 諛 愿젴洹쒓꺽
- 젣뭹꽕紐 : 젣뭹쓽 媛쒖슂/紐낆묶/紐⑤뜽紐/遺꾨쪟/벑湲, 슚뒫/듅꽦, 젣뭹꽕紐, 궗吏/꽕怨꾨룄/쉶濡쒕룄 벑, 궗슜옄 꽕紐낆꽌/移대떎濡쒓렇
- 븘닔슂援ъ궗빆 泥댄겕由ъ뒪듃 : MDD Annex I쓽 슂援ъ궗빆뿉 뵲瑜 利앷굅옄猷
- 愿젴臾몄꽌: 蹂닿퀬꽌 (硫멸퇏, 겕由곕8 쑀슚꽦 솗씤, 냼봽듃썾뼱 쑀슚꽦 솗씤, 쐞뿕꽦 遺꾩꽍) Test report, 씪踰, 궗슜옄 꽕紐낆꽌 빐떦洹쒓꺽 쐞뿕꽦遺꾩꽍-EN1441, 씪踰 諛 몴湲곗궗빆-EN980, EN1041, 쟾湲곌났넻-EN60601-1, EN60601-1-2, 硫멸퇏怨듯넻 -EN556, 깮泥댁쟻빀꽦-ISO 10993
- 썝옄옱 由ъ뒪듃 : 썝옄옱紐, 벑湲, 삎떇, 빐떦洹쒓꺽(ISO, EN, IEC, KS) 솕븰臾쇱쭏(MSDS, Technicl data), 쟾옄遺뭹(Spec 듅씤 뿬遺-CE, UL), Test report
- 젣議/QC 怨듭젙룄 : 쓲由꾨룄濡 옉꽦, 愿젴臾몄꽌踰덊샇 諛 蹂닿쐞移
- Test report : 빐떦 洹쒓꺽쓣 異⑹”떆궓떎뒗 옄猷, 떎瑜 湲곌린 議고빀릺뼱 궗슜릺뒗 寃쎌슦, 슂援ъ궗빆뿉 遺빀맂떎뒗 궡슜
- 쑀슚꽦 솗씤 寃곌낵 : 硫멸퇏, 냼봽듃썾뼱 쑀슚꽦 솗씤
- 쐞뿕꽦 遺꾩꽍 : EN 1441뿉 뵲瑜 쐞뿕꽦 遺꾩꽍 蹂닿퀬꽌
- 엫긽옄猷 : 븞쟾꽦, 쑀슚꽦뿉 븳 臾몄꽌(끉臾, 븰쉶吏 벑), 쑀궗젣뭹怨쇱쓽 鍮꾧탳, 뙋留 諛 怨좉컼遺덈쭔 湲곕줉 벑쑝濡 援ъ꽦
- 씪踰 諛 룷옣 : EN 980/1041, 빐떦젣뭹洹쒓꺽, Annex1쓽 13빆쓣 怨좊젮븯뿬 옉꽦. 룷옣Box쓽 移섏닔굹 옱吏덈룄 꽕紐
- EC Declaration ofconformity

쓽猷뚭린湲캜E/MDD씤利-93/42/EEC-2007/42/EC-移쇰━뀒뒪듃씤利앹썝(www.kalitest.co.kr)

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