Baz\u0131 belirli Japon Sa\u011fl\u0131k \u00dcr\u00fcnleri i\u00e7in kullan\u0131m s\u00fcresi g\u00f6sterimi gereklidir (Japon \u0130la\u00e7 Makineleri Yasas\u0131 59. Madde 10. F\u0131kra).<\/p>\n\n\n\n
Kullan\u0131m s\u00fcresi g\u00f6sterimi gereken Japon Sa\u011fl\u0131k \u00dcr\u00fcnleri, 1980 y\u0131l\u0131nda (Showa 55) Japon Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131’n\u0131n 116 numaral\u0131 bildirisi ile a\u015fa\u011f\u0131daki gibi belirlenmi\u015ftir. Ancak, \u00fcretim veya ithalat sonras\u0131 uygun saklama ko\u015fullar\u0131 alt\u0131nda \u00fc\u00e7 y\u0131l\u0131 a\u015fk\u0131n bir s\u00fcre boyunca \u00f6zellikleri ve kalitesi stabil olan Japon Sa\u011fl\u0131k \u00dcr\u00fcnleri bu kapsam\u0131n d\u0131\u015f\u0131ndad\u0131r.<\/p>\n\n\n\n
\n1. Ascorbic asit, esterleri ve tuzlar\u0131 preparatlar\u0131
2. Peroksit bile\u015fikleri ve preparatlar\u0131
3. Bal\u0131k ya\u011f\u0131 ve preparatlar\u0131 (Japon Sa\u011fl\u0131k \u00dcr\u00fcnleri, t\u0131bbi cihazlar vb. kalite, etkinlik ve g\u00fcvenlik sa\u011flama hakk\u0131ndaki yasa uygulama emri (1961 y\u0131l\u0131nda (Showa 36) 11 numaral\u0131 h\u00fck\u00fcmet emri) 20. Madde 2. F\u0131kra h\u00fck\u00fcmlerine g\u00f6re Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakan\u0131 taraf\u0131ndan belirlenen Japon Sa\u011fl\u0131k \u00dcr\u00fcnleri ile s\u0131n\u0131rl\u0131d\u0131r.)
4. Enzimler ve preparatlar\u0131
5. Sistein ve hidroklor\u00fcr tuzlar\u0131 preparatlar\u0131
6. Tiamin, t\u00fcrevleri ve tuzlar\u0131 preparatlar\u0131
7. Tioglikolik asit ve tuzlar\u0131 preparatlar\u0131
8. Tokoferol preparatlar\u0131
9. Laktik asit bakterileri ve preparatlar\u0131
10. K\u00f6p\u00fck tipi preparatlar
11. Parafenilendiamin vb. oksidatif boyalar\u0131n preparatlar\u0131
12. Vitamin A ya\u011f\u0131 preparatlar\u0131
13. Piretroid tipi insektisit bile\u015fenlerin tozlar\u0131
14. Organik fosfor tipi insektisit bile\u015fenlerin zehirli yemleri veya tozlar\u0131
15. Retinol ve esterleri preparatlar\u0131
16. Yukar\u0131daki maddeler d\u0131\u015f\u0131nda, 14. veya 19.2 maddelerine dayal\u0131 onay konular\u0131 olarak etkin s\u00fcre belirlenen Japon Sa\u011fl\u0131k \u00dcr\u00fcnleri<\/p>\n1980 y\u0131l\u0131nda (Showa 55) Japon Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakanl\u0131\u011f\u0131’n\u0131n 116 numaral\u0131 bildirisi<\/cite><\/blockquote>\n\n\n\n<\/span>T\u00fcrler<\/span><\/h3>\n\n\n\n\u00d6nceden belirtilen s\u0131n\u0131fland\u0131rmaya g\u00f6re, t\u0131bbi cihazlar\u0131n t\u00fcrlerine ili\u015fkin g\u00f6sterimlerin ambalaj vb. \u00fczerinde yap\u0131lmas\u0131 zorunlu hale getirilmi\u015ftir.<\/p>\n\n\n\n
\u0130la\u00e7 Makinesi Yasas\u0131’n\u0131n (Japanese Pharmaceutical and Medical Device Act) 2. maddesinin 2. f\u0131kras\u0131n\u0131n 2. bendi taraf\u0131ndan belirlenen, insan veya hayvan sa\u011fl\u0131\u011f\u0131 i\u00e7in fare, sinek, sivrisinek, pire ve bunlarla benzer canl\u0131lar\u0131n kontrol\u00fc amac\u0131yla kullan\u0131lan ve mekanik aletler vb. olmayan \u00fcr\u00fcnler i\u00e7in, “Kontrol Ama\u00e7l\u0131 T\u0131bbi Cihaz” ifadesinin kullan\u0131lmas\u0131 gerekmektedir.<\/p>\n\n\n\n
Dahas\u0131, kontrol ama\u00e7l\u0131 t\u0131bbi cihazlar aras\u0131nda, insan v\u00fccuduna do\u011frudan uygulanan bit \u00f6ld\u00fcr\u00fcc\u00fc insektisitler vb. hari\u00e7 olmak \u00fczere, “Dikkat – \u0130nsan v\u00fccudunda kullanmay\u0131n” ifadesinin kullan\u0131lmas\u0131 da gerekmektedir.<\/p>\n\n\n\n
Ayr\u0131ca, \u0130la\u00e7 Makinesi Yasas\u0131’n\u0131n (Japanese Pharmaceutical and Medical Device Act) 59. maddesinin 7. bendine dayanarak Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakan\u0131 taraf\u0131ndan belirlenen “Belirlenmi\u015f T\u0131bbi Cihazlar” i\u00e7in, “Belirlenmi\u015f T\u0131bbi Cihaz” ifadesinin kullan\u0131lmas\u0131 gerekmektedir.<\/p>\n\n\n\n
Ve bu t\u00fcrlerin d\u0131\u015f\u0131ndaki t\u0131bbi cihazlar (\u00f6nceden belirtilen 6 madde) i\u00e7in, “T\u0131bbi Cihaz” ifadesinin kullan\u0131lmas\u0131 gerekmektedir.<\/p>\n\n\n\n
G\u00f6sterilmesi gereken ifadeleri \u00f6zetlersek, a\u015fa\u011f\u0131daki gibidir:<\/p>\n\n\n\n
\n- \u0130la\u00e7 Makinesi Yasas\u0131’n\u0131n (Japanese Pharmaceutical and Medical Device Act) 2. maddesinin 2. f\u0131kras\u0131n\u0131n 2. bendinin t\u0131bbi cihazlar\u0131 (insektisitler vb.) – “Kontrol Ama\u00e7l\u0131 T\u0131bbi Cihaz”, do\u011frudan insan v\u00fccudunda kullan\u0131lmayanlar i\u00e7in “Dikkat – \u0130nsan v\u00fccudunda kullanmay\u0131n”<\/li>\n\n\n\n
- \u0130la\u00e7 Makinesi Yasas\u0131’n\u0131n (Japanese Pharmaceutical and Medical Device Act) 59. maddesinin 7. bendine dayanarak Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakan\u0131 taraf\u0131ndan belirlenen belirlenmi\u015f t\u0131bbi cihazlar – “Belirlenmi\u015f T\u0131bbi Cihaz”<\/li>\n\n\n\n
- Yukar\u0131dakiler d\u0131\u015f\u0131nda – “T\u0131bbi Cihaz”<\/li>\n<\/ul>\n\n\n\n
<\/span>\u0130sim ve \u0130\u00e7erik Miktar\u0131 vb.<\/span><\/h3>\n\n\n\n\u0130la\u00e7 d\u0131\u015f\u0131 \u00fcr\u00fcnler i\u00e7in, \u00fcr\u00fcnle ilgili a\u015fa\u011f\u0131daki bilgilerin g\u00f6sterilmesi de gereklidir.<\/p>\n\n\n\n
\n- \u00dcretici veya sat\u0131c\u0131 firman\u0131n ad\u0131 veya unvan\u0131 ve adresi (Japon \u0130la\u00e7 Makineleri Yasas\u0131 59. Madde 1. F\u0131kra)<\/li>\n\n\n\n
- \u0130la\u00e7 d\u0131\u015f\u0131 \u00fcr\u00fcn\u00fcn ad\u0131 (Japon \u0130la\u00e7 Makineleri Yasas\u0131 59. Madde 4. F\u0131kra)<\/li>\n\n\n\n
- \u00dcretim numaras\u0131 veya \u00fcretim i\u015fareti (Japon \u0130la\u00e7 Makineleri Yasas\u0131 59. Madde 5. F\u0131kra)<\/li>\n\n\n\n
- A\u011f\u0131rl\u0131k, dozaj veya say\u0131 gibi i\u00e7erik miktar\u0131 (Japon \u0130la\u00e7 Makineleri Yasas\u0131 59. Madde 6. F\u0131kra)<\/li>\n\n\n\n
- Standartlar\u0131 Japon \u0130la\u00e7 Yasas\u0131 42. Madde 2. F\u0131kra h\u00fck\u00fcmlerine g\u00f6re belirlenen ila\u00e7 d\u0131\u015f\u0131 \u00fcr\u00fcnler i\u00e7in belirli konular (Japon \u0130la\u00e7 Makineleri Yasas\u0131 59. Madde 11. F\u0131kra)<\/li>\n<\/ul>\n\n\n\n
Not: “Standartlar\u0131 Japon \u0130la\u00e7 Yasas\u0131 42. Madde 2. F\u0131kra h\u00fck\u00fcmlerine g\u00f6re belirlenen ila\u00e7 d\u0131\u015f\u0131 \u00fcr\u00fcnler” i\u00e7in, asl\u0131nda standartlar\u0131 belirlenen ila\u00e7 d\u0131\u015f\u0131 \u00fcr\u00fcn bulunmamaktad\u0131r.<\/p>\n\n\n\n
<\/span>Bile\u015fen Adlar\u0131<\/span><\/h3>\n\n\n\n\u00d6nleyici ve tedavi edici ila\u00e7lar ile belirli ila\u00e7lar hakk\u0131nda, Japon \u0130la\u00e7lar ve T\u0131bbi Cihazlar Yasas\u0131’n\u0131n (Pharmaceuticals and Medical Devices Act) 59. ve 7. maddelerine dayanarak, etkin bile\u015fenin ad\u0131n\u0131n (genel bir ad\u0131 varsa) ve miktar\u0131n\u0131n belirtilmesi gerekmektedir.<\/p>\n\n\n\n
Ayr\u0131ca, Japon Sa\u011fl\u0131k, \u00c7al\u0131\u015fma ve Refah Bakan\u0131 taraf\u0131ndan belirlenen bile\u015fenleri i\u00e7eren ila\u00e7lar hakk\u0131nda, bu bile\u015fenlerin adlar\u0131n\u0131n belirtilmesi de zorunlu hale getirilmi\u015ftir.<\/p>\n\n\n\n
\u00d6rne\u011fin, parf\u00fcm i\u00e7eren ila\u00e7lar (v\u00fccuda do\u011frudan uygulananlar) hakk\u0131nda, parf\u00fcm i\u00e7erdi\u011fini belirten bir ifadenin kullan\u0131lmas\u0131 gerekti\u011fi y\u00f6n\u00fcnde bir bildiri bulunmaktad\u0131r (1980 (Showa 55) y\u0131l\u0131 9 Ekim tarihli \u0130la\u00e7 Bildirisi 1330).<\/p>\n\n\n\n
<\/span>Di\u011fer<\/span><\/h3>\n\n\n\nYukar\u0131dakilere ek olarak, Japon \u0130la\u00e7 Makinesi Yasas\u0131’n\u0131n (Pharmaceuticals and Medical Devices Act) 60. maddesi, 52. maddenin 1. f\u0131kras\u0131n\u0131n 1. bendinin h\u00fck\u00fcmlerini uygular ve bu nedenle, t\u0131bbi cihazlar\u0131n ek belgelerinde, kullan\u0131m \u015fekli ve dozu (onaylanm\u0131\u015f kullan\u0131m \u015fekli ve doz), di\u011fer kullan\u0131m ve i\u015flemle ilgili gereken dikkat noktalar\u0131n\u0131 belirtmek gerekmektedir.<\/p>\n\n\n\n
Ayr\u0131ca, baz\u0131 t\u0131bbi cihazlar i\u00e7in, belirli bir bildiriye dayanarak belirtilmesi gereken hususlar belirlenmi\u015ftir.<\/p>\n\n\n\n
Tersine, Japon \u0130la\u00e7 Makinesi Yasas\u0131’n\u0131n (Pharmaceuticals and Medical Devices Act) 60. maddesi, 54. maddenin uygulanmas\u0131yla, a\u015fa\u011f\u0131daki hususlar\u0131n belirtilmesi yasakt\u0131r:<\/p>\n\n\n\n
\n- Yan\u0131lt\u0131c\u0131 veya yan\u0131lt\u0131c\u0131 bilgiler<\/li>\n\n\n\n
- Onaylanmam\u0131\u015f etkinlik ve etkiler<\/li>\n\n\n\n
- Sa\u011fl\u0131k ve hijyen a\u00e7\u0131s\u0131ndan tehlikeli olan kullan\u0131m \u015fekli, doz veya kullan\u0131m s\u00fcresi<\/li>\n<\/ul>\n\n\n\n