Krajina: Taliansko
Jazyk: angličtina
Zdroj: Ministero della Salute
Coldsterilizing solution, based on Adazone and Peracetic acid, to be used in ERS, endoscopes sterilizer.
INTERNATIONAL MEDICAL SERVICE
D050102
ACTIVATED AND DILUTED SOLUTION Adazone (5,7-diphenyl-1,3 diazoadamantan-6-one) 0.00055 g., peracetic acid 0,0900 g., excipients and purified water q.s. to 100 ml.
10000 ml size, I box contains 2 cans with buffer and activator
Adazone and Peracetic acid
Connect one bottle of Solution A and one bottle of Solution B to the automated single shot sterilizer endoscope reprocessors ERS (manufactured by CISA) according to the Operator's Manual.
Adaspor sterilizes in 5 minutes.
SAFETY DATA SHEET ADASPOR ERS MEDICAL DEVICE _CLASS IIB_ IDENTIFICATION CODE ADA/CE/29 IMS SRL CHEMICAL AND HEALTCARE COMPANY VIA LAURENTINA 169 00040 POMEZIA (RM) ED. 1 REV. 9 ON: 27.10.2010 PAGE 1/6 EDITED IN ACCORDANCE WITH ATTACHMENT II OF THE REGULATION N. 1907/2006 OF THE EUROPEAN PARLIAMENT AND COMMITTEE (OFFICIAL EUROPEAN JOURNAL L 136/84 OF 29.05.2007) 1. IDENTIFICATION OF SUBSTANCE OR PRODUCT AND COMPANY/MANUFACTURER 1.1 IDENTIFICATION OF THE PRODUCT ADASPOR ERS Chemical denomination: water solution of adazone and peracetic acid Medical Device classification: classe IIb - Directive 2007/47/EC 1.2 USE OF THE PRODUCT Cold sterilant solution for Medical Devices to be used only in ERS Automated sterilizer 1.3 COMPANY IDENTIFICATION IMS srl - Via Laurentina, n. 169 – 00040 Pomezia (RM) 1.4 EMERGENCY PHONE Italy: +39 - 06/9145399 2. HAZARD IDENTIFICATION 2.1 CLASSIFICATION OF DANGEROUSNESS End product is not classifiable as dangerous product 2.2 CLASSIFICATION OF INGREDIENTS The active ingredient peracetic acid is a dangerous product. 2.3 HAZARD IDENTIFICATION SOLUTION A (containing peracetic acid 5%) is corrosive and comburent. THE PRUDUCT, ACTIVATED AND DILUTED AND SOLUTION B (containing Adazone and coformulants ) does not show hazard indications on the label 2.3.1 INGESTION SOLUTION A is noxious for ingestion 2.3.2 SKIN CONTACT SOLUTION A is noxious for contact with skin SOLUTION A can cause severe burns 2.3.3 EYE CONTACT SOLUTION A is noxious for contact with eyes 2.3.4 INHALATION SOLUTION A IS NOXIOUS FOR INHALATION 2.3.5 EFFECTS ON TARGET ORGAN ///// 2.3.6 EFFECTS ON SEXUAL REPRODUCTION ///// 2.3.7 MUTAGENIC EFFECTS ///// 2.3.8 SENSIBILIZATION End product doesn’t cause sensibilization 2.4 WARNINGS End product should be handled by qualified personnel with appropriated safety rules. SAFETY DATA SHEET Prečítajte si celý dokument
IMS SRL CHEMICAL AND HEALTHCARE COMPANY VIA LAURENTINA 169 00040 POMEZIA (RM) TECHNICAL DATA SHEET ADASPOR ERS MEDICAL DEVICE _CLASS IIB _ IDENTIFICATIFICATION CODE ADA/CE/29 ED. 1 REV. 9 ON: 01.07.2014 PAG. 1/6 1. MEDICAL DEVICE NAME ADASPOR ERS 0 5 4 6 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Activated solution/diluted (A + B) - Adazone (5,7-diphenyl-1,3-diazoadamantan-6-one, CAS n. 263768-83-8) g 0,00055 - Peracetic acid g 0,09000 - Coformulants (stabilisers, buffers, anticorrosives) and purified water to ml 100,0 3. PRODUCT PRESENTATION DESCRIPTION OF THE ACTIVATED SOLUTION (A+B): Concentrated sterilizing solution, with sporicidal, tuberculocidal, virucidal, fungicidal and bactericidal activity for the sterilization of endoscopes and invasive and non invasive medical devices exclusively in automated ERS ( CISA ) reprocessors ( AER ). PACKAGING: 2 tanks (10000 ml or 5000 ml Solution A and 10000 ml or 5000 ml Solution B) in one case. 4. MICROBIOLOGICAL ACTIVITY AND PROPERTIES STERILISING ACTIVITY ACCORDING TO UNI EN ISO14937:2002 PAR 5.3.1 AND COMPLIES TO UNI EN ISO 11138-1:2006 METHODS EMPLOYED UNI EN 14937:2002 PAR 5.3.1 AND UNI EN ISO 11138-1:2006 STRAINS EMPLOYED _Bacillus subtilis_ ATCC 6633 _Bacillus cereus_ CIP 7803 _Clostridium sporogenes_ ATCC 19404 _Geobacillus stearothermophylus_ ATCC 7953 _Candida albicans_ ATCC 10231 _Aspergillus niger_ ATCC 16404 _Mycobacterium terrae_ ATCC 15755 _Pseudomonas aeruginosa_ ATCC 15442 _Staphylococcus aure Prečítajte si celý dokument