Country: Իտալիա
language: անգլերեն
source: 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 read_full_document
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 read_full_document