Ország: Fehéroroszország
Nyelv: orosz
Forrás: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)
Advanced Sterilization Products, Inc., СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ
изделия медицинского назначения
Advanced Sterilization Products
2019-11-29
159154-50 2020-10 _page 1 of 89_ Tyvek ® Pouch with STERRAD ™ Chemical Indicator (Heat Seal (125XX) and Self Seal (123XX)) Tyvek ® Roll with STERRAD ™ Chemical Indicator (124XX) © ASP 2021 33 Technology Drive, Irvine, CA 92618, USA +1(888)-STERRAD www.asp.com ADVANCED STERILIZATION PRODUCTS, INC. ASP, The Netherlands BV BIC 1 5657 BX Eindhoven, The Netherlands 159154-50 2020-10 _page 2 of 89_ ENGLISH 3 FRANÇAIS 6 DEUTSCH 9 ITALIANO 12 ESPAÑOL 15 PORTUGUÊS 18 БЪЛГАРСКИ 21 ČEŠTINA 24 DANSK 27 ΕΛΛΗΝΙΚΆ 30 EESTI 33 SUOMI 36 HRVATSKI 39 MAGYAR 42 BAHASA INDONESIA 45 日本語 48 LIETUVIŠKAI 51 LATVIEŠU 54 МАКЕДОНСКИ 57 NEDERLANDS 60 NORSK 63 POLSKI 66 ROMÂNĂ 69 РУССКИЙ 72 SLOVENSKY 75 SLOVENŠČINA 78 SVENSKA 81 TÜRKÇE 84 УКРАЇНСЬКА 87 159154-50 2020-10 _page 3 of 89_ Tyvek ® Pouch with STERRAD ™ Chemical Indicator (Heat Seal (125XX) and Self Seal (123XX)) Tyvek ® Roll with STERRAD ™ Chemical Indicator (124XX) INSTRUCTIONS FOR USE INDICATIONS FOR USE: Tyvek ® Pouches and Rolls with STERRAD ™ Chemical Indicator are intended to be used to enclose medical devices that are to be terminally sterilized in the STERRAD Sterilization Systems and Cycles, in a single or double pouch configuration, and to indicate, by color change, that the pouch has been exposed to sterilant. After completion of the sterilization process, the pouch/roll is intended to maintain sterility of the enclosed device until used. The pouches and rolls are printed with a chemical indicator bar which is a process indicator (ISO 11140‑1:2014 [Type I]) that changes from red to the color (or lighter) indicated on the comparator bar included on the shelf pack when exposed to hydrogen peroxide vapor during processing in the STERRAD Sterilization Systems. The pouches and rolls can be used in the STERRAD Sterilization Systems and Cycles shown in Table 1. TABLE 1: INDICATIONS FOR USE STERRAD / CYCLE SINGLE-CHANNEL STAINLESS STEEL LUMENS OTHER LUMENS LOAD REQUIREMENTS STERRAD 100S ≥1 mm ID x Olvassa el a teljes dokumentumot