Материалы расходные к стерилизаторам медицинским STERRAD: рулоны Тайвек с химическим индикатором STERRAD / Tyvek Roll with STERRAD Chemical Indicator,

Страна: Беларусь

Язык: русский

Источник: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Доступна с:

Advanced Sterilization Products, Inc., СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

класс:

изделия медицинского назначения

Производитель:

Advanced Sterilization Products

Дата Авторизация:

2022-02-18

Характеристики продукта

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