Комплект инструментов для рентгенэндоваскулярной операционной и его комплектующие: кабели соединительные для катетеров диагностических и аблационных

Страна: Беларусь

Язык: русский

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

Доступна с:

Irvine Biomedical, Inc. a St. Jude Medical Company, СОЕДИНЕННЫЕ ШТАТЫ АМЕРИКИ

класс:

изделия медицинского назначения

Производитель:

Irvine Biomedical

Дата Авторизация:

2021-05-27

Характеристики продукта

CARDIOVASCULAR AND ABLATION TECHNOLOGIES
DIVISION
Document No. 90152516
Ver. A
DHF No: N/A
Document Type: Shelf Life / Accelerated Aging
Protocol __ Report X
Product: N/A
Page: 1 of 10
DOCUMENT NAME:
Packaging Accelerated Aging Shelf Life Report for SBS systems using
the Tyvek/Poly
pouch material
_This confidential document is the property of St. Jude Medical and
shall not be reproduced, distributed, disclosed or used without the
express written consent of _
_St. Jude Medical. _
1.0
PURPOSE
The purpose of this testing was to verify the stability, after 3 years
accelerated aging, of all Sterile
Barrier Systems (SBS) assembled by or for St. Jude Medical Irvine
using pouch materials consisting
of DuPont® Mangar 92 GA PET/ .002LDPE, U/C 1073B Tyvek. All SJM
Irvine pouch part
numbers using the same sealing methodology and materials of
construction can be addressed by this
report with appropriate assessments/ rationale.
2.0
SCOPE
The scope of this report is to specify the tests, test parameters,
sample sizes and rationale used to
determine the shelf life stability for SBS and the materials that make
up those systems and verify
their ability to maintain integrity and strength over time using
accelerated aging principals.
3.0
APPLICABLE DOCUMENTS
3.1
APPLICABLE DOCUMENTS
DOCUMENT
NUMBER
TITLE
VERSION
90082940
Design FMEA, Cables Family
A
90002587
Design Verification WI
G
3.2
REFERENCE DOCUMENTS
DOCUMENT
NUMBER
TITLE
VERSION
ISO 11607-
1:2006
Packaging for Terminally Sterilized Medical Devices: Part 1
Standard
ISO 11607-
2:2006
Packaging for Terminally Sterilized Medical Devices: Part 2
Standard
ASTM
International
F1886-09
Standard Test Method for Determining Integrity of Seals for
Flexible Packaging by Visual Inspection
Standard
ASTM
International
F2096-11
Standard Test Method for Detecting Gross Leaks in Porous Medical
Packaging by Internal Pressurization
Standard
ASTM
International
F88M-09
Standard Test Method for Seal Strength of Flexible Barrier Materials
Standard
ASTM
International
Standard Guide for Accelerated Ag