Low prices! Originals & Translations! Save your budget and time!
ONLINENORMS: Online Standards Store
Click View Shopping Cart
  1. Home
  2. DANSK
  3. DANSK DS/EN ISO 11607-2 PDF

DANSK DS/EN ISO 11607-2 PDF

DANSK DS/EN ISO 11607-2 PDF

Name:
DANSK DS/EN ISO 11607-2 PDF

Published Date:
01/20/2020

Status:
[ Active ]

Description:

Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

Publisher:
Dansk Standard

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Russian version):
200 business days
SKU:
Choose Document Language:
$19.2
Need Help?
SAME AS ISO 11607-2

This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized. It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.


Edition : 20#
File Size : 1 file , 1.9 MB
Number of Pages : 26
Product Code(s) : DS-026, DS-026
Published : 01/20/2020

History

DANSK DSF/EN ISO 11607-2/PRA1
DANSK DSF/EN ISO 11607-2/PRA1
Published Date:
Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
$12
DANSK DS/EN ISO 11607-2
DANSK DS/EN ISO 11607-2
Published Date: 01/20/2020
Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
$19.2
DANSK DS/EN ISO 11607-2
DANSK DS/EN ISO 11607-2
Published Date: 07/31/2017
Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
$19.2
DANSK DS/EN ISO 11607-2
DANSK DS/EN ISO 11607-2
Published Date: 04/20/2006
Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes
$19.2

Related products

DANSK DSF/ISO/DIS 9012
DANSK DSF/ISO/DIS 9012
Published Date:
Gas welding equipment – Air-aspirated hand blowpipes – Specifications and tests
$9.6
DANSK DS/EN 60512-14-4
DANSK DS/EN 60512-14-4
Published Date: 07/05/2006
Connectors for electronic equipment - Tests and measurements - Part 14-4: Sealing tests - Test 14d: Immersion - Waterproof
$11.4
DANSK DSF/PREN ISO 14246
DANSK DSF/PREN ISO 14246
Published Date:
Gas cylinders – Cylinder valves – Manufacturing tests and examinations (ISO/DIS 14246:2021)
$8.7
DANSK DS/EN 13523-16
DANSK DS/EN 13523-16
Published Date: 11/29/2004
Coil coated metals - Test methods - Part 16: Resistance to abrasion
$11.4

Best-Selling Products

NEN NEN 1006+A1
NEN NEN 1006+A1
Published Date: 06/01/2018
Algemene voorschriften voor leidingwaterinstallaties
$15.9
NEN NEN 1010
NEN NEN 1010
Published Date: 01/01/2020
Elektrische installaties voor laagspanning – Nederlandse implementatie van de HD-IEC 60364-reeks
$130.8
NEN NEN 1059
NEN NEN 1059
Published Date: 06/01/2019
Nederlandse editie op basis van NEN-EN 12186 en NEN-EN 12279 - Gasvoorzieningsystemen - Gasdrukregel- en meetstations voor transport en distributie
$26.4
NEN NEN 11298-2
NEN NEN 11298-2
Published Date: 10/01/1995
Process measurement and control devices - General methods and procedures for evaluating performance - Part 2: Test under reference conditions
$17.1
NEN NEN 2075
NEN NEN 2075
Published Date: 09/01/2018
Quality measuring system and process control system for cleaning performance
$19.8
NEN NEN 2767‐1+C1
NEN NEN 2767‐1+C1
Published Date: 05/01/2019
Condition assessment built environment ‐ Part 1: Methodology
$21.3