AAMI/ISO 11607-2:2019/A1:2023 PDF

Name:
AAMI/ISO 11607-2:2019/A1:2023 PDF

Published Date:
2024

Status:
Active

Description:

Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes Amendment 1: Application of risk management

Document status:

Active

Format:

Electronic (PDF)

Delivery time:

10 minutes

Delivery time (for Russian version):

200 business days

SKU:

This amendment adds Annex B on risk management and related modifications to the text.

ANSI :	ANSI Approved
File Size :	1 file , 320 KB
ISBN(s) :	9781570209000
Note :	This product is unavailable in Ukraine, Russia, Belarus
Number of Pages :	18
Published :	2024

Published Date: 02/04/2024

Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials

$60.3

Published Date: 09/23/2008

Aseptic processing of health care products - Part 6: Isolator systems

$44.7

Published Date: 01/11/2005

Published Date: 10/26/2005

Published Date: 04/01/1988

$39