GOST ISO 11607-2011
Packaging for terminally sterilized medical devices. General requirements

Standard No.

GOST ISO 11607-2011

Release Date

2011

Published By

RU-GOST R

Status

Be replaced 2018-06

Replace By

GOST ISO 11607-2-2018

Latest

GOST ISO 11607-2-2018

GOST ISO 11607-2011 Referenced Document

• ISO 11140-1:1995 Sterilization of health care products - Chemical indicators - Part 1: General requirements
• ISO 186:1994 Paper and board - Sampling to determine average quality
• ISO 2859-1:1989 Sampling procedures for inspection by attributes — Part 1: Sampling plans indexed by acceptable quality level (AQL) for lot-by-lot inspection
• ISO 9001:2000 Quality management systems - Requirements

GOST ISO 11607-2011 history

• 2018 GOST ISO 11607-2-2018 Packaging for terminally sterilized medical devices. Part 2. Validation requirements for forming, sealing and assembly processes
• 2011 GOST ISO 11607-2011 Packaging for terminally sterilized medical devices. General requirements