UNLIMITED FREE
ACCESS TO THE WORLD'S BEST IDEAS

SUBMIT
Already a GlobalSpec user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your GlobalSpec Experience

Select Your Free Newsletters

Industry Newsletters

Select Your Free Product Alerts

Finish!
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

BSI - BS EN ISO 11607-2 - TC

Tracked Changes (Redline) - Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes

inactive
Buy Now
Organization: BSI
Publication Date: 9 August 2019
Status: inactive
Page Count: 57
ICS Code (Sterilized packaging): 11.080.30

Document History

BS EN ISO 11607-2 - TC
November 12, 2020
Tracked Changes (Redline) - Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
A description is not available for this item.
BS EN ISO 11607-2 - TC
August 9, 2019
Tracked Changes (Redline) - Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
A description is not available for this item.

References

This document references:
AAMI ST65 - Processing of reusable Surgical textiles for use in health care facilities
Published by AAMI on January 1, 2008
General This recommended practice provides guidelines for properly handling, processing, and preparing reusable surgical textiles for use in health care facilities. These guidelines describe a...
This document references:
AAMI ST77 - Containment devices for reusable medical device sterilization
Published by AAMI on January 1, 2013
General This standard applies to containment devices intended for use in sterilizing reusable medical devices in health care facilities. NOTE—For purposes of this standard, “health care facilities”...
This document references:
AAMI ST90 - Processing of health care products-Quality management systems for processing in health care facilities
Published by AAMI on January 1, 2017
This document is intended for sterile processing personnel and specifies minimum requirements for a quality management system (QMS) in a health care organization to effectively, efficiently, and...
This document references:
EN 13795-1 - Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
Published by CEN on April 1, 2019
This document specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing...
This document references:
EN 868-5 - Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
Published by CEN on December 1, 2018
This document specifies test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with...
View Less
View All
Advertisement