Skip to content Skip to footer
0 items - P0.00 0

BOS ISO 11607-2:2019

P421.80

Packaging for terminally sterilized medical devices — Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes

SKU: BOS ISO 11607-2:2019 Category: Product ID: 27618

Additional information

ICS Code

ICS Name

Edition

Pages

Published Date

Replaced by

Replaces

Sector

Standard Development Stage

Standard Status

Technical Committee

Type of Standards

Description

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. 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.

IMPARTIALITY AND CONFIDENTIALITY STATEMENT
The Botswana Bureau of Standards (BOBS) understands the importance of impartiality and confidentiality in carrying out its management system certification activities. BOBS management is committed to gaining and maintaining the reputation, credibility and ultimately, confidence of its stakeholders in rendering its certification services. Additionally, BOBS strives to continuously manage foreseen potential conflicts of duty and interest and ensures objectivity of its activities under the management system certification. To achieve the above, BOBS shall identify, analyse, record and manage potential conflict of duty and interest to ensure that certification services are not provided within relationships that have been identified to pose an unacceptable threat to impartiality. An Impartiality Committee shall periodically review activities of the certification function to verify commitment to credibility and fairness. The Committee shall further assist in the development of policies relating to impartiality of providing certification activities. BOBS is committed to maintaining in strict confidence all information accessed while rendering the certification services and shall ensure that such information is not divulged to third parties without the Client’s written consent unless if required by law.
Demand Quality

When things don't work as they should, it often means that standards are absent.

BOBS Head Office
Physical Address —
Plot No, 55745, Block 8, Mail Airport Road
Postal Address —
Private Bag B048,
Gaborone, Botswana
Francistown office

Physical Address —
Plot No, 44149, MVA Fund House,
1st Floor, Behind Galo Mall
Postal Address —
Private Bag F465,
Francistown, Botswana

BOBS Weighbridge
Physical Address —
Plot No: 20683, Ramakukane
Road, Block 3 Industrial,
Gaborone, Botswana
BOBS © Copyright 1992 – 2024. All Rights Reserved. Developed by Weblogic.
Go to Top