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BOS ISO 11607-1:2019

P627.00

Packaging for terminally sterilized medical devices —
Part 1: Requirements for materials, sterile barrier systems and packaging systems.

SKU: BOS ISO 11607-1:2019 Category: Product ID: 27617

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Description

This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized. It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations. It does not describe a quality assurance system for control of all stages of manufacture.It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.

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.

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