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BOS ISO 7886_1_2017

P535.80

Sterile hypodermic syringes for single use — Part 1: Syringes for manual use

SKU: BOS ISO 7886_1_2017 Category: Product ID: 30105

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Description

This document specifies requirements and test methods for verifying the design of empty sterile single-use hypodermic syringes, with or without needle, made of plastic or other materials and intended for the aspiration and injection of fluids after filling by the end-users. This document does not provide requirements for lot release. The syringes are primarily for use in humans. Sterile syringes specified in this document are intended for use immediately after filling and are not intended to contain the medicament for extended periods of time.
It excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit for filling by a pharmacist).
Hypodermic syringes without a needle specified in this document are intended for use with hypodermic needles specified in ISO 7864.

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.
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