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>BSI Standards >11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.70 Ophthalmic equipment>BS EN ISO 16671:2025 - TC Tracked Changes. Ophthalmic implants. Irrigating solutions for ophthalmic surgery
immediate downloadReleased: 2025-06-27
BS EN ISO 16671:2025 - TC Tracked Changes. Ophthalmic implants. Irrigating solutions for ophthalmic surgery

BS EN ISO 16671:2025 - TC

Tracked Changes. Ophthalmic implants. Irrigating solutions for ophthalmic surgery

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Standard number:BS EN ISO 16671:2025 - TC
Pages:81
Released:2025-06-27
ISBN:978 0 539 37585 5
Status:Tracked Changes
DESCRIPTION

BS EN ISO 16671:2025 - TC


This standard BS EN ISO 16671:2025 - TC Tracked Changes. Ophthalmic implants. Irrigating solutions for ophthalmic surgery is classified in these ICS categories:
  • 11.040.70 Ophthalmic equipment
This document defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer. This document applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.
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