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Homepage>BS Standards>11 HEALTH CARE TECHNOLOGY>11.040 Medical equipment>11.040.70 Ophthalmic equipment>BS EN ISO 15798:2022 Ophthalmic implants. Ophthalmic viscosurgical devices
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immediate downloadReleased: 2022-07-19
BS EN ISO 15798:2022 Ophthalmic implants. Ophthalmic viscosurgical devices

BS EN ISO 15798:2022

Ophthalmic implants. Ophthalmic viscosurgical devices

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Standard number:BS EN ISO 15798:2022
Pages:32
Released:2022-07-19
ISBN:978 0 539 12121 6
Status:Standard
BS EN ISO 15798:2022 Ophthalmic Implants. Ophthalmic Viscosurgical Devices

BS EN ISO 15798:2022 Ophthalmic Implants. Ophthalmic Viscosurgical Devices

Standard Number: BS EN ISO 15798:2022

Pages: 32

Released: 2022-07-19

ISBN: 978 0 539 12121 6

Name: Ophthalmic implants. Ophthalmic viscosurgical devices

Status: Standard

Overview

Introducing the BS EN ISO 15798:2022, a comprehensive standard dedicated to ophthalmic implants and ophthalmic viscosurgical devices. This essential document is a must-have for professionals in the field of ophthalmology, providing detailed guidelines and specifications to ensure the highest quality and safety in ophthalmic surgical procedures.

Key Features

  • Comprehensive Coverage: Spanning 32 pages, this standard offers an in-depth look at the requirements and best practices for ophthalmic implants and viscosurgical devices.
  • Up-to-Date Information: Released on July 19, 2022, this document reflects the latest advancements and regulatory requirements in the field.
  • International Recognition: As an ISO standard, it is recognized and respected globally, ensuring that your practices meet international benchmarks.
  • ISBN: 978 0 539 12121 6, making it easy to reference and locate in professional and academic settings.

Why Choose BS EN ISO 15798:2022?

The BS EN ISO 15798:2022 standard is an invaluable resource for ophthalmic surgeons, medical device manufacturers, and regulatory bodies. Here’s why:

  • Enhanced Patient Safety: By adhering to the guidelines set forth in this standard, you can significantly reduce the risk of complications during ophthalmic surgeries.
  • Quality Assurance: Ensure that your ophthalmic implants and viscosurgical devices meet the highest quality standards, enhancing their performance and reliability.
  • Regulatory Compliance: Stay compliant with international regulations, avoiding potential legal issues and ensuring smooth market access for your products.
  • Professional Credibility: Demonstrate your commitment to excellence and patient safety by following a globally recognized standard.

Detailed Content

The BS EN ISO 15798:2022 standard covers a wide range of topics, including but not limited to:

  • Specifications for ophthalmic implants
  • Requirements for ophthalmic viscosurgical devices
  • Testing methods and procedures
  • Quality control measures
  • Safety and performance criteria
  • Labeling and packaging requirements

Who Should Use This Standard?

This standard is designed for a variety of stakeholders in the ophthalmic field, including:

  • Ophthalmic Surgeons: Ensure that your surgical procedures are safe and effective by following the latest guidelines.
  • Medical Device Manufacturers: Develop and produce high-quality ophthalmic implants and viscosurgical devices that meet international standards.
  • Regulatory Bodies: Use this standard as a benchmark for evaluating the safety and efficacy of ophthalmic devices.
  • Academic Institutions: Incorporate this standard into your curriculum to educate future ophthalmic professionals on best practices and regulatory requirements.

Conclusion

The BS EN ISO 15798:2022 standard is an essential tool for anyone involved in the field of ophthalmology. With its comprehensive guidelines and up-to-date information, it ensures that ophthalmic implants and viscosurgical devices are safe, effective, and of the highest quality. By adhering to this standard, you can enhance patient safety, ensure regulatory compliance, and maintain professional credibility.

Invest in the BS EN ISO 15798:2022 standard today and take a significant step towards excellence in ophthalmic care.

DESCRIPTION

BS EN ISO 15798:2022


This standard BS EN ISO 15798:2022 Ophthalmic implants. Ophthalmic viscosurgical devices is classified in these ICS categories:
  • 11.040.70 Ophthalmic equipment
This document is applicable to ophthalmic viscosurgical devices (OVDs), a class of surgical invasive medical devices with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intraocular tissues and to manipulate tissues during surgery. This document specifies requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices.